10 mg/g cream
Terbinafine hydrochloride
What Terbisil is and what it is used for
You must talk to your doctor if you do not feel better or if you feel worse after 7 or 14 days.
Terbisil cream contains the active substance terbinafine hydrochloride and belongs to the antifungal group. Terbisil is used to treat athlete’s foot between the toes and fungal infection in the groin (also candida ).
Terbinafine hydrochloride contained in Terbisil cream may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before using Terbisil
Do not use Terbisil
- if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). You can recognize hypersensitivity by, for example, red rashes and blisters or itching.
Warnings and precautions
Talk to your doctor or pharmacist before using Terbisil.
Terbisil is intended for external use only. Terbisil can irritate the eyes, therefore contact with the eyes should be avoided. If the cream accidentally comes into contact with the eyes, these should be rinsed thoroughly with running water.
Children and young people
Terbisil is not recommended for children under 12 years of age due to limited experience in the treatment of children in this age group.
This medicine should be kept out of the sight and reach of children.
Other medicines and Terbisil
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
This medicine is not known to affect other medicines when applied to the skin. However, as a precaution, you should avoid using other medications on the treated skin areas.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You should not use Terbisil cream if you are pregnant or planning to become pregnant. Inform the doctor if you become pregnant while using Terbisil.
Breast-feeding
Terbinafine passes into breast milk. Do not use Terbisil cream if you are breastfeeding.
Babies should not come into contact with treated areas of skin, including the breasts.
Driving ability and use of machinery
Terbisil does not affect the ability to drive and use machines when used as directed and only externally.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Terbisil contains benzyl alcohol, cetyl alcohol, and stearyl alcohol
Terbisil cream contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram of cream.
Benzyl alcohol can cause allergic reactions and mild local irritation.
Terbisil cream contains cetyl alcohol and stearyl alcohol
These can cause local skin reactions (e.g. contact dermatitis).
How to use Terbisil
Always use 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.
Dosage and treatment times
Adults and adolescents (from 12 years)
- Athlete’s foot ( Tinea pedis ) between the toes: Once daily for a week. Symptoms associated with an athlete’s foot are itching, redness, and scaling between the toes. Cracks sometimes occur (especially between the toes). 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. Often the skin changes are localized to warm, moist areas such as the groin. 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 (in the case of athlete’s foot) or 2 weeks (in the case of a fungal infection in the groin).
Older
There is no evidence that older patients require a different dosage or have a different side effect profile than younger patients.
Children
Terbisil cream is not recommended for children under 12 years of age due to limited experience in treating children.
How to use Terbisil cream
This medicine is for external use only.
- 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 just enough cream to form a thin layer on and around the affected skin.
- Gently apply cream one. If the infestation is in skin folds (between the toes or in the groin), the skin can be covered with a sterile compress, especially at night.
- Wash hands after treatment.
If you have used too much Terbisil
It is not harmful if you have used too much Terbisil cream, but contact the doctor if you are unsure.
If someone, e.g. a child, swallowed Terbisil cream by mistake, side effects similar to those observed in an overdose of terbinafine tablets can be expected, e.g. headache, nausea stomach pain, and dizziness. Contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Terbisil
Continue the treatment without using more cream or treating extra time.
If you stop using Terbisil
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.
Common side effects ( may affect up to 1 in 10 users)
- skin flaking, itching.
Uncommon side effects ( may affect up to 1 in 100 users)
- skin damage, scab, skin change, pigmentation disorder, skin redness ( erythema ), burning sensation on the skin where the cream has been applied
- pain at the application site, irritation at the application site.
Rare side effects ( may affect up to 1 in 1,000 users)
- worsening fungal infection.
- eye irritation.
- allergic reactions such as itching ( pruritus ), rash, bullous dermatitis, and hives ( urticaria ).
- dry skin, contact dermatitis, and eczema.
Has been reported (occurring in an unknown number of users)
- rash
- hypersensitivity reaction.
How Terbisil should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the tube and carton after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive.
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, 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.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers:
Gedeon Richter Plc. 1103 Budapest, Gyömrői út 19-21, Hungary
Cosmo SpA Via C.Colombo 1, 20020 Lainate (MI), Italy
Doppel Farmaceutici Srl, Via Martiri della Foibe 1, 29016 Cortemaggiore (PC), Italy
PharmaCoDane ApS, Marielundvej 46A, 2730 Herlev, Denmark
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria
Centrafarm Services BV, Van de Reijtstraat 31-E, 4814 NE Breda, The Netherlands
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark