Document: Ivoxel cutaneous emulsion ENG PL change

• Ivoxel cutaneous emulsion PL
• Ivoxel cutaneous emulsion ENG PL

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PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ivoxel 1 mg/g cutaneous emulsion

Mometasone furoate

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ivoxel is and what it is used for

2. What you need to know before you use Ivoxel

3. How to use Ivoxel

4. Possible side effects

5. How to store Ivoxel

6. Contents of the pack and other information

1. What Ivoxel is and what it is used for

Ivoxel contains the active substance mometasone furoate, which belongs to a group of medicines called topical corticosteroids (or steroids).

Topical corticosteroids can be divided into four degrees of strength or potency: mild, moderate, potent and very potent. The active ingredient of Ivoxel is classified as a “potent corticosteroid”.

In adults and children, aged 6 years and over, Ivoxel is used to reduce symptoms caused by certain inflammatory skin problems such as psoriasis (excluding widespread plaque psoriasis) and some types of dermatitis. In addition, Ivoxel is used to reduce symptoms caused by certain inflammatory and itching skin problems of the scalp such as scalp psoriasis.

2. What you need to know before you use Ivoxel

Do not use Ivoxel

if you, or your child are allergic (hypersensitive) to the active substance mometasone furoate, or other corticosteroids or to any of the other ingredients of Ivoxel included in section 6

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

• itching around the anus and genitals

• nappy rash

• bacterial infections such as impetigo (school sores, skin infection), pyodermas (appears as pus-filled lesions, skin infection), tuberculosis, syphilis (a sexually transmitted disease)

• viral infections such as cold sores, shingles, chickenpox (varicella), common warts, genital and water warts

• parasitical skin infections such as scabies

• fungal infections such as athlete’s foot (red, itchy, flaky skin on the feet), or thrush (an infection affecting the vagina that can cause discharge and itching)

• wounds and ulcerated skin

if you have a reaction to a vaccination (e.g. for flu).

Warnings and precautions

• Ivoxel should not be put on the eyelids.

• Take care not to get Ivoxel in the eye. However, if this should occur rinse thoroughly with clean water. If eye irritation remains please see your doctor.

• If irritation or sensitisation develops with the use of Ivoxel, discontinue treatment and tell your doctor immediately.

• Do not apply a bandage or dressing to the area being treated with Ivoxel, unless specially directed to do so by your doctor.

• When this medication is used on psoriasis, it may make the conditions 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 supervision.

• Do not use Ivoxel on your face without close supervision by your doctor.

Other medicines and Ivoxel

Please tell your doctor or pharmacist, if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription and any other remedies or dietary supplements such as vitamins.

Ask your doctor for advice before taking any medicine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine.

During pregnancy or while you are breast-feeding, treatment with Ivoxel should only be started following instructions from your doctor

If your doctor does prescribe Ivoxel to you during pregnancy or while you are breast-feeding, you should avoid using large doses and the use should be limited to a short period.

Do not apply Ivoxel to the breast area whilst breast-feeding.

Driving and using machines

Mometasone furoate is not known to affect your ability to drive and use machines.

Ivoxel contains propylene glycol monocaprylate

Ivoxel contains propylene glycol monocaprylate which may cause skin irritation.

3. How to use Ivoxel

Ivoxel is for use on the skin (cutaneous use).

This medicinal product is for external use only.

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

Your doctor should review your treatment at regular intervals, especially when Ivoxel is applied on the face, as potent topical corticosteroids generally should not be applied to the face without close monitoring by the physician.

If not indicated otherwise by your doctor, turn the bottle upside down, gently squeeze the bottle and count 10 to 12 drops in the palm of your hand. This amount is enough to cover an area twice the size of an adult hand.

For smaller areas, use a smaller amount.

Ivoxel should be applied to the affected skin area once daily.

Massage gently and thoroughly until the medicine disappears.

Adults, including the elderly:

You should not use Ivoxel on large areas of the body (over 20 % of body surface area) or for a long time (for example every day for over three weeks).

Unless directed by your doctor, do not apply a bandage or dressing to the area being treated. This will increase absorption of the preparation and increase possible side effects.

Children (6 years of age and over):

Do not use Ivoxel for children over 6 years of age on any part of their body without close supervision of the doctor.

Do not apply Ivoxel to more than 10 % of the child’s body surface area.

Do not use in skin folds or under airtight dressings.

Do not use for more than 3 weeks.

