Zovirax Intensive

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zovirax Intensive (Acevirex)

50 mg/g, cream
Aciclovirum
Zovirax Intensive and Acevirex are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor, pharmacist, or nurse.

• You should keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 10 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Zovirax Intensive and what is it used for

Zovirax Intensive cream for topical use contains the active substance acyclovir with antiviral action, showing a strong effect on the herpes simplex virus (Herpes simplex).
Zovirax Intensive cream is indicated for the local treatment of recurrent herpes of the lips and face, caused by the herpes simplex virus Herpes simplex.

2. Important information before using Zovirax Intensive

When not to use Zovirax Intensive:

Warnings and precautions

Before starting treatment with Zovirax Intensive, you should consult a doctor, pharmacist, or nurse 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 about the treatment of any infection
• the herpes has not disappeared, has not healed completely, or has worsened after 10 days
• a particularly severe recurrent herpes of the lips has occurred

You should not use the cream:

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

Zovirax Intensive should only be used on herpes located on the lips and face.
You should avoid contact between the medicine and the eyes.
If the medicine gets into the eyes, they should be rinsed thoroughly with warm water. In case of doubt, you should consult a doctor.
Before and after applying the medicine, you should wash your hands to prevent the spread of infection to other areas of the skin. During treatment, you should not scratch the blisters or crusts or touch them with a towel.
To limit the risk of spreading the infection to other people, you should not let them touch the herpetic skin lesions, use shared towels, etc.

Zovirax Intensive and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Interactions between Zovirax Intensive and other medicines are not known.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you think you may be pregnant or are planning to become pregnant, you should consult a doctor or pharmacist before using this medicine.

Driving and using machines

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

Zovirax Intensive contains propylene glycol, sodium lauryl sulfate, and cetearyl alcohol.

Zovirax Intensive contains 400 mg of propylene glycol in each gram of cream.
Due to the presence of the excipient propylene glycol, the medicine may cause skin irritation.
This medicine should not be used in children under 4 weeks of age, on open wounds, or on large areas of damaged or broken skin (e.g., burned skin) without consulting a doctor or pharmacist.
Zovirax Intensive contains 7.5 mg of sodium lauryl sulfate in each gram of cream.
Sodium lauryl sulfate may cause local skin irritation (such as stinging or burning) or exacerbate skin reactions caused by other medicines used on the same skin area.
Patients with weakened skin barriers, such as atopic dermatitis, are more sensitive to the irritating properties of sodium lauryl sulfate.
Due to the presence of the excipient cetearyl alcohol, the medicine may cause a local skin reaction (e.g., contact dermatitis).

3. How to use Zovirax Intensive

This medicine should always be used exactly as described in the patient leaflet or according to the recommendations of a doctor, pharmacist, or nurse. If in doubt, you should consult a doctor, pharmacist, or nurse.
Zovirax Intensive cream is intended for topical use. Usually, unless otherwise prescribed by a doctor, the medicine is used as described below.
The medicine should be applied 5 times a day to the affected areas of the skin 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, you should consult a doctor.
To prevent the worsening or spread of infection, you should 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, you should consult a doctor.

Using a higher dose of Zovirax Intensive than recommended

No toxic symptoms should occur, even after accidental ingestion of the entire contents of the Zovirax Intensive tube. However, if a large amount of cream is swallowed, you should contact a doctor or pharmacist.

Missing a dose of Zovirax Intensive

You should not use a double dose to make up for a missed dose. If you miss a dose, you should apply the cream as soon as you remember and continue treatment as before.

4. Possible side effects

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

You should stop using this medicine and contact a doctor immediately if you experience:

• an allergic reaction with symptoms including facial swelling.

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

• mild drying or flaking of the skin
• a 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 Zovirax Intensive.

Very rare(may affect up to 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 side effects not listed in the leaflet, you should inform 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zovirax Intensive

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging. Do not store in the refrigerator.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zovirax Intensive contains

• The active substance of the medicine is acyclovir. 1 g of cream contains 50 mg of acyclovir.
• The other ingredients are: propylene glycol, white petrolatum, cetearyl alcohol, liquid paraffin, Arlacel 165 (glyceryl monostearate and macrogol stearate), poloxamer 407, sodium lauryl sulfate, dimethicone 20, purified water.

What Zovirax Intensive looks like and what the packaging contains

The medicine is a white cream in an aluminum tube in a cardboard box.
The packaging contains 5 g of cream.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189, 60-322 Poznań, Poland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Romania, the country of export:10459/2017/01

Parallel import authorization number: 42/23 Date of leaflet approval: 14.03.2023

[Information about the trademark]