Document: Terbinafine Dermapharm cream ENG PL change

• Terbinafine Dermapharm cream PL
• Terbinafine Dermapharm cream ENG PL

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The PL includes alternative texts for different legal status in different countries as follows:

-Boxed texts are only applicable for OTC versions.

-Grey-shaded texts are only applicable for prescription versions.

For OTC use in Sweden, please refer to the approved Swedish package leaflet published on MPA’s web site.

Package leaflet: Information for the user

Terbinafine Dermapharm 10 mg/g cream

Terbinafine hydrochloride

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.

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

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

• Ask your pharmacist if you need more information or advice.

• 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.

• You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

<{to be completed nationally}>

What is in this leaflet

Terbinafine Dermapharm is a white cream which contains 10 mg/g of terbinafine hydrochloride as the active ingredient.

Terbinafine Dermapharm is used externally for the treatment of fungal or yeast infections of the skin, such as athletes foot.

Do not use Terbinafine Dermapharm

Warnings and precautions

Talk to your doctor or pharmacist before using Terbinafine Dermapharm

Children

Terbinafine Dermapharm is not recommended in children under 12 years old. The experience in children is limited.

Other medicines and Terbinafine Dermapharm

There is no evidence that Terbinafine Dermapharm has any negative effects on other medications.

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

Pregnancy and breast-feeding

Pregnancy:

You should not use this medicine during pregnancy unless it’s clearly necessary.

Breast-feeding:

As terbinafine is transferred into mother’s milk, you should not use Terbinafine Dermapharm if you are breast-feeding your child. Infants must not be allowed to come into contact with any treated skin, including the breast.

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.

Driving and using machines

This medicinal product has no influence on the ability to drive and use machines.

Terbinafine Dermapharm contains cetylstearyl alcohol

Cetylstearyl alcohol may cause local skin reactions (e.g.contact dermatitis).

Method of Administration

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

The tube is sealed with an aluminium seal. This seal can be broken by applying slight pressure with the turned cap of the tube.

For use on skin only.

Clean and dry the skin carefully prior to applying the cream.

Apply a thin layer of the cream on the infected skin and slightly beyond that region. Rub the cream in lightly. Wash your hands after rubbing in, unless your hands are is the area that is being treated.

Duration and Frequency of Use

Adults and children over 12 years of age:

Once a day for 1 week

Once a day for 1 week

Once a day for 1 to 2 weeks

One to two times daily for 2 weeks

You will generally see an improvement of the symptoms within just a few days. Irregular use or premature discontinuation of the treatment will increase the probability that the symptoms will recur. If you see no improvement after two weeks of treatment, please consult your doctor or your pharmacist.

Elderly people:

There is no evidence that different dosages may be required for older patients, or other side effects may occur than seen in younger patients.

Use in children

Since only limited information is available with regard to the use of Terbinafine Dermapharm in children under 12 years of age, the use of this medication is not recommended for this age group.

If you use more Terbinafine Dermapharm than you should

Casesof overdoseofTerbinafine Dermapharm arenotknownwhen used externally.

In case of any uncertainty regarding the use, please ask your doctor or pharmacist.

In the event of accidental ingestion of Terbinafine Dermapharm, e.g. by a child, the side effects to be expected will be similar to those of an overdose of terbinafine tablets (such symptoms may include headache, nausea, dizziness and stomach pain). In this case please contact a doctor or seek emergency care.

In the event that the cream has accidentally come into contact with your eyes, flush your eyes thoroughly with clean, running water.

If you forget to use Terbinafine Dermapharm

Continue the treatment. Do not add extra applications or a larger amount than usual.

If you stop using Terbinafine Dermapharm

Please note that if you discontinue the use of Terbinafine Dermapharm before the end of the treatment period, the initial symptoms may recur.

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

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

Stop using the cream and seek medical help immediately if you have any of the following symptoms of an allergic reaction:

• severe itching of the skin, with a red rash or raised lumps, hives or blisters

• shortness of breath or swelling of the mouth, face, lips, tongue or throat

The frequency with which these allergic reactions occur is not known (cannot be estimated from the data available).

The following side effects have also been reported:

Common (may affect more than 1 in 10 people):

Peeling skin (exfoliation), pruritus (itching)

Uncommon (may affect up to 1 in 100 people):

Skin lesion, scab, skin disorder, pigmentation disorder, redness (erythema), skin burning sensation, pain, application site pain, application site irritation

Rare (may affect up to 1 in 1,000 people):

Dry skin, contact dermatitis, eczema, worsening of your underlying fungal infection

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

Hypersensitivity, rash

If Terbinafine Dermapharm accidentally gets into the eyes, this may in rare cases cause irritation.

Reporting of side effects

If you get any side effects, talk to your doctororpharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via [to be completed nationally]. 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 use this medicine after the expiry date which is stated on the tube and on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Instructions regarding shelf life after opening

The shelf life of Terbinafine Dermapharm is 6 months after first opening the tube.

What Terbinafine Dermapharm contains

The active substance is:

terbinafine hydrochloride

One gram of cream contains 10 mg of terbinafine hydrochloride.

The other ingredientsare:

purified water, cetylstearyl alcohol, isopropyl myristate, cetyl palmitate,sorbitan stearate, benzyl alcohol, polysorbate 60, sodium hydroxide

What Terbinafine Dermapharm looks like and contents of the pack

Terbinafine Dermapharmis a white cream.

It is available in tubes at 15 g and 30 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<To be completed nationally>

Manufacturer

<To be completed nationally>

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

Austria: <To be completed nationally>

Germany: <To be completed nationally>

Poland: <To be completed nationally>

Sweden: <To be completed nationally>

This leaflet was last revised in 2016-03-08