Hirudoid

Package Leaflet: Information for the User

HIRUDOID, 0.3 g/100 g ointment

(Mucopolysaccharide polysulfate)
Read the entire leaflet 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.
• 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 medicines used locally 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 4-hydroxybenzoate, propyl 4-hydroxybenzoate, or any excipient.
Do not apply the ointment to open wounds and damaged skin.

When to exercise special caution when using HIRUDOID

See section 3.

Using HIRUDOID with other medicines

Tell your doctor about all the medicines you have taken recently, including those available without a prescription.
No interactions with other medicines have been found.

Pregnancy and breastfeeding

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

Driving and using machines

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

Hirudoid ointment contains cetostearyl alcohol and emulsifier.

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

Hirudoid ointment contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate.

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

3. How to use HIRUDOID

Hirudoid ointment is a medicine for local 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 rubbed 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.
Treatment of blunt injuries 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 way the Hirudoid preparation is administered, overdose is unlikely.
In case of overdose symptoms, contact a doctor.
As a result of accidental ingestion of the Hirudoid medicinal product, no overdose symptoms caused by the active substance should occur.

Missing a dose of HIRUDOID

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

Important information about some ingredients of HIRUDOID ointment

Due to the content of cetostearyl alcohol and myristyl alcohol, the medicine 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.

Reporting side effects

If you experience any side effects, including any possible side effects 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 gather more information on the safety of the medicine.

5. How to store HIRUDOID

Keep out of the reach and sight of children.
Store in a temperature below 25°C.
Do not use HIRUDOID after the expiry date stated on the label. 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 needed. This will help protect the environment.

6. Contents of the pack and other information

What HIRUDOID contains

The active substance of the medicine is mucopolysaccharide polysulfate 0.3 g/100 g, which corresponds to 25,000 units.*
(*Units determined based on APTT).
The other ingredients are: glycerol 85%, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, stearic acid, ointment base with lanolin alcohols, cetostearyl alcohol, emulsifier, myristyl alcohol, isopropyl alcohol, potassium hydroxide, thymol, purified water.

What HIRUDOID looks like and what the pack contains

An aluminum tube containing 40 g or 100 g of ointment.

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

• 1. Mobilat Produktions GmbH, Luitpoldstraße 1, 85276 Pfaffenhofen, Germany
• 2. STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
• 3. Wagener & Co. GmbH, Lohesch 60, 49525 Lengerich, Germany

Date of last revision of the leaflet: