Niddafin 1% creme, creme 10 mg/g

• [Nationally completed name] belongs to the group of antifungal preparations. [Nationally completed name] is used to treat patients with fungal and yeast infections of the skin.
• [Nationally completed name] is active against certain yeasts and skin fungi, of which athlete’s foot is the most well-known. See also section 3 for more information about the other fungal infections.

You must talk to your doctor, if you do not feel better or if you feel worse after 1 to 2 weeks.

Do not use [Nationally completed name]:

• if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). You can recognise hypersensitivity for example by red spots and lumps on the skin or itching.

Warnings and precautions

Talk to your doctor or pharmacist before using [Nationally completed name].

Terbinafine cream is for external use only. It may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Children and adolescents

Take special care with [Nationally completed name] if you are under 12 years of age. Terbinafine cream should be kept out of the reach of children.

Consult your doctor if one of the above warnings applies to you or has done so in the past.

Niddafin NL/H/0747/001 Binnnida NL/H/0748/001 29.11.2012

Other medicines and [Nationally completed name]

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

There is no evidence that [Nationally completed name] has an effect on other products.

Pregnancy and breast-feeding Pregnancy

You should not use [Nationally completed name] if you are pregnant or planning to get pregnant. If you get pregnant whilst using this medicine tell your doctor.

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

Breast-feeding

Because terbinafine passes into the breast milk, you should not use [Nationally completed name] during breast-feeding. Also infants must not be allowed to come into contact with any treated skin, including the breast. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Terbinafine cream has no influence on the ability to drive and use machines.

[Nationally completed name] contains cetyl alcohol and stearyl alcohol

May cause local skin reactions (e.g. contact dermatitis).

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.

Kind of administration:

Cutaneous use

The opening of the tube is sealed with aluminium. You can break the seal with the inverted top of the tube, exerting slight pressure. Before applying the cream, the skin must be carefully washed and dried.

Smear a thin layer of cream on the inflamed skin and a little round about. Rub the cream in gently. If the inflammation is in a skin fold (under the breasts, between the toes or fingers, in the groin or between the buttocks) the skin can be covered with a sterile gauze, especially at night. Wash your hands after rubbing in, unless your hands are the area that is being treated.

Use in adults and adolescents (> 12 years of age )

Duration and frequency of treatment

Athlete’s foot (Tinea pedis): once a day for one week.

The symptoms that can be associated with athlete’s foot are itching, redness and scaling between the toes and on the soles of the feet. Cracks sometimes also appear (particularly between the toes) and oozing blisters can occur as well. Athlete’s foot usually produces an unpleasant odour.

Ringworm (tinea cruris and tinea corporis): once a day for one week.

Ringworm consists of slowly growing, itchy, red and scaling ring-shaped patches that can be dispersed over the body.

Skin fungus (cutaneous candidiasis): once a day for 1 to 2 weeks.

Niddafin NL/H/0747/001 Binnnida NL/H/0748/001 29.11.2012

Candida is a species of yeast that can cause an infection of the skin in certain circumstances. Often the skin abnormalities are located in warm, damp areas such as the groin or under the breasts. The symptoms consist of itching, redness and scaling.

Pityriasis versicolor: 1 to 2 times a day for 2 weeks.

The yeast that causes pityriasis versicolor is Malassezia furfur. An infection with this yeast mainly occurs on the shoulders and the upper part of the trunk and upper arms. The symptoms consist of slightly itchy and slightly scaling patches. In people who are fairly sun-tanned, the patches are usually lighter than the rest of the skin, and in people who have been exposed to little or no sun, the spots are usually light brown.

An improvement in the symptoms usually occurs after a few days. Irregular use or premature stoppage of the cream increases the chance of the symptoms recurring. If no improvement has occurred after 1 to 2 weeks, contact your doctor or pharmacist.

Use in the elderly

There is no evidence that elderly patients require a different dose or will suffer different side effects from younger patients.

Use in children

There is only limited experience with the administration of [Nationally completed name] to the skin of children under 12 years of age and therefore use in this age group is not recommended.

If you use more [Nationally completed name] than you should

If you have used too much [Nationally completed name], this will not cause any harm, but contact your doctor or pharmacist if you are uncertain.

If someone, e.g. a child, swallows [Nationally completed name] accidentally, adverse effects similar to those observed with an overdose of tablets containing terbinafine (e.g. headache, nausea, bellyache and dizziness) are to be expected. In this case, contact your doctor or poison information centre.

In case of contact with the eyes, rinse eyes thoroughly with running water.

If you forget to use [Nationally completed name]:

Continue the treatment without applying [Nationally completed name] an extra time or using it more than normal.

If you stop using [Nationally completed name]

If you suddenly stop using [Nationally completed name], the old symptoms can 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 allergic reactions:

• 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

[Nationally completed name] can occasionally cause redness, a burning feeling, stinging sensation, or itching at the application site. These effects are usually harmless and you can carry on using the cream.

Other side effects:

Niddafin NL/H/0747/001 Binnnida NL/H/0748/001 29.11.2012

Common (may affect up to 1 in 10 users)

• peeling skin (exfoliation)

Uncommon (may affect up to 1 in 100 users)

• pigmentation disorder

Rare (may affect up to 1 in 1,000 users)

• eye irritation
• dry, flaky skin
• worsening of your underlying fungal infection

If you suffer badly from the side effects mentioned, it is advisable to consult your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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 label and carton after: “Exp“. The expiry date refers to last day of that month.

Store in the original package.

Do not freeze.

Keep the tube tightly closed.

You can use [nationally completed name] 3 months after first opening of the tube.

What [Nationally completed name] contains

• The active substance is terbinafine hydrochloride. One gram of cream contains 10 mg terbinafine hydrochloride.
• The other ingredients are sodium hydroxide (E524), benzyl alcohol, sorbitan stearate (E491), cetyl palmitate, cetyl alcohol, cetostearyl alcohol, polysorbate 60 (E435), isopropyl myristate, purified water.

What [Nationally completed name] looks like and contents of the pack

[Nationally completed name] is presented in the form of a cream. The contents of the aluminium tube with a polyethylene screw cap are 7.5, 15 and 30 grams.

The cream is white or almost white.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Niddafin NL/H/0747/001 Binnnida NL/H/0748/001 29.11.2012

Dit geneesmiddel is geregistreerd in lidstaten van de EEA onder de volgende namen:

Niddafin NL/H/0747/001

Duitsland (DE) Terbinafin-CT 1% Creme

Nederland (NL) Niddafin 1% Creme

This leaflet was last revised in {month YYYY}.

Oktober 2013