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TERBINAFINE AbZ 10 mg- g cream 15 g

AbZ Pharma GmbH

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Terbinafine AbZ 10mg / g cream

Active ingredient: Terbinafine hydrochloride .

Areas of application: fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, mainly those caused by the genus Candida (e.g. Candida albicans). Pityriasis (tinea) versicolor, caused by Pityrosporum orbiculare (Malassezia furfur).

Warning: cream contains cetyl alcohol and cetyl stearyl alcohol. Pharmacy only.

For TERBINAFINE information on risks and side effects, read the package insert and ask your doctor or pharmacist. Status: 05/2012

TERBINAFINE Active ingredients

  • 10 mg terbinafine hydrochloride

Auxiliary materials

  • Sodium hydroxide for pH adjustment
  • Benzyl alcohol
  • Sorbitan stearate
  • Cetyl palmitate
  • Cetyl alcohol
  • Cetostearyl alcohol
  • Polysorbate 60
  • Isopropyl myristate
  • Purified water

TERBINAFINE Indication / application

  • If you do not feel better or even worse after 7-14 days, you must contact your doctor.
  • The medicine contains the active substance terbinafine hydrochloride and belongs to a group of medicines for fungal infections. This medicine is intended for the treatment of fungi and yeast on the skin.
  • The medicine is used against certain yeasts and skin fungi, the best known of which is athlete's foot. For more information on other fungal infections, see the Dosage category.

TERBINAFINE dosage

  • 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.
  • Adults and adolescents (12 years and older)
    • 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 flaking between the toes and on the soles of the feet.
        • Occasionally, the skin (especially between the toes) and weeping blisters can occur.
        • Athlete's foot often causes an unpleasant odor.
      • Lichen (Tinea corporis):
        • Once a day for 1 week.
        • A lichen consists of slowly growing, itchy, reddened, and flaky circular spots that can be spread all over the body.
      • Fungal skin (cutaneous candidiasis):
        • Once a day for 1 to 2 weeks.
        • Candida is a yeast that, under certain circumstances, can cause skin infections. The damage to the skin is often found in warm, moist areas of the body such as the groin or under the breasts. The symptoms are itching, redness, and flaking.
      • Bran lichen (Pityriasis versicolor):
        • 1 to 2 times a day for 2 weeks.
        • The yeast that causes the bran (Pityriasis versicolor) is called Malassezia furfur.
        • Infection with this yeast mainly occurs on the shoulders, torso, and upper arms. The symptoms consist of slightly itchy and slightly scaly patches. In people who have a tan, the spots are generally lighter than the rest of the skin, while in people who have little or no exposure to the sun, they usually appear light brown.
        • In general, symptoms improve after a few days. Irregular use or premature discontinuation of treatment increases the likelihood that symptoms will recur.
        • If you do not see any improvement after one to two weeks, please inform your doctor or pharmacist.
  • Elderly people
    • There is no evidence that elderly patients need different doses or experience different side effects than younger patients.
  • children
    • The medicine is not recommended for use in children under 12 years of age due to limited experience in this age group.

 

  • If you use more than you should
    • If you have used too much medicine it will not do any harm. However, if you are unsure, ask your doctor or pharmacist.
    • Should it, e.g. If, for example, a child accidentally ingests the terbinafine cream, side effects similar to those observed with overdosing with terbinafine tablets (e.g. headache, nausea, pain in the upper abdomen and dizziness) must be expected. In this case, call a doctor or an emergency doctor.

 

  • If you forget to use
    • Continue treatment without using the medicine one more time or applying more than usual.

 

  • If you cancel the application
    • If you stop using it prematurely, the original symptoms may return.

 

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

TERBINAFINE way

  • This medicine is intended for external use only.
  • Apply just enough cream that the affected skin area and its surroundings are covered with a thin layer of cream. Rub them in lightly. If the treated area of ​​skin is in a fold of skin (under the breasts, between the toes or fingers, in the groin or between the buttocks), you should cover the skin with a sterile gauze, especially at night. If the application of the cream is not intended to treat your hands, please wash your hands afterwards.

TERBINAFINE Side effects

  • Like all medicines, this medicine can have side effects, although not everybody gets them.
  • Common (may affect up to 1 in 10 people):
    • Peeling of the skin, itching (pruritus).
  • Uncommon (affects up to 1 in 100 people):
    • Skin injuries, scabs, skin problems, changes in skin color, redness (erythema), burning sensation,
    • Pain, pain and / or irritation at the treated area.
  • Rare (affects up to 1 in 1,000 people):
    • Worsening of the basic condition,
    • Eye irritation,
    • allergic reaction, such as B. Itching (pruritus), rash, inflammatory skin reaction with blistering (bullous dermatitis), hives (urticaria),
    • dry skin, contact dermatitis, inflammatory skin changes (eczema).
  • Not known (frequency cannot be estimated from the available data):
    • Rash,
    • Hypersensitivity.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

TERBINAFINE Interactions

  • Use with other medicines
    • Tell your doctor or pharmacist if you are taking, have recently used, or may use any other medicines.
    • There is no evidence that this medicine has any effect on other medicines when applied to the skin. As a precaution, you should not use other medicines in the affected area during treatment.

TERBINAFINE Contraindications

  • The drug must not be used
    • if you are allergic to terbinafine or any of the other ingredients of this medicine. You can recognize hypersensitivity by red spots and swelling of the skin or itching, for example.

TERBINAFINE pregnancy and breast feeding period

  • Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
  • pregnancy
    • The medicine 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.
  • Breastfeeding
    • Because terbinafine is excreted in breast milk, you should not use the medicine if you are breast-feeding a child. In addition, children must not come into contact with treated skin, including the mother's breast.

 

TERBINAFINE Patient information

  • Warnings and Precautions
    • Talk to your doctor or pharmacist before using the medicine.
    • The drug is intended for external use only. Contact with the eyes can cause irritation and should therefore be avoided. If the cream accidentally gets into the eyes, they should be rinsed thoroughly under running water.
    • children
      • Use is not recommended in children under 12 years of age due to limited experience in this age group.
      • This medicine should be kept out of the reach and sight of children.

 

  • Driving and using machines
    • The use of the drug has no influence on the ability to drive and use machines, as long as it is used according to the instructions for use and only externally.