- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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 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.
Paediatric populationThere 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.
Fertility:There are no adequate data from the use of docosanol on fertility in humans.
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
Nervous system disordersVery common: Headache (10.4% of docosanol-treated patients and 10.7% of placebo-treated patients).
General disorders and administration site conditionsCommon: 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 reactionsReporting 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.
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