ZOVIRAX 50 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before using the medicine, as it
2. What is Zovirax Intensive and what is it used for
3. Important information before using Zovirax Intensive
   1. Warnings and precautions
   2. Before using Zovirax Intensive, the patient should consult a doctor, pharmacist, or nurse if:
   3. Zovirax Intensive and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Zovirax Intensive contains propylene glycol, sodium lauryl sulfate, and cetearyl alcohol.
4. How to use Zovirax Intensive
   1. Using more than the recommended dose of Zovirax Intensive
   2. Missing a dose of Zovirax Intensive
5. Possible side effects
   1. The patient should stop using the medicine and contact their doctor immediately if they experience:
   2. Reporting side effects
6. How to store Zovirax Intensive
7. Contents of the pack and other information
   1. What Zovirax Intensive contains
   2. What Zovirax Intensive looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer:
   5. Date of last revision of the leaflet: November 2024

Package Leaflet: Information for the Patient

ZOVIRAX INTENSIVE
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 or as directed by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• 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 pack and other information

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

Zovirax Intensive cream for topical use contains the active substance aciclovir, which has antiviral properties and is particularly effective against the herpes simplex virus (Herpes simplex).
Zovirax Intensive cream 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 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 using Zovirax Intensive, the patient should consult a doctor, pharmacist, or nurse if:

• the patient's immune system is not functioning properly (e.g., if the patient has had a bone marrow transplant or has AIDS); patients with impaired immune function should consult a doctor about treating any infection
• the herpes has not cleared up or has worsened after 10 days
• there is a particularly severe recurrence of cold sores

The cream should not be used:

• 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 lesions located on the lips and face.
Contact with the eyes should be avoided.
If the medicine gets into the eyes, they should be rinsed thoroughly with warm water. If in doubt, a doctor should be consulted.
Hands should be washed before and after using the medicine to prevent the spread of infection to other areas of the skin. During treatment, the patient should not scratch or touch the blisters or scabs with a towel.
To minimize the risk of spreading the infection to others, they should not be allowed to touch the herpetic skin lesions, share towels, etc.

Zovirax Intensive and other medicines

The patient should inform 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, during breastfeeding, or if the patient is planning to become pregnant, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

Zovirax Intensive has no 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 per 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 per 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 area of skin.
Patients with impaired skin barrier, such as atopic dermatitis, are more susceptible 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 package leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult a doctor, pharmacist, or nurse.
Zovirax Intensive cream is for topical use. Unless otherwise directed by a doctor, the medicine should be used as described below.
The cream should be applied 5 times a day to the affected areas of the skin at approximately 4-hour intervals, with a night-time 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 at a later stage of the disease, when blisters or vesicles appear.
Treatment should be continued for at least 4 days.
If the skin lesions have not healed, treatment can be extended up to 10 days. If the lesions do not clear up 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 the patient should 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, they should consult a doctor.

Using more than the recommended dose of Zovirax Intensive

No toxic symptoms are expected to occur, even after accidental ingestion of the entire contents of the tube of Zovirax Intensive. 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 their doctor immediately if they experience:

• An allergic reaction with symptoms including swelling of the face.

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 reactions 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 Pharmacovigilance, 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 .
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.

5. How to store Zovirax Intensive

The medicine should be kept out of sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
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 they no longer use. This will help protect the environment.

6. Contents of the pack 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, poloxamer 407, sodium lauryl sulfate, dimethicone, purified water.

What Zovirax Intensive looks like and contents of the pack

The medicine is a white cream in a tube or plastic dispenser in the form of a pump.
The pack contains 2 g of cream.

Marketing authorization holder

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

Date of last revision of the leaflet: November 2024