What is Antifungal Cream HTP Terbinafine HCl 10 mg/g and what is it used for? 

Antifungal Cream HTP Terbinafine HCl 10 mg/g contains the active ingredient terbinafine hydrochloride and belongs to a group of medicines known as antifungal preparations. Antifungal Cream HTP Terbinafine HCl is used to treat fungal and yeast infections of the skin. Antifungal Cream HTP Terbinafine HCl 10 mg/g is effective against certain yeasts and skin fungi, of which athlete’s foot is the best known.

How do you use this medicine?

Always use this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. Not sure about the correct use? Contact your doctor or pharmacist.

Download the package leaflet

Age indication

From 12 years of age. Antifungal Cream HTP Terbinafine HCl 10 mg/g is not recommended for use in children under 12 years of age due to limited experience in this age group.

Dosage

Adults and adolescents (12 years and older)

• Athlete’s foot (tinea pedis): once daily for 1 week. Symptoms of athlete’s foot may include itching, redness and flaking between the toes and on the soles of the feet. Cracks may also develop, particularly between the toes, and blisters containing fluid may occur. Athlete’s foot often causes an unpleasant odour.

• Ringworm (tinea corporis): once daily for 1 week. Ringworm consists of slowly growing, itchy, red and scaly ring-shaped patches that can occur on different parts of the body.

• Skin fungal infection (cutaneous candidiasis): once daily for 1 to 2 weeks. Candida is a type of yeast that can cause a skin infection under certain conditions. The affected areas are often warm and moist, such as the groin or underneath the breasts. Symptoms include itching, redness and flaking.

• Pityriasis versicolor: once or twice daily for 2 weeks. The yeast that causes pityriasis versicolor is Malassezia furfur. An infection with this yeast usually occurs on the shoulders, upper torso and upper arms. Symptoms consist of slightly itchy, mildly scaly patches. In people with tanned skin, the patches are usually lighter than the surrounding skin. In people with little or no sun exposure, the patches are usually light brown.

Symptoms usually improve after a few days. Irregular use or stopping treatment too early increases the chance that symptoms will return. If you do not notice any improvement within 2 weeks after starting treatment, contact your doctor or pharmacist.

Have you used too much of this medicine? Using too much of this medicine is not harmful, but if you are unsure, contact your doctor or pharmacist.

If someone, for example a child, accidentally swallows Antifungal Cream HTP Terbinafine HCl 10 mg/g, side effects similar to those observed following an overdose of terbinafine-containing tablets may occur, such as headache, nausea, abdominal pain and dizziness. In this case, contact your doctor or a poison control centre.

Forgot to use this medicine? Continue the treatment without applying an extra amount of cream or using more than usual.

If you suddenly stop using Antifungal Cream HTP Terbinafine HCl 10 mg/g, your previous symptoms may return.

Older people

• There is no evidence that older people require a different dosage or experience different side effects compared with younger people.

Use in children

• Antifungal Cream HTP Terbinafine HCl 10 mg/g is not recommended for use in children under 12 years of age due to limited experience in this age group.

Method of administration

This medicine is for external use only.

• The opening of the tube is sealed with aluminium. Pierce the seal by pressing the reversed cap firmly onto it.

• Wash and dry the skin carefully before applying the cream.

• Apply just enough cream to form a thin layer over the affected skin and a small area around it.

• Gently rub in the cream. If the treated area is in a skin fold, such as underneath the breasts, between the toes or fingers, in the groin or between the buttocks, the skin should be covered with sterile gauze after application, particularly at night.

• Wash your hands afterwards, unless your hands are the area being treated.

Warnings

When should you not use this medicine or when should you take extra care?

When should you not use this medicine?

Do not use this medicine if you are allergic to any of its ingredients. These can be found under the section ‘Ingredients’. Signs of an allergy may include red spots, bumps on the skin or itching.

When should you take extra care with this medicine?

Contact your doctor or pharmacist before using this medicine. Antifungal Cream HTP Terbinafine HCl 10 mg/g is intended for external use only. It may irritate the eyes, so avoid all contact with the eyes. If the cream accidentally gets into the eyes, rinse them thoroughly with running water.

Are you using any other medicines?

Are you using any other medicines in addition to Antifungal Cream HTP Terbinafine HCl 10 mg/g, have you recently used any other medicines, or might you use other medicines in the near future? Tell your doctor or pharmacist.

This medicine is not known to affect other medicines when used on the skin. However, as a precaution, avoid using other medicines on the same treated areas of skin at the same time.

Use during pregnancy and/or breastfeeding

Are you pregnant, think you may be pregnant, planning to become pregnant or breastfeeding? Contact your doctor or pharmacist before using this medicine.

• Pregnancy: Do not use Antifungal Cream HTP Terbinafine HCl 10 mg/g if you are pregnant or planning to become pregnant. If you become pregnant while using this medicine, inform your doctor.

• Breastfeeding: Because terbinafine passes into breast milk, you must not use Antifungal Cream HTP Terbinafine HCl 10 mg/g while breastfeeding. Infants must also not come into contact with treated skin, including the breasts.

Driving and using machines

When used externally as directed, Antifungal Cream HTP Terbinafine HCl 10 mg/g has no effect on your ability to drive or operate machinery.

Antifungal Cream HTP Terbinafine HCl contains benzyl alcohol, cetyl alcohol and cetostearyl alcohol

This medicine contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation. Antifungal Cream HTP Terbinafine HCl also contains cetyl alcohol and cetostearyl alcohol. These substances may cause local skin reactions, such as contact dermatitis.

Possible side effects

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

• Common (may affect fewer than 1 in 10 users):

  • Skin peeling, itching.

• Uncommon (may affect fewer than 1 in 100 users):

  • Skin lesions, crusting, skin condition, changes in skin colour, redness, burning sensation.

  • Pain, pain at the application site, irritation at the application site.

• Rare (may affect fewer than 1 in 1,000 users):

  • Worsening of the condition.

  • Eye irritation.

  • Skin rash with severe itching (hives) and raised bumps (urticaria).

  • Dry skin, skin inflammation caused by contact with irritating substances or substances to which someone is allergic (contact dermatitis), eczema.

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

  • Skin rash.

  • Hypersensitivity.

Reporting side effects

If you experience any side effects, contact your doctor or pharmacist. This also applies to possible side effects not listed in this leaflet. You can also report side effects directly via the Netherlands Pharmacovigilance Centre Lareb. By reporting side effects, you can help provide more information on the safety of this medicine.

How should you store this medicine?

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after “Do not use after:” or “Exp.:”. The month and year are shown. The expiry date refers to the last day of that month.
• Store in the original packaging to protect from light.
• Do not freeze.
• Keep the tube tightly closed.
• Antifungal Cream HTP Terbinafine HCl 10 mg/g may be used for up to 3 months after the tube is first opened.
• Do not dispose of medicines via wastewater, the toilet or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

Specifications

• Dosage form: Cream. This medicine is for external use only.
• Contents: Aluminium tube with polyethylene screw cap containing 15 grams of cream.
• Supply status: Pharmacy or drugstore only medicine (UAD).
• Registration number: RVG, Register of Packaged Medicines 33309
  Main ingredient: Terbinafine hydrochloride

Marketing authorisation holder:

Healthypharm B.V. Van de Reijtstraat 31-E 4814 NE Breda, The Netherlands

Manufacturer:

Gedeon Richter Plc. Gyömrői út 19–21, 1103 Budapest, Hungary

View this medicine in the Medicines Information Bank

Please note: This product is only available for shipping within the Netherlands. Unfortunately, orders from other countries cannot be processed.