ACICLOVIR TEVA 50 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Aciclovir Teva 50 mg/g Cream EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

Contents of the pack:

1. What is Aciclovir Teva and what is it used for
2. What you need to know before you use Aciclovir Teva
3. How to use Aciclovir Teva
4. Possible side effects
5. Storage of Aciclovir Teva
6. Contents of the pack and other information

1. What is Aciclovir Teva and what is it used for

Aciclovir belongs to a group of medicines called antivirals. It is indicated for the treatment of initial and recurrent genital herpes, cold sores, and localized mucocutaneous infections caused by the herpes simplex virus.

2. What you need to know before you use Aciclovir Teva

Do not use Aciclovir Teva

If you are allergic to the active substance, aciclovir, propylene glycol, or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aciclovir Teva

• You should avoid contact of the cream with the eyes, and in case it occurs, wash abundantly with water and consult a doctor.
• If you have genital herpes with visible lesions, you should avoid sexual intercourse since there is a risk of transmitting the infection to your partner. Do not apply to the mouth or vaginal mucosa as it may cause irritation.
• Before starting treatment with this medicine, patients with immunosuppression, for example, patients with HIV infection or those who have received transplants, should consult their doctor.

Use of Aciclovir Teva with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions with other medicines have been described for this route of administration.

Use of Aciclovir Teva with food and drinks

No interactions with food and drinks have been described for this route of administration.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There is not enough information on the effects of administering the preparation during pregnancy. Systemic administration of aciclovir in rats and rabbits has not produced teratogenic or embryotoxic effects.

Aciclovir Teva contains cetostearyl alcohol emulsifier type A

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.

3. How to use Aciclovir Teva:

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The medicine should be applied to the lesions or imminent lesions as soon as possible after the start of the infection. It is essential to start treatment of recurrent episodes during the period when the lesions have not yet appeared or when they appear for the first time.

Remember to use your medicine.

Adults and children

Apply enough to cover the affected area, five times a day, for 5 days, except during sleep hours. If after this time the healing is not complete, treatment will continue for 5 more days, up to a total of 10 days.

The product will be administered as soon as possible, once the diagnosis has been made, after the appearance of signs or symptoms of the process.

In order to avoid spreading the lesion to other areas of the body or contaminating other people, the preparation should not be applied directly with the hand.

After applying this medicine, wash your hands to avoid spreading the lesion to other areas of the body or infecting other people.

This medicine contains a specially formulated base and should not be diluted or used as a base for incorporating other medicines.

If you think the action of Aciclovir Teva is too strong or too weak, tell your doctor or pharmacist.

If you use more Aciclovir Teva than you should:

Overdose is unlikely due to its low absorption.

Prolonged use of the product in cream may lead to sensitivity phenomena; if it appears, treatment should be discontinued and a doctor consulted.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Aciclovir Teva:

Do not use a double dose to make up for forgotten doses.

Do not exceed the recommended frequency of applications or treatment duration.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people)

• Transient burning or itching after applying aciclovir cream
• Mild dryness or flaking of the skin
• Itching sensation

Rare (may affect up to 1 in 1,000 people)

• Redness of the skin
• Contact dermatitis (a type of local allergy) after application. Most of the time, the substances that cause it are components of the cream other than aciclovir, which is the active substance.

Very rare (may affect up to 1 in 10,000 people)

• Immediate allergic reactions, including angioedema, which manifests with throat inflammation or difficulty swallowing or breathing. If this effect is very intense, you should go to a medical center as it requires emergency measures.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Teva

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Teva

• The active substance is aciclovir. Each gram contains 50 mg of aciclovir.
• The other ingredients (excipients) are: liquid paraffin, soft white paraffin, cetostearyl alcohol emulsifier type A, methylparaben, propylparaben, purified water.

Appearance of the product and contents of the pack

It is available in packs of one tube containing 2 or 15 grams of cream.

Marketing authorisation holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B,

28108 Alcobendas

Madrid

Spain

Manufacturer:

Laboratorios Feltor, S.A.

C/Roques Blanques, 3 y 5

Pol. Ind. Moli de les Planes

08470 Sant Celoni (Barcelona)

Spain

or

Laboratorios Iquinosa S.A.

Alpedrete, 24 (Madrid)- 28045 Spain

Date of last revision of this leafletOctober 2015

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es