FENLIPS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PENCICLOVIR

متاح من:

PERRIGO ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

D06BB06

الشكل الصيدلاني:

CREAM

تركيب:

PENCICLOVIR 10 MG/G

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

OMEGA PHARMA LTD. UNITED KINGDOM

المجموعة العلاجية:

PENCICLOVIR

المجال العلاجي:

PENCICLOVIR

الخصائص العلاجية:

For the topical treatment for cold sores (oral herpes).

تاريخ الترخيص:

2014-12-31

نشرة المعلومات

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed without a doctor’s
prescription
FENLIPS
Cream
1 gram of cream contains:
Penciclovir 10 mg
Inactive
ingredients
and
allergens
in
the
medicine are listed in section 6.
READ
THIS
ENTIRE
LEAFLET
CAREFULLY
BEFORE
USING THE MEDICINE. This leaflet contains
concise information about the medicine. If you
have further questions, refer to the doctor or
pharmacist.
Use the medicine according to the instructions
in the dosage section of this leaflet. Consult
a pharmacist if you need more information.
Refer to the doctor if the symptoms of illness
worsen or do not improve after 4 days.
1.
WHAT
IS
THE
MEDICINE
INTENDED FOR?
Fenlips is intended for local treatment of cold
sores )Herpes labialis(.
THERAPEUTIC GROUP: Anti-viral for local use.
2. BEFORE USING THE
MEDICINE
DO NOT USE THE MEDICINE IF:
• you
are
hypersensitive
)allergic(
to
the
active ingredient penciclovir, to famciclovir
or
to
any
of
the
other
ingredients
the
medicine contains )mentioned in section 6(.
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE
• Do not use the cream inside your mouth, in
or near your eyes, nose or on your genital
area. Avoid applying the cream near your
eyes.
Talk to the doctor or pharmacist before starting
to use Fenlips.
!
BEFORE TREATMENT WITH FENLIPS CONSULT THE
DOCTOR IF:
• you are unsure that your sore is a cold sore.
• you
have
a
condition,
or
are
receiving
treatment
which
weakens
your
immune
system
)i.e.
the
way
your
body
fights
infection(, for example, HIV infection, a bone
marrow transplant or cancer treatment.
• you need to treat ulcers or blisters which
appear around your eyes or genital area.
Contact your doctor if your cold sore gets
worse or is severe.
!
CHILDREN AND ADOLESCENTS
• Fenlips
is
not
recommended
for
the
treatment of children under 12 years of age.
!
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER
MEDICINES,
INCLUDING
NON-PRESCRIPTION
MEDICINES AND NUTRITIONAL SUPPL

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCTS
Fenlips / Fenlips Color
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of the cream contains:
10 mg penciclovir
Excipients with known effect: cetostearyl alcohol, propylene glycol
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream
Smooth white cream of homogeneous appearance.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fenlips / Fenlips Color is indicated for the topical treatment of cold
sores
(oral herpes).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including older people) and children over 12 years of age:
Fenlips / Fenlips Color should be applied at approximately two hourly
intervals during waking hours (approximately 8 times a day). Treatment
should be continued for 4 days. If the condition gets worse or does
not
improve after 4 days treatment, seek medical advice.
Treatment should be started as early as possible after the first sign
of an
infection; moreover the product has been shown to be beneficial in
accelerating lesion healing, reducing lesion pain and shortening the
duration of viral shedding even in patients who begin treatment later
in the
disease (e.g. when the papule or vesicle has developed).
Children (under 12 years):
No work has been carried out in children below 12 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to penciclovir, famciclovir or to any of the
excipients listed
in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The cream should only be used on cold sores on the lips and around the
mouth. It is not recommended for application to mucous membranes (e.g.
in the eyes, mouth, or nose or on the genitals). Particular care
should be
taken to avoid application in or near the eyes.
Patient with particularly severe cold sores should be encouraged to
seek
medical advice.
Patients should be advised to avoid transmitting the virus,
particularly
when active lesions are present.
Immunocompromised patients (e.g. AIDs patients or bone marrow
transplant recipients) shoul