BLISTEX COLD SORE Cream Ref.[2759] Active ingredients: Docosanol

Avoid application close to or in the eyes.

Should only be used for cold sores on the mouth and face.

Must not be used to treat genital or ocular herpes infections

Avoid transmitting the virus, particularly when active lesions are present.

The cream should not be used in immuno compromised patients.

Treatment with the cream should not be initiated at the stage of an already developed blister or ulcer.

If the recurrent cold sore is particularly severe, consult doctor.

Immunocompromised patients should consult a pharmacist or doctor concerning treatment of any infection, including cold sores.

Paediatric population

There is no treatment experience available for the use in children below the age of 12 years and only limited experience in adolescent (aged 12-18 years). It is recommended that the cream should not be used in children under 12 years.

This formulation contains propylene glycol and may cause skin irritation.

No interaction studies have been performed. Therefore, Blistex Cold Sore Cream should not be used simultaneously with other topical medicinal products at the same application site.

Pregnancy

There are no data from the use of docosanol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Since systemic exposure to docosanol is negligible, docosanol can be used during pregnancy.

Lactation

There are no data from the use of docosanol in breast feeding women. No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to docosanol is negligible. Docosanol can be used during breast-feeding.

Due to its negligible absorption docosanol has no influence on the ability to drive and use machines.

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data).

Results from clinical trials of the treatment of recurrent labial herpes simplex demonstrate no difference in the frequency or type of undesirable effects in patients treated with Blistex Cold Sore Cream or placebo.

Nervous system disorders

Very common: Headache (10.4% of docosanol-treated patients and 10.7% of placebo-treated patients).

General disorders and administration site conditions

Common: Application site adverse reactions which include dry skin, rashes and skin disorders (2.9% of docosanol-treated patients and 2.3% of placebo-treated patients).

Facial oedema has also been reported but these application site adverse reactions are consistent with normal facial reactions experienced with cold sores.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

Not applicable.