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DCIT	Denominazione Comune Italiana

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Clobex Lotion

clobetasol propionate

Dosage Form: lotion
Clobex®

(Clobetasol propionate) Lotion, 0.05%


Rx Only

For dermatologic use only

Not for ophthalmic, oral or intravaginal use

Clobex Lotion Description

CLOBEX® (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3, 20-dione17-propionate, with the empirical formula C25H32CIFO5, a molecular weight of 466.98 (CAS Registry Number 25122-46-7).

The following is the chemical structure:

Clobetasol propionate is a white to practically-white crystalline powder insoluble in water.

Each gram of CLOBEX® (clobetasol propionate) Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a vehicle base composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.

Clobex Lotion - Clinical Pharmacology

Like other topical corticosteroids, CLOBEX® (clobetasol propionate) Lotion, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion. For example, occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.

There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Due to the fact that circulating levels are usually below the level of detection, the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

CLOBEX® (clobetasol propionate) Lotion, 0.05% is in the super-high range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, CLOBEX® Lotion, 0.05% demonstrated rates of suppression that were numerically higher than those of a clobetasol propionate 0.05% cream (Temovate E® Emollient, 0.05%), (See PRECAUTIONS).

Clinical Studies

The efficacy of CLOBEX® (clobetasol propionate) Lotion, 0.05% in psoriasis and atopic dermatitis has been demonstrated in two adequate and well-controlled clinical trials. The first study was conducted in patients with moderate to severe plaque psoriasis. Patients were treated twice daily for 4 weeks with either CLOBEX® (clobetasol propionate) Lotion, 0.05% or vehicle lotion. Study results demonstrated that the efficacy of CLOBEX® Lotion, 0.05% in treating moderate to severe plaque psoriasis was superior to that of vehicle.

At the end of treatment (4 weeks), 30 of 82 patients (36.6%) treated with CLOBEX® Lotion, 0.05% compared with 0 of 29 (0%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, plaque elevation, or scaling) on the Global Severity scale of psoriasis.

The second study was conducted in patients with moderate to severe atopic dermatitis. Patients were treated twice daily for 2 weeks with either CLOBEX® (clobetasol propionate) Lotion, 0.05% or vehicle lotion. Study results demonstrated that the efficacy of CLOBEX® Lotion, 0.05% in treating moderate to severe atopic dermatitis was superior to that of vehicle.

At the end of treatment (2 weeks), 41 of 96 patients (42.7%) treated with CLOBEX® Lotion, 0.05% compared with 4 of 33 (12.1%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, induration/papulation, oozing/crusting, or pruritus) on the Global Severity scale of atopic dermatitis.

Indications and Usage for Clobex Lotion

CLOBEX® (clobetasol propionate) Lotion, 0.05% is a super-high potent corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 2 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl.oz.) per week.

For the treatment of moderate to severe plaque psoriasis, localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment with CLOBEX® (clobetasol propionate) Lotion, 0.05% may be treated for up to 2 additional weeks. Any additional benefits of extending treatment should be weighed against the risk of HPA axis suppression before prescribing for more than 2 weeks.

Patients should be instructed to use CLOBEX® (clobetasol propionate) Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).

Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS: Pediatric Use).

Contraindications

CLOBEX® (clobetasol propionate) Lotion, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

Precautions

General

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which increase systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression (see laboratory tests below). If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

The effect of CLOBEX® Lotion, 0.05% on HPA axis function was compared to clobetasol propionate cream 0.05% (Temovate E® Emollient, 0.05%) in adults in two studies, one for psoriasis and one for atopic dermatitis. In total, 8 of 10 evaluable patients with moderate to severe plaque psoriasis experienced adrenal suppression following 4 weeks of CLOBEX® Lotion, 0.05% therapy (treatment beyond 4 consecutive weeks is not recommended in moderate to severe plaque psoriasis). In follow-up testing, 1 of 2 patients remained suppressed after 8 days. In this comparative study, for clobetasol propionate cream, 0.05% there were 3 of 10 evaluable patients with HPA axis suppression. Furthermore, 5 of 9 evaluable patients with moderate to severe atopic dermatitis experienced adrenal suppression following 2 weeks of CLOBEX® Lotion, 0.05% therapy (treatment beyond 2 consecutive weeks is not recommended in moderate to severe atopic dermatitis). Of the 3 patients that had follow-up testing, one patient failed to recover adrenal function 7 days post-treatment. For patients treated with clobetasol propionate cream, 0.05%, 4 of 9 evaluable patients experienced adrenal suppression following 2 weeks of treatment. Of the 2 patients that had follow-up testing, both recovered adrenal function 7 days post-treatment. The proportion of subjects suppressed may be underestimated because the adrenal glands were stimulated weekly with cosyntropin in these studies.

The potential increase in systemic exposure does not correlate with any proven benefit, but may lead to an increased potential for hypothalamic-pituitary-adrenal (HPA) axis suppression. Patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Patients should be instructed to use CLOBEX® Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results (See INDICATIONS AND USAGE).

If irritation develops, CLOBEX® Lotion, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX® Lotion, 0.05% should be discontinued until the infection has been adequately controlled.

CLOBEX® Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

• This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.


• This medication should not be used for any disorder other than that for which it was prescribed.


• The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.


• Patients should wash their hands after applying the medication.


• Patients should report any signs of local or systemic adverse reactions to the physician.


• Patients should inform their physicians that they are using CLOBEX® (clobetasol propionate) Lotion, 0.05% if surgery is contemplated.


• This medication is for external use only. It should not be used on the face, underarms, or groin area, and avoid contact with the eyes and lips.


• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.


• Patients should be informed to not use more than 50 g (50 mL or 1.75 fl.oz.) per week of CLOBEX® Lotion, 0.05%.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

• Cosyntropin stimulation test


• AM plasma cortisol test


• Urinary free cortisol test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli  B WP2 fluctuation test.

Studies in the rat following subcutaneous administration at dosage levels up to 50 μg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Pregnancy

Teratogenic effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of CLOBEX® (clobetasol propionate) Lotion, 0.05%. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 μg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of CLOBEX® (clobetasol propionate) Lotion, 0.05%. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

A teratogenicity study in rats using the dermal route resulted in dose related maternal toxicity and fetal effects from 0.05 to 0.5 mg/kg/day of clobetasol propionate. These doses are approximately 0.14 to 1.4 times, respectively, the human topical dose of CLOBEX® (clobetasol propionate) Lotion, 0.05%. Abnormalities seen included low fetal weights, umbilical herniation, cleft palate, reduced skeletal ossification, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. CLOBEX® (clobetasol propionate) Lotion, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quanitities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX® Lotion, 0.05% is administered to a nursing woman.

Pediatric Use

Use of CLOBEX® Lotion, 0.05% in pediatric patients is not recommended due to the potential for HPA axis suppression (see PRECAUTIONS: General).

The HPA axis suppression potential of CLOBEX® Lotion, 0.05% has been studied in adolescents (12 to 17 years of age) with moderate to severe atopic dermatitis covering a minimum of 20% of the total body surface area. In total 14 patients were evaluated for HPA axis function. Patients were treated twice daily for 2 weeks with CLOBEX® Lotion, 0.05%. After 2 weeks of treatment, 9 out of 14 of the patients experienced adrenal suppression. One out of 4 patients treated with CLOBEX® Lotion, 0.05% who were retested remained suppressed two weeks post-treatment. In comparison, 2 of 10 of the patients treated with clobetasol propionate cream, 0.05% demonstrated HPA axis suppression. One patient who was retested recovered.

None of the patients who developed HPA axis suppression had concomitant clinical signs of adrenal suppression and none of them was discontinued from the study for reasons related to the safety or tolerability of CLOBEX® Lotion, 0.05%. However patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of CLOBEX® (clobetasol propionate) Lotion, 0.05% did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

In controlled clinical trials with CLOBEX® (clobetasol propionate) Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia.

The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with CLOBEX® (clobetasol propionate) Lotion, 0.05% at 1.0% or greater was:

Adverse Reaction	Incidence
Skin Atrophy	4.2%
Telangiectasia	3.2%
Discomfort Skin	1.3%
Skin Dry	1.0%

Other local adverse events occurred at rates less than 1.0%. Similar rates of local adverse reactions were reported in the comparator (clobetasol propionate cream, 0.05%). Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender.

The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Overdosage

Topically applied CLOBEX® (clobetasol propionate) Lotion, 0.05% can be absorbed in sufficient amount to produce systemic effects. (See PRECAUTIONS).

Clobex Lotion Dosage and Administration

CLOBEX® Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE.)

CLOBEX® Lotion, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to:

• 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses,

• and up to 2 additional weeks in very localized lesions of moderate to severe plaque psoriasis (no more than 10% body surface area) that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® (clobetasol propionate) Lotion 0.05%.

The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Use in pediatric patients younger than 18 years is not recommended because of numerically high rates of HPA axis suppression (See PRECAUTIONS: Pediatric Use).

Unless directed by physician, CLOBEX® Lotion, 0.05% should not be used with occlusive dressings.

How is Clobex Lotion Supplied

CLOBEX® Lotion, 0.05% is supplied in the following sizes:

2 fl. oz./59 mL NDC 0299-3848-02 high density polyethylene bottles.

4 fl. oz./118 mL NDC 0299-3848-04 high density polyethylene bottles.

Store at controlled room temperature 68˚ to 77˚F (20˚-25˚C). Protect from freezing.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas  76177  USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas  78215  USA

GALDERMA is a registered trademark.

