Lloydspharmacy Athletes Foot 1% W/W Cream
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Terbinafine Hydrochloride 10 mg/g cream
terbinafine hydrochloride
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you..
- Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you
- Keep this leaflet. You may want to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet
- You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
What is in this leaflet
1. What Terbinafine Hydrochloride 10 mg/g cream (hereafter Terbinafine) is and what it is used for
2. What you need to know before you use Terbinafine
3. How to use Terbinafine
4. Possible side effects
5. How to store Terbinafine
6. Contents of the pack and other 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 such as Athlete’s foot and jock itch. You can treat mild, transient complaints before seeking medical attention or supervision. To achieve optimal effect you should use this medicine carefully and expertly.
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 is not for nail infections
2. What you need to know before you use Terbinafine Do not use Terbinafine:
- if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
- the use of Terbinafine is not recommended for children.
Warnings and precautions
Talk to your doctor or pharmacist before using Terbinafine.
Terbinafine is 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.
After application you should always wash your hands.
Children
The use of Terbinafine is not recommended for children.
Other medicines and Terbinafine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known drug interactions with Terbinafine.
Pregnancy and breast-feeding
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.
Pregnancy
Ask your doctor or pharmacist for advice before using Terbinafine.
Terbinafine should not be used during pregnancy unless a physician advises, who decides the potential benefits outweigh any potential risks.
Breast-feeding
Ask your doctor or pharmacist for advice before using Terbinafine.
Terbinafine passes into mother’s milk, therefore, it should not be used during breastfeeding period. Infants must not be allowed to come into contact with any treated skin, including the breast.
Driving and using machines
Terbinafine has no influence on the ability to drive and use machines.
Terbinafine contains cetyl alcohol and stearyl alcohol, so the medicinal product can induce local skin irritation (e.g. contact dermatitis).
3. How to use Terbinafine
Always use this medicine exactly as described in this leaflet or 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.
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.
Duration of treatment according to types of infections:
Fungal infection of the foot:
1 week/once or twice daily treatment should be continued for one week even if the affected area starts healing earlier. This way you can avoid the return of infection and treatment will be successful.
The effect of use of the cream will stop the infection quickly due to the killing of the pathogenic fungus. However, complete healing may take longer depending on the extent of inflammation. The effect of Terbinafine cream persists after treatment, even when you have finished using the preparation.
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.
Use in children
The use of Terbinafine is not recommended for children.
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.
If you use more Terbinafine than you should
If you use more Terbinafine cream than you should please contact your doctor or pharmacist.
In case of accidental ingestion of Terbinafine cream, headache, nausea, epigastric pain and dizziness may be expected. Contact a doctor who will introduce appropriate follow up.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local symptoms such as itching (pruritus), peeling of the skin (skin exfoliation), application site pain, application site irritation, pigmentation disorder, skin burning sensation, redness of the skin (erythema), scab, etc. may occur at the site of application. These harmless symptoms must be distinguished from hypersensitivity reactions including rash, which are reported in sporadic cases and require discontinuation of therapy. In case of accidental contact with the eyes terbinafine may be irritating to the eyes. In rare cases the underlying fungal infection may be worsened.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Not known: frequency cannot be estimated from the available data.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Common Peeling skin, itching of the skin
Uncommon Damage to the skin, scab, skin disorder, pigmentation disorder, redness of the
skin (erythema), skin burning sensation, pain, application site pain, application site irritation
Rare Eye irritation
Dry skin, redness and swelling of the skin (contact dermatitis), eczema Worsening of the skin condition
Not known Hypersensitivity*, rash*
*Based on post-marketing experience
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Terbinafine
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.
Keep out of the sight and reach of children.
Only keep it if your doctor tells you to.
If your doctor decides to stop your treatment, return any left over medicine to the pharmacist.
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
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 and 15 g)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Application held by: Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19-21, Hungary
Manufactured by: Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19-21, Hungary
Leaflet revised in