ACICLOVIR KERN PHARMA 50 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Aciclovir Kern Pharma 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 symptoms are the same as yours.

• If you experience 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 Kern Pharma and what is it used for
2. What you need to know before you use Aciclovir Kern Pharma
3. How to use Aciclovir Kern Pharma
4. Possible side effects
5. Storing Aciclovir Kern Pharma
6. Contents of the pack and other information

1. What is Aciclovir Kern Pharma and what is it 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 (with a properly functioning immune system).

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

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

Do not use Aciclovir Kern Pharma

• If you are allergic (hypersensitive) to aciclovir 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 this medicine.

• Do not apply to the mucous membranes of the mouth, eye, or vagina as it may cause irritation. Be careful to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.
• Do not exceed the recommended frequency of applications or duration of treatment.
• Before starting treatment with this medicine, immunodeficient patients (e.g., patients with HIV/AIDS, those who have received transplants, or are undergoing radiotherapy or chemotherapy) should consult their doctor.
• Since cold sores are a recurrence of an infection inside the mouth that is usually contracted at an early age, a medical diagnosis is necessary, especially in children, in whom the symptoms of this first infection may go unnoticed or be confused with teething disorders or other oral conditions.
• Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting the infection to the partner. Aciclovir does not prevent the transmission of herpes. The use of a condom probably would. Do not exceed the recommended frequency of applications or 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 done under medical supervision.

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

Using Aciclovir Kern Pharma with other medicines

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

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

There is no information on the levels of aciclovir that appear in breast milk after topical administration.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

Aciclovir Kern Pharma contains cetyl alcohol and propylene glycol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl 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 of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Remember to use your medicine.

Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment before it is completed, as the infection caused by the virus may recur.

Adults and children over 12 years:

Apply five times a day, approximately every four hours, except during sleep hours.

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

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

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

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

Aciclovir Kern Pharma contains a specially formulated base and should not be diluted or used as a base for the incorporation of other medicines.

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

If you use more Aciclovir Kern Pharma than you should

It is unlikely that poisoning will occur due to external use, however, consult your doctor or pharmacist immediately.

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 Kern Pharma

Do not use a double dose to make up for forgotten doses, simply continue with the usual treatment as soon as possible.

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

If you stop using Aciclovir Kern Pharma

Do not stop treatment before your doctor advises, as your cure may not be complete and your disease may recur.

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 cutaneous application of aciclovir
• 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 of the medicine. When sensitivity tests have been performed, it has been shown that, more frequently, the substances that cause it are components of the cream rather than aciclovir

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

• Immediate hypersensitivity reactions including angioedema (an inflammatory process of the deep skin that 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.

Prolonged use of the medicine in cream may lead to sensitivity phenomena; if they appear, treatment should be discontinued and a doctor consulted.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Aciclovir Kern Pharma

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Kern Pharma

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

• The other ingredients are: poloxamer 407, cetyl alcohol emulsifier (type B), white petrolatum, liquid paraffin, propylene glycol (E-1520), and purified water.

Appearance and packaging of the product

White or yellowish cream.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: January 2015

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