VECTAVIR COLD SORE 1 %w/w Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
PENCICLOVIR
Available from:
Novartis Consumer Health UK Limited
INN (International Name):
PENCICLOVIR
Dosage:
1 %w/w
Pharmaceutical form:
Cream
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vectavir Cold Sore Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of the cream contains:
Active substance: 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
Vectavir Cold Sore Cream is indicated for the treatment of cold sores (herpes labialis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children over 12 years of age:
Vectavir Cold Sore Cream should be applied at approximately two hourly intervals during waking hours.Vectavir Cold
Sore Cream 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.
Treatment should be started as early as possible after the first sign of an infection.
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 of the formulation (eg. 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 (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.
Severely immunocompromised patients (eg AIDs patients or bone marrow transplant recipients) should be encouraged
to consult a physician in case oral therapy is indicated.
The cream contains cetosteary
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