Zidenac

Package Leaflet: Information for the Patient

Zidenac, 1 mg/g, Gel

Dimetindene Maleate

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 7 days (2 days in children) there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Zidenac and what is it used for
• 2. Important information before using Zidenac
• 3. How to use Zidenac
• 4. Possible side effects
• 5. How to store Zidenac
• 6. Contents of the pack and other information

1. What is Zidenac and what is it used for

Zidenac is a gel for application to the skin. Zidenac contains the active substance dimetindene maleate, which inhibits the action of histamine. Histamine is a substance released by the body during contact with an allergen and causes the development of an allergic reaction. Zidenac acts locally as an antihistamine and relieves itching. It has local anesthetic properties. Zidenac is used for short-term relief of itching associated with skin diseases, hives, insect bites, sunburn, and superficial skin burns (first-degree - skin redness).

2. Important information before using Zidenac

When not to use Zidenac:

• if the patient is allergic to dimetindene maleate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Zidenac, the patient should discuss it with their doctor or pharmacist. When applying the Zidenac gel to a large area of skin, the patient should avoid prolonged exposure to sunlight on the areas covered with the gel. The patient should inform their doctor in case of very severe itching or widespread skin changes.

Children

Zidenac should be avoided in infants and small children on large areas of skin, especially in cases of injuries and inflammatory skin conditions.

Zidenac and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Zidenac should not be applied to large areas of skin, especially if the skin is injured or inflamed, during pregnancy and breastfeeding. Breastfeeding women should not apply this medicine to the breast skin or nipples, as it may be ingested by the child with breast milk.

Driving and using machines

Zidenac has no influence on the ability to drive and use machines.

Zidenac contains propylene glycol and benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride in 1 g of gel. Benzalkonium chloride may irritate the skin. This medicine contains 150 mg of propylene glycol in 1 g of gel. Propylene glycol may cause skin irritation.

3. How to use Zidenac

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Zidenac, unless the doctor has prescribed otherwise, should be applied up to 3 times a day, applying a thin layer of gel to the affected and itchy skin surface. During application, the patient should not press or scratch the skin surface. The medicine should be applied to undamaged skin; do not apply to open wounds. If after 7 days (2 days in children) there is no improvement or the patient feels worse, they should contact their doctor. The medicine should not be used for more than 7 days without consulting a doctor.

Using more than the recommended dose of Zidenac

In case of ingestion, the patient should immediately contact their doctor. In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zidenac can cause side effects, although not everybody gets them. Frequency not known (cannot be estimated from the available data):

• skin burning sensation,
• skin dryness,
• skin allergic reactions.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zidenac

The medicine should be stored out of sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zidenac contains

• The active substance is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
• The other ingredients are: purified water, propylene glycol (E 1520), carbomer (type 974 P), sodium hydroxide, disodium edetate dihydrate, benzalkonium chloride.

What Zidenac looks like and contents of the pack

Transparent, colorless, homogeneous, and odorless gel. Aluminum tube with a membrane, coated internally with epoxy-phenolic lacquer, closed with a white polyethylene cap. Pack sizes: 30 g, 50 g. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

GALENICA S.A., Asklipiou 4-6, Kryoneri, Attiki, 14568, Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Dimetin ADGC, Poland, Portugal: Zidenac, Czech Republic, Slovakia: Moniret

For further information about this medicine, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel: +48 22 375 92 00

Date of last revision of the leaflet: