Axoviral

Patient Information Leaflet

Axoviral, 50 mg/g, cream
Aciclovirum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 10 days of treatment, or if you feel worse, contact your doctor.

Table of Contents

1. What Axoviral is and what it is 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 Axoviral is and what it is used for

Axoviral cream for topical application contains the active substance aciclovir, an antiviral agent with strong activity against herpes simplex virus (Herpes simplex).
Axoviral is indicated for the local treatment of recurrent herpes labialis (cold sores) 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 aciclovir, valaciclovir, propylene glycol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Axoviral, consult 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 weakened immunity should consult a doctor when treating any infection;
• the patient has experienced particularly severe recurrent cold sores;
• there is no improvement after 10 days, the cold sore has not completely healed, or the condition has worsened.

Do not use the cream:

• for skin infections other than cold sores;
• to treat genital herpes;
• on mucous membranes (e.g. eyes, inside the mouth or nose).

Axoviral should be used only for cold sores located on the lips and face.
Avoid contact with the eyes. If the medicine gets into the eyes, rinse thoroughly with warm water.
If in doubt, consult a doctor.
Wash hands before and after applying the medicine to prevent spreading the infection to other areas of the skin.
During treatment, do not scratch blisters or scabs, and do not touch them with a towel.
To reduce the risk of spreading the infection to others, do not allow them to touch the skin lesions or to share towels, etc.

Axoviral and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Interactions between Axoviral and other medicines are not known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Axoviral has no effect or has a negligible effect on the ability to drive and operate machinery.

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

3. How to use Axoviral

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Axoviral cream is intended for topical use on the skin.
Recommended dose
Apply the medicine to the affected areas of the skin five times daily at approximately four-hour intervals, with a break during the night.
The medicine is most effective when treatment is started as soon as possible after the first symptoms of herpes appear, such as burning, itching or redness. Treatment may also be started at a later stage of the disease, when papules or blisters appear.
Treatment should be continued for at least 4 days. If skin lesions have not healed, treatment may be extended up to 10 days.
If skin lesions have not resolved after 10 days of using the medicine, the patient should consult a doctor.
To prevent worsening or spreading of the infection, hands should be washed before and after applying the medicine, and avoid unnecessary rubbing of the affected areas or touching them with a towel.
If the patient feels that the effect of the medicine is too strong or too weak, medical advice should be sought.
Use of a higher than recommended dose of Axoviral
Toxic symptoms are unlikely to 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.
Missed dose of Axoviral
Do not use a double dose to make up for a missed dose.
If a dose is missed, apply the cream as soon as the patient remembers, then continue treatment at the usual intervals between doses.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop using this medicine and contact your doctor immediately if you experience
an allergic reaction, with symptoms such as swelling of the face, lips or tongue,
or difficulty breathing.
The following adverse reactions may occur:
Not common (may affect up to 1 in 100 patients)

• mild skin dryness or peeling;
• transient sensation of burning, stinging or tingling (may occur immediately after applying the cream);
• itching.
  Rare (may affect up to 1 in 1,000 patients)
• redness;
• contact dermatitis following application of the medicine.
  Very rare (may affect up to 1 in 10,000 patients)
• sudden hypersensitivity reactions, including severe reactions such as angioedema and urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Axoviral

Store below 25°C.
Keep the medicine in a place inaccessible and out of sight 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 stated month.
Medicines must 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 package and other information

What Axoviral contains

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

What Axoviral looks like and contents of the pack
Axoviral is a white, smooth cream with a characteristic odour.
The medicine is available in an aluminium tube placed in a cardboard box.
Pack size: 10 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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