Hirudoid

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Hirudoid (Hirudoid - Salbe)

0.3 g/100 g, ointment
Mucopolysaccharide polysulfate
Hirudoid and Hirudoid - Salbe are different trade names for the same drug.
The entire leaflet should be read carefully, 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.
• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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 packaging and other information

1. What is HIRUDOID and what is it used for

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

• blunt injuries with or without hematomas,
• superficial vein inflammation that cannot be treated with a compression bandage. Hirudoid ointment can also be used for phonophoresis and iontophoresis. During iontophoresis, the ointment is administered under the cathode.

2. Important information before using HIRUDOID

When not to use HIRUDOID

If there is hypersensitivity (allergy) to mucopolysaccharide polysulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, or any other excipient.
The ointment should not be applied to open wounds and damaged skin.

When to exercise special caution when using HIRUDOID

See section 3.

Using HIRUDOID with other medicines

The doctor should be informed about all medicines taken recently, including those available without a prescription.
No interactions with other medicines have been found.

Pregnancy and breastfeeding

Before using any medicine, a doctor or pharmacist should be consulted.
The drug can be used during pregnancy and breastfeeding.

Driving and operating machinery

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

Hirudoid ointment contains cetostearyl alcohol, emulsifying (type A)

The drug may cause local skin reactions (e.g., contact dermatitis).

Hirudoid ointment contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The drug may cause allergic reactions (possible late reactions).

3. How to use HIRUDOID

Hirudoid ointment is a topical medicine for use on the skin.
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 ointment is sufficient.
Hirudoid ointment should be massaged into the affected areas. In the case of painful inflammation, the ointment should be gently spread over the affected areas. Hirudoid ointment can be used as an ointment dressing.
In the case of blunt injuries, treatment usually lasts up to 10 days, and in the case of superficial vein inflammation, from 1 to 2 weeks. Hirudoid can also be used for phonophoresis and iontophoresis. During iontophoresis, the ointment is administered under the cathode.

Using a higher dose of HIRUDOID than recommended

Due to the method of administration of Hirudoid, overdose is unlikely.
In the event of symptoms of overdose, a doctor should be consulted.
In the event of accidental ingestion of Hirudoid, no symptoms of overdose caused by the active substance should occur.

Missing a dose of HIRUDOID

A double dose should not be used to make up for a missed dose.
In case of doubts about the use of the medicine, a doctor or pharmacist should be consulted.

Important information about some ingredients of HIRUDOID ointment

Due to the presence of cetostearyl alcohol, emulsifying (type A), and myristyl alcohol, the drug may cause local skin reactions (e.g., contact dermatitis).

4. Possible side effects

Like all medicines, HIRUDOID 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, may occur.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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 the medicine.

5. How to store HIRUDOID

Store in a place out of sight and reach of children.
Store at a temperature below 25°C.
Do not use HIRUDOID after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What HIRUDOID contains

The active substance of the drug is mucopolysaccharide polysulfate 0.3 g/100 g, which corresponds to 25,000 units.*
(*Units determined based on APTT).
The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol 85%, stearic acid, ointment base with lanolin alcohols, cetostearyl alcohol, emulsifying (type A), myristyl alcohol, isopropyl alcohol, thymol, potassium hydroxide, purified water.

What HIRUDOID looks like and what the packaging contains

An aluminum tube containing 40 g of ointment.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Austria, the country of export:

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

Manufacturer:

Mobilat Produktions GmbH
85276 Pfaffenhofen, Germany
Stada Arzneimittel AG
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: 8.527

Parallel import license number: 89/17 Date of approval of the leaflet: 03.03.2022

[Information about the trademark]