10 mg/g cream
terbinafine hydrochloride
What Terbinafine ABECE is and what it is used for
Terbinafine Abece cream contains the active substance terbinafine. It is an antifungal agent used for the treatment of athlete’s foot between the toes and fungal infection in the groin (also candida). Terbinafine blocks a reaction in the fungus’s metabolism, which causes the fungus to die and the infection to heal faster.
Terbinafine contained in Terbinafine Abece 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 ABECE
Do not use Terbinafine ABECE
– if you are allergic to terbinafine or any of the ingredients of this medicine (listed in section 6).
Warnings and precautions
Terbinafine Abece cream is intended for external use only. Terbinafine Abece cream can be irritating to the eyes. Avoid getting the cream in the eyes, on mucous membranes, or in wounds. Rinse with copious amounts of running water if the cream accidentally comes into contact with any of these areas.
Terbinafine Abece cream is not intended for the treatment of fungal infection of the nails. If you suspect that you have a fungal nail infection (eg discoloration or thickening of the nail), see a doctor.
Children
Experience from the use of Terbinafine Abece cream in children under 12 years of age is limited. Use in this age group is therefore not recommended.
Other medicines and Terbinafine ABECE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use other medications on the treated skin areas.
It is not known that Terbinafine Abece cream would affect or be affected by other medicines.
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
Clinical experience from the use of terbinafine in pregnant women is limited.
Do not use Terbianfin Abece if you are pregnant or planning to become pregnant unless your doctor considers it necessary.
Breast-feeding
Because terbinafine passes into breast milk, you should not use Terbinafine Abece if you are breastfeeding. Babies should not come into contact with skin treated with Terbinafine Abece, including the breasts.
Fertility
No effects have been seen on fertility when using Terbinafine Abece.
Driving ability and use of machinery
The use of Terbinafine Abece on the skin does not affect the ability to drive or use machines.
Terbinafine ABECE contains stearyl alcohol, cetyl alcohol, and benzyl alcohol
This medicine contains the excipients stearyl alcohol and cetyl alcohol. These substances can cause local skin reactions (e.g. contact dermatitis).
This medicine contains 15 mg of benzyl alcohol per g of cream. Benzyl alcohol may cause allergic reactions and/or mild local irritation.
How to use Terbinafine ABECE
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.
Adults and adolescents from 12 years of age:
Athlete’s foot between the toes: 1 time a day for 1 week.
Fungal infection in the groin (also candida ): 1 time per day for 1-2 weeks.
The symptoms usually disappear after a few days and the skin heals completely after some time, but it is important to complete the treatment to avoid recurrence. Contact a doctor if improvement does not occur after 1 week (for athlete’s foot ) or 2 weeks (for fungal infection in the groin), as your discomfort may have been caused by something other than a fungal infection.
For the treatment of other fungal infections, follow your doctor’s recommendation.
Instructions for use
For use on the skin.
Wash and dry the skin thoroughly before applying the cream.
Spread a thin layer on the inflamed skin and a little around. Gently apply cream one.
If the infection is in a skin fold (eg in the groin), the smeared skin can be covered with sterile gauze, especially at night. Wash your hands after applying the cream.
If you have used too much Terbinafine ABECE
Overdose of Terbinafine Abece, when used on the skin, is not likely. However, if you ingest the cream by mistake, you may have side effects similar to those that can be expected from an overdose of terbinafine in tablet form. These include headache, nausea, stomach pain, and dizziness.
If you have ingested too much medicine or if, for example, a child accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Terbinafine ABECE
Continue treatment as usual. Do not use a double dose to make up for a missed dose.
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.
Some users may experience local symptoms such as itching, skin flaking, pain, irritation, pigment changes, burning sensation in the skin, skin redness and scabs may appear on the treated skin areas. These symptoms are usually mild, but still inform your doctor if such symptoms appear as they may be signs of an allergy, especially in the case of rashes, blisters, and hives. Your doctor may decide to end the treatment with Terbinafine Abece.
Common (may affect up to 1 in 10 users):
- Flaking skin, itching
Uncommon (may affect up to 1 in 100 users):
- Skin and pigment changes, skin redness, burning sensation, pain, and irritation on the treated skin areas.
Rare (may affect up to 1 in 10,000 users):
- Eye irritation
- Dry skin, contact dermatitis
- Aggravated fungal infection
Has been reported (occurring in an unknown number of users):
- Hypersensitivity reaction, rash
How to store Terbinafine ABECE
Store out of sight and reach of children.
No special storage instructions.
Use before the expiry date stated on the carton and tube after the Expiration date. The expiration date is the last day of the specified month.
Once the tube has been opened, the cream must be used within 6 months.
Do not use Terbinafine Abece if you notice that the cream has changed.
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 g of cream contains 10 mg of terbinafine hydrochloride.
– Other ingredients are stearyl alcohol, cetyl alcohol, sorbitan stearate, cetyl palmitate, isopropyl myristate, benzyl alcohol, polysorbate 60, sodium hydroxide, and purified water.
Appearance and package sizes of the medicine
White cream. The cream is supplied either in a white collapsible aluminum tube with a lacquered interior, sealed with latex, and with a perforated polypropylene screw cap, or in an aluminum laminated plastic tube with a polypropylene screw cap.
Package sizes:
7.5 g tube
15g tube
30 g tube
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer:
SC Laropharm SRL
145 A Alexandria street
Bragadiru, Ilfov, 077025
Romania