Temovate E is a registered trademark of Glaxo SmithKline.

www.clobex.com

325067-1004

Revised: October 2004

CLOBEX®

(clobetasol propionate) Lotion, 0.05%

PATIENT INFORMATION

For External Use Only

Not for Ophthalmic (Eye) Use

Read the Patient Information that comes with CLOBEX® (KLO-bex) Lotion before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is CLOBEX® Lotion?

CLOBEX® Lotion is a medicine called a topical (skin use only) corticosteroid. It is used for a short time to reduce the inflammation and itching of:

• Moderate to severe skin conditions (atopic dermatitis and other skin problems)

• Moderate to severe plaque psoriasis

CLOBEX® Lotion is a super-high potent (very strong) topical corticosteroid. It is very important that you use CLOBEX® Lotion only as directed, in order to avoid serious side effects.

Who should not use CLOBEX® Lotion?

Do not use CLOBEX® Lotion if you are allergic to any of its ingredients, or to any other corticosteroid. The active ingredient is clobetasol propionate. See the end of this leaflet for the complete list of other ingredients in CLOBEX® Lotion. Ask your doctor or pharmacist if you need a list of other corticosteroids.

CLOBEX® Lotion is not recommended for use on anyone younger than 18 years of age. CLOBEX® Lotion has not been studied in children under 12 years old. Children have smaller body sizes and have a higher chance of side effects.

What should I tell my doctor before using CLOBEX® Lotion?

Tell your doctor: 

• if you are pregnant, think you are pregnant or plan to be pregnant. Talk with your doctor before using CLOBEX® Lotion or if you are already using CLOBEX® Lotion, as it is not known if CLOBEX® Lotion can harm your unborn child.


• if you are breastfeeding. It is not known if CLOBEX® Lotion passes into your milk.


• if you think you have a skin infection. You may need another medicine to treat the skin infection before you use CLOBEX® Lotion.

Tell your doctor about all the other medicines and skin products you use, including prescription and non-prescription medicines, cosmetics, vitamins, and herbal supplements. Some medicines can cause serious side effects if used while you are using CLOBEX® Lotion.

How should I use CLOBEX® Lotion?

• Use CLOBEX® Lotion exactly as directed by your doctor. CLOBEX® Lotion is for skin use only.


• Apply CLOBEX® Lotion twice a day, once in the morning and once at night, or as directed by your doctor.


• Use only enough to cover the affected areas. Do not apply CLOBEX® Lotion to your face, neck, groin or armpits. Do not get CLOBEX® Lotion on your lips or in or near your eyes.


• Make sure your skin is clean and dry before applying CLOBEX® Lotion.


• Turn the bottle of CLOBEX® Lotion upside down. Pour a small amount, less than 1 teaspoonful of CLOBEX® Lotion onto your fingertips, or directly on your affected skin area. Gently, rub the CLOBEX® Lotion into your affected skin area, until the lotion disappears.


• Wash your hands after using CLOBEX® Lotion.


• If you forget to apply CLOBEX® Lotion at the scheduled time, use it as soon as you remember. Then go back to your regular schedule. If it is about time for your next dose, apply just that 1 dose, and continue with your normal application schedule. Do not try to make up for the missed dose. If you miss several doses, tell your doctor.


• Throw away unused CLOBEX® Lotion.

What should I avoid while using CLOBEX® Lotion?

Do not do the following while using CLOBEX® Lotion:

• Do not get CLOBEX® Lotion on your face, lips, or in or near your eyes because this might cause irritation. If you do, use a lot of water to rinse the CLOBEX® Lotion off your face, lips, or out of your eyes. If your eyes keep stinging after rinsing them well with water, call your doctor right away.


• Do not apply CLOBEX® Lotion to your groin or armpits.


• Do not bandage or cover your treated areas unless your doctor tells you to do so.


• Do not wear tight fitting clothes over your treated skin areas.


• Do not use CLOBEX® Lotion any longer than 2 weeks (14 days) for moderate to severe conditions (atopic dermatitis and other skin problems).


• Do not use CLOBEX® Lotion any longer than an extra 2 weeks (4 weeks total) for psoriasis on a small area of your body (less than 10 percent of your body surface area) that is not much better after the first 2 weeks of treatment.


• Do not use more than 50 grams (50 mL or 1.75 fluid ounces) of CLOBEX® Lotion a week. CLOBEX® Lotion comes in 2 different size bottles, a 2-ounce and a 4-ounce bottle.

What are the possible side effects of CLOBEX® Lotion?

CLOBEX® Lotion can pass through your skin. Too much CLOBEX® Lotion passing through your skin can shut down your adrenal glands.This usually happens if you use too much CLOBEX® Lotion, or you use it for too long. If this happens, your adrenal glands may not start working immediately once you stop using CLOBEX® Lotion. Shutting down of the adrenal glands can cause nausea, vomiting, fever, low blood pressure, heart attack, and even death because your body cannot respond to any stress or illness.

Your doctor may do special blood and urine tests to check your adrenal gland function while you are using CLOBEX® Lotion.

Other possible side effects with CLOBEX® Lotion include mild burning, stinging, itching, redness, irritation, and dry skin. Also, thinning of the skin, widening of small blood vessels in the skin, and skin discomfort at the site of application may happen. Sometimes your condition will get worse with use of CLOBEX® Lotion.

If you are ill or injured, or going to have surgery, tell your doctor that you are using CLOBEX® Lotion.

Tell your doctor if you:

• are going to have surgery


• get sick or don’t feel right. Call your doctor right away.


• have irritation of the treated skin area that does not go away.


• have any unusual effects that you do not understand.


• have affected areas that do not seem to be getting better after 2 weeks of using CLOBEX® Lotion.

These are not all the possible side effects of CLOBEX® Lotion. For more information, ask your doctor or pharmacist.

General information about the safe and effective use of CLOBEX® Lotion.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CLOBEX® Lotion for a condition for which it was not prescribed. Do not give CLOBEX® Lotion to other people, even if they have the same symptoms you have. It may harm them. Keep CLOBEX® Lotion and all medicines out of reach of children.

This leaflet summarizes the most important information about CLOBEX® Lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX® Lotion that is written for health professionals.

What are the ingredients of CLOBEX® Lotion?

Active Ingredient: clobetasol propionate

Inactive Ingredients: hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.

Rx Only

US Patent No. 6,106,848

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

www.clobex.com

325070-1005

Revised: October 2005

PACKAGE LABEL

Rx Only

NDC 0299-3848-04

Clobex®

(clobetasol propionate)

LOTION

0.05%

4 FL OZ

(118 mL)

GALDERMA

For external use only. Not for eye use.

Usual dosage: Apply twice daily, once in the morning and once at night. Use only enough to cover the affected areas. Do not apply Clobex® Lotion, 0.05% to the face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information.

Each gram contains: Active: clobetasol propionate 0.5 mg. Inactive: hypromellose, polyoxyethylene glycol 300 isostearate, carbomer 1342, mineral oil, propylene glycol, sodium hydroxide, and purified water.

Store at controlled room temperature 68° to 77°F (20° - 25°C). Protect from freezing. See lot no. and expiration date on bottom of bottle.

US Patent No. 6,106,848

Marketed by:

GALDERMA LABORTORIES, L.P.

Fort Worth, Texax 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

www.clobex.com

326197-0406

CLOBEX   clobetasol propionate  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0299-3848 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clobetasol Propionate (Clobetasol) Clobetasol 0.05 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength Propylene Glycol   Mineral Oil   Carbomer 1342   Sodium Hydroxide   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0299-3848-02 59 mL In 1 BOTTLE None 2 0299-3848-04 118 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021535	08/01/2003

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Operations
DPT Laboratories, Ltd.		832224526	MANUFACTURE

Revised: 09/2010Galderma Laboratories, L.P.

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• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Lichen Sclerosus
• Psoriasis

Tyloveto S

Tyloveto S may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tyloveto S

Tylosin

Tylosin tartrate (a derivative of Tylosin) is reported as an ingredient of Tyloveto S in the following countries:

• South Africa

International Drug Name Search

Erazon

Erazon may be available in the countries listed below.

Ingredient matches for Erazon

Piroxicam

Piroxicam is reported as an ingredient of Erazon in the following countries:

• Bosnia & Herzegowina


• Croatia (Hrvatska)

International Drug Name Search

Talaporfin

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0110230-98-3

Chemical Formula

C38-H41-N5-O9

Molecular Weight

711

Therapeutic Category

Photosensitizing agent

Chemical Names

N-[[(2S,3S)-18-carboxy-2-(2-carboxyethyl)-13-ethyl-2,3-dihydro-3,7,12,17-tetramethyl-8-vinylporphyrin-20-yl]acetyl]-L-aspartic acid (WHO)

N-[[(7S,8S)-3-Carboxy-7-(2-carboxyethyl)-13-ethenyl-18-ethyl-7,8-dihydro-2,8,12,17-tetramethyl-21H,23H-porphin-5-yl]acetyl]-L-aspartic acid

(2S,3S)-18-Carboxy-20-[N-(S)-1,2-dicarboxyethyl]carbamoylmethyl-13-ethyl-3,7,12,17-tetramethyl-8-vinylchlorin-2-propanoic acid

mono-L-aspartyl chlorin e₆

Foreign Names

• Talaporfinum (Latin)
• Talaporfin (German)
• Talaporfine (French)
• Talaporfina (Spanish)

Generic Names

• NPe6 (IS)
• Talaporfin Sodium (OS: USAN, JAN)
• LS-11 (IS)
• ME-2906 (IS)

Brand Name

• Laserphyrin
  Meiji Seika Kaisha, Japan

International Drug Name Search

Glossary

IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Taiklonal

Taiklonal may be available in the countries listed below.

