ACICLOVIR VIATRIS 50 MG/G CREAM EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Viatris 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, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Aciclovir Viatris contains aciclovir, an active substance that belongs to a group of medicines called antivirals.

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

2. What you need to know before using Aciclovir Viatris

Do not use Aciclovir Viatris

If you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other ingredients of this medicine (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

Talk to your doctor or pharmacist before using Aciclovir Viatris.

Before using this medicine, your doctor needs to know:

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

Talk to your doctor if you think this applies to you, so they can decide whether you should switch to an oral formulation.

Application of aciclovir on mucous membranes such as in the mouth, eyes, or vagina is not recommended, as it may be irritating. Special care should be taken to avoid accidental contact with the eyes. If accidental contact with the eyes occurs, wash thoroughly with plenty of water and consult an ophthalmologist if necessary.

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

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

Children and adolescents

For administration instructions, see section 3.

Use in children should always be under medical supervision.

Other medicines and Aciclovir Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will assess the benefit to you and the risk to your baby of using Zovirax cream during pregnancy.

Breastfeeding

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

Consult your doctor before using this medicine.

Driving and using machines

The effect on the ability to drive or operate machinery is none or negligible.

Aciclovir Viatris contains propylene glycol and cetyl alcohol

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

Propylene glycol may cause skin irritation.

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

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

3. How to use Aciclovir Viatris

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Remember to use your medicine.

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

Your doctor will advise you on the duration of treatment. Do not stop treatment prematurely, as the viral infection may recur.

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• Applications of this medicine should be spaced four hours apart, omitting the nighttime application. Suggested times are: 7 a.m., 11 a.m., 3 p.m., 7 p.m., and 11 p.m.
• Treatment should continue for 5 days. If healing has not occurred within 5 days, treatment may be extended for another 5 days, up to a total of 10 days.
• If symptoms worsen or no improvement is observed within 10 days of treatment, discontinue use and consult your doctor.

Application of this medicine:

• This medicine should only be applied to the skin.
• It is not for oral, ophthalmic, or vaginal use.
• Do not mix this medicine with anything, including water or other medicines.
• Always wash your hands before and after using the cream to prevent spreading the infection to other areas of the body or to other people.

If you think that 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 medicine than recommended, carefully remove the excess. Overdose symptoms are unlikely with this medicine.

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 Viatris

If you forget to apply a dose, apply it as soon as possible. However, if it is close to the time for your next dose, skip the missed dose.

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

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

If you stop treatment with Aciclovir Viatris

Do not interrupt treatment without consulting your doctor.

It is important to use this medicine for the full prescribed duration to completely eliminate the infection.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

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

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

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

• Redness of the skin

Very rare adverse 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 faint, particularly when standing

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

Reporting of adverse effects

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

5. Storage of Aciclovir Mylan

Keep this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Aciclovir Viatris

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

Appearance of the product and contents of the container

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

Only certain package sizes may be marketed.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer responsible for manufacturing

Laboratorios Liconsa, S.A.

Avda. Miralcampo nº7, Pol. Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent review of this leaflet: March 2022

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