FENLIPS COLOR

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

PENCICLOVIR

Verfügbar ab:

PERRIGO ISRAEL AGENCIES LTD, ISRAEL

ATC-Code:

D06BB06

Darreichungsform:

CREAM

Zusammensetzung:

PENCICLOVIR 10 MG/G

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

Not required

Hergestellt von:

OMEGA PHARMA LTD. UNITED KINGDOM

Therapiebereich:

PENCICLOVIR

Anwendungsgebiete:

For the topical treatment for cold sores (oral herpes)

Berechtigungsdatum:

2015-04-01

Gebrauchsinformation

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed without a doctor’s
prescription
FENLIPS COLOR
Cream
1 gram of cream contains:
Penciclovir 10 mg
The inactive and allergenic ingredients in the
medicine are listed in section 6.
READ THIS 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 intended for children over
the age of 12 and adults. Below this age, refer
to a doctor. Use the medicine properly. If you
need more information, consult a pharmacist.
Refer to the doctor if the signs of the illness
(symptoms) worsen or do not improve after
4 days.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Fenlips color 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 sensitive (allergic) to the active
ingredient penciclovir, famciclovir, or to
any of the additional ingredients contained
in the medicine, such as propylene glycol
(listed in section 6).
∙ Do not use the medicine on mucous
membranes (e.g., genitals and inside the
mouth) and in the eyes.
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE
∙ If you have a WEAKENED IMMUNE SYSTEM,
only use Fenlips color upon the doctor’s
recommendation.
∙ If you are uncertain WHETHER YOUR SORE IS
A COLD SORE, consult a doctor.
∙ Fenlips color has not been tested in children
under 12 years of age. Therefore, do not
use the medicine in children under 12 years
of age. BEFORE TREATMENT WITH FENLIPS COLOR,
TELL THE DOCTOR IF you are suffering from
other ailments, or if you are suffering from
allergies. DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN
OTHER MEDICINES, INCLUDING NON -PRESCRIPTION
MEDICINES AND FOOD SUPPLEMENTS, TELL THE
DOCTOR OR PHARMACIST. PREGNANCY AND BREASTFEEDING
If you are pregnant or breastfeeding, consul

Fachinformation

1 NAME OF THE MEDICINAL PRODUCTS
FENLIPS / FENLIPS COLOR
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of Fenlips contains 10 mg penciclovir.
Excipients: 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 (herpes labialis) suspected
to be caused by Herpes simplex virus.
Penciclovir significantly shortens healing time, reduces
lesion-associated pain and
significantly shortens the duration of viral shedding.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) 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). Fenlips may be applied with a clean
finger or with a single-use
applicator (for packages which contain applicators), in the amount
required for the size of the
affected area of skin. 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).
4
Children (under 12 years):
No work has been carried out in children below 12 years of age.
4.3 CONTRAINDICATIONS
Known hypersensitivity to penciclovir, famciclovir or any of the
excipients in the formulation (e.g.
propylene glycol).
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, such as in the mouth
or eye, or on the genitals.
It must not be used in o