ACICLOVIR VIATRIS 50mg/g CREAM

Introduction

Leaflet: information forthe user

Aciclovir Viatris 50 mg/g cream EFG

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Aciclovir Viatris and what is it used for
2. What you need to know before starting to use Aciclovir Viatris
3. How to use Aciclovir Viatris
4. Possible side effects
5. Storage of Aciclovir Viatris
6. Package contents and additional information

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

Aciclovir Viatris contains aciclovir, an active ingredient belonging to the group of antiviral medications.

It is indicated for the treatment of mucocutaneous skin infections caused by the herpes simplex virus, including initial genital herpes and its recurrences, and cold sores.

2. What you need to know before starting to use Aciclovir Viatris

Do not use Aciclovir Viatris

If you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other components of this medication (listed in section 6).

If you think this applies to you, do not use Zovirax cream until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aciclovir Viatris.

Before using this medication, your doctor needs to know:

• If recurrences are frequent, if you have a condition in which your immune system functions worse or your body is less able to fight infections (e.g., if you have HIV or AIDS, or if you have received a bone marrow transplant).

Consult your doctor if you think this applies to you, so that they can decide whether you should switch to an oral administration form.

Aciclovir should not be applied to mucous membranes, such as the mouth, eyes, or vagina, as it may be irritating. Special care should be taken to avoid accidental introduction into the eyes. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

Genital herpes can be transmitted through sexual contact, even if the partner does not show symptoms. Sexual contact should be avoided if a partner has signs or symptoms of genital herpes. Aciclovir does not prevent the transmission of herpes.

The recommended frequency of applications and treatment duration should not be exceeded.

Children and adolescents

For instructions on administering the medication, see section 3.

Administration in children should always be done under medical supervision.

Other medications and Aciclovir Viatris

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

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will assess the benefits for you and the risks for your baby of using Zovirax cream during pregnancy.

Breastfeeding

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

Consult your doctor before using this medication.

Driving and using machines

The influence on driving or using machines is nil or insignificant.

Aciclovir Viatris contains propylene glycol and cetyl alcohol

This medication contains 150 mg of propylene glycol per gram of cream.

Propylene glycol may cause skin irritation.

Do not use this medication in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

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

3. How to use Aciclovir Viatris

Follow the administration instructions for the medication exactly as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Remember to use your medication.

It should be applied to lesions or impending lesions as soon as possible after the onset of infection. It is essential to start treatment during the period when lesions have not yet appeared or when they first appear.

Your doctor will indicate the duration of treatment. Do not stop treatment before completing the recommended duration, as the infection may recur.

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• Applications should be spaced 4 hours apart, omitting the nighttime application. Suggested schedules are: 7 am, 11 am, 3 pm, 7 pm, and 11 pm.
• Treatment should be continued for 5 days. If healing has not occurred after 5 days, treatment may be extended for an additional 5 days, up to a total of 10 days.
• If symptoms worsen or no improvement is observed after 10 days of treatment, stop using the cream and consult your doctor.

Application of this medication:

• It should only be applied to the skin.
• It is not for oral, ophthalmic, or vaginal use.
• Do not mix this medication with anything, including water or other medications.
• Wash your hands always before and after using the cream to avoid spreading to other areas of the body or infecting others.

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

If you use more Aciclovir Viatris than you should

If you use more medication than you should, carefully remove the excess. Overdose is unlikely with this medication.

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 medication and the amount ingested.

If you forget to use Aciclovir Viatris

If you forget an application, do it as soon as possible; however, if it is close to the time of your next application, skip the missed application.

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

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

If you interrupt treatment with Aciclovir Viatris

Do not interrupt treatment without consulting your doctor.

It is essential to use this medication for the indicated time to completely eliminate the infection.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon side effects (may affect up to 1 in 100 people)

• Transient burning or itching after application
• Mild dryness or flaking of the skin
• Itching sensation

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

• Redness of the skin

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

• Immediate hypersensitivity reactions.

Signs of hypersensitivity may include:

• swelling of the face, lips, tongue, or other parts of the body (angioedema)
• rash, itching, or hives on the skin
• shortness of breath, difficulty breathing, or wheezing
• unexplained fever and feeling of fainting, especially when standing

Contact a doctor immediately if you experience any of these symptoms. Stop using this medication.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aciclovir Mylan

Keep this medication out of sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date shown on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Aciclovir Viatris

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components (excipients) are: Arlatone 983 S (a mixture of glycerol monostearate and polyoxyethylene-30 stearate), dimethicone, cetyl alcohol, liquid paraffin, white petrolatum, propylene glycol (E-1520), sodium hydroxide, and purified water.

Appearance of the product and package contents

Aciclovir Mylan is a white or almost white cream. It is available in aluminum tubes containing 2 g or 15 g of cream.

Not all package sizes may be marketed.

Marketing authorization holder

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo nº7, Pol. Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this leaflet:March 2022

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