Teva Cold Sore 5% Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEVA COLD SORE 5% CREAM Aciclovir
Read all of this leaflet carefully before you receive this medicine
- Keep this leaflet. You may need to read it again
- Ask your pharmacist if you need more information or advice
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
- You must contact a doctor if your symptoms worsen or do not improve after 10 days IN THIS LEAFLET:
1. What Teva Cold Sore 5% Cream is and what it is used for
2. Before you use Teva Cold Sore 5% Cream
3. How to use Teva Cold Sore 5% Cream
4. Possible side effects
5. How to store Teva Cold Sore 5% Cream
6. Further information
1. WHAT TEVA COLD SORE 5% CREAM IS AND WHAT IT IS USED FOR
Teva Cold Sore 5% Cream contains the active ingredient aciclovir. Teva Cold Sore 5% Cream belongs to a group of medicines known as antivirals, which are used to treat viral infections. Teva Cold Sore 5% Cream is used to treat labial herpes (cold sores) caused by the Herpes simplex virus.
2. BEFORE YOU USE TEVA COLD SORE 5% CREAM Do not take Teva Cold Sore 5% Cream if you
- are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of Teva Cold Sore 5% Cream (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
Take special care with Teva Cold Sore 5% Cream if you
- are severely immunocompromised (have a weak immune system)
- develop a skin reaction.
Teva Cold Sore 5% Cream should not come into contact with the mucous membranes, such as in the mouth, eye or vagina, as it may cause irritation.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You may use Teva Cold Sore 5% Cream while pregnant and while breast-feeding unless your doctor tells you not to. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Teva Cold Sore 5% Cream is unlikely to interfere with your ability to drive or use machines.
Important information about some of the ingredients of Teva Cold Sore 5% Cream
This medicinal product contains propylene glycol and cetyl alcohol. Propylene glycol and cetyl alcohol may cause skin irritation (e.g. contact dermatitis).
3. HOW TO USE TEVA COLD SORE 5% CREAM
Dosage
Adults and children
Teva Cold Sore 5% Cream should be applied to the affected area five times daily at intervals of approximately four hours, (but not during the night). Teva Cold Sore 5% Cream should be applied to the sore or the start of a sore as early as possible.
Do not apply the cream to the inside of the mouth, the eyes or inside the vagina as it might cause irritation. Treatment should be continued for five days. If healing is not complete, treatment may be continued for up to another five days.
If you miss a dose of Teva Cold Sore 5% Cream
If you miss a dose, use the cream as soon as you can. However, do not apply a double dose to make up for a forgotten dose. If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Teva Cold Sore 5% Cream can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects have been reported:
Uncommon (between 1 and 10 patients out of 1000):
• temporary burning or stinging
• mild drying or scaling of the skin
• itching.
Rare (between 1 and 10 patients out of 10,000):
• erythema (redness)
• contact dermatitis (skin rash).
Very rare (less than 1 patient out of 10,000):
• hypersensitivity (allergic) reactions including angioedema (swelling of the face and hands), urticaria (nettle rash).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to 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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine
5. HOW TO STORE TEVA COLD SORE 5% CREAM
Keep out of the reach and sight of children
Do not store above 25°C.
Do not refrigerate or freeze.
Do not use after the expiry date which is stated on the carton. Teva Cold Sore 5% Cream should be used within 28 days of first opening of the tube. 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 Teva Cold Sore 5% Cream contains:
The active substance is aciclovir. The other ingredients are: propylene glycol, white soft paraffin, liquid paraffin, cetyl alcohol, dimeticone, stearoyl macrogolglycerides and purified water.
What Teva Cold Sore 5% Cream looks like and contents of the pack
Teva Cold Sore 5% Cream is a white cream and comes in aluminium tubes of 2 g with plastic screw caps.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited,
Eastbourne,
BN22 9AG.
Manufacturer
Merckle GmbH Ludwig Merckle Str. 3 89143 Blaubeuren Germany.
This leaflet was last revised in May 2015
PL 00289/1606
REG0060606 Version 1.4 Approved Page 3 of 4