Package leaflet: Information for the patient

Warning! Keep this 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.
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
your doctor, pharmacist, or nurse.

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 side 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, contact your doctor.

Contents of the package leaflet:

What Zovirax Intensive is and what it is used for
Important information before using Zovirax Intensive
How to use Zovirax Intensive
Possible side effects
How to store Zovirax Intensive
Contents of the pack and other information

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

Zovirax Intensive cream for topical application contains the active substance aciclovir, an antiviral agent with strong activity 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.

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 weakened immunity should consult a doctor regarding treatment of any infection
cold sores have not disappeared or completely healed within 10 days, or have worsened
there is a particularly severe recurrent cold sore

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)

Zovirax Intensive should only be used for cold sores located on the lips and face.
Avoid contact with the eyes.
If the medicine gets into the eyes, rinse them thoroughly with warm water. If in doubt, consult a doctor.
Hands should be washed 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, they should not be allowed to touch the affected skin lesions, use shared towels, etc.

Zovirax Intensive and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans 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 planned, consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Zovirax Intensive has no effect or has 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, or on open wounds or 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 atopic dermatitis, are more sensitive to the irritating properties of sodium lauryl sulfate.
Due to the presence of the excipient cetostearyl 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 as directed by a
doctor, pharmacist, or nurse. If in doubt, consult a doctor,
pharmacist, or nurse.
Zovirax Intensive cream is intended for topical application to the skin. Unless otherwise advised by a doctor,
the medicine should be used as described below.
The medicine should be applied 5 times daily to the affected skin areas at intervals of approximately
four hours, with a break during the night. The medicine works most effectively if 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 blisters or vesicles appear.
Treatment should continue for at least 4 days.
If the skin lesions have not healed, treatment may be extended up to 10 days. If the lesions do not resolve after 10 days of using the medicine, consult a 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, as well as contact with towels.
If the medicine's effect seems too strong or too weak, consult a 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
tube of Zovirax Intensive. However, if a large amount of the cream is swallowed, contact a
doctor or pharmacist.
Missed dose of Zovirax Intensive
Do not use 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 before.

4. Possible adverse reactions

Like any medicine, this medicine may 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:

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 peeling
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)

redness – contact dermatitis after using Zovirax Intensive.

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 effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Zovirax Intensive

Keep this medicine out of 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 package.
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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Zovirax Intensive contains

The active substance is acyclovir. 1 g of cream contains 50 mg of acyclovir.
The other ingredients are: propylene glycol, white soft paraffin, 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
The medicine is a white cream contained in an aluminium tube within a cardboard box.
The pack contains 5 g of cream.
For further detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, 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
Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Romania, country of export: 10459/2017/01
Parallel import authorisation number: 42/23