BATRAFEN NAIL LACQUER

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CICLOPIROX

Available from:

PHARMA SHALOM

ATC code:

D01AE14

Pharmaceutical form:

LACQUE

Composition:

CICLOPIROX 80 MG/G

Administration route:

TOPICAL-NAIL

Prescription type:

Not required

Manufactured by:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

CICLOPIROX

Therapeutic area:

CICLOPIROX

Therapeutic indications:

For the treatment of fungal infections of the nails.

Authorization date:

2014-09-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS)
– 1986
The medicine is dispensed without a doctor’s prescription
NAME OF THE PREPARATION AND ITS FORM:
BATRAFEN NAIL LACQUER
ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each 1 gram contains:
Ciclopirox 80 mg
Inactive ingredients - see section 6 - Further information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
THIS MEDICINE IS NOT INTENDED FOR USE IN CHILDREN UNDER THE AGE OF 12;
UNDER THIS
AGE, REFER TO A DOCTOR.
This medicine does not require a doctor’s prescription. You must
always use it as
described in this leaflet or in accordance with the instructions you
received from the
doctor or pharmacist. Consult the pharmacist if you need further
information. Refer to
the doctor if the symptoms of the illness worsen or are not improving
after 6 months of
treatment.
Keep this leaflet, you may need to read it again.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of fungal infections of the
fingernails and
toenails.
THERAPEUTIC GROUP:
Antimycotic (antifungal) from the hydroxypyridone group.
2.
BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE:
•
If you are sensitive (allergic) to the active ingredient, ciclopirox,
or to any of the
additional ingredients contained in the medicine (see Section 6).
•
If you are pregnant or breastfeeding.
•
In children under the age of 12.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
•
In the following cases, do not use the preparation without consulting
a doctor
before starting treatment:
If you are a diabetic patient being treated with insulin or if you
have diabetic
neuropathy, if you suffer or have suffered in the past from immune
system
suppression, for example: if you have undergone a transplant, if you
are taking
medicines for epilepsy, if you are using topical corticosteroids
regularly (on a
mon

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Batrafen Nail Lacquer
Active substance: ciclopirox
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g medicated nail lacquer contains 80 mg ciclopirox.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Medicated nail lacquer for application to the nails.
4.
CLINICAL PARICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of fungal infections of the nails
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Batrafen Nail Laquer is applied in a thin layer every other day in the
first month, at least twice
weekly in the second month and once a week from the third month
onwards.
METHOD OF ADMINISTRATION
As much as possible of the destroyed nail material should be removed
before the start of
treatment with Batrafen Nail Laquer, for example with scissors or with
the enclosed disposable
nail files.
Unless directed otherwise, Batrafen Nail Laquer is applied in a thin
layer to the diseased nail
every other day in the first month. In this way, the nail is saturated
with the active substance.
In the second month of treatment, application can be reduced to at
least twice weekly and to
once a week from the third month of treatment onwards.
Throughout the application period the entire layer of lacquer is
removed once a week with
alcohol swabs. During this process too, as much as possible of the
affected nail material
should be removed with disposable nail files.
If in the meantime the layer of lacquer becomes damaged, it is
sufficient to paint over the
chipped areas again with Batrafen Nail Laquer.
Do not use nail polish or other nail cosmetic products on the treated
nails.
DURATION OF ADMINISTRATION
The duration of use depends on the severity of the infection, but
should not exceed a treatment
period of 6 months.
In this period, the pathogens of the nail fungal infection are
generally killed off. The doctor will
decide whether it is necessary to continue treatment.
PEDIATRIC PATIENTS
Based on the safety profile in adults, Batrafen Nail Laquer is
considered safe for use in chil