Aciclovir 5% Mylan Viatris Tube 2 gr

1. WHAT IS ACICLOVIR MYLAN 5% Cream AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

This medicine is an antiviral agent.

Therapeutic indications

It is used in the manifestations of certain herpetic infections, as prescribed by the physician.

2. WHAT YOU SHOULD KNOW BEFORE USING ACICLOVIR MYLAN 5% cream

List of information needed before taking the medicine

Not applicable.

Contraindications

Never use ACICLOVIR MYLAN 5% cream in the following cases:

-Known allergy to aciclovir or any of the other components of this medication,

-When applied to the eye, mouth or vagina.

Precautions for use; special warnings

Not applicable.

Interactions with other drugs

Taking or using other drugs

ACICLOVIR MYLAN 5% cream should not be used with other creams.

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and lactation

Long-term administration in recurrent herpes in pregnant women is not recommended, especially at the end of pregnancy, nor during breastfeeding.

Tell your doctor if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medication.

Sportsmen

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with a known effect

List of excipients with a notorious effect:propylene glycol.

3. HOW TO USE ACICLOVIR MYLAN 5% cream

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage/Method of Administration/Frequency of Administration

In all cases, strictly adhere to your doctor's prescription.

The dosage is usually 5 applications per day.

Treatment should be started as soon as possible, at the first signs of infection.

If you feel that the effect of ACICLOVIR MYLAN 5% cream is too strong or too weak, consult your doctor or pharmacist.

Dermal.

It is recommended that the cream be applied liberally around the lesions.

Applications should be spread out over the day.

For example:

-In the morning after breakfast,

-Atnoon after lunch,

-Around 4-5 pm,

-In the evening after dinner,

-In the evening before bedtime.

Duration of treatment

The duration of treatment is between 5 and 10 days.

Symptoms and instructions in case of overdose

If you have used more ACICLOVIR MYLAN 5% cream than you should have

Talk to your doctor or pharmacist.

Instructions in case of missed dose(s)

If you forget to use ACICLOVIR MYLAN 5% cream

Do not use a double dose to make up for the dose you forgot to use.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medications, ACICLOVIR MYLAN 5% cream may have side effects, although not everyone is susceptible.

-Transient stinging or burning may follow application,

-erythema (redness) or dryness of the skin,

-risk ofeczema (allergic skin reactions), due to the presence of propylene glycol.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.

5. HOW DO I USE ACICLOVIR MYLAN 5% cream?

Keep out of the reach and sight of children

Expiration date

Do not use ACICLOVIR MYLAN 5% cream after the expiration date stated on the box.

Conditions of storage

No special storage precautions.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of medicines in the sewage system or in your household waste. Ask your pharmacist what to do with unused medication. This will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active substances and excipients

What does ACICLOVIR MYLAN 5% cream contain?

The active substance is:

Aciclovir ................................................................................................................................................. 5 g

For 100 g of cream.

The other components are:

Dimeticone, stearic macrogolglycerides, cetyl alcohol, petrolatum, liquid kerosene, propylene glycol, purified water.

Pharmaceutical form and content

What is ACICLOVIR MYLAN 5% cream and what does it contain?

This medicine is presented as a cream. Tube of 10 g.

Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different

Holder

MYLAN SAS

117, allée des Parcs

69800 SAINT-PRIEST

FRANCE