Document: Amorolfine Pierre Fabre medicated nail lacquer ENG PL change

• Amorolfine Pierre Fabre medicated nail lacquer PL
• Amorolfine Pierre Fabre medicated nail lacquer ENG PL

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The PL includes alternative texts for different legal status in different countries as follows:

- Boxed texts are only applicable for OTC versions.

- [Grey-shaded texts in brackets] are only applicable for prescription versions.

For OTC use in Sweden, please refer to the approved Swedish package leaflet published on our Webb site.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amorolfine Pierre Fabre 5% Medicated Nail Lacquer

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.

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 prescribed in this leaflet or as your doctor or pharmacist has told you.

- Keep this leaflet. You may need 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. See section 4.

- You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1. What Amorolfine Pierre Fabre 5% is and what it is used for

2. What you need to know before you use Amorolfine Pierre Fabre 5%

3. How to use Amorolfine Pierre Fabre 5%

4. Possible side effects

6. Contents of the pack and other information

Amorolfine Pierre Fabre 5% contains the active ingredient amorolfine (as the hydrochloride), which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections. Amorolfine Pierre Fabre 5% is used to treat fungal infections of the nails.

Do not use Amorolfine Pierre Fabre 5%

Warnings and precautions

Talk to your doctor or pharmacist before using Amorolfine Pierre Fabre 5%.

- Avoid contact of the lacquer with eyes, ears and mucous membranes.

- Nail files used for affected nails must not be used for healthy nails.

- During the treatment of Amorolfine Pierre Fabre 5% no cosmetic nail lacquer or artificial nails shall be used.

- If you are working with organic solvents (thinners, white spirit, etc.) you shall wear impermeable gloves in order to protect the Amorolfine Pierre Fabre 5% on the nails.

Children and adolescents

Amorolfine Pierre Fabre 5% is not recommended for children below the age of 18 years.

Other medicines and Amorolfine Pierre Fabre 5%

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

It has not been investigated whether Amorolfine Pierre Fabre 5% may interact with other medicines or not.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Experience with amorolfine use during pregnancy and breast-feeding is limited. Amorolfine Pierre Fabre 5% should not be used during pregnancy and breast-feeding unless the doctor considers it clearly necessary.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Always use this medicine exactly as described in this leaflet or as you doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults (above 18 years)

Amorolfine Pierre Fabre 5% should be applied to the affected finger nails once or twice a week or toe nails once a week exactly as directed by your doctor.

It is important to carry on using Amorolfine Pierre Fabre 5% until the infection has cleared and healthy nails have grown back. This usually takes 6 months for fingernails and 9 to 12 months for toenails. Your doctor will probably check how your treatment is progressing about every 3 months.

Check with your doctor or pharmacist if you are not sure.

Instructions for use

1. File the nail

F ile down the infected areas of nail, including the nail surface, as much as possible using a nail file (provided in some of the packs of Amorolfine Pierre Fabre 5%).

CAUTION: 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.

2. Clean the nail

U se one of the swabs provided (a swab impregnated with nail lacquer remover) to clean the nail surface. Repeat steps 1 and 2 for each affected nail.

3. Take some lacquer from the bottle

D ip one of the re-usable applicators into the bottle of nail lacquer. The lacquer must not be wiped off on the edge of the bottle before it is applied.

4. Apply the lacquer

A pply the nail lacquer evenly over the entire surface of the nail. Repeat steps 3 and 4 for each affected nail.

5. Allow to dry

L et the treated nail(s) dry for approximately 3 minutes.

6. Clean the applicator

T he applicators provided are re-useable. 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 the swab carefully as it is inflammable.

Before using Amorolfine Pierre Fabre 5% again, first remove the old lacquer 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, you should wear rubber or other impermeable gloves to protect the lacquer on your fingernails.

Important

If you use more Amorolfine Pierre Fabre 5% than you should

-If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.

If you stop using Amorolfine Pierre Fabre 5%

It is important to carry on using Amorolfine Pierre Fabre 5% until the infection has cleared and healthy nails have grown back. If you stop using it too early the infection may not disappear.

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 or it may become loose or start to separate from the nail bed.

• Breaking of the nails.

• Brittle nails.

Very rare (may affect up to 1 in 10,000 people):

Frequency not known (cannot be estimated from the available data):

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 the national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationnally]

5. How to store Amorolfine Pierre Fabre 5%

Keep this medicine out of the sight and reach of children.

Keep the bottle tightly closed.

Once opened, the product may be stored for a maximum of 6 months.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

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 Pierre Fabre 5% contains

The active substance is: amorolfine as the hydrochloride

The other ingredients are: ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethanol

What Amorolfine Pierre Fabre 5% looks like and contents of the pack

Amorolfine Pierre Fabre 5% is presented in a bottle with 2.5 or 5 ml medicated nail lacquer with spatulas and with or without cleansing swabs and nail files.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder : [to be completed nationally]

Manufacturer : P.W. Beyvers GmbH, Schaffhausener Str. 26 – 34, D-12099 Berlin, Germany.

This medicinal product is authorised in the Member States of the EEA under the following names:

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in 29 September 2016