Zovirax Intensive

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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.

It is necessary to 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.

• The leaflet should be kept so that it can be re-read if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 there is no improvement or the patient feels worse after 10 days, 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 skin use contains the active substance aciclovir with antiviral action, showing strong action against the herpes simplex virus.
Zovirax Intensive cream is indicated for local treatment of recurrent herpes labialis and facial herpes, caused by the herpes simplex virus.

2. Important information before using Zovirax Intensive

When not to use Zovirax Intensive:

• 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 Zovirax Intensive, the patient 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 reduced immunity should consult a doctor about treating any infection
• the herpes has not disappeared, has not healed completely, or has worsened after 10 days
• there is a particularly severe recurrent herpes labialis

The cream should not be used:
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• 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.
Eye contact with the medicine should be avoided.
If the medicine gets into the eyes, they should be rinsed thoroughly with warm water. In case of doubt, a doctor should be consulted.
Hands should be washed before and after applying the medicine to prevent the spread of infection to other areas of the skin. During treatment, the patient should not scratch the blisters or touch them with a towel.
To limit the risk of spreading the infection to others, they should not be allowed to touch the herpetic skin lesions, use shared towels, etc.

Zovirax Intensive and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Interactions between Zovirax Intensive and other medicines are not known.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if the patient is planning a pregnancy, they 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.
The 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 impaired skin barrier, 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 local skin reactions (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, the patient should consult a doctor, pharmacist, or nurse.
Zovirax Intensive cream is for skin use. Usually, unless otherwise prescribed by a doctor, the medicine is used as described below.
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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 lesions do not disappear after 10 days of using the medicine, the patient should consult a doctor.
To prevent the spread of infection, hands should be washed before and after applying the medicine, and unnecessary touching or rubbing of the affected areas should be avoided.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.

Using more than the recommended dose of Zovirax Intensive

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, the patient should contact a doctor or pharmacist.

Missing a dose of Zovirax Intensive

A double dose should not be used to make up for a missed dose. If a dose is missed, the patient should apply the cream as soon as they remember and continue treatment as before.

4. Possible side effects

Like all medicines, Zovirax Intensive can cause side effects, although not everybody gets them.

The patient should stop using the medicine and contact a doctor immediately if:

• an allergic reaction occurs, 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.
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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. The patient should ask their 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 is aciclovir. 1 g of cream contains 50 mg of aciclovir.
• 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 a tube in a cardboard box.
The packaging contains 5 g of cream.
For more detailed information, the patient 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
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 10459/2017/01

Parallel import authorization number: 16/24

Date of leaflet approval: 15.01.2024

[Information about the trademark]
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