Label: information for the userAciclovir Viatris 50 mg/g cream EFG

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

-Keep this label, as you may need to read it again.

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

-This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Aciclovir Viatris and how is it used

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

3.How to use Aciclovir Viatris

4.Possible adverse effects

5.Storage of Aciclovir Viatris

6. Contents of the package and additional information

Aciclovir Viatris contains aciclovir, an active ingredient 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 and cold sores.

No use Aciclovir Viatris

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

If you think this affects you, do not use Zovirax cream until you consult your doctor.

Warnings and precautions

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

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 (for example, if you have an HIV or AIDS infection or if you have received a bone marrow transplant).

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

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 contact with 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.Shouldavoid sexual contact if a partner shows signs or symptoms of genital herpes. Aciclovir does not prevent the transmission of herpes.

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

Children and adolescents

For instructions on administering the medication, see section 3.

Administration in children should be carried out under medical supervision at all times.

Other medications and Aciclovir Viatris

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Consult your doctor before using this medication.

Driving and operating machinery

The influence on driving or operating machinery is negligible or insignificant.

Aciclovir Viatris contains propylenglycol and cetomacrogol

This medication contains 150 mg of propylenglycol in each gram of cream.

Propylenglycol 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 cetomacrogol.

Follow exactly the medication administration instructions indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Remember to use your medication.

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

Your doctor will indicate the duration of treatment. Do not discontinue treatment as the infection caused by the virus may recur.

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• It should space the applications of this medication four hours apart, omitting the application at night. The suggested schedules are: 7 h, 11 h, 15 h, 19 h, and 23 h.
• Treatment should be continued for 5 days. If no cure is achieved in 5 days, treatment may be extended for 5 more days up to a total of 10 days.
• If symptoms worsen or no improvement is observed within 10 days of treatment, discontinue use of the cream and consult your doctor.

Applicationof this medication:

• This medication 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 handsalways before and after using the cream,to prevent the spread to other areas of the body or the transmission to other people.

If you estimate that the action 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. It is unlikely that overdose symptoms will occur with this medication.

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

If you forgot to use Aciclovir Viatris

In case of forgetting an application, perform it as soon as possible, however, if it is close to the time of your next application, omit the missed application.

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

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

If you interrupt the treatment with Aciclovir Viatris

Do not discontinue treatment without consulting your doctor.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects that are infrequent (may affect up to 1 in 100 people)

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

Adverse effects that are rare (may affect up to 1 in 1,000 people)

• Redness of the skin

Adverse effects that are very rare (may affect up to 1 in 10,000 people)

• Immediate hypersensitivity reactions

The signs of hypersensitivity may include:

• Swelling of the face, lips, tongue, or other parts of the body (angioedema)
• Rash, itching, or urticaria on the skin
• Shortness of breath, difficulty breathing, or wheezing
• Unexplained fever and feeling of fainting, particularly when standing

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the 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 that appears 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 monoestearate of glycerol and polyoxiethylene-30 stearate) dimethicone, cetyl alcohol, liquid paraffin, white vaseline, propylene glycol (E-1520), sodium hydroxide, and purified water.

Appearance of the product and content of the container

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Responsible for manufacturing

Laboratorios Liconsa, S.A.

Avda. Miralcampo nº7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:March 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/