PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
HIRUDOID
0.3 g/100 g, gel
Mucopolysaccharide polysulphate
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist.
Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

What HIRUDOID is and what it is used for
Important information before using HIRUDOID
How to use HIRUDOID
Possible side effects
How to store HIRUDOID
Contents of the pack and other information

1. What HIRUDOID is and what it is used for

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

blunt injuries with or without bruising (haematomas),
superficial thrombophlebitis that cannot be treated with compression bandages.

HIRUDOID may also be used in phonophoresis and iontophoresis. In iontophoresis, the gel is applied under the cathode.

2. Important information before using HIRUDOID

When not to use HIRUDOID
Do not use this medicine if the patient is allergic to mucopolysaccharide polysulphate or any of the other
ingredients of this medicine (listed in section 6).
HIRUDOID contains isopropyl alcohol and therefore contact with open wounds, mucous membranes and eyes should be avoided.
Warnings and precautions
Before starting to use HIRUDOID, discuss it with a doctor or pharmacist.
HIRUDOID and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines have been reported.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy and breastfeeding.
Driving and operating machinery
HIRUDOID has no effect on 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 medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
HIRUDOID is a topical medicine for use on the skin.
Recommended dose
Apply HIRUDOID 2 to 3 times daily to the affected areas, or more frequently if necessary.
Depending on the size of the treated area, application of 3 to 5 cm of gel is usually sufficient.
Apply HIRUDOID gel gently by massaging it into the affected areas.
Do not use the medicinal product under a dressing.
In cases of blunt injuries, treatment usually lasts up to 10 days; in cases of superficial
phlebitis, treatment lasts from 1 to 2 weeks. HIRUDOID may also be used in phonophoresis and
iontophoresis.
During iontophoresis, the gel is applied under the cathode.
Use of a higher than recommended dose of HIRUDOID
Due to the route of administration, overdose of HIRUDOID is unlikely.
If symptoms of overdose occur, contact a doctor.
Following accidental ingestion of HIRUDOID, no overdose symptoms related to the active substance
are expected.
However, 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 initiated immediately.
Missed dose of HIRUDOID
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequency less than 1 in 10,000 patients – very rare.
Very rarely, local hypersensitivity reactions such as skin redness may occur,
which usually resolve quickly after discontinuation of the medicinal product.
The HIRUDOID medicine contains propylene glycol, which may cause skin irritation.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store HIRUDOID medicine

Keep the medicine out of the sight and reach of children.
Store 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.
Translation of some abbreviations appearing on the immediate packaging:
Verw. bis - Expiry date
Ch.-B. - Batch number

6. Contents of the packaging and other information

What HIRUDOID contains
The active substance is mukopolysaccharide polysulfate 0.3 g/100 g.
The other ingredients are:
sodium hydroxide, propylene glycol, carbomers, isopropyl alcohol, purified water.

What HIRUDOID looks like and contents of the pack
Aluminium tube with a screw cap, packed in a cardboard box. Pack size: 40 g.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Austria, country of export:
Stada Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

Manufacturer:
Mobilat Produktions GmbH
85276 Pfaffenhofen
Germany
Stada Arzneimittel AG
61118 Bad Vilbel
Germany

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Austria, country of export: 14.830
Parallel import authorisation number: 392/19