1. Name of the medicinal product

Mometasone Furoate 0.1% w/w Cream

2. Qualitative and quantitative composition

One gram of cream contains 1 mg of mometasone furoate (0.1 % w/w mometasone furoate).

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Cream

White to off-white, smooth cream.

4. Clinical particulars

4.1 Therapeutic indications

Mometasone Furoate 0.1% w/w Cream is indicated for the treatment of inflammatory pruritic manifestations of and psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis in adults and children aged 2 to 18 years.

4.2 Posology and method of administration

Posology

A thin film of Mometasone Furoate 0.1% w/w Cream should be applied to the affected areas of skin once daily.

Method of administration

One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand.

Use of topical corticosteroids in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen, and duration of treatment should be no more than 5 days.

Paediatric population

Mometasone Furoate 0.1% w/w Cream is not recommended for use in children below 2 years of age as the safety and efficacy of Mometasone Furoate 0.1% w/w Cream in this age group has not been established.

4.3 Contraindications

Hypersensitivity to the active substance mometasone furoate, or other corticosteroids or to any of the excipients listed in section 6.1.

Mometasone Furoate 0.1% w/w Cream is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminata, molluscum contagiosum), parasitical) and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions.

Mometasone Furoate 0.1% w/w Cream should not be used on wounds or on skin which is ulcerated.

4.4 Special warnings and precautions for use

If irritation or sensitisation develop with the use of Mometasone Furoate 0.1% w/w Cream, treatment should be withdrawn and appropriate therapy instituted.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteriods can produce reversible hypothalamicpituitaryadrenal (HPA) axis 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. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Paediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of Mometasone Furoate 0.1% w/w Cream in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended.

Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.

Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.

Hyperglycaemia and glucosuria can occur in some patients after topical application due to systemic absorption.

Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Mometasone Furoate 0.1% w/w Cream topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

4.6 Fertility, pregnancy and lactation

Pregnancy

During pregnancy and lactation treatment with Mometasone Furoate 0.1% w/w Cream should be performed only on the physician’s order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with Mometasone Furoate 0.1% w/w Cream in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Mometasone Furoate 0.1% w/w Cream should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.

Breast-feeding

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Mometasone Furoate 0.1% w/w Cream should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long-term application is indicated, breast-feeding should be discontinued.

4.7 Effects on ability to drive and use machines

Mometasone Furoate 0.1% w/w Cream has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions are listed in Table 1 according to MedDRA system organ class and in decreasing frequency defined as follows:

Very common (≥ 1/10)

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1,000 to < 1/100)

Rare (≥ 1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

Not known (frequency cannot be estimated from the available data)

Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.

Paediatric population

Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface to body weight ratio.

Chronic corticosteroids therapy may interfere with the growth and development of children.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Excessive, prolonged use of topical corticosteroids may suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of applications or to substitute for a less potent steroid.

The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Corticoids, potent (group III)

Mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.

In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.

In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.

5.2 Pharmacokinetic properties

Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application.

Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Hexylene Glycol

Water, purified

Beeswax white

Hydrogenated soybean lecithin

Titanium Dioxide

Aluminium Starch octenylsuccinate

Phosphoric acid concentrated (for pH adjustment)

Paraffin, white soft

All-rac-α-tocopherol – as an antioxidant in paraffin, white soft.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

After first opening: 12 weeks

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

Do not refrigerate or freeze.

6.5 Nature and contents of container

10 g, 15 g, 20 g, 30 g, 50 g, 60 g and 100 g latex lacquered aluminium tubes with high density polyethylene screw cap in a cardboard carton. Each carton contains one tube.

Not all packs sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Mometasone Furoate Cream USP 0.1% w/w Taj Pharma

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section

What is in this leaflet:

The name of your medicine is “Mometasone Furoate 0.1% w/w Cream” but will mostly be referred to as “Mometasone Cream” throughout this leaflet.

1. What Mometasone Cream is and what it is used for
2. What you need to know before you use Mometasone Cream
3. How to use Mometasone Cream
4. Possible side effects
5. How to store Mometasone Cream
6. Contents of the pack and other information

1. WHAT MOMETASONE CREAM IS AND WHAT IT IS USED FOR

Mometasone Cream is one of a group of medicines called topical corticosteroids. Mometasone Cream is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.

