Boots Avert Cold Sore Cream

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 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. 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, oral dosing should be considered. These patients should be encouraged to consult a physician concerning the treatment of any infection.

Action cold sore cream SmPC – PL 15773/0092/IB/011 –December 2006

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,

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 Pregnancy And Lactation

There are no adequate and controlled studies to date using aciclovir in pregnant women and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the foetus.

No information is available on levels of aciclovir which may appear in breast milk after topical administration of aciclovir, though systemic availability after topical application is absent or very small.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

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

4.9 Overdose

Not applicable after topical administration. No measures are required after swallowing of small amounts of the cream.

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

Action cold sore cream SmPC – PL 15773/0092/IB/011 –December 2006

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, dimeticone 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 day of manufacture. The shelf-life after first opening is 4 weeks.

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

6.4 Special Precautions For Storage

Store below 25°C. Do not refrigerate or freeze.

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 And Other Handling

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

D-89079 Ulm Germany

8. Marketing Authorisation Number(S)

PL 15773/0092

9. Date Of First Authorisation/Renewal Of The Authorisation

15 January 2002

10. Date Of Revision Of The Text

June 2007