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CLAVUSIMYL 5% W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE / AMOROLFINE HYDROCHLORIDE / AMOROLFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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.
2.
3.
4.
5.
6.

What Clavusimyl is and what it is used for
What you need to know before you use Clavusimyl
How to use Clavusimyl
Possible side effects
How to store Clavusimyl
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).
• Do not inhale
• Cosmetic nail varnish or artificial nails should not be used
during treatment.
• Wear impermeable (waterproof) gloves when using organic
solvents e.g. paint strippers, thinners, to stop the nail lacquer
from being removed.

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 and breast-feeding

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

3. Apply the nail lacquer 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 nail lacquer. 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.

Date: 03 MAY 2016

Description Amorolfine 5% all
Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 875465

SAP No. N/A

Colours

Superceded Affiliate Item Code 602844
TrackWise PR No. 875465
MA No. 36143/0004
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 279885
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 13:08
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 100 x 340 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.
• B
 efore 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)

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 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 bottle with child-proof plastic cap containing a clear
colourless solution.
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 Authorization 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 Schuman – 51100 Reims France
This leaflet was last revised in 05/2016
875465

Date: 03 MAY 2016

Description Amorolfine 5% all
Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 875465

SAP No. N/A

Colours

Superceded Affiliate Item Code 602844
TrackWise PR No. 875465
MA No. 36143/0004
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 279885
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 13:08
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 100 x 340 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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