Patient leaflet - Loceryl 0.25% w/w cream
1. What Loceryl is and what it is used for
- Loceryl is used to treat certain fungal infections of the skin (e.g. athlete’s foot). • Loceryl contains the active substance amorolfine (as the hydrochloride), which belongs to a group of medicines known as antifungals.
2. Before you use Loceryl
This medicine can cause allergic reactions, some can be serious. If this happens, stop applying the product, immediately wash away the product with water and soap and seek medical advice. The product must not be reapplied.
You must get urgent medical help if you have any of the following symptoms:
- You have difficulty breathing
- Your face, lips, tongue or throat swell
- Your skin develops a severe rash
Remove the product carefully in cleaning the skin.
The product should not be reapplied.
Do not use Loceryl
- If you are allergic (hypersensitive) to amorolfine or any of the other ingredients of Loceryl (see section 6 for other ingredients).
- If you are pregnant, planning to become pregnant, or are breast-feeding.
Take special care with Loceryl
- Avoid the cream coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils). Using other medicines
There are no known interactions with other medicines.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding, you should not use Loceryl unless clearly necessary.
Your doctor will then decide whether you should use Loceryl.
Do not apply Loceryl to your chest if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Loceryl
This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis).
3. How to use Loceryl
- Always use Loceryl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
- The cream should be rubbed gently into the infected skin area each evening after washing. It is important to continue using the cream until the infection clears up and for about 3 to 5 days after that. This generally means that you will need to use the cream for at least 2 to 3 weeks, but for some foot infections up to 6 weeks treatment may be needed.
If you get Loceryl in your eyes or ears
If you get Loceryl in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
If you accidently swallow Loceryl
If you, or anyone else, accidentally swallows the cream contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Loceryl
If you miss a treatment one evening, do not worry. Apply the cream the next evening and continue as directed by your doctor.
If you stop using Loceryl
Do not stop using Loceryl before your doctor tells you to or your infection could come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Loceryl can cause side effects, although not everybody gets them. In addition to the beneficial effects of Loceryl, it is possible that unwanted effects will occur during treatment, even when it is used as directed.
Rare: may affect up to 1 in 1,000 people
•Nail damages, nail discoloration, fragile or brittle nails.
Very rare: may affect up to 1 in 10,000 people
•Skin burning sensation.
Not known: frequency cannot be estimated from the available data
•Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)
•Redness, itching, hives, blister, allergic skin 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 or pharmacist.
5. How to store Loceryl
- Keep out of the reach and sight of children.
- Do not use Loceryl after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
- Keep the pack away from heat (Do not store above 25°C). 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 Loceryl contains
Loceryl contains 0.25% w/w of the active substance amorolfine (as the hydrochloride). The other ingredients are 2-phenoxy ethanol, polyoxyl 40 stearate, stearyl alcohol, liquid paraffin, white soft paraffin, carbomer, sodium hydroxide, disodium edetate and purified water.
What Loceryl looks like and contents of the pack
Loceryl is available in a tube with a screw cap. Each tube contains 20 g of cream.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Galderma (U.K.) Limited, Evergreen House North, Grafton Place, London, England, NW1 2DX. (PL 10590/0041)
Manufacturer: Laboratoires Galderma, ZI Montdésir, 74540 Alby sur Chéran, France.
Further information
You can get more information on Loceryl Cream from your doctor or pharmacist.