1% cream
terbinafine hydrochloride
WHAT LAMISIL IS AND WHAT IT IS USED FOR
Lamisil cream is used to treat foot fungus between the toes and fungal infection in the groin (also candida ). Cream one can also be prescribed by a doctor for other uses
Lamisil cream blocks a reaction in the fungus’ metabolism, which causes the fungus to die and infection can heal faster.
BEFORE YOU USE LAMISIL
Do not use Lamisil
- if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).
Take special care with Lamisil
The cream can irritate the eyes. Avoid contact with the eyes. If cream accidentally comes into contact with the eyes, rinse them with running water. Contact a doctor if discomfort persists.
Lamisil cream is not intended for the treatment of fungal infections of the nails. If you suspect that you have a fungal infection of the nails (eg discoloration or thickening of the nail), consult a doctor.
For external use.
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
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 taking this medicine.
Pregnancy
Do not use Lamisil during pregnancy unless your doctor tells you it’s necessary.
Breast-feeding
This medicine can pass into breast milk. If you are breastfeeding, talk to your doctor before using this medicine. Infants should not come into contact with treated skin areas, including the breasts.
Driving and using machines
Lamisil has no known effect on the ability to drive or use machines.
Important information about some of the ingredients of Lamisil cream
Lamisil cream contains benzyl alcohol
This medicine contains 10 mg / g benzyl alcohol.
Benzyl alcohol can cause allergic reactions and mild local irritation.
Lamisil cream contains cetyl alcohol
Cetyl alcohol may cause local skin reactions (eg contact dermatitis).
Lamisil cream contains stearyl alcohol
Stearyl alcohol can cause local skin reactions (eg contact dermatitis).
HOW TO USE LAMISIL
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults and children from 12 years and up Show larger
| Foot fungus between the toes: | Once a day for a week. |
| Fungal infection and candida in the groin: | Once-daily for two 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 so as not to have a relapse. If the symptoms do not start to disappear within two weeks after starting treatment with Lamisil cream, you should contact your doctor, as your problems may have been caused by something other than a fungal infection.
Lamisil Cream is not recommended for children under 12 years without a doctor’s prescription.
Instructions for use
Thoroughly clean and dry affected areas before using Lamisil cream. Apply a thin layer of cream on and around the affected skin and rub it lightly.
Wash your hands after the treatment so that the cream does not accidentally get in the eyes.
If you use more Lamisil than you should
If you have ingested too much medicine or if e.g. a child accidentally ingested the drug. contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
POSSIBLE SIDE EFFECTS
Like all medicines, Lamisil cream can cause side effects, although not everybody gets them. Some may suffer from redness of the skin, itching, flaking of the skin, pain, irritation, pigment changes, scabies, or burning in the treated areas. These symptoms are usually mild but still inform your doctor if such symptoms occur as they may be a sign of an allergy, especially in rashes, blisters, and hives.
Common (affects more than 1 user in 100): Peeling, itching
Uncommon (affects less than 1 in 100 people): Skin damage, scabies, skin changes, pigmentation disorders, reddening of the skin, pain, irritation, and burning sensation on the skin where the cream has been applied.
Rare (affects less than 1 in 1,000 people): Dry skin, contact dermatitis, eczema.
No known frequency (can not be calculated from the available data): Hypersensitivity, rash
If you accidentally get cream in your eyes, terbinafine may be irritating to your eyes. In rare cases, the underlying fungal infection may worsen.
HOW TO STORE LAMISIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
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.
FURTHER INFORMATION
Content declaration
The active substance is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride.
The other ingredients are sodium hydroxide, benzyl alcohol ( preservative ), sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.
What the medicine looks like and contents of the pack
The cream one is white.
Lamisil cream is available in aluminum tubes internally coated with varnish or in laminated aluminum tubes with polyethylene on the inside, with or without aluminum membranes, and closed with screw caps made of polypropylene.
Lamisil is packaged in tubes in sizes 7.5 g, 15 g, and 30 g.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare ApS
PO Box 61
2610 Rødovre
Denmark
Tel: 020-100579
Manufacturer
GlaxoSmithKline Consumer Healthcare ApS
Nykær 68
2605 Brøndby
Denmark