Zovirax intensive

Package leaflet: information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Zovirax Intensive (Acevirex)
50 mg/g, cream
Aciclovirum
Zovirax Intensive and Acevirex are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, 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, or if your condition worsens, consult your doctor.

Contents of the leaflet:

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

Zovirax Intensive cream is a topical antiviral medicine containing the active substance aciclovir, which acts specifically against the herpes simplex virus.
Zovirax Intensive cream is indicated for the local treatment of recurrent herpes labialis (cold sores) of the lips and face caused by 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 to use Zovirax Intensive, 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 a weakened immune system should consult a doctor regarding treatment of any infection
• cold sores have not disappeared after 10 days, have not completely healed, or have worsened
• there has been a particularly severe recurrent cold sore

Do not use the cream:
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• for skin infections other than cold sores
• to treat genital herpes
• on mucous membranes (e.g. eyes, inside the mouth or nose)

Zovirax Intensive should be used only for cold sores 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. 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 other people, do not allow them to touch the cold sore skin lesions, use shared towels, etc.

Zovirax Intensive and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use. Interactions between Zovirax Intensive and other medicines are not known.

Pregnancy, breastfeeding, and fertility
During pregnancy or breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.

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

Zovirax Intensive contains propylene glycol, sodium lauryl sulfate, and cetostearyl alcohol.
Zovirax Intensive contains 400 mg of propylene glycol in each gram of cream.
Due to the presence of the excipient propylene glycol, this medicine may cause skin irritation.

Do not use this medicine in children under 4 weeks of age, on open wounds, or on large areas of damaged or injured skin (e.g. burns), 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 worsen skin reactions caused by other medicines applied to the same area of skin.
Patients with impaired skin barrier function, such as those with atopic dermatitis, are more sensitive to the irritating properties of sodium lauryl sulfate.

Due to the presence of the excipient cetostearyl alcohol, this 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 information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Zovirax Intensive cream is intended for topical use on the skin. Unless otherwise directed by a doctor, the medicine should be used as described below.
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The cream should be applied 5 times daily to the affected skin areas, at approximately four-hour intervals, with a nighttime break. The medicine works most effectively when treatment is started as early as possible after the first signs of herpes appear, such as burning, itching, or redness. Treatment may also be started later in the course of the disease, when blisters or nodules appear.
Treatment should be continued for at least 4 days.
If the skin lesions have not healed, treatment may be extended up to 10 days. If the lesions have not resolved after 10 days of treatment, consult your doctor.
To prevent worsening or spreading of the infection, hands should be washed before and after applying the medicine, and unnecessary touching or rubbing of the affected areas should be avoided, including contact with towels.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Zovirax Intensive
Toxic symptoms are unlikely to occur, even after accidental ingestion of the entire contents of the Zovirax Intensive tube. However, if a large amount of the cream is swallowed, contact your doctor or pharmacist.
Missed dose of Zovirax Intensive
Do not apply a double dose to make up for a missed dose. If a dose is missed, apply the cream as soon as remembered and continue treatment as previously directed.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should stop using this medicine and contact your doctor immediately if any of the following occur:

• An allergic reaction with symptoms including facial swelling.

The following adverse reactions may occur:
Not common (may occur in 1 out of 100 patients)

• Mild skin dryness or desquamation
• Transient sensation of burning, stinging or tingling may occur immediately after application of the cream – itching.

Rare (may occur in 1 out of 1,000 patients)

• Erythema – contact dermatitis after application of Zovirax Intensive cream.

Very rare (may occur in 1 out of 10,000 patients)

• Sudden hypersensitivity reactions, including severe ones such as angioedema and urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please 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.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity. Reporting adverse reactions helps to provide more information on the safety of using the medicine.
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5. How to store Zovirax Intensive

Keep this medicine out of the sight and reach of children.
Store 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 stated month.
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 Zovirax Intensive contains

• The active substance is aciclovir. Each 1 g of cream contains 50 mg of aciclovir.
• The other ingredients are: propylene glycol, white vaseline, cetostearyl alcohol, liquid paraffin, Arlacel 165 (glycerol monostearate and polyoxyethylene stearate), poloxamer 407, sodium lauryl sulfate, dimethicone 20, purified water.

What Zovirax Intensive looks like and contents of the pack
Zovirax Intensive is a white cream contained in a tube, packed in a cardboard box.
The pack contains 5 g of cream.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, the country of export:
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A., 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., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorization number in Romania, the country of export: 10459/2017/01
Parallel import authorization number: 16/24
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