Momate S 0.1%/5% tepalas 20g N1

Mometasone furoate belongs to a group of medicines called corticosteroids or steroids as they are simply known.

Mometasone is a strongly acting glucocorticoid with anti-inflammatory and antipruritic effect. Salicylic acid helps to remove dry and scaling skin. Salicylic acid also increases the uptake of mometasone.

Momate-S is used to treat psoriasis, especially in case of intensive scaling, in adults and adolescents 12 years of age and older.

Do not use Momate-S ointment

• if you are allergic to mometasone furoate, salicylic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have a bacterial infection (e.g. pyoderma [pus-producing skin disease], syphilis, tuberculosis), viral infection (e.g. herpes simplex, chicken pox, shingles, warts, genital warts, molluscum contagiosum), fungal infection (dermatophyte, yeast) and/ or parasitic infection, unless the causes of these diseases are being treated as well.
• in cases of post-vaccine reactions or inflammations of the skin in the facial area (perioral dermatitis), reddening, scaling, other changes of the skin in the facial area (rosacea), acne or thinning of the skin (skin atrophy).
• if you are in the final trimester of a pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using Momate-S.

Avoid ointment in your eyes or on mucous membranes. Momate-S is not to be used in the face without prescription by your doctor. Treatment during longer periods and on large body surface areas, on wounds
and sounded skin, and in the armpits and groins should be avoided. The ointment should not be used under bandages or similar.

Glucocorticoids can mask, trigger or worsen skin infections. If you develop skin infections while using this ointment, your doctor will give you an appropriate treatment for fungal or bacterial infections. If you do not respond to treatment, please discontinue Momate-S until the infection is under control.

Contact your doctor if irritation, including excessive dryness, develops. The treatment might need to be discontinued and appropriate therapy instituted.

Salicylic acid may act as a sunscreen agent. If you are receiving ultraviolet treatment you should therefore take care to remove the ointment and to wash the treated area before ultraviolet treatment. This will reduce the risk of burn injuries on surrounding skin that is not protected by ointment. When the ultraviolet treatment is completed you can apply the ointment again.

Side effects that may happen with oral or injectable corticosteroids may also occur with corticosteroids used on the skin, especially in children.

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

Children

Momate-S can be used in children 12 years of age and older.

Other medicines and Momate-S

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

Pregnancy and breast-feeding

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. Momate-S must not be used during the last three months of pregnancy, and it should be avoided during the first six months of pregnancy.

It is unknown whether Momate-S passes over into breast-milk. Therefore always consult your doctor before starting treatment with Momate-S if you are breast-feeding.

Driving and using machines

Momate-S does not affect your ability to drive or operate machinery.

Momate-S contains propylene glycol stearate

Momate-S contains propylene glycol stearate which can cause irritation to the skin.

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

The dose and treatment duration is decided by your doctor. The maximal daily dose is 15 g of ointment. Do not treat your skin with a larger amount of ointment or for a longer period than recommended by your doctor.

Apply carefully a thin layer of ointment to the affected area in the morning and in the evening, or as prescribed by your doctor. Wash your hands carefully with soap afterwards.

If symptoms do not improve, or if they get worse, you should consult your doctor.

If you use more Momate-S than you should

If you accidentally take a larger dose than you were told to, tell your doctor.

If you forget to use Momate-S

Do not use twice as much ointment to make up for a forgotten dose. Make up for the dose you forgot as soon as possible, and then continue treatment at the regularly scheduled intervals.

If you stop using Momate-S

Do not interrupt treatment suddenly. As is the case with all strong steroids, treatment should be discontinued gradually.

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

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

Common side effects (occur in fewer than 1 in 10, but more than 1 in 100 treated) are a weak to moderate sense of burning on the site where the ointment is applied, itching (pruritus) and localized thinning of the skin (skin atrophy).

Uncommon side effects (occur in fewer than 1 in 100, but more than 1 in 1000 treated) are stretch marks, infections, rosacea-like inflammations, irregular bleeding into the skin (ecchymoses) and inflammationsof the hair follicles.

Rare side effects (occur in fewer than 1 in 1000 treated, but more than 1 in 10,000 treated) are a decreased function of the adrenal cortex, increased hair growth, hypopigmentation (a loss of skin pigment), hypersensitivity.

Other side effects (the frequency is not known) are skin irritation, dry skin, acne, contact dematitis and blurred vision.
Skin changes such as skin exfoliation, small blood vessels of skin more visible, softening of the skin or white spots.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not store above 25°C. Use within 6 weeks after opening.

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

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 to protect the environment.