Patient leaflet - Terbinafine Hydrochloride 1 % cream
1. What Terbinafine is and what it is used for
Terbinafine Cream is an anti-fungal preparation. It kills fungi, which cause skin infections. Terbinafine cream is used for the local treatment of fungal infections such as Athlete's foot and jock itch. You can treat mild, transient complaints before seeking medical attention or supervision. For external use only.
Fungal infections can develop in the following areas of the body:
Fungal infection of the foot (Athlete's foot) appears on the feet, mainly between the toes. It can spread to the soles, edges or the instep of the feet. It may affect one or both feet. The most common symptoms can be inflammation, cracking or scaling of the skin, unpleasant itching. In more severe cases, small weeping blisters, peeling skin and painful, deep cracks can appear
Terbinafine Cream is not for nail infections.
2. What you need to know before you use Terbinafine
Do not use Terbinafine if:
- you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of Terbinafine Cream (see section 6).
- you are not sure about the nature of your skin problems., Consult your doctor or pharmacist before starting to use Terbinafine Cream
- you are younger than 12 years of age.
Take special care with Terbinafine:
- for external use only
- avoid contact of the cream with your eyes. If it gets into the eyes accidentally, the eyes should be washed with plenty of water and the patient should consult an ophthalmologist if necessary • wash your hands after applying Terbinafine Cream.
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Pregnancy, breast-feeding and fertility:
Do not use this medicine if you are pregnant or breastfeeding, unless advised to by your doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Terbinafine does not affect your ability to drive or operate machinery when used as directed and only externally.
Terbinafine contains cetosteryl alcohol, cetyl alcohol and benzyl alcohol
Terbinafine Cream contains cetosteryl alcohol and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Terbinafine Cream contains benzyl alcohol which may cause mild local irritation and allergic reactions.
3. How to use Terbinafine Cream
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You can open the sealed tube by using the spike at the top of the cap. Always clean and dry your hands before using the cream.
Directions for use: The cream should be applied once or twice daily on the previously cleansed and dried area. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly.
Apply the cream once or twice a day, for one to two weeks, but this will depend upon the type and area of infection. Infections usually appear to improve within a few days of starting to use Terbinafine Cream, but may reappear if the cream is not applied regularly or is stopped too early. If there are no signs of improvement after two weeks of starting treatment, consult your doctor or pharmacist.
To avoid re-infection it is important to take the following hygienic measures: The affected area should be kept clean; after use of the cream you should always wash your hands; you should use your own clean towel. Avoid scratching the affected area, although it may be itchy, because it can cause further damage to the skin and slow down the healing process or spread the infection.
Children
Use in children is not recommended, since there are no data to support use in this population.
If you accidentally swallow Terbinafine cream
If you or someone else accidentally swallow some cream, contact your doctor or nearest hospital emergency department. Take any remaining medicine and this leaflet with you if possible. Symptoms of accidental ingestion include headache, nausea (feeling sick), dizziness and stomach pain.
If you forget to use Terbinafine
If you forget to use your cream, apply the cream as soon as possible, and then continue the rest of your treatment as usual. It is important to try to use the cream at the correct times as forgotten applications could risk the infection returning.
If you stop using Terbinafine Cream
Infections may come back if you do not use the cream regularly, or if you stop the treatment too early. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicinecan have side effects, although not everybody gets them.
Stop using the cream and seek medical help immediately if you have any of the following very rare allergic reactions:
- difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic reaction).
- severe itching of the skin, with a red rash or raised lumps, hives or blisters.
Common: (may affect up to 1 in 10 people)
- Skin peeling
- Itching.
Uncommon: (may affect up to 1 in 100 people):
- Skin lesions,
- Scab,
- Skin colour changes,
- Redness,
- Burning,
- Pain
- Irritation at the site of application.
These common and uncommon side effects are usually harmless and you can carry on using the cream.
Rare: (may affect up to 1 in 1000 people):
- Eye irritation,
- Dry skin,
- Contact dermatitis,
- Eczema,
- Worsening of symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Terbinafine
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date stated on the pack. The expiry date refers to the last day of that month.
No special precautions for storage. Store in original container.
Do not use Terbinafine if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Terbinafine contains:
Do not use Terbinafine if you are allergic to any of these ingredients.
The active substance is terbinafine hydrochloride. The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, cetostearyl alcohol, polysorbate 60, isopropyl myristate, water purified.
What Terbinafine looks like and contents of the pack:
White or almost white cream, with slight almond odour. Packs contain 1 tube of cream (7.5 g or 15 g).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Viatris, Station Close, Potters Bar, EN6 1TL, United Kingdom.
Manufacturer
Gedeon Richter Plc. 1103 Budapest, Gyömröi út 19-21, Hungary.