Blistex Cold Sore Cream 100mg/g cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Docosanol

Available from:

D.D.D. Limited

ATC code:

D06BB; D06BB11

INN (International Name):

Docosanol

Dosage:

100 milligram(s)/gram

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antivirals; docosanol

Authorization status:

Not marketed

Authorization date:

2007-06-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BLISTEX
COLD SORE CREAM
100MG/G CREAM, DOCOSANOL
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Blistex Cold
Sore Cream 100mg/g cream carefully to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must stop using the cream and contact a doctor if your symptoms
worsen or do
not improve after 10 days.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What is Blistex Cold Sore Cream 100mg/g cream and what it is used for
2.
Before you use Blistex Cold Sore Cream 100mg/g cream
3.
How to use Blistex Cold Sore Cream 100mg/g cream
4.
Possible side effects
5.
How to store Blistex Cold Sore Cream 100mg/g cream
6.
Further information
1.
WHAT BLISTEX COLD SORE CREAM 100MG/G CREAM IS AND WHAT IT IS USED
FOR
Docosanol is an antiviral agent. Blistex Cold Sore Cream 100mg/g cream
is a white cream
used for the treatment of early stages of recurrent labial herpes
simplex infection (cold sores) )
in adults and adolescents (over 12 years old).
To be effective, treatment with Blistex Cold Sore Cream 100mg/g cream
should start in the
early stages of a cold sore, before the blisters appear. Start using
Blistex Cold Sore Cream
100mg/g cream as soon as you get any of the symptoms of a cold sore,
such as redness,
itching, pain, tingling or prickling. Continue using until the cold
sore is healed, usually 4-6
days.
The cause of cold sores is a herpes simplex virus infection. The
infection may break out when
the immune system is weakened, during stress or during a menstrual
period. The virus causes
blisters or sores, mainly on the lips.
2.
BEFORE YOU USE BLISTEX COLD SORE CREAM 100MG/G CREAM
DO NOT USE BLISTEX COLD SORE CREAM 100MG/G CREAM
If you are allergic (hypersensitiv

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blistex Cold Sore Cream 100mg/g cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 100 mg of docosanol.
Excipient: 50 mg propylene glycol/gram cream.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
White cream
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of early stages (prodrome or erythema phase) of recurrent
labial herpes simplex infection (cold sores) in
immunocompetent adults and adolescents (over 12 years old).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Cutaneous use
_Posology_
_Adults and adolescents (12-18 years):_ Apply a thin film carefully
over the entire cold sore 5 times a day
(approximately every 3 hours during waking hours).
Treatment must begin as soon as possible after the first cold sore
symptoms or signs appear (pain,
burning/itching/tingling or redness) as efficacy has not been
demonstrated when the treatment is initiated at the stage of
an already developed blister or ulcer.
Treatment should continue until healing has occurred, usually 4 to 6
days, or for a maximum of 10 days.
_Elderly:_ No special dose recommendation.
Paediatric population
The safety and efficacy of Blistex Cold Sore Cream 100 mg/g in
children aged younger than 12 years have not been
established (see section 4.4).
_Dosage in renal failure:_ No dose adjustments necessary due to
negligible topical absorption.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance "docosanol" or to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid application close to or in the eyes.
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