SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Action Cold Sore Cream Boots Avert Cold Sore Cream Tesco Aciclovir Cold Sore Cream Sainsbury’s Aciclovir Cold Sore Cream

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Cream, containing 50 mg/g Aciclovir Ph. Eur.

For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Action Cold Sore Cream is indicated for:

- treatment of herpes labialis (cold sore) in non-immunocompromised patients.

4.2    Posology and method of administration

Action Cold Sore Cream should be applied five times a day, every four hours, for five or in some cases up to ten days in thin layers on the affected skin, making sure that all lesions are adequately covered.

If lesions have not healed after 10 days treatment, patients should be advised to consult a doctor.

4.3    Contraindications

Action Cold Sore Cream is contra-indicated in patients in case of hypersensitivity to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of the cream.

4.4    Special warnings and precautions for use

Action Cold Sore Cream should not be applied in the eye or mucosal skin of the mouth or the vagina as it might be irritant. Particular care should be taken to avoid accidental introduction into the eye.

Action Cold Sore Cream is for topical use only and should not be swallowed.

Paediatric and geriatric use: no unusual toxicity or paediatric-specific problems have been observed.

In severely immunocompromised patients, (e.g. AIDS patients or bone marrow transplant recipients) oral dosing should be considered. These patients should be encouraged to consult a physician concerning the treatment of any infection.

Action Cold Sore Cream must not be used for the treatment of ocular or genital herpes.

Patients with particularly severe Herpes labialis should be encouraged to seek medical advice.

Cold sore sufferers should be advised to avoid transmitting the virus, particularly when active lesions are present,

The excipient propylene glycol can cause skin irritation and the excipient cetyl alcohol can cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

No interactions resulting from administration of other drugs concomitantly with topical aciclovir have been reported.

4.6 Fertility, pregnancy and lactation

Pregnancy

The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of aciclovir cream is very low.

A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of aciclovir. The registry findings have not shown an increase in the number of birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.

Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.

In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

Lactation

Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by a nursing infant following maternal use of aciclovir cream or ophthalmic ointment would be insignificant.

4.7 Effects on ability to drive and use machines

Topically applied aciclovir does not effect the ability to drive or use machines.

4.8 Undesirable effects

The following convention has been used for the classification of undesirable effects in terms of frequency:- Very common >1/10, common >1/100 and <1/10, uncommon 1/1000 and <1/100, rare >1/10,000 and <1/1000, very rare <1/10,000.

Clinical trial data have been used to assign frequency categories to adverse reactions observed during clinical trials with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse events observed, it is not possible to determine unequivocally which events were related to the administration of the drug and which were related to the disease. Spontaneous reporting data has been used as a basis for allocating frequency for those events observed post-marketing.

Skin and subcutaneous tissue disorders

Uncommon: Transient burning or stinging following application of aciclovir cream. Mild drying or flaking of the skin.

Itching.

Rare: Erythema. Contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have most often been shown to be components of the cream rather than aciclovir.

Immune system disorders

Very rare: Immediate hypersensitivity reactions including angioedema and urticaria.

Action Cold Sore Cream is usually well tolerated. Other undesirable effects that may occur after use of Action Cold Sore Cream are redness, tension, or pain of the skin at the site of the application.

4.9    Overdose

No untoward effects would be expected if the entire contents of the tube containing 500 mg of aciclovir (cream) were ingested orally.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Aciclovir exerts its antiviral effect on herpes simplex viruses and varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. Aciclovir is converted to aciclovir monophosphate principally via virus-coded thymidine kinase. The monophosphate is subsequently phosphorylated to the diphosphate via cellular guanylate kinase and then to the triphosphate via other cellular enzymes (e.g. phosphoglycerate kinase, pyruvate kinase, phosphoenolpyruvate carboxykinase). The formation of the monophosphate seems to be the rate determining step in this process and occurs minimally in uninfected cells.

Aciclovir triphosphate acts as an inhibitor of, and substrate for, the herpes-specified DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes.

5.2    Pharmacokinetic properties

After oral or intravenous administration aciclovir is widely distributed in tissues and body fluids. However, after topical application on intact skin no detectable levels of aciclovir in plasma or urine are found. Also, systemic availability after application on affected skin appears to be minimal.

5.3    Preclinical safety    data

No remarks

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

The following excipients are used in Action Cold Sore Cream: purified water, propylene glycol, liquid paraffin, white soft paraffin, cetyl alcohol, dimethicone and Arlatone 983 S.

6.2    Incompatibilities

No incompatibilities are reported between topically applied aciclovir and other drugs.

6.3    Shelf life

The shelf-life is 36 months from the date of manufacture. The shelf-life after first opening is 4 weeks.

The expiry date is printed on the box and the tube ("Use by"). Do not use after this date.

6.4    Special precautions for storage

Do not store above 30°C.

6.5    Nature and contents of container

Action Cold Sore Cream is packed in aluminium tubes containing 2g of cream. The tube is lacquered with epoxy-phenolic resin and closed by a HDPE cap. Single tubes are packed in a carton box.

6.6 Special precautions for disposal

Before and after application of the cream it is advised to wash the hands thoroughly, to avoid contamination of other parts of the body. It may be advisable to use a finger cot or rubber glove. Close the tube carefully after usage.

Action Cold Sore Cream should be applied as early as possible after the start of an infection, ideally during the prodromal period.

7 MARKETING AUTHORISATION HOLDER

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany

8    MARKETING AUTHORISATION NUMBER(S)

PL 15773/0092

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

03/111998 / 28/11/2003

10 DATE OF REVISION OF THE TEXT

15/07/2011