DOCOSANOL 10% CREAM - patient leaflet, side effects, dosage

1. what docosanol 10%cream is and what it is used for

Docosanol is an antiviral agent. Docosanol 10% Cream is a white cream used for the treatment of early stages of recurrent labial herpes simplex infection (cold sores) in adults and adolescents (over 12 years old). To be effective, treatment with Docosanol 10% Cream must start in the early stages of a cold sore before the blisters appear. Start using Docosanol 10% Cream as soon as you get any of the symptoms of a cold sore such as redness, itching, pain, tingling or prickling. Continue using until the cold sore is healed, usually 4–6 days. The cause of cold sores is a herpes simplex virus infection. The infection may break out when the immune system is weakened, during stress or during a menstrual period. The virus causes blisters or sores, mainly on the lips.

2. before you use docosanol 10% cream

Do not use Docosanol 10% Cream

• If you are allergic (hypersensitive) to docosanol or any of the other ingredients in the cream listed at the end of this leaflet (see section 6).

Take special care with Docosanol 10% Cream

• Docosanol 10% Cream is intended for cutaneous use only. Avoid getting the cream in or close to your eyes as this may cause irritation. If you accidentally get cream in your eyes rinse them thoroughly with plenty of water.
• Do not use this product if you have been told you are immunocompromised (if your immune system’s ability to fight infectious diseases is known to be reduced, e.g. by a serious illness such as leukaemia or AIDS or if you may have had an organ transplant). If you are immunocompromised and you develop a cold sore consult your doctor immediately.
• Do not apply the cream if the cold sore has already formed a blister or ulcer like appearance.

Children

• Children under 12 years should not use Docosanol 10% Cream.

Using other medicines

It is unlikely that Docosanol 10% Cream affects, or is affected by, other medicines since Docosanol 10% Cream is intended for cutaneous use only, however do not apply other cold sore medicines whilst using Docosanol 10% Cream.

Ask your doctor or pharmacist if you have any questions regarding how Docosanol 10% Cream is affected by, or affects, other medicines.

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Docosanol 10% Cream can be used during pregnancy and breast-feeding.

Driving and using machines

Docosanol 10% Cream has no effect on driving or using machines.

Important information about some of the ingredients of Docosanol 10% Cream

Docosanol 10% Cream contains propylene glycol which can cause skin irritation.

3. how to use docosanol 10% cream

• Adults and adolescents over 12 years: Start treatment as soon as you notice the first symptoms or signs of a cold sore, for instance itching, stinging, burning or prickling in the affected area.

• Wash your hands thoroughly before and after treatment to avoid spreading the infection.
• Apply a thin film carefully over the entire cold sore 5 times a day. (Approximately e­very

3 hours during waking hours.)

• Use a fingertip or, preferably, a cotton bud and avoid touching the end of the tube after you have touched the cold sore.
• Continue treatment until healing is complete, usually between 4–6 days.
• If you notice no difference after 10 days you should stop the treatment and contact your doctor.
• Remember that Docosanol 10% Cream is your medicine. If you lend the tube to anyone you risk spreading the infection to others.

If you use more Docosanol 10% Cream than you should

No serious problem should arise if you have used a large amount of the cream on your skin. No special treatment is necessary.

If you forget to use Docosanol 10% Cream

If you forget to use Docosanol 10% Cream, use it as soon as you remember.

If you have any further questions on the use of this product, ask your pharmacist.

4. possible side effects

Like all medicines, Docosanol 10% Cream can cause side effects, although not everybody gets them.

For the frequency of occurrence of side effects, the following phrases are used: very common (more than 1 in 10 users), common (between 1 in 100 users and 1 in 10 users), uncommon (between 1 in 1000 users and 1 in 100 users), rare (between 1 in 10000 users and 1 in 1000 users, very rare (in less than 1 in 10000 users).

Nervous system problems :

Very common: headhe.

Skin problems:

Common: skin disorders including dry skin, skin rashes and facial swelling occurring where the cream has been applied.

If a more severe skin reaction occurs you should cease treatment, and if the problem does not disappear you should contact your doctor.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store docosanol 10% cream

Keep out of the reach and sight of children.

Do not use Docosanol 10% Cream after the expiry date which is stated on the carton as “Expiry date month/year”. The expiry date refers to the last day of that month.

The cream is stable for 6 months after first opening the tube.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6. FURTHER INFORMATION

What Docosanol 10% Cream looks like and contents of the pack

Marketing Authorisation Holder DDD Ltd., Watford, Herts, WD18 7JJ, UK.

Manufacturers

Fleet Laboratories Limited,

94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ, England.

This leaflet was last updated in May 2017.

LTD0150

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