Out of date information, search another

Clavusimyl 5% W/V Medicated Nail Lacquer

Out of date information, search another

PACKAGE LEAFLET: INFORMATION FOR THE USER

CLAVUSIMYL® 5% W/V 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.

What is in this leaflet

1. What Clavusimyl is and what it is used for.

2. What you need to know before you use Clavusimyl.

3. How to use Clavusimyl.

4. Possible side effects.

5. How to store Clavusimyl.

6. Contents of the pack and other information.

1. What Clavusimyl is and what it is used for

Clavusimyl 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. Clavusimyl is used to treat fungal infections of the nails.

2. What you need to know before you use Clavusimyl Do not use Clavusimyl:

• 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 Clavusimyl:

• Avoid the lacquer coming into contact with the eyes, ears or mucousmembranes (e.g. mouth and nostrils).

• Cosmetic nail varnish or artificial nails should not be used during treatment.

Children and adolescents

There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

Other medicines and Clavusimyl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility

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 using this medicine. Your doctor will then decide whether you should use Clavusimyl.

3. How to use Clavusimyl

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Clavusimyl 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 Clavusimyl, 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. (Fig. 1)

Fig.1

Fig. 3

2. Clean the surface of the nail and remove any grease using the swabs provided. (Fig. 2)

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. (Fig. 3)

Fig. 6

4. Repeat the operations 1 to 3 for each affected nail.

5. Clean the spatula using the swabs provided. (Fig. 5)

6. Seal the bottle completely. Let the treated nail(s) dry for approximately 3 minutes.

(Fig. 6)

Date: 02 APR 2014

Description	Clavusimyl 5% ALL			No. of colours
Component Type	Leaflet	Pharma Code	N/A	Colours
Affiliate Item Code	398404	SAP No.	N/A	Non-Print Colours
Superceded Affiliate Item Code	353101	Vendor Job No.	227519	Non-Print Colours
TrackWise PR No.	398404	Proof No.	1	Equate CMYK
MA No.	36143/0004	Client Market	UK	with
Packing Site/Printer	NA	Keyline/DrawingNo]	N/A	Main Font
Supplier Code	TBC	Barcode Info	N/A	Dimensions
Sign-offs

Black

Myriad Pro 100 x 340mm

Time: 14:55

Page Count I

Body Text Size 9 pt

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 Clavusimyl 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 Clavusimyl 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 Clavusimyl in your eyes or ears

If you get Clavusimyl in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.

If you accidentally swallow Clavusimyl

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

If you forget to use Clavusimyl

Don't worry if you forget to use Clavusimyl at the right time. When you remember, start using the product again, in the same way as before.

If you stop using Clavusimyl

Do not stop using Clavusimyl 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:

• Redness of the skin (erythema)

• Itching of the skin (pruritus)

• Allergic skin reaction (contact dermatitis)

• Hives (urticaria)

• Blisters

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 Clavusimyl

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 Clavusimyl contains

The active substance is amorolfine hydrochloride. 1 ml of Clavusimyl 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 Clavusimyl looks like and contents of the pack

Amber glass type I bottle stopped with HDPE cap with a Teflon liner.

Pack sizes: 2.5 ml, 3 ml, 5 ml. All packs contain 30 cleansing swabs, 10 spatulas and 30 nail files. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire EN6 1TL, UK.

Manufacturer

Farmaclair at 440, avenue du General de Gaulle, 14200 Herouville Saint Clair, France.

Sodia, Avenue Robert Schumann, Reims, 51100 France

This leaflet was last revised in: 03/2014 398404

00000000