In adults and children above aged 2 to 18 years, Mometasone Cream is used to reduce redness and itchiness caused by certain skin problems called psoriasis or dermatitis.

Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and other parts of the body. Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOMETASONE CREAM

Do not use Mometasone Cream

• if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of

Mometasone Cream (listed in section 6), or to similar medicines.

• on any other skin problems as it could make them worse especially
  • rosacea (a skin condition affecting the face)
  • acne
  • skin atrophy (thinning of the skin)
  • dermatitis around the mouth
  • genital itching
  • nappy rash
  • cold sores
  • shingles
  • chickenpox
  • warts
  • ulcerated skin
  • wounds and
  • other skin

Ask your doctor or pharmacist if you are not sure.

Warnings and precautions

Talk to your doctor or pharmacist before using Mometasone Cream

• when this medicine is used on psoriasis, as it may make the condition worse (e.g. a pustular form of the disease may occur). You should let your doctor review your progress at regular intervals, as such treatment needs careful
• if your skin becomes irritated or sensitive after using Mometasone Cream, you should stop using it and tell your

Contact your doctor if you experience blurred vision or other visual disturbance.

Children and adolescents

Mometasone Cream is not for use in children below 2 years of age.

Other medicines and Mometasone cream

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. HOW TO USE MOMETASONE CREAM

Always use Mometasone Cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Usually for adults and children above 2 years, a thin layer of Mometasone Cream should be gently rubbed into the affected areas of skin once a day.

• You only need to use a small amount of this
• One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand. Never apply more than this quantity or more often than advised by your doctor or

Special care should be used:

• Do not use it on your face for more than 5
• Do not apply the cream to children, on any part of the body, for more than 5
• Do not put the cream under your child’s nappy, as this makes it easier for the active drug to pass through the skin and possibly cause some unwanted
• You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or
• You should not use the cream on large areas of the body for a long time (for example every day for many weeks or months).
• Do not use in or around your eyes, including eye-lids.

Use in children

Mometasone Cream is not recommended for children under the age of 2.

If you use more Mometasone Cream than you should

If you (or somebody else) accidentally swallow the cream, it should not produce any problems. However, if you are worried, you should see your doctor.

If you use the cream more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affect their growth and development.

If you have not used the cream as you were told to do and have used it too often and/or for a long time, you should tell your doctor or pharmacist.

If you forget to use Mometasone Cream

If you forget to apply the cream at the right time, use it as soon as you remember and then carry on as before.

If you stop using Mometasone Cream

If you have been using Mometasone Cream for a long time and your skin problems seems to have got better, you should not suddenly stop using the cream. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the cream until you stop treatment altogether.

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

4. POSSIBLE SIDE EFFECTS

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

A few people may find that they suffer from some of the following side effects after using Mometasone Cream:

• allergic skin reactions
• bacterial and secondary skin infections
• acne
• inflammation and/or infection of the hair follicles
• thinning of the skin
• red marks with associated prickly heat
• loss of skin colour
• burning
• stinging
• itching
• tingling
• excessive hair growth
• softening of the skin and stretch marks
• blurred vision

Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.

Do not use Mometasone Cream after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not refrigerate or freeze.

Discard the opened tube with any remaining cream after 12 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

5. CONTENTS OF THE PACK AND OTHER INFORMATION What Mometasone Furoate 0.1% w/w Cream contains

• The active substance is mometasone furoate. Each gram of Mometasone Furoate 0.1% w/w Cream contains 1mg of mometasone
• The other ingredients are hexylene glycol, water, white beeswax (E901), hydrogenated soybean lecithin, titanium dioxide (E171), aluminium starch octenylsuccinate, phosphoric acid, and white soft paraffin which contains traces of all-rac-α-tocopherol.

What Mometasone Furoate 0.1% w/w Cream looks like and contents of the pack

Mometasone Furoate 0.1% w/w Cream is a white to off-white smooth cream.

It is available in tubes containing 10g, 15g, 20g, 30g, 50g, 60g or 100 g of cream. Not all packs sizes may be marketed.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com