Ingredient matches for Taiklonal

Teicoplanin

Teicoplanin is reported as an ingredient of Taiklonal in the following countries:

• Argentina

International Drug Name Search

Natil

Natil may be available in the countries listed below.

Ingredient matches for Natil

Flunarizine

Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Natil in the following countries:

• Germany

International Drug Name Search

Talavir

Talavir may be available in the countries listed below.

Ingredient matches for Talavir

Valacyclovir

Valaciclovir hydrochloride (a derivative of Valaciclovir) is reported as an ingredient of Talavir in the following countries:

• Italy

International Drug Name Search

Boots Vapour Chest Rub

1. Name Of The Medicinal Product

Boots Vapour Chest Rub or

Boots Vapour Rub

2. Qualitative And Quantitative Composition

Active Ingredients	%w/w
Racemic Camphor	6%
Levomenthol natural or synthetic	1%
Eucalyptus Oil	1.5%

3. Pharmaceutical Form

Ointment

4. Clinical Particulars

4.1 Therapeutic Indications

For head colds, stuffy nose, coughs and chest colds.

4.2 Posology And Method Of Administration

Unless otherwise directed by the doctor:

For Adults and Children over 3 Months

Apply liberally to the chest and back particularly at bedtime. Use sparingly on infants and young children. Massage gently. For faster relief from a stuffy nose and tight chest, add one teaspoonful of Vapour Rub to half a pint of hot - not boiling - water and inhale the vapour.

Children under 3 Months.

Not recommended for children under 3 months of age.

Elderly

There is no need for dosage reduction.

For topical application and inhalation.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only.

If symptoms do not go away talk to your pharmacist or doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of Vapour Rub during pregnancy and lactation has not been established but its use during these periods is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasional hypersensitivity and irritant skin reactions.

4.9 Overdose

Overdosage may result in skin irritation.

Misuse:

Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.

Following oral ingestion, symptoms of overdosage may include colic, dizziness, delirium, muscle twitching, epileptiform convulsions and depression of the central nervous system. Breathing may be difficult. There may also be haematuria and albuminuria.

Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain and headache, vertigo, feeling hot/flushing, convulsions, respiratory depression and coma.

Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.

Convulsions may be controlled by the intravenous administration of diazepam 5-10 mg.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Eucalyptus Oil, Camphor and Levomenthol are volatile substances and are thought to produce an irritant effect on the respiratory tract, probably via a nasal/pulmonary arc.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White Soft Paraffin

Thymol

Turpentine Oil

Pumilio Pine Oil BP'80

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

An amber glass jar with a tinplate cap with waxed aluminium faced pulpboard liner or a thermoset plastic cap with waxed aluminium faced pulpboard liner.

Pack size 45g.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/5331R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation:	29 August 1984
Date of Last Renewal:	23 May 1996

10. Date Of Revision Of The Text

August 2010

Saridon

Saridon may be available in the countries listed below.

Ingredient matches for Saridon

Ibuprofen

Ibuprofen sodium (a derivative of Ibuprofen) is reported as an ingredient of Saridon in the following countries:

• Slovakia


• Switzerland

Paracetamol

Paracetamol is reported as an ingredient of Saridon in the following countries:

• Austria


• Netherlands


• Philippines

Propyphenazone

Propyphenazone is reported as an ingredient of Saridon in the following countries:

• Austria


• Netherlands

International Drug Name Search

Talerdin

Talerdin may be available in the countries listed below.

Ingredient matches for Talerdin

Cetirizine

Cetirizine is reported as an ingredient of Talerdin in the following countries:

• Ecuador

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Talerdin in the following countries:

• Costa Rica


• Dominican Republic


• El Salvador


• Nicaragua

International Drug Name Search

Mohexal

Mohexal may be available in the countries listed below.

Ingredient matches for Mohexal

Moclobemide

Moclobemide is reported as an ingredient of Mohexal in the following countries:

• Australia

International Drug Name Search

Travasept

Travasept may be available in the countries listed below.

Ingredient matches for Travasept

Cetrimide

Cetrimide is reported as an ingredient of Travasept in the following countries:

• United Kingdom

Chlorhexidine

Chlorhexidine diacetate (a derivative of Chlorhexidine) is reported as an ingredient of Travasept in the following countries:

• United Kingdom

International Drug Name Search

Qualiclovir

Qualiclovir may be available in the countries listed below.

Ingredient matches for Qualiclovir

Acyclovir

Aciclovir is reported as an ingredient of Qualiclovir in the following countries:

• Hong Kong

International Drug Name Search

Trimébutine Biogaran

Trimébutine Biogaran may be available in the countries listed below.

