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CLAVUSIMYL 5% W/V MEDICATED NAIL LACQUER

Active substance(s): AMOROLFINE HYDROCHLORIDE

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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

Fig. 1

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

Fig. 2

Fig. 3
Fig. 5

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)
4. Repeat the operations 1 to 3 for each
affected nail.
5. Clean the spatula using the swabs provided.
(Fig. 5)

Fig. 6

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

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 or Type III 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: 03/2015

602844

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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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