Package leaflet: Information for the patient

Dimastin, 1 mg/g, gel
Dimethinden maleate
Please read the entire leaflet carefully before using this 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
physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your physician or pharmacist. See section 4.
If there is no improvement within 2 days of use in children or 7 days in adults and adolescents, or if your condition worsens, consult a physician. See section 3.

Table of contents

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

1. What Dimastin is and what it is used for

Dimastin is a topical gel. Dimastin contains the active substance dimethinden maleate, which inhibits the action of histamine – a substance responsible for allergic reactions.
When applied to the skin, Dimastin acts locally as an antiallergic and potent antipruritic agent (except in cholestatic pruritus), reduces swelling, and soothes skin irritation.
It also exhibits local anesthetic properties. The cooling effect further helps soothe irritated skin.

Indications:
Relief of itching associated with skin disorders such as skin rashes and urticaria, as well as in cases of insect bites, sunburn, and superficial first-degree burns (skin redness).
Dimastin is indicated for use in adults, adolescents, and children aged 1 year and older.

2. Important information before using Dimastin

When not to use Dimastin

if the patient is allergic to dimethindene maleate or any of the other ingredients of this medicine (listed in section 6),
in cases of second- and third-degree burns.

Warnings and precautions
Before starting to use Dimastin, discuss this with your doctor or pharmacist.
When applying Dimastin gel to large areas of skin, avoid exposing the treated areas to sunlight.
Inform your doctor if there is severe itching or extensive skin lesions.
If symptoms worsen or persist, if the patient feels worse, or if treatment longer than 2 days in children and 7 days in adults and adolescents is required, consult a doctor.

Children
Avoid using the medicine in young children over large skin areas, especially in cases of wounds, burns, and inflammatory skin conditions.

Dimastin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is no experience with the use of Dimastin in pregnant or breastfeeding women.
Dimastin should not be used during pregnancy and breastfeeding unless otherwise advised by a doctor.
During pregnancy and breastfeeding, do not apply the medicine to large areas of skin, especially if the skin is injured or inflamed.
During breastfeeding, do not apply the medicine to the nipples. For further information, see "Dimastin contains benzalkonium chloride and propylene glycol (E 1520)".

Driving and operating machinery
Dimastin has no effect or has a negligible effect on the ability to drive and operate machinery.

Dimastin contains benzalkonium chloride and propylene glycol (E 1520)
The medicine contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may irritate the skin.
Breastfeeding women should not apply this medicine to the breast skin, as it may be ingested by the child with breast milk.
The medicine contains 150 mg of propylene glycol (E 1520) per gram of gel. Propylene glycol may cause skin irritation.

3. How to use Dimastin

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 your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Usually, unless otherwise advised by a doctor, the medicine should be applied 2 to 4 times daily, with a thin layer of gel covering the affected, itchy skin area.
If symptoms worsen or persist, if the patient feels worse, or if treatment longer than 2 days in children and 7 days in adults and adolescents is required, consult a doctor.
Use of a higher than recommended dose of Dimastin
No cases of overdose have been reported with topical application of dimethindene maleate.
In case of accidental ingestion, seek medical advice immediately.
Missed dose of Dimastin
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

dry skin,
skin burning sensation,
skin allergic reactions including rash and itching.

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

Keep this medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Shelf life after first opening of the tube: 18 months.
Do not use this medicine after the expiry date stated on the carton and tube 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Dimastin contains

The active substance is dimetindene maleate. 1 gram of gel contains 1 mg of dimetindene maleate.
Other ingredients are: benzalkonium chloride, carbomer 974 P, propylene glycol (E 1520), disodium edetate, sodium hydroxide 10% (for pH adjustment), purified water.

What Dimastin looks like and contents of the pack
Dimastin is a transparent, colourless to pale yellow, odourless, homogeneous gel.
Pack: Aluminium tube with a sealing membrane, internally coated with epoxy-phenolic varnish, fitted with a polyethylene (HDPE) cap equipped with a piercing device, together with the package leaflet, placed in a cardboard box.
Pack size: 30 g

Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Jesienna 9
80-298 Gdańsk
Poland
Tel.: +48 58 521 34 00

Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
Przemysłowa 12
83-050 Kolbudy
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Dimastin
Czech Republic: Fanin