Children (under 6 years of age):

Ivoxel is not recommended to be used in children under 6 years of age.

If you used more Ivoxel than you should

If you (or somebody else) accidentally swallow Ivoxel, it should not produce any undesirable effects. However, if you are worried, you should see your doctor or pharmacist.

If you use Ivoxel 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 followed the dosage instructions or your doctor’s advice and have used Ivoxel too frequently and/or for a long time, you should tell your doctor or pharmacist.

If you forget to use Ivoxel

If you forget to apply Ivoxel at the scheduled time, do it as soon as you remember and then carry on as before.

Do not apply twice as much or use twice in one day to make up for a missed application.

If you stop using Ivoxel

Do not stop treatment suddenly if you have used it for a long time since this may be harmful.

Treatment should be stopped gradually, as advised by your doctor.

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

4. Possible side effects

Like all medicines, Ivoxel can cause unwanted side effects, although not everybody gets them. If your symptoms do not begin to improve after using this preparation as instructed by your doctor or if they get worse, check with your doctor.

Side effects in children and adults that have been reported with the use of topical corticosteroids include:

Common: may affect up to 1 in 10 people

These include mild to moderate burning sensations at the application site, tingling/stinging, itching, bacterial infections, abnormal sensations on the skin (paraesthesia), skin boils (furunculosis), and thinning of the skin (skin atrophy).

Uncommon: may affect up to 1 in 100 people

These include irregular skin marks or stripes (striae), skin irritation, increased hair growth (hypertrichosis), decrease of skin colour, dermatitis around the mouth (perioral dermatitis), softening and whitening of the skin (maceration), allergic contact dermatitis, pus-filled blisters on facial skin (papulous rosacea-like dermatitis), acne-like reactions, purple or dark blue discoloration of the skin (ecchymoses), heat rash (miliaria), dryness, sensitisation, inflammation of skin follicles (folliculitis) and secondary infection.

Very rare: may affect up to 1 in 10,000 people

Dilated blood vessels on the skin or spider veins.

Increased usage, treatment of large areas of skin, long term use and use under a dressing may increase the risk of side effects.

Corticosteroids may affect the normal production of steroids in the body. This is more likely to happen if high doses are being used over a long period of time.

Allergic (hypersensitivity) reactions have been reported in connection with propylene glycol and frequencies are unknown.

Children in particular, treated with corticosteroid preparations can absorb the steroid through the skin and this can lead to a disorder called Cushing’s syndrome which includes many symptoms, such as a fat, round face and weakness. Children on long term treatment may grow more slowly than others. Your doctor will help prevent this happening by prescribing the lowest dose of steroid at which your symptoms are well-controlled.

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 Ivoxel

Keep out of the reach and sight of children.

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

Do not store above 25°C.

Do not freeze.

Discard the opened bottle with any remaining cutaneous emulsion after 3 months.

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.

6. Contents of the pack and other information

What Ivoxel contains

The active substance is mometasone furoate.

Each gram of Ivoxel contains 1 mg of mometasone furoate (0.1 % w/w mometasone furoate).

Each drop of Ivoxel contains 0.05 mg of mometasone furoate.

The other ingredients are:

Purified water, liquid paraffin, hexylene glycol, octyldodecanol, medium‑chain triglycerides, macrogol stearyl ether (21), macrogol stearyl ether (2), diisopropyl adipate, propylene glycol monocaprylate, hard paraffin, phenoxyethanol, anhydrous citric acid, sodium citrate, xanthan gum.

What Ivoxel looks like and contents of the pack

Ivoxel is a white cutaneous emulsion. The cutaneous emulsion is filled in polyethylene bottles fitted with a blue or white polyethylene screw cap with a nozzle in a cardboard carton.

Pack sizes: 20 g, 30 g, 50 g and 60 g emulsion.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

Tel: +49 40 727 04 0

Fax: +49 40 7229296

E-mail: info@almirall.de

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

Country	Trade names
Belgium	Frondava 1 mg/g emulsion pour application cutanée / emulsie voor cutaan gebruik / Emulsion zur Anwendung auf der Haut
Czech Republic	Frondava 1 mg/g
Estonia	Frondava
Spain	Monovo 1 mg/g emulsión cutánea
Iceland	Monovo
Latvia	Frondava 1 mg/g uz ādas lietojama emulsija
Lithuania	Frondava 1 mg/g odos emulsija
Slovakia	Frondava
Sweden	Ivoxel

This leaflet was last approved in 2014-04-28

[To be completed nationally]