10mg/g cream
terbinafine hydrochloride
What Terbinafine Teva is and what it is used for
Terbinafine Teva cream belongs to the antifungal group.
Terbinafine Teva is used to treat athlete’s foot between the toes and fungal infection in the groin (also candida ).
You must speak to a doctor if you do not feel better or if you feel worse after 1 week (for athlete’s foot ) or 2 weeks (for fungal infection in the groin).
Terbinafine contained in Terbinafine Teva cream may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have further questions, and always follow their instructions.
What you need to know before you use Terbinafine Teva
Do not use Terbinafine Teva
- if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity manifests itself, for example, as red rashes and blisters or itching.
Warnings and precautions
Talk to your doctor or pharmacist before using Terbinafine Teva
- Terbinafine Teva cream is intended for external use only. The cream can be irritating to the eyes. Avoid contact with eyes. If the cream accidentally comes into contact with the eyes, these should be rinsed thoroughly with running water.
Children and young people
Terbinafine Teva cream is not recommended for children under 12 years of age due to limited experience in treating children.
Terbinafine Teva should be kept out of the sight and reach of children.
Consult a doctor if you are unsure whether any of the warnings above apply/have applied to you.
Other medicines and Terbinafine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There is no evidence that Terbinafine Teva cream has any effect on other medicines.
Pregnancy and breastfeeding
Pregnancy
You should not use Terbinafine Teva cream if you are pregnant or planning to become pregnant. Tell your doctor if you become pregnant while using Terbinafine Teva.
Breast-feeding
Terbinafine passes into breast milk. Do not use Terbinafine Teva cream if you are breastfeeding. Babies should not come into contact with treated areas of skin, including the breasts.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Terbinafine Teva does not affect the ability to drive or use machines.
Terbinafine Teva cream contains cetyl alcohol and cetostearyl alcohol
Can cause local skin reactions (e.g. contact dermatitis).
Terbinafine Teva cream contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol can cause allergic reactions.
How to use Terbinafine Teva
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Mode of administration
For external use.
The opening of the tube is sealed with aluminum. Press the opposite side of the screw cap lightly against the seal to open the tube.
Before using the cream, the skin must be clean and dry.
Apply a thin layer of cream on and around the affected skin and rub it lightly. If the infestation is in skin folds (in the groin), the skin can be covered with a sterile compress, especially at night. Wash your hands after treatment so that the cream does not accidentally get into your eyes.
Use in adults and adolescents (>12 years)
Dosage and treatment times
Athlete’s foot ( Tinea pedis ) between the toes: Once daily for a week.
Symptoms can be itching, redness, and scaling between the toes. Cracks sometimes occur. You can also get oozing blisters. An athlete’s foot usually smells bad.
Fungal infection and candida in the groin: Once daily for 1-2 weeks.
Candida is a yeast that can cause skin infections in some cases. The symptoms are itching, redness and scaling.
An improvement in symptoms is usually seen after a few days, but it is important to continue the treatment to avoid relapse. Contact a doctor if improvement does not occur after 1 week (for athlete’s foot ) or 2 weeks (for fungal infection in the groin).
Use in the elderly
There is no evidence that older patients require a different dosage or have a different side effect profile than younger patients.
Use in children
Terbinafine Teva cream is not recommended for children under 12 years of age due to limited experience in treating children.
If you have used too much Terbinafine Teva
It is not harmful if you have used too much Terbinafine Teva cream, but contact the doctor if you are unsure.
If someone, such as a child, accidentally swallows terbinafine cream, side effects similar to those observed in an overdose of terbinafine tablets can be expected, such as headache, nausea, stomach pain, and dizziness. Contact a doctor or hospital for an assessment of the risk and advice.
If the cream should come into contact with the eyes, these should be rinsed thoroughly under running water.
If you forget to use Terbinafine Teva
Continue the treatment without using more cream or treating extra time.
If you stop using Terbinafine Teva
If you stop the treatment prematurely, the symptoms may return.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the cream immediately and seek medical attention if you experience any of the following allergic reactions:
- severe itching of the skin, with red rashes or raised nodules, hives, or blisters.
- shortness of breath or swelling of the mouth, face, lips, tongue, or throat.
Other side effects:
Common (may affect up to 1 in 10 users)
- scaly skin
- itching ( pruritus )
Uncommon (may affect up to 1 in 100 users)
- pigment disorders
- pain and skin irritation at the application site
- skin lesions, scabies
- skin changes
- skin redness ( erythema )
- burning sensation in the skin
Rare (may affect up to 1 in 1,000 users)
- eye irritation
- dry scaly skin
- worsening of the fungal infection
If you have severe problems with these side effects, you should contact a doctor.
How to store Terbinafine Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.
Store in the original packaging.
Do not freeze.
Close the tube well.
Cream one can be used 3 months after opening the tube.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is terbinafine hydrochloride. 1 gram of cream contains 10 mg of terbinafine hydrochloride.
- Other ingredients are sodium hydroxide (E524), benzyl alcohol, sorbitan stearate (E491), cetyl palmitate, cetyl alcohol, cetostearyl alcohol, polysorbate 60 (E435), isopropyl myristate, purified water
Appearance and package sizes of the medicine
The cream one is white or almost white.
Aluminum tube with a polyethylene screw cap containing: 7.5 grams, 15 grams, or 30 grams.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany