Aciclovir Ziaia

Package Leaflet: Information for the Patient

Aciclovir Ziaja, 50 mg/g, Cream

Aciclovirum

Read the Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Aciclovir Ziaja and What is it Used For
• 2. Important Information Before Using Aciclovir Ziaja
• 3. How to Use Aciclovir Ziaja
• 4. Possible Side Effects
• 5. How to Store Aciclovir Ziaja
• 6. Contents of the Pack and Other Information

1. What is Aciclovir Ziaja and What is it Used For

Aciclovir Ziaja cream for cutaneous use contains the active substance acyclovir with antiviral action, showing strong activity against the herpes simplex virus.
Aciclovir Ziaja is indicated for the local treatment of recurrent herpes labialis (cold sores) caused by the herpes simplex virus.
If after 10 days there is no improvement or you feel worse, you should consult your doctor.

2. Important Information Before Using Aciclovir Ziaja

When Not to Use Aciclovir Ziaja

• if you are allergic to acyclovir, valacyclovir, or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting to use Aciclovir Ziaja, you should discuss it with your doctor or pharmacist.
Aciclovir Ziaja should only be used on cold sores on the lips and face.
You should not use Aciclovir Ziaja on mucous membranes, such as the mouth, nose, or eyes, or for the treatment of genital herpes. You should avoid contact of the medication with your eyes. If the medication accidentally comes into contact with your eyes, you should rinse them thoroughly with running water.
Patient with particularly severe recurrent cold sores should consult their doctor.
It is not recommended to use Aciclovir Ziaja if you have a weakened immune system. Patients with weakened immune systems should consult their doctor about the treatment of any infection.
Before and after using the medication, you should wash your hands to prevent the spread of infection to other people, and you should not let them touch the cold sore areas, use shared towels, etc.

Aciclovir Ziaja and Other Medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Interactions between Aciclovir Ziaja and other medications are not known.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medication.

Driving and Using Machines

Aciclovir Ziaja does not affect your ability to drive or use machines.

Aciclovir Ziaja Contains Propylene Glycol, Cetostearyl Alcohol, and Sodium Lauryl Sulfate

The medication contains 400 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation.
The medication contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
The medication 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 exacerbate skin reactions caused by other medications used on the same skin area.

3. How to Use Aciclovir Ziaja

This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Aciclovir Ziaja cream is for cutaneous use.
Recommended dose
The medication should be applied to the affected areas of the skin 5 times a day at approximately 4-hour intervals, with a break at night.
The medication works best if treatment is started as soon as possible after the first symptoms of cold sores appear, such as burning, itching, or redness. Treatment can also be started later, when blisters or crusts 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 skin lesions do not disappear after 10 days of using the medication, you should consult your doctor.
To prevent the worsening or spread of infection, you should wash your hands before and after applying the medication, and avoid unnecessary rubbing of the affected areas or touching them with a towel.

Using More Than the Recommended Dose of Aciclovir Ziaja

No toxic symptoms should occur, even after accidental ingestion of the entire contents of the tube of Aciclovir Ziaja. However, if you have swallowed a large amount of the medication, you should contact your doctor or pharmacist.

Missing a Dose of Aciclovir Ziaja

You should not use a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medications, Aciclovir Ziaja can cause side effects, although not everybody gets them.
You should stop using the medication and contact your doctor immediately if you experience an allergic reaction, with symptoms such as swelling of the face, lips, or tongue, or difficulty breathing.
The following side effects may occur:

• Frequently(occurring in 1 to 10 users in 100): mild dryness or flaking of the skin.
• Infrequently(occurring in 1 to 10 users in 1000): transient burning or tingling sensation, itching.
• Rarely(occurring in 1 to 10 users in 10,000): redness, contact dermatitis.
• Very Rarely(occurring in less than 1 user in 10,000): sudden allergic reactions, including urticaria and angioedema (severe allergic reaction).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Aciclovir Ziaja

The medication should be stored out of sight and reach of children.
Store in a temperature below 30°C. Do not store in the refrigerator or freeze.
Shelf life after first opening the tube: 2 years, but no longer than the expiration date stated on the packaging.
Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Aciclovir Ziaja Contains

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

What Aciclovir Ziaja Looks Like and What the Pack Contains

Aciclovir Ziaja is a white or almost white cream.
Packaging:
An aluminum tube internally coated with epoxy-phenolic lacquer, with a membrane and a PE (polyethylene) cap equipped with a piercer, containing 5 g of cream, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

ZIAJA Ltd Pharmaceutical Works sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Phone: +48 58 521 34 00

Date of the Last Update of the Leaflet: