Amorolfine 5% W/V Medicated Nail Lacquer
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Amorolfine
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Amorolfine Nail Lacquer is and what it is used for
2. What you need to know before you use Amorolfine Nail Lacquer
3. How to use Amorolfine Nail Lacquer
4. Possible side effects
5. How to store Amorolfine Nail Lacquer
6. Contents of the pack and other information
1. WHAT AMOROLFINE NAIL LACQUER IS AND WHAT IT IS USED FOR
Amorolfine Nail Lacquer contains the active substance amorolfine (as amorolfine hydrochloride), which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections.
Amorolfine Nail Lacquer is used to treat fungal infections of the nails.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE NAIL LACQUER
Do not use Amorolfine Nail Lacquer:
• if you are allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Amorolfine Nail Lacquer
• Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils).
• Avoid use of nail varnish or artificial nails during treatment.
• When using chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on your fingernails.
Children and adolescents
Children should not be treated with Amorolfine Nail Lacquer owing to the lack of clinical experience available to date.
Other medicines and Amorolfine Nail Lacquer
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 using this medicine. Your doctor will then decide whether you should use Amorolfine Nail Lacquer.
3. HOW TO USE AMOROLFINE NAIL LACQUER
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Amorolfine Nail Lacquer should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor.
Instructions for use
1. Before the first application of Amorolfine Nail Lacquer, carefully clean your nails: file down the affected area of the nail (particularly its surface) as completely as possible using the nail file provided. Take care not to file the skin around the nail.
2. Clean the surface of the nail and remove any grease using the swabs provided.
3. Apply the varnish using one of the reusable spatulas (provided in the carton) to the entire affected nail. Clean the reusable spatula between use on different nails, to avoid contaminating the varnish. Do not wipe the spatula on the edge of the bottle.
4. Repeat the operations 1 to 3 for each affected nail.
5. Clean the spatula using the swabs provided.
6. Seal the bottle completely.. Let the treated nail(s) dry for approximately 3 minutes.
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Do not use nail files used for infected nails on healthy nails, otherwise you may spread the infection. To prevent the spread of infection take care that no one else uses the files from your kit.
The spatulas provided are re-usable. However, it is important to clean them thoroughly after completing each treatment procedure, using the same swab you used for nail cleansing. Avoid touching newly treated nails with the swab. Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable.
• Before using Amorolfine Nail Lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
• Re-apply the lacquer as described above.
• When dry the nail lacquer is unaffected by soap and water, so you may wash your hands and feet as normal. If you need to use chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on your fingernails.
• It is important to carry on using Amorolfine Nail Lacquer until the infection has cleared and healthy nails have grown back. This usually takes 6 months for finger nails and 9 to 12 months for toe nails.
Your doctor will probably check how your treatment is progressing every 3 months or so.
If you get Amorolfine Nail Lacquer in your eyes or ears
If you get Amorolfine Nail Lacquer in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
If you accidentally swallow Amorolfine Nail Lacquer
If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Amorolfine Nail Lacquer
Don't worry if you forget to use Amorolfine Nail Lacquer at the right time. When you remember, start using the product again, in the same way as before.
If you stop using Amorolfine Nail Lacquer
Do not stop using Amorolfine Nail Lacquer before your doctor tells you to or your infection could come back.
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.
Rare: may affect up to 1 in 1,000 people
Your nail may become discoloured, broken or brittle.
Very rare: may affect up to 1 in 10,000 people
A burning sensation may occur in the area around the nail.
Not known: frequency cannot be estimated from the available data
Allergic skin reaction (contact dermatitis), skin reddening, itchy skin, hives, blisters.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: 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 AMOROLFINE NAIL LACQUER
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 pack after EXP The expiry date refers to the last day of that month. Protect from heat. Keep bottle tightly closed after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Amorolfine Nail Lacquer contains
• The active substance is amorolfine hydrochloride. 1 ml of Amorolfine Nail Lacquer contains amorolfine hydrochloride corresponding to 50 mg amorolfine.
• The other ingredients are: Ethanol anhydrous, Ammonio Methacrylate Copolymer (type A), Ethyl acetate, Butyl acetate, Triacetin.
What Amorolfine Nail Lacquer looks like and contents of the pack
Amber glass type I or III bottle stopped with HDPE cap with a Teflon liner
Pack sizes:
2.5ml, 3ml, 5ml
All packs contain 30 cleansing swabs, 10 spatulas and 30 nail files. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 HafnarfjorQur Iceland
Manufacturer
Sodia, Avenue Robert Schuman, 51100 Reims, France This leaflet was last revised June 2014.
AAAG7645
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Amorolfine 5% w/w Nail Laquer PIL - UK (Arrow) |
colours/plates: | ||
|
1. Black | |||
|
^actavis creating value In pharmaceutical! |
item no: AAAG7645 |
dimensions: 100 x 340 |
2. |
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print proof no: 6 |
pharmacode: |
3. | |
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4. | |||
|
origination date: 08.04.14 |
min pt size: 7.8 |
5. | |
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6. | |||
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approved for print/date |
revision date: 09.09.14 |
Technical Approval |
Non Printing Colours |
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1. | |||
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date sent: 08.04.14 | |||
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2. | |||
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supplier: Sodia |
approved: 28.04.14 |
3. | |