Fenistil Cold Sore 1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Penciclovir

Available from:

Omega Pharma Ltd

ATC code:

D06BB06

INN (International Name):

Penciclovir

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100300; GTIN: 0000050080755

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENISTIL COLD SORE CREAM
PENCICLOVIR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 4 days.
WHAT IS IN THIS LEAFLET
1. What Fenistil Cold Sore Cream is and what it is used for
2. What you need to know before you use Fenistil Cold Sore Cream
3. How to use Fenistil Cold Sore Cream
4. Possible side effects
5. How to store Fenistil Cold Sore Cream
6. Contents of the pack and other information
1. WHAT FENISTIL COLD SORE CREAM IS AND WHAT IT IS USED FOR
The active ingredient in this medicine is Penciclovir, an antiviral
which is used to treat infections caused by
viruses. Fenistil Cold Sore Cream can be used to treat cold sores on
the lips and around the mouth.
You must talk to a doctor if you do not feel better or if you feel
worse after 4 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENISTIL COLD SORE CREAM
DO NOT USE FENISTIL COLD SORE CREAM
• If you are allergic to penciclovir, famciclovir or any of the
other ingredients of Fenistil Cold Sore Cream
(listed in section 6.)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Fenistil Cold Sore
Cream.
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.
Please check with your doctor or pharmacist before using Fenistil Cold
Sore Cream:
• if you are unsure that your sore is a cold sore,
• if you have a condition, or are receiving treatment which weakens
your immune system (i.e. the way your
body fights infection), for example,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fenistil Cold Sore Cream
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
Fenistil Cold Sore Cream is indicated for the treatment of herpes
simplex virus
infections of the lips and face (herpes labialis) in adults (including
older
people) and children over 12 years of age.
Immunocompromised patients: Fenistil Cold Sore Cream is not
recommended
for
use
in
immunocompromised
patients;
such
patients
should
consult
a
physician concerning the treatment of any infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including older people) and children over 12 years of age
Fenistil Cold Sore Cream 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.
Paediatric population
Children (under 12 years):
The safety and efficacy of Fenistil Cold Sore Cream in children below
12
years of age have not been established.
No data are available.
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,
p