Aciclovir Kern Pharma 50 mg/g cream EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Aciclovir Kern Pharma 50 mg/g cream EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Aciclovir Kern Pharma is and what it is used for
2. What you need to know before using Aciclovir Kern Pharma
3. How to use Aciclovir Kern Pharma
4. Possible adverse effects
5. How to store Aciclovir Kern Pharma
6. Contents of the pack and other information

1. What Aciclovir Kern Pharma is and what it is used for

This medicine 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 in immunocompetent patients (patients with a properly functioning immune system).

You should consult a doctor if your condition worsens or does not improve after 10 days.

2. What you need to know before using Aciclovir Kern Pharma

Do not use Aciclovir Kern Pharma

• If you are allergic (hypersensitive) to aciclovir or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

• Do not apply on the mucous membranes of the mouth, eye, or vagina, as it may cause irritation. Take special care to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
• Do not exceed the recommended frequency of applications or the recommended duration of treatment.
• Before starting treatment with this medicine, immunocompromised patients (for example, patients with HIV infection (AIDS), organ transplant recipients, or those undergoing radiotherapy or chemotherapy) should consult their doctor.
• Since cold sores are a recurrence of an infection inside the mouth, usually acquired at an early age, an initial medical diagnosis is necessary, especially in children, in whom symptoms of this first infection may go unnoticed or be mistaken for teething disorders or other oral conditions.
• Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting the infection to their partner. Aciclovir does not prevent transmission of herpes. The use of a condom may help prevent transmission. Do not exceed the recommended frequency of applications or the recommended duration of treatment.
• In cases of severe disease or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

Application in children under 12 years of age should always be carried out under medical supervision.

Administration in adolescents over 12 years of age is the same as for adults; see below.

Use of Aciclovir Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

No interactions have been reported for aciclovir associated with this route of administration (topical).

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is insufficient information on the effects of the cream during pregnancy. Systemic administration of aciclovir to rats and rabbits has not produced teratogenic or embryotoxic effects.

Breastfeeding

There is no information available on the levels of aciclovir in breast milk following topical administration.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is none or negligible.

Aciclovir Kern Pharma contains cetostearyl alcohol and propylene glycol

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

This medicine contains 393 mg of propylene glycol (E-1520) per gram of product.

Propylene glycol may cause skin irritation.

3. How to use Aciclovir Kern Pharma

Follow exactly the administration instructions for this medicine as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

The medicine should be administered as soon as possible after diagnosis, once signs or symptoms of the condition have appeared.

Remember to use your medicine.

Your doctor will determine how long you should take this medicine. Do not stop treatment prematurely, as the infection caused by the virus may recur.

Adults and children over 12 years of age:

Apply five times daily, approximately every four hours, except during sleeping hours.

Apply a sufficient amount of the product to cover the affected area with a thin layer.

Continue treatment for 5 days. If complete healing has not occurred within 5 days, treatment may be extended for another 5 days, up to a total of 10 days.

Consult your doctor if your condition worsens or does not improve after 10 days.

After applying this medicine, wash your hands to avoid spreading the lesion to other parts of the body or transmitting it to other people.

Aciclovir Kern Pharma contains a specially formulated base and must not be diluted or used as a base for incorporating other medicines.

If you think that the effect of Aciclovir Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir Kern Pharma than you should

Cases of intoxication are unlikely due to its external use; however, consult your doctor or pharmacist immediately.

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

If you forget to use Aciclovir Kern Pharma

Do not apply a double dose to make up for missed doses. Simply continue your treatment as soon as possible.

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

If you interrupt treatment with Aciclovir Kern Pharma

Do not interrupt treatment earlier than advised by your doctor, as healing may not be complete and your condition may recur.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Uncommon (may affect up to 1 in 100 people):

• Transient burning or itching after topical application of aciclovir
• Mild dryness or peeling of the skin
• Itching sensation

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

• Skin redness
• Contact dermatitis (a type of local allergy) following application of the medicine. In sensitization tests, the substances causing this reaction have been shown more frequently to be components of the cream rather than aciclovir itself

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

• Immediate hypersensitivity reactions including angioedema (an inflammatory process affecting deep layers of the skin, manifesting as swelling of the throat or difficulty swallowing or breathing). If this effect is severe, seek medical attention immediately, as emergency measures may be required.

Prolonged use of the cream may lead to sensitivity phenomena; if any such symptoms occur, treatment should be discontinued and a doctor consulted.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Kern Pharma

• The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.

• The other components are: poloxamer 407, emulsifying cetostearyl alcohol (type B), white soft paraffin, liquid paraffin, propylene glycol (E-1520), and purified water.

Appearance of the product and contents of the container

White or yellowish cream.

It is presented in cardboard boxes containing tubes with 2 g and 15 g of cream.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

Date of the most recent review of this leaflet: January 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/