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 medicinal product.

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• This medicinal product should always be used exactly as described in the patient leaflet or as directed by the 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 any possible side effects not listed in this leaflet, tell your doctor or pharmacist. 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 locally applied medicinal products used in cases of:

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

Hirudoid Gel may also be used for phonophoresis and iontophoresis. During iontophoresis, the gel is applied 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 medicinal product (listed in section 6).
Hirudoid Gel contains isopropyl alcohol and should be avoided in contact with open wounds, mucous membranes, and eyes.

Warnings and precautions

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

Hirudoid and other medicinal products

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

Pregnancy, breastfeeding, and fertility

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 medicinal product.
The medicinal product can be used during pregnancy and breastfeeding.

Driving and using machines

Hirudoid does not affect the ability to drive or operate machinery.

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

Propylene glycol may cause skin irritation.

3. How to use Hirudoid

This medicinal product should always be used exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Hirudoid Gel is a locally applied medicinal product, 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 treated surface, 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 may also be used for phonophoresis and iontophoresis. During iontophoresis, the gel is applied 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 your doctor.
In the event of accidental ingestion of Hirudoid, no symptoms of overdose caused by 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 case 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 doubts about using this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicinal products, this medicinal product 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 discontinuation of the medicinal product.
Hirudoid Gel contains propylene glycol, which may cause skin irritation.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicinal product.

5. How to store Hirudoid

Keep the medicinal product out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Shelf life after first opening the tube - 1 year.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products 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 0.3 g/100 g, which corresponds to 25,000 units.*
(* units determined based on the partial thromboplastin time (APTT) test).
The other ingredients are: sodium hydroxide, propylene glycol, carbomers, isopropyl alcohol, purified water.

What Hirudoid looks like and contents of the pack

Aluminum tube with a screw cap in a cardboard box. Pack size 40 g or 100 g.
For more detailed information, please contact the marketing authorization holder or the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:14.830
Parallel import authorization number:498/13

Date of leaflet approval: 25.10.2023

[Information about the trademark]