Lamisil 1% Cream
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(terbinafine hydrochloride)
Read all of this leaflet carefully before you start taking 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 or pharmacist.
The name of your medicine is LAMISIL 1% Cream but it will be referred to as Lamisil Cream throughout this leaflet.
In this leaflet:
1. What Lamisil Cream is and what it is used for
2. Before you use Lamisil Cream
3. How to use Lamisil Cream
4. Possible side effects
5. How to store Lamisil Cream
6. Further information
1. What Lamisil Cream is and what it is used for
Lamisil Cream is used to treat patients with fungal and certain yeast infections of the skin. It attacks and kills the fungus or yeast which is causing your infection.
2. Before you use Lamisil Cream
Do NOT use Lamisil Cream if you:
• are allergic (hypersensitive) to any of the ingredients in the product (see Section 6)
The cream is NOT recommended for use on children.
Take special care with Lamisil Cream
The cream is for external use only. Do not use on the face. Avoid contact with eyes. In case of accidental contact with eyes, rinse thoroughly with running water.
Taking 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 and breast-feeding
Do not use the cream if you are pregnant or breast-feeding, unless advised to by your doctor. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Lamisil Cream is not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Lamisil Cream
• cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis).
For other ingredients see Section 6.
3. How to use Lamisil Cream Adults
Your doctor will decide the right amount of Lamisil Cream for you to use and will tell you for how long to use your medication.
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 Lamisil Cream, but may reappear if the cream is not applied regularly or is stopped too early.
Directions for use:
• Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin.
• Unscrew the cap then gently squeeze out a small amount of the cream onto your finger.
• Apply just enough cream to form a thin layer on the affected skin and surrounding areas.
• Rub in gently. When used between the toes, buttocks or on the groin, the treated area may be covered with a light, fresh gauze strip, especially at night.
• Replace the cap on the tube and wash your hands.
Even though you will not be using Lamisil Cream during the second week for Athlete's foot, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.
Children
Use in Children is NOT recommended, since there are no data to support use in this population.
If you accidently swallow Lamisil Cream
Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some cream. 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 Lamisil Cream
If you miss an application, apply the cream as soon as possible then continue your treatment as before. If you only remember at the time of your next application, just apply the cream and carry on as normal. 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 Lamisil 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, Lamisil Cream can cause 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 and 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.
If any of these side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.
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 at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Lamisil Cream
Do not take your medicine after the expiry date which is stated on the carton and tube label after ‘Exp'. The expiry date refers to the last day of that month.
Do not store above 30°C.
Replace the cap on the tube after use.
Keep out of the sight and reach of children. Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your cream become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
6. Further information
What Lamisil Cream contains
Lamisil Cream contains 1% w/w terbinafine hydrochloride.
The other ingredients are: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate and water demineralised.
(See also end of Section 2 for further information on some of the ingredients).
What Lamisil Cream looks like and contents of the pack
Lamisil Cream is a white smooth cream in aluminium tubes with a white screw cap.
Lamisil Cream is available in tubes of 15g.
Manufactured by: Novartis Consumer Health SA, Nyon 1, CH-1260, Switzerland.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK. I POM I
LAMISIL® 1% Cream PL No: 18799/2032
Leaflet date: 19.03.2015
Lamisil is a registered trade mark of Novartis.
TERBINAFINE
HYDROCHLORIDE 1% Cream
Read all of this leaflet carefully before you start taking 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 or pharmacist.
The name of your medicine is TERBINAFINE HYDROCHLORIDE 1% Cream but it will be referred to as Terbinafine hydrochloride Cream throughout this leaflet.
In this leaflet:
1. What Terbinafine hydrochloride Cream is and what it is used for
2. Before you use Terbinafine hydrochloride Cream
3. How to use Terbinafine hydrochloride Cream
4. Possible side effects
5. How to store Terbinafine hydrochloride Cream
6. Further information.
1. What Terbinafine hydrochloride Cream is and what it is used for
Terbinafine hydrochloride Cream is used to treat patients with fungal and certain yeast infections of the skin. It attacks and kills the fungus or yeast which is causing your infection.
2. Before you use Terbinafine hydrochloride Cream
Do NOT use Terbinafine hydrochloride Cream if you:
• are allergic (hypersensitive) to any of the ingredients in the product (see Section 6)
The cream is NOT recommended for use on children.
Take special care with Terbinafine hydrochloride Cream
The cream is for external use only. Do not use on the face. Avoid contact with eyes. In case of accidental contact with eyes, rinse thoroughly with running water.
Taking 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 and breast-feeding
Do not use the cream if you are pregnant or breast-feeding, unless advised to by your doctor. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Terbinafine hydrochloride Cream is not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Terbinafine hydrochloride Cream
• cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis).
For other ingredients see Section 6.
3. How to use Terbinafine hydrochloride Cream Adults
Your doctor will decide the right amount of Terbinafine hydrochloride Cream for you to use and will tell you for how long to use your medication.
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 hydrochloride Cream, but may reappear if the cream is not applied regularly or is stopped too early.
Directions for use:
• Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own clean towels and clothes, and not rubbing or scratching the skin.
• Unscrew the cap then gently squeeze out a small amount of the cream onto your finger.
• Apply just enough cream to form a thin layer on the affected skin and surrounding areas.
• Rub in gently. When used between the toes, buttocks or on the groin, the treated area may be covered with a light, fresh gauze strip, especially at night.
• Replace the cap on the tube and wash your hands.
Even though you will not be using Terbinafine hydrochloride Cream during the second week for Athlete's foot, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.
Children
Use in Children is NOT recommended, since there are no data to support use in this population.
If you accidently swallow Terbinafine hydrochloride Cream
Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some cream. 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 hydrochloride Cream
If you miss an application, apply the cream as soon as possible then continue your treatment as before. If you only remember at the time of your next application, just apply the cream and carry on as normal. 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 hydrochloride 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, Terbinafine hydrochloride Cream can cause 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 and 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.
If any of these side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.
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 at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Terbinafine hydrochloride Cream
Do not take your medicine after the expiry date which is stated on the carton and tube label after ‘Exp'. The expiry date refers to the last day of that month.
Do not store above 30°C.
Replace the cap on the tube after use.
Keep out of the sight and reach of children. Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your cream become discoloured or show any signs of deterioration, seek the advice of your pharmacist
6. Further information
What Terbinafine hydrochloride Cream
contains
Terbinafine hydrochloride Cream contains 1% w/w terbinafine hydrochloride.
The other ingredients are: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate and water demineralised.
(See also end of Section 2 for further information on some of the ingredients).
What Terbinafine hydrochloride Cream looks like and contents of the pack
Terbinafine hydrochloride Cream is a white smooth cream in aluminium tubes with a white screw cap.
Terbinafine hydrochloride Cream is available in tubes of 15g.
Manufactured by: Novartis Consumer Health SA, Nyon 1, CH-1260, Switzerland.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK. I POM I
TERBINAFINE HYDROCHLORIDE 1% Cream PL 18799/2032
Leaflet date: 19.03.2015