Zovirax intensive

Package leaflet: Information for the patient

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 of 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 advised 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, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 10 days, or if you feel worse, contact your doctor.

Table of 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 for topical application contains the active substance aciclovir, which has
antiviral activity and shows strong action against the herpes simplex virus (Herpes simplex).
Zovirax Intensive cream is indicated for the 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, 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 weakened immunity should consult a doctor regarding treatment of any infection
• the herpes has not disappeared or completely healed after 10 days, or has worsened
• the patient has a particularly severe recurrent cold sore. Do 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 for herpes 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 herpes skin lesions or use shared towels, etc.

Zovirax Intensive and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used. Interactions between Zovirax Intensive and other medicines are not known.

Pregnancy, breastfeeding, and fertility
During pregnancy or breastfeeding, if pregnancy is suspected, or if planning to become pregnant, 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 sulphate, 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 sulphate in each gram of cream.
Sodium lauryl sulphate 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 sulphate.
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 this patient information 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.
Apply the cream 5 times daily to affected skin areas, at approximately four-hour intervals, with a break at night. The medicine works most effectively when treatment is started as early as possible after the first symptoms of herpes appear, such as burning, itching, or redness. Treatment may also be started later in the course of the disease, when blisters or bumps appear.
Treatment should be continued for at least 4 days.
If 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, wash hands before and after applying the medicine, and avoid unnecessary rubbing of the affected areas or touching them with a towel.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a larger than recommended dose of Zovirax Intensive
Toxic symptoms should not 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 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 before.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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:
Uncommon (may affect up to 1 in 100 patients)

• mild skin dryness or peeling
• transient burning, stinging or tingling sensation which may occur immediately after application of the cream – itching.

Rare (may affect up to 1 in 1,000 patients)

• redness – contact dermatitis following the use of Zovirax Intensive medicine.

Very rare (may affect up to 1 in 10,000 patients)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at the 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.
Adverse reactions can also be reported to the marketing authorisation holder or the parallel importer.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

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 container.
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. 1 g of cream contains 50 mg of aciclovir.
• The other ingredients are: propylene glycol, white soft paraffin, cetostearyl alcohol, liquid paraffin, Arlacel 165 (glycerol monostearate and polyglyceryl 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 an aluminium tube within a cardboard box.
The pack contains 5 g of cream.
For more detailed 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 Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin 24, D24 YK11
Ireland
Parallel importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. Forteczna 35-37 Tymiankowa 24/28
Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorization number in Romania, the country of export: 10459/2017/01
Parallel import licence number: 31/25