Axoviral

Package Leaflet: Information for the Patient

Axoviral, 50 mg/g, Cream

Aciclovir

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 10 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Axoviral and what is it used for
• 2. Important information before using Axoviral
• 3. How to use Axoviral
• 4. Possible side effects
• 5. How to store Axoviral
• 6. Contents of the pack and other information

1. What is Axoviral and what is it used for

Axoviral cream for cutaneous use contains the active substance acyclovir with antiviral action, showing a strong effect on the herpes simplex virus (Herpes simplex).
Axoviral is indicated for the local treatment of recurrent herpes labialis and facial herpes, caused by the herpes simplex virus (Herpes simplex).

2. Important information before using Axoviral

When not to use Axoviral:

• if the patient is allergic to acyclovir, valacyclovir, propylene glycol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting Axoviral, discuss it with your doctor or pharmacist, especially if:

• the patient's immune system is not working properly (e.g., if the patient has had a bone marrow transplant or has AIDS); patients with reduced immunity should consult a doctor in case of treatment of any infection;
• the patient has had a particularly severe recurrent herpes labialis;
• after 10 days, there is no improvement, the herpes has not healed completely, or has worsened.

Do not use the cream:

• for skin infections other than herpes
• for the treatment of genital herpes
• on mucous membranes (e.g., eyes, inside the mouth or nose).

Axoviral should only be used for herpes located on the lips and face.
Avoid contact of the medicine with the eyes. If the medicine gets into the eyes, rinse them thoroughly with warm water. In case of doubt, consult a doctor.
Before and after using the medicine, wash your hands to prevent the spread of infection to other areas of the skin.
During treatment, do not scratch the blisters or crusts or touch them with a towel.
To limit the risk of spreading the infection to others, do not let them touch the herpetic skin lesions, use shared towels, etc.

Axoviral and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Interactions of Axoviral with other medicines are not known.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Axoviral has no influence or negligible influence on the ability to drive and use machines.

Axoviral contains cetostearyl alcohol and propylene glycol.

Due to the presence of the excipient cetostearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of the excipient propylene glycol, the medicine may cause skin irritation.

3. How to use Axoviral

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Axoviral cream is for cutaneous use.
Recommended dose
The medicine should be applied to the affected areas of the skin 5 times a day at approximately 4-hour intervals, with a night break.
The medicine works best if treatment is started as soon as possible after the first symptoms of herpes appear, such as burning, itching, or redness. Treatment can also be started later, when bumps or blisters appear.
Treatment should be continued for at least 4 days. If the skin lesions have not healed, treatment can be extended to 10 days.
If the skin lesions do not disappear after 10 days of using the medicine, the patient should consult a doctor.
To prevent the worsening or spread of infection, wash your hands before and after applying the medicine, and avoid unnecessary rubbing of the affected areas or touching them with a towel.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Using more than the recommended dose of Axoviral

No toxic symptoms should occur, even after accidental ingestion of the entire contents of the tube of Axoviral. However, if a large amount of this medicine is swallowed, contact a doctor or pharmacist.

Missing a dose of Axoviral

Do not use a double dose to make up for a missed dose.
If you miss a dose, apply the cream as soon as you remember, and then continue treatment with the normal intervals between doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using this medicine and contact a doctor immediately if you experience an allergic reaction, with symptoms such as swelling of the face, lips, or tongue, or difficulty breathing.

The following side effects may occur:
Uncommon(may affect up to 1 in 100 people)

• mild drying or flaking of the skin;
• transient burning, stinging, or tingling sensation (may occur immediately after applying the cream);
• itching. Rare(may affect up to 1 in 1,000 people)
• redness;
• contact dermatitis after using the medicine. Very rare(may affect less than 1 in 10,000 people)
• sudden hypersensitivity reactions, including severe ones, such as angioedema and urticaria.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Axoviral

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Axoviral contains

• The active substance is acyclovir. 1 g of cream contains 50 mg of acyclovir.
• The other ingredients are cetostearyl alcohol, liquid paraffin, propylene glycol, sodium lauryl sulfate, poloxamer 407, white petrolatum, and purified water.

What Axoviral looks like and contents of the pack

Axoviral is a white, smooth cream with a characteristic odor.
The medicine is available in an aluminum tube, placed in a cardboard box.
Pack size: 10 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw

Manufacturer

Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5
Condeixa-a-Nova
3150-194 Sebal
Portugal
Date of last revision of the leaflet:November 2023