Patient Information Leaflet

Aciclovir Ziaja, 50 mg/g, cream
Aciclovirum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

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

Table of contents

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

1. What Aciclovir Ziaja is and what it is used for

Aciclovir Ziaja cream for topical application contains the active substance aciclovir, which has antiviral activity and shows strong action against the herpes simplex virus (Herpes simplex).
Aciclovir Ziaja is indicated for the local treatment of recurrent herpes labialis and facial herpes (so-called "cold sores") caused by the herpes simplex virus.
If there is no improvement after 10 days, or if you feel worse, you should consult your doctor.

2. Important information before using Aciclovir Ziaja

When not to use Aciclovir Ziaja

if the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Aciclovir Ziaja, please discuss this with your doctor or pharmacist.
Aciclovir Ziaja should only be used for cold sores located on the lips and face.
Do not apply Aciclovir Ziaja to mucous membranes, such as the mouth, nose or eyes, and do not use it to treat genital herpes. Avoid contact of the medicine with the eyes. In case of accidental contact with the eyes, rinse thoroughly with running water.
Patients who have experienced particularly severe recurrent cold sores should consult a doctor.
Use of Aciclovir Ziaja is not recommended in individuals with weakened immune systems. Patients with weakened immunity should consult their doctor regarding treatment of any infection.
Hands should be washed before and after applying the medicine to prevent spreading the infection to others. Others should not touch the skin lesions, share towels, etc.
Aciclovir Ziaja and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Interactions between Aciclovir Ziaja and other medicines are not known.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Aciclovir Ziaja has no effect on the ability to drive or operate machinery.
Aciclovir Ziaja contains propylene glycol, cetostearyl alcohol, and sodium lauryl sulfate
The medicine contains 400 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation.
The medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
The medicine 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.

3. How to use Aciclovir Ziaja

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Aciclovir Ziaja cream is intended for topical application to the skin.
Recommended dose
Apply the medicine to the affected areas of the skin five times daily at approximately four-hour intervals, with a break at night.
The medicine is most effective when 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 nodules 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 lesions do not resolve after 10 days of using the medicine, the patient should consult a doctor.
To prevent worsening or spreading of the infection, hands should be washed before and after applying the medicine, and unnecessary rubbing of the affected areas or touching them with a towel should be avoided.
Use of a higher than recommended dose of Aciclovir Ziaja
Toxic symptoms are not expected, even after accidental ingestion of the entire contents of the Aciclovir Ziaja tube. However, if a large amount of this medicine is swallowed, contact a doctor or pharmacist.
Missed dose of Aciclovir Ziaja
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment with this medicine should be discontinued and a doctor should be contacted immediately if an allergic reaction occurs, with symptoms such as swelling of the face, lips or tongue, or difficulty breathing.

The following adverse reactions may occur:

Common (occur in 1 to 10 people out of 100): mild skin dryness or peeling.
Uncommon (occur in 1 to 10 people out of 1,000): transient sensation of burning or tingling, itching.
Rare (occur in 1 to 10 people out of 10,000): erythema, contact dermatitis.
Very rare (occur in less than 1 person out of 10,000): sudden allergic reactions, including urticaria and angioedema (a severe allergic reaction).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. 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 Warszawa
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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Aciclovir Ziaja

Keep the medicine out of the sight and reach of children.
Store below 30°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the tube: 2 years, but not beyond the expiry date stated on the packaging.
Do not use this medicine after the expiry date indicated on the packaging following "EXP". 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. This will help protect the environment.

6. Contents of the pack and other information

What Aciclovir Ziaja contains

The active substance is aciclovir. One gram of cream contains 50 mg of aciclovir.
The other ingredients are: propylene glycol, white soft paraffin, cetostearyl alcohol, light liquid paraffin, poloxamer 407, sodium lauryl sulfate, purified water.

What Aciclovir Ziaja looks like and contents of the pack
Aciclovir Ziaja is a white or almost white cream.
Packaging:
An aluminium tube internally coated with epoxy-phenolic lacquer, with a membrane and a polyethylene (PE) cap equipped with a piercing device, containing 5 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Tel.: +48 58 521 34 00