Package leaflet: Information for the patient

Zidenac, 1 mg/g, gel
Dimetindene maleate
Please read carefully all the information in this leaflet 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 a
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, pharmacist or nurse. See section 4.
If there is no improvement after 7 days (2 days in children), or if you feel worse, consult your doctor.

Table of contents

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

1. What Zidenac is and what it is used for

Zidenac is a topical gel. Zidenac contains the active substance dimetindene maleate, which inhibits the action of histamine. Histamine is a substance released by the body upon contact with an allergen and causes the development of allergic reactions.
Zidenac acts locally as an antiallergic agent and relieves itching.
It also has local anaesthetic properties.
Zidenac is used for short-term relief of itching associated with skin disorders, urticaria, insect bites, sunburn, and superficial skin burns (first-degree – redness of the skin).

2. Information before using Zidenac

When not to use Zidenac:

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

Warnings and precautions
Before starting treatment with Zidenac, consult your doctor or pharmacist.
When applying Zidenac gel over a large skin surface area, avoid prolonged exposure of treated areas to sunlight.
Inform your doctor if you experience severe itching or extensive skin lesions.

Children
Avoid using this medicine in infants and young children over large skin areas, particularly in cases of skin injuries or inflammatory skin conditions.

Zidenac and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use Zidenac on large areas of skin, especially if the skin is injured or inflamed, during pregnancy or breastfeeding.
Breastfeeding women should not apply this medicine to the breast area or nipples, as it may be ingested by the infant with breast milk.

Driving and operating machinery
Zidenac has no effect on the ability to drive or operate machinery.

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

3. How to use Zidenac medicine

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.
Unless otherwise advised by a physician, apply Zidenac up to 3 times daily, by applying a thin layer of gel to the affected and itchy skin area. During treatment, do not press or scratch the treated skin area.
The medicine should be applied only to intact skin; do not apply to open wounds.
If there is no improvement after 7 days (after 2 days in children), or if symptoms worsen, consult a doctor.
Do not use the medicine for longer than 7 days without consulting a doctor.
Use of a higher than recommended dose of Zidenac
In case of accidental ingestion, seek immediate medical advice from a doctor.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Frequency unknown (cannot be estimated from available data):

burning sensation of the skin,
dry skin,
skin allergic reactions.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
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 Zidenac

Keep this medicine out of the 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 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 Zidenac contains

The active substance is dimethindene maleate. Each gram of gel contains 1 mg of dimethindene 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
A clear, colourless, homogeneous and odourless gel.
Aluminium tube with a membrane, internally coated with epoxy-phenolic varnish, closed with a white polyethylene cap.
Pack sizes: 30 g, 50 g.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Dimetin ADGC
Poland, Portugal: Zidenac
Czech Republic, Slovak Republic: Moniret
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: +48 22 375 92 00