FUNGIZID-

FUNGICIDE ratiopharm Extra Cream

Important notes (mandatory information)

Fungizid-ratiopharm Extra 10 mg/g Cream. Active ingredient: Terbinafine hydrochloride. Areas of application: This medicine is intended for the treatment of fungi and yeasts on the skin, against certain yeasts and skin fungi, of which athlete's foot is the most well-known. Warning: Contains. Cetyl alcohol and cetyl stearyl alcohol.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Fungizid-ratiopharm Extra 10 mg/g Cream
Active ingredient: Terbinafine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 1 to 2 weeks, talk to your doctor.

What this package leaflet contains

1. WHAT IS FUNGIZID-RATIOPHARM EXTRA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING FUNGIZID-RATIOPHARM EXTRA?
3. HOW IS FUNGIZID-RATIOPHARM EXTRA USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FUNGIZID-RATIOPHARM EXTRA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS FUNGIZID-RATIOPHARM EXTRA AND WHAT IS IT USED FOR?

Fungizid-ratiopharm Extra belongs to a group of medicines for fungal infections. This medicine is intended for the treatment of fungi and yeasts on the skin, against certain yeasts and skin fungi, of which athlete's foot is the most well-known. You can find more information about other fungal infections under 3. "How is Fungizid-ratiopharm Extra used?". If you do not feel better or if you feel worse after 1 to 2 weeks, talk to your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING FUNGIZID-RATIOPHARM EXTRA?

Fungizid-ratiopharm Extra must not be used if you are allergic to terbinafine or any of the other ingredients of this medicine listed in section 6. You can recognise a hypersensitivity, for example, by red spots and swelling of the skin or itching.

Warnings and precautions

Please talk to your doctor or pharmacist before using Fungizid-ratiopharm Extra. Fungizid-ratiopharm Extra is only intended for external use. The cream can cause eye irritation. Contact with the eyes should be avoided. If the cream accidentally gets into your eyes, rinse them thoroughly with running water.

Children and adolescents

Special care is required when using Fungizid-ratiopharm Extra in children under 12 years of age. Fungizid-ratiopharm Extra should be kept out of the reach of children. Talk to your doctor if any of the above warnings apply to you or have applied to you in the past.

Using Fungizid-ratiopharm Extra together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. There is no evidence that Fungizid-ratiopharm Extra has any effect on other medicines.

Pregnancy and

breastfeeding

Pregnancy

Fungizid-ratiopharm Extra should not be used during pregnancy or if you are planning to become pregnant. Please inform your doctor if you become pregnant during treatment with Fungizid-ratiopharm Extra.

Breastfeeding

Since terbinafine passes into breast milk, you should not use Fungizid-ratiopharm Extra while breastfeeding. In addition, infants must not come into contact with treated skin (including the breast). Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

Fungizid-ratiopharm Extra has no influence on the ability to drive and use machines.

Fungizid-ratiopharm Extra contains cetyl stearyl alcohol and cetyl alcohol

Cetyl stearyl alcohol and cetyl alcohol can cause localised skin irritation (e.g. contact dermatitis).

3. HOW IS FUNGIZID-RATIOPHARM EXTRA USED?

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

Method of administration
Application to the skin. The opening of the tube is sealed with aluminium. This seal can be opened with the inverted tube cap under light pressure. Before applying the cream, the skin must be carefully cleaned and dried. Apply the cream in a thin layer to the inflamed skin and a little beyond and rub it 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), you can cover the skin with a sterile gauze bandage, especially at night. If the cream is not applied to treat your hands, please wash your hands afterwards.

Use in adults and adolescents over 12 years of age

Duration and frequency of use

Athlete's foot (Tinea pedis)

Once a day for 1 week. Possible symptoms of athlete's foot are itching, redness and scaling between the toes and on the soles of the feet. Occasionally, there may also be cracks in the skin (especially between the toes) and weeping blisters. Athlete's foot often causes an unpleasant odour.

