Document: Elosalic ointment ENG PL change

• Elosalic ointment PL
• Elosalic ointment ENG PL

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Package leaflet: Information for the user

Elosalic 1 mg/g + 50 mg/g ointment

mometasone furoate/salicylic acid

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 again.

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

• 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 yours.

• 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 4.

What is in this leaflet:

1. What Elosalic is and what it is used for

2. What you need to know before you use Elosalic

3. How to use Elosalic

4. Possible side effects

6. Contents of the pack and otherinformation

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.

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

Do not use Elosalicointment

- if you are allergic (hypersensitive) 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 usingElosalic.

Avoid ointment in your eyes or on mucous membranes. Elosalic 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 Elosalicuntil 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.

Children

Elosalic can be used in children 12 years of age and older.

Other medicinesand Elosalic

Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines, including medicines obtained without a prescription.

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. Elosalic 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 Elosalic passes over into breast-milk. Therefore always consult your doctor before starting treatment with Elosalic if you are breast-feeding.

Driving and using machines

Elosalic does not affect your ability to drive or operate machinery.

Elosalic contains propylene glycol stearate

Elosalic contains propylene glycol stearate which can cause irritation to the skin.

Always use Elosalic exactly as your doctor has told you. You should 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 Elosalicthan you should

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

If you forget to use Elosalic

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 Elosalic

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.

4. Possible side effects

Like all medicines, Elosalic 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, contacts dematitis.

Skin changes such as skin exfoliation, small blood vessels of skin more visible, softning 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. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Elosalic

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 Elosalic after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of the 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.

What Elosalic contains

• The active substance are mometasone furoate and salicylic acid.

• The other ingredients are hexylene glycol, propylene glycol stearate, white beeswax, white soft paraffin and purified water.

What Elosalic looks like and contents of the pack

Elosalic is a white to off-white ointment. It is sold in packages of 15 g, 25 g, 45 g and 50 g. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Schering-Plough Labo nv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic: MOMESALIC

Estonia, Germany, Lithuania: ELOSALIC

Latvia: Elosalic 1 mg/50 mg/g ointment

Portugal: Monsalic

Spain: Elocom Plus 1mg/g + 50 mg/g pomada

Sweden: Elosalic

This leaflet was last revised in 2015-02-11