Hirudoid

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Hirudoid (Hirudoid Gel)

0.3 g/100 g, gel
Mucopolysaccharide polysulfate
Hirudoid and Hirudoid Gel are different trade names for the same medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, talk to a pharmacist.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Hirudoid and what is it used for

Mucopolysaccharide polysulfate belongs to a group of medicines used topically in cases of:

• blunt injuries with or without hematomas,
• superficial vein inflammation that cannot be treated with a compression bandage.

Hirudoid gel can also be used for phonophoresis and iontophoresis. During iontophoresis, the gel is administered under the cathode.

2. Important information before using Hirudoid

When not to use Hirudoid

If you are allergic to mucopolysaccharide polysulfate or any of the other ingredients of this medicine (listed in section 6).
Hirudoid gel contains isopropyl alcohol and should be avoided on open wounds, mucous membranes, and eyes.

Warnings and precautions

Before starting to use Hirudoid, discuss it with your doctor or pharmacist.

Hirudoid and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been found.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
The medicine can be used during pregnancy and breastfeeding.

Driving and using machines

Hirudoid does not affect the ability to drive or use machines.

Hirudoid contains 5 mg of propylene glycol per 1 g of gel

Propylene glycol may cause skin irritation.

3. How to use Hirudoid

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist.
Hirudoid gel is a topical medicine, for use on the skin.
Recommended dose
Hirudoid should be applied 2 to 3 times a day to the affected areas or, if necessary, more frequently. Depending on the size of the area to be treated, usually 3 to 5 cm of gel is sufficient.
Hirudoid gel should be gently massaged into the affected areas. Do not use under a bandage.
Treatment usually lasts up to 10 days for blunt injuries and 1 to 2 weeks for superficial vein inflammation. Hirudoid can also be used for phonophoresis and iontophoresis. During iontophoresis, the gel is administered under the cathode.

Using more than the recommended dose of Hirudoid

Due to the way Hirudoid is administered, overdose is unlikely.
If symptoms of overdose occur, contact a doctor.
In the event of accidental ingestion of Hirudoid, no symptoms of overdose due to the active substance should occur.
Due to the presence of isopropyl alcohol, accidental ingestion of a large amount of Hirudoid may cause alcohol poisoning, especially in children.
In the event of alcohol poisoning, appropriate symptomatic treatment should be applied immediately.

Missing a dose of Hirudoid

Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency less than 1 in 10,000 patients - very rare.
Very rare local hypersensitivity reactions, such as skin redness, which usually resolve quickly after discontinuing the medicine.
Hirudoid gel contains propylene glycol, which may cause skin irritation.

Reporting side effects

If you get any side effects, talk to your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hirudoid

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
After first opening, the medicine remains stable for 12 months.
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 Hirudoid contains

The active substance is mucopolysaccharide polysulfate. 100 g of gel contains: mucopolysaccharide polysulfate 0.3 g, equivalent to 25,000 units*.
(*units determined based on the partial thromboplastin time (APTT) assay).
The other ingredients are: sodium hydroxide, propylene glycol, carbomers, isopropyl alcohol, purified water.

What Hirudoid looks like and contents of the pack

Aluminum tube in a cardboard box.
Pack size 40 g or 100 g.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Stada Arzneimittel GmbH, Muthgasse 36/2, A-1190 Vienna, Austria

Manufacturer:

Mobilat Produktions GmbH, Luitpoldstraße 1, 85276 Pfaffenhofen, Germany
Stada Arzneimittel AG, Stadastraße 2 – 18, 61118 Bad Vilbel, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Austrian export license number: 14.830

Parallel import license number: 860/12 Date of approval of the leaflet: 30.11.2022

[Information about the trademark]