Ringworm (Tinea cruris and Tinea corporis)

Once a day for 1 week. Ringworm consists of slowly growing, itchy, reddened and scaly circular patches that can be distributed over the entire body.

Skin fungus (Cutaneous candidiasis)

Once a day for 1 to 2 weeks. Candida is a yeast fungus that can cause a skin infection under certain circumstances. The skin lesions are often located in warm, moist areas of the body such as the groin or under the breasts. The symptoms are itching, redness and scaling.

Pityriasis versicolor

1 to 2 times a day for 2 weeks. The yeast fungus that causes pityriasis versicolor is called Malassezia furfur. An infection with this yeast occurs mainly on the shoulders, upper body and upper arms. The symptoms are slightly itchy and slightly scaly patches. In people with a suntan, the patches are generally lighter than the rest of the skin, while in people who are exposed to the sun only a little or not at all, they usually appear light brown.

In general, the symptoms improve after a few days. Irregular use or premature discontinuation of treatment increases the likelihood that the symptoms will recur. If you do not notice any improvement after 1 to 2 weeks, please inform your doctor or pharmacist.

Use in elderly patients

There is no evidence that different dosages are required in elderly patients or that side effects occur other than in younger patients.

Use in children

Since there is only limited experience with the use of Fungizid-ratiopharm Extra in children under 12 years of age, the use of this medicine is not recommended in this age group.

If you have used more Fungizid-ratiopharm Extra than you should

If you have used too much Fungizid-ratiopharm Extra, this will not cause any harm. However, if you are unsure, ask your doctor or pharmacist. If Fungizid-ratiopharm Extra is accidentally ingested, e.g. by a child, similar side effects are to be expected as those observed with an overdose of terbinafine tablets (e.g. headache, nausea, upper abdominal pain and dizziness). In this case, a doctor or emergency doctor should be consulted. If the cream accidentally gets into your eyes, you should rinse them thoroughly with running water.

If you forget to use Fungizid-ratiopharm Extra

Continue treatment without using Fungizid-ratiopharm Extra an additional time or applying a larger amount than usual.

If you stop using Fungizid-ratiopharm Extra

If you stop using Fungizid-ratiopharm Extra prematurely, the original symptoms may recur.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using the cream immediately and see a doctor if you experience any of the following allergic reactions:

• red skin rash or raised nodules with severe itching, hives or blistering,
• shortness of breath or swelling of the mouth, face, lips, tongue or throat.

Other side effects

Common (may affect up to 1 in 10 people):

• skin peeling,
• skin itching (pruritus).

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

• pigmentation disorders,
• pain and irritation at the site of application,
• skin abrasion, scab,
• skin disorders,
• skin redness (erythema),
• burning of the skin.

Rare (may affect up to 1 in 1000 people):

• eye irritation,
• dry, scaly skin,
• worsening of the underlying fungal infection.

If you suffer severely from the side effects mentioned, it is advisable to talk to your doctor about it.

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD FUNGIZID-RATIOPHARM EXTRA BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container after "Use by". The expiry date refers to the last day of the month indicated. Store in the original package. Do not freeze. Keep the tube tightly closed. Fungizid-ratiopharm Extra can be used for a further 3 months after the tube has been opened for the first time.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fungizid-ratiopharm Extra contains

The active ingredient is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride. The other ingredients are: sodium hydroxide (E 524), benzyl alcohol, sorbitan stearate (E 491), cetyl palmitate, cetyl alcohol, cetyl stearyl alcohol, polysorbate 60 (E 435), isopropyl myristate, purified water.

What Fungizid-ratiopharm Extra looks like and contents of the pack

Fungizid-ratiopharm Extra is a cream. An aluminium tube with a polyethylene screw cap contains 15 or 30 g of cream. The cream is white or almost white.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Terbinafine hydrochloride. Areas of application: This medicine is intended for the treatment of fungi and yeasts on the skin, against certain yeasts and skin fungi, of which athlete's foot is the most well-known. Warning: Contains. Cetyl alcohol and cetyl stearyl alcohol.