Terbinafine Hydrochloride 1% Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER TERBINAFINE HYDROCHLORIDE 1% CREAM Terbinafine hydrochloride
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Terbinafine Hydrochloride 1% cream (thereafter Terbinafine) is and what it is used for
2. Before you use Terbinafine
3. How to use Terbinafine
4. Possible side effects
5. How to store Terbinafine
6. Further information
1. WHAT TERBINAFINE IS AND WHAT IT IS USED FOR
Terbinafine is an anti-fungal preparation. It kills fungi, which cause skin infections.
Terbinafine is used for the local treatment of fungal infections of the skin such as Athlete’s foot and Jock itch (an infection in the groin area, characterised by red ring like areas, sometimes with small blisters, and itching).
For external use only.
2. 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
• if you are under 16 years of age
• for nail infections
Take special care with Terbinafine
• For external use only.
• Avoid getting the cream in your eyes. However if this should accidentally happen rinse your eyes thoroughly with plenty of clean water. If eye irritation continues please see your doctor.
• After application you should always wash your hands.
•
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using Terbinafine if you are pregnant or breastfeeding.
If you do become pregnant whilst using Terbinafine, tell your doctor.
Driving and using machines
Terbinafine cream will not affect your ability to drive or operate machinery when used as directed and only externally.
Important information about some of the ingredients of Terbinafine
Cetyl alcohol and cetostearyl alcohol, which are among the other ingredients of the cream, may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE TERBINAFINE
Open the sealed tube using the spike at the top of the cap.
Always clean and dry your hands before using the cream.
Your doctor will decide the right amount of Tebinafine for you to use and will tell you how long to use your medicine. Follow your doctor’s instructions exactly.
Unless otherwise instructed by your doctor, apply the cream once or twice daily. The cream is generally used for 1 to 2 weeks, but this will depend upon the type and area of infection. Make sure that you have cleaned and dried the affected skin and surrounding areas thoroughly before applying Terbinafine cream in a thin layer. The cream should be rubbed in gently and the affected areas may be covered with a gauze dressing, especially at night.
Treatment should be continued for the duration above, even if the affected area starts healing earlier. This way you can avoid the return of infection and treatment will be successful. Using Terbinafine cream will help stop the infection quickly by killing the pathogenic fungus (disease producing). However, complete healing may take longer depending on the extent of inflammation.
The effect of Terbinafine cream continues after treatment, even when you have finished using the cream.
If there are no signs of improvement after two weeks of therapy, consult your doctor.
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 towel; you should frequently change underwear; you should wear cotton socks and it is advised to disinfect footwear.
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
If you or someone else including a child, accidentally swallow the cream, contact your doctor immediately.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Terbinafine can have side effects, although not everybody gets them.
Redness, itching or stinging occasionally occur at the site of application. Allergic (hypersensitive) reactions may develop with any medicine.
Therefore, if you experience any of the following symptoms, such as swelling of the treated area, pain and redness, you should stop treatment and contact your doctor.
If you experience any of the following while you are using Terbinafine, stop using this medicine and tell your doctor as soon as possible:
These side effects may occur with certain frequencies, which are defined as follows:
Common: affects 1 to 10 users in 100.
Uncommon: affects 1 to 10 users in 1,000.
Rare: affects 1 to 10 users in 10,000.
Not Known: frequency cannot be estimated with the available data Common
• Skin exfoliation, itching, inflammatory skin eruption (erythema)
Uncommon
• Skin problems such as superficial growth or patch of the skin that does not resemble the area surrounding it (skin lesion), pigmentation, burning sensation of the skin.
• Irritation and pain at the site of application
Rare
• Eye irritation
• Dry skin, inflammation of the outer layer of the skin (eczema)
Not known
• Rash
• Hypersensitivity reaction
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE TERBINAFINE Keep out of the reach and sight 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.
If your doctor decides to stop your treatment, return any leftover medicine to the pharmacist.
Only keep it if your doctor tells you to.
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. FURTHER INFORMATION What Terbinafine contains
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, 15 g or 30 g)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Application held by:
ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany.
Manufactured by:
Merckle GmbH, Ludwig Merckle strasse 3,
89143 Blaubeuren, Germany. or
Gedeon Richter Ltd. 1103 Budapest, Gyomroi ut 19-21, Hungary.
Leaflet revised in: October 2012.