Ingredient matches for Trimébutine Biogaran

Trimebutine

Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Trimébutine Biogaran in the following countries:

• France

International Drug Name Search

Trijodthyronin

Trijodthyronin may be available in the countries listed below.

Ingredient matches for Trijodthyronin

Liothyronine

Liothyronine sodium salt (a derivative of Liothyronine) is reported as an ingredient of Trijodthyronin in the following countries:

• Austria

International Drug Name Search

Pharmaniaga Atenolol

Pharmaniaga Atenolol may be available in the countries listed below.

Ingredient matches for Pharmaniaga Atenolol

Atenolol

Atenolol is reported as an ingredient of Pharmaniaga Atenolol in the following countries:

• Malaysia

International Drug Name Search

Azonit

Azonit may be available in the countries listed below.

Ingredient matches for Azonit

Isoconazole

Isoconazole nitrate (a derivative of Isoconazole) is reported as an ingredient of Azonit in the following countries:

• Oman

International Drug Name Search

Tramadol Zydus

Tramadol Zydus may be available in the countries listed below.

Ingredient matches for Tramadol Zydus

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol Zydus in the following countries:

• France

International Drug Name Search

Asmanex Twisthaler 120 Dose

Generic Name: mometasone inhalation (moe MET a sone)

Brand Names: Asmanex Twisthaler 120 Dose, Asmanex Twisthaler 14 Dose, Asmanex Twisthaler 30 Dose, Asmanex Twisthaler 60 Dose, Asmanex Twisthaler 7 Dose

What is Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Mometasone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Mometasone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Do not use mometasone inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication. Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 weeks of treatment.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you were switched from an oral (taken by mouth) steroid to mometasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

What should I discuss with my healthcare provider before using Asmanex Twisthaler 120 Dose (mometasone inhalation)?

You should not use this medication if you are allergic to mometasone, or to milk proteins.

To make sure you can safely take mometasone inhalation, tell your doctor if you have been sick or had an infection of any kind.

FDA pregnancy category C. It is not known whether mometasone inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether mometasone inhalation passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Mometasone inhalation can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. Do not give this medicine to a child younger than 4 years old without the advice of a doctor.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use mometasone inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

Mometasone is a powder that comes with a special inhaler device preloaded with the medicine. The device will deliver a measured dose of mometasone as a fine spray of powder each time you use the inhaler.

You may or may not be able to feel or taste this powder in your mouth while using the inhaler. Do not use extra doses if you do not feel or taste the powder. Tell your doctor or pharmacist if you think your inhaler is not working properly.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using mometasone inhalation. Do not swallow.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 weeks of treatment.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks. If you were switched from an oral (taken by mouth) steroid to mometasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency. Store mometasone inhalation at room temperature away from moisture and heat. When you first open the foil pouch and remove the inhaler device, write the date on the device. Throw away the inhaler after 45 days, or when the dose counter shows "00."

Do not wash your inhaler device or allow it to get wet. Wipe the mouthpiece with a clean dry tissue or cloth after each use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of mometasone inhalation is not expected to produce life-threatening symptoms.

What should I avoid while using Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Mometasone inhalation can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using mometasone inhalation.

Asmanex Twisthaler 120 Dose (mometasone inhalation) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  wheezing or breathing problems after using this medication;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or

  
  


• 
  

  worsening asthma symptoms.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  runny nose, increased sinus allergy symptoms;

  
  


• 
  

  stuffy nose, sinus pain, sore throat, nosebleed;

  
  


• 
  

  muscle or joint pain, back pain;

  
  


• 
  

  nausea, upset stomach, loss of appetite;

  
  


• 
  

  changes in menstrual periods;

  
  


• 
  

  tired feeling; or

  
  


• 
  

  hoarseness or deepened voice.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Before using mometasone inhalation, tell your doctor if you are using ketoconazole (Nizoral).

There may be other drugs that can interact with mometasone inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Asmanex Twisthaler 120 Dose resources

• Asmanex Twisthaler 120 Dose Side Effects (in more detail)
• Asmanex Twisthaler 120 Dose Use in Pregnancy & Breastfeeding
• Asmanex Twisthaler 120 Dose Drug Interactions
• Asmanex Twisthaler 120 Dose Support Group
• 6 Reviews for Asmanex Twisthaler20 Dose - Add your own review/rating

• Mometasone Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• mometasone Inhalation, oral/nebulization Advanced Consumer (Micromedex) - Includes Dosage Information


• Mometasone Furoate Monograph (AHFS DI)

Compare Asmanex Twisthaler 120 Dose with other medications

• Asthma, Maintenance
• Hay Fever
• Nasal Polyps

Where can I get more information?

• Your pharmacist can provide more information about mometasone inhalation.

See also: Asmanex Twisthaler20 Dose side effects (in more detail)

Danol

Danol 100mg Capsules

Danol 200mg Capsules

(danazol)

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Danol is and what it is used for


• 2. Before you take Danol


• 3. How to take Danol


• 4. Possible side effects


• 5. How to store Danol


• 6. Further Information

What Danol is and what it is used for

Danol contains a medicine called danazol. It works by changing the way some hormones act in your body. It is used to treat:

• Endometriosis – an illness where some of the tissues that line the womb are found elsewhere in the body. One way of treating this is to have an operation and to take Danol as well. Danol can also be used on its own, where other treatments have not worked


• Breast cysts (lumps) which may be painful, but not malignant. Danol is used where other treatments have not worked or when they cannot be taken

Before you take Danol

Do not take this medicine and tell your doctor if:

• You are allergic (hypersensitive) to danazol or any of the other ingredients of Danol (listed in Section 6 Further Information)
  
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  


• You have a rare inherited illness which affects your metabolism (called ‘porphyria’)


• You are pregnant, might become pregnant, or think you may be pregnant.


• You are breast-feeding


• You have severe kidney, liver or heart disease


• You have ever had blood clots (thrombosis)


• You have a type of cancer which is affected by hormones


• You have unusual vaginal bleeding which has not been checked by a doctor

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Danol.

Take special care with Danol

Check with your doctor or pharmacist before taking your medicine if:

• You have any liver or kidney problems


• You have an illness which could be made worse by fluid retention


• You have high blood pressure or heart disease


• You have diabetes


• You have an illness in which the blood gets thicker (called ‘polycythaemia’)


• You have fits (epilepsy)


• You have blood fat problems (called ‘lipid disorders’)


• You have ever had a bad reaction to a hormonal treatment similar to Danol


• You get migraines


• You have cancer or possible breast cancer

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Danol.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Danol can affect the way some other medicines work. Also some medicines can affect the way Danol works.

In particular, tell your doctor if you are taking any of the following:

• Steroids such as testosterone, estrogen, progesterone (including ‘the Pill’ or hormone replacement therapy - known as HRT)

Danol may increase the effect of the following medicines:

• Medicines for epilepsy, fits or convulsions (anti-convulsants)


• Medicines used to thin the blood (anti-coagulants such as warfarin)


• Anaesthetics (see ‘Operations or tests’ section below)


• Ciclosporin and tacrolimus - used to stop the rejection of organs after a transplant. Danol can increase the levels of these medicines in your blood and may damage your kidneys


• Alpha calcidol (a form of vitamin D) used for vitamin D deficiency and illnesses where there is not enough calcium in the blood

Danol may lower the effect of the following medicines:

• Medicines for diabetes


• Medicines for high blood pressure (anti-hypertensives)


• Medicines for migraine

Operations or tests

If you are due to have an operation, tell your doctor you are taking Danol. This is because Danol can increase the effect of some anaesthetics.

If you have to take Danol for more than six months your doctor will arrange for an ultrasound test to check your liver.

Taking Danol with food and drink

Do not drink alcohol while you are taking Danol. This is because drinking alcohol while taking Danol can make you feel sick or short of breath.

Pregnancy and breast-feeding

Do not take Danol if you are pregnant, might become pregnant or think you may be pregnant. If you think you may have become pregnant while taking Danol, stop taking it straight away and talk to your doctor.

Do not breast-feed if you are taking Danol. This is because small amounts may pass into mothers’ milk. If you are planning to breast-feed, talk to your doctor or pharmacist.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Important information about some of the ingredients of Danol

This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

How to take Danol

Always take Danol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth


• Swallow the capsules whole with a drink of water


• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor


• It is important that you do not become pregnant while taking Danol. Start taking the capsules on the first day of your period. Use reliable contraception (such as an Intra Uterine Device or barrier method in conjunction with contraceptive foam or jelly). The contraceptive pill should not be used until your treatment with Danol has finished

How much to take

The usual dose depends on your needs and the illness being treated:

• Endometriosis: 200 to 800mg a day for three to six months


• Breast cysts: 300mg a day for three to six months

The dose for each day may be split between two and four separate doses.

DO NOT TAKE more than 8 of the 100mg capsules or 4 of the 200mg capsules in one day.

If you take more Danol than you should

If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Danol

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Danol

Keep taking Danol until your doctor tells you to stop taking it. Do not stop taking Danol just because you feel better. If you stop your illness may get worse.

Blood tests

Your doctor may carry out regular blood tests to check your liver is working properly and your blood levels are normal. Also, taking Danol may affect the results of some other blood tests. These include the following tests:

• Hormone testosterone levels


• Liver and thyroid function


• Lipids (fats), sugars and protein levels in your blood

If you are going to have a blood test, it is important to tell your doctor you are taking Danol.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Danol Side Effects

Like all medicines, Danol can cause side effects, although not everybody gets them.

Stop taking Danol and see a doctor or go to a hospital straight away if:

• You have an allergic reaction. The signs may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue


• Pain or tightness in the chest, jaw or arm. These could be signs of a heart attack

Stop taking Danol and tell a doctor straight away if you notice any of the following side effects – you may need urgent medical treatment:

• Clitoris becomes larger


• Blurred vision, problems with eyesight, difficulty wearing contact lenses


• Liver problems that may cause the eyes or skin to go yellow (jaundice)


• Severe headache and vomiting (being sick)


• Pain when moving arms or legs (this may be due to a blood clot)


• Feeling weak together with numb arms or legs which you may not be able to move (this may be a stroke)


• Bruising more easily, getting more infections than usual. These could be signs of a blood problem


• Any other severe symptoms which you cannot explain

Tell your doctor as soon as possible if you have any of the following side effects:

• Migraines which are worse than usual


• Hair loss (similar to male baldness)


• More hair than usual on the body or face


• Sore throat, hoarse voice or your voice sounds higher or lower than usual


• Your epilepsy gets worse


• Blood in the urine


• Stomach or chest pain


• Skin rashes or blistering. Changes in skin colour or sensitivity to the sun.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

• Putting on weight, or increased appetite


• Spots, acne, greasy skin or rashes


• Water retention or bloating


• Changes to your menstrual period, vaginal dryness, changes to your sex drive (libido) or if your breasts get smaller


• High temperature with skin rashes


• Backache, muscle cramps, twitching of the muscles, pain or swelling in your joints, arms or legs


• Feeling sick, dizzy or balance problems (vertigo)


• Headache, feeling tired


• Flushing


• Feeling depressed, anxious or more nervous than usual


• Palpitations, fast heart beat, high blood pressure


• Lowered fertility in men (may be caused by a lowering in the level of sperm)

Tell your doctor or pharmacist if any of the side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

How to store Danol

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Danol after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Danol contains

• Each 100mg capsule contains 100mg of the active substance, danazol


• Each 200mg capsule contains 200mg of the active substance, danazol


• The other ingredients are lactose monohydrate, maize starch, talc, magnesium stearate and gelatine. The black ink used to print on the capsules contains shellac, shellace glaze and propylene glycol and black iron oxide.

What Danol looks like and contents of the pack

Danol 100mg capsules are grey and white with Danol 100 printed on it in black ink. It is coloured with black iron oxide and titanium dioxide.

Danol 200mg capsules are orange and white with Danol 200 printed on them in black ink. They are coloured with red iron oxide, yellow iron oxide and titanium dioxide.

Danol capsules are supplied in cartons of 60 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Fawdon Manufacturing Centre

Edgefield Avenue

Fawdon

Newcastle-upon-Tyne

Tyne & Wear

NE3 3TT

UK

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 02/2007

© sanofi-aventis, 1974 - 2007

30405607

Acetaminophen Capsules

Pronunciation: a-seet-a-MIN-oh-fen
Generic Name: Acetaminophen
Brand Name: Examples include Tylenol and Tylophen

Acetaminophen Capsules is used for:

Treating minor aches and pains due to headache, muscle aches, backache, arthritis, the common cold, flu, toothache, menstrual cramps, and immunizations, and for temporarily reducing fever.

Acetaminophen Capsules is an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Acetaminophen Capsules if:

• you are allergic to any ingredient in Acetaminophen Capsules

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen Capsules:

Some medical conditions may interact with Acetaminophen Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of alcohol abuse or you drink more than 3 alcohol-containing drinks every day


• if you have liver or kidney problems, hepatitis, or phenylketonuria (PKU)

Some MEDICINES MAY INTERACT with Acetaminophen Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Acetaminophen Capsules


• Isoniazid because the risk of liver problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen Capsules:

Use Acetaminophen Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen Capsules by mouth with or without food.


• Replace original bottle cap to maintain child resistance.


• If you miss a dose of Acetaminophen Capsules and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen Capsules.

Important safety information:

• Acetaminophen Capsules has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Acetaminophen Capsules may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen Capsules. Talk to your doctor before you take Acetaminophen Capsules or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.


• Acetaminophen Capsules may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Acetaminophen Capsules and need to check your blood cholesterol at home.


• For pain and fever in ADULTS: Stop use of Acetaminophen Capsules and ask your doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, or new symptoms occur or redness or swelling is present.


• For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen Capsules while you are pregnant. Acetaminophen Capsules is found in breast milk. If you are or will be breast-feeding while you use Acetaminophen Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Acetaminophen Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Acetaminophen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Acetaminophen Capsules:

Store Acetaminophen Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Acetaminophen Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acetaminophen resources

• Acetaminophen Side Effects (in more detail)
• Acetaminophen Dosage
• Acetaminophen Use in Pregnancy & Breastfeeding
• Drug Images
• Acetaminophen Drug Interactions
• Acetaminophen Support Group
• 24 Reviews for Acetaminophen - Add your own review/rating

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