Dimastin

Package Leaflet: Information for the Patient

Dimastin, 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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 days of using the medicine in children and 7 days in adults and adolescents, there is no improvement or the patient feels worse, consult a doctor. See section 3.

Table of Contents of the Leaflet

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

1. What is Dimastin and what is it used for

Dimastin is a gel for application to the skin. Dimastin contains the active substance dimetindene maleate, which inhibits the action of histamine - a compound responsible for allergic reactions.
The medicine applied to the skin acts locally as an antihistamine, strongly anti-itching (excluding cholestatic itching), reduces swelling, and soothes irritations.
It exhibits local anesthetic properties. It cools, which further soothes irritated skin.

Indications:

Relieving itching associated with skin diseases, such as skin rashes and urticaria, as well as in the case of insect bites, sunburns, and superficial skin burns of the first degree (skin redness).
Dimastin is indicated for use in adults, adolescents, and children from the age of 1 year and older.

2. Important information before using Dimastin

When not to use Dimastin

• 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 Dimastin, discuss it with your doctor or pharmacist.
In the case of applying the Dimastin gel to a large area of skin, avoid exposing the areas covered by it to sunlight.
Inform your doctor in case of very strong itching or extensive changes.
If the symptoms worsen or persist, the patient feels worse, or if the use of the medicine is required for longer than 2 days in children and 7 days in adults and adolescents, consult a doctor.

Children

Avoid using the medicine in small children on large areas of skin, especially in cases of injuries, burns, and skin inflammation.

Dimastin and other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
There is no experience with the use of Dimastin in pregnant and breastfeeding women.
Dimastin should not be used in pregnant and breastfeeding women, unless the doctor recommends otherwise.
During pregnancy and breastfeeding, do not use the medicine on large areas of skin, especially if it is injured or inflamed.
During breastfeeding, do not apply to the nipples. For further information, see "Dimastin contains benzalkonium chloride and propylene glycol (E 1520)".

Driving and using machines

Dimastin has no influence or negligible influence on the ability to drive and use machines.

Dimastin contains benzalkonium chloride and propylene glycol (E 1520)

The medicine contains 0.05 mg of benzalkonium chloride in each gram of gel. Benzalkonium chloride may irritate the skin.
Breastfeeding women should not use this medicine on the breast skin, as it may be ingested by the child with breast milk.
The medicine contains 150 mg of propylene glycol (E 1520) in each 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 package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The medicine is intended for application to the skin.
Usually, unless the doctor recommends otherwise, the medicine should be applied 2 to 4 times a day, covering the affected and itchy skin surface with a thin layer of gel.
If the symptoms worsen or persist, the patient feels worse, or if the use of the medicine is required for longer than 2 days in children and 7 days in adults and adolescents, consult a doctor.

Using more than the recommended dose of Dimastin

No cases of overdose with dimetindene maleate applied topically to the skin have been reported.
In case of ingestion of the medicine, consult a doctor immediately.

Missing a dose of Dimastin

Do not use a double dose to make up for a missed dose.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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
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 medicine.

5. How to store Dimastin

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage temperature.
Store in the original packaging to protect from light.
Shelf life after first opening 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 given month.
Medicines should 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 Dimastin contains

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

What Dimastin looks like and contents of the pack

Dimastin is a transparent, colorless to light yellow, odorless, homogeneous gel.
Packaging: aluminum tube with a sealing membrane, coated internally with epoxy-phenolic varnish, with a polyethylene (HDPE) screw cap equipped with a piercer, placed together with the leaflet in a cardboard box.
Pack size: 30 g

Marketing authorization holder

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

Manufacturer

ZIAJA Ltd Pharmaceutical Works Ltd.
ul. Przemysłowa 12
83-050 Kolbudy
Poland

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

Poland: Dimastin
Czech Republic: Fanin

Date of last revision of the leaflet: