Hirudoid
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Hirudoid (Hirudoid Gel)
0.3 g/100 g, gel
Mucopolysaccharide polysulphate
Hirudoid and Hirudoid Gel are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as 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, as you may need to read it again.
- If advice or further information is needed, consult the pharmacist.
- If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
Table of 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 (haematoma),
- superficial thrombophlebitis that cannot be treated with compression bandages.
Hirudoid gel may also be used in phonophoresis and iontophoresis. During iontophoresis, the gel is applied under the cathode.
2. Important information before using Hirudoid
When not to use Hirudoid
If the patient is allergic to polysaccharide polysulphate or any of the other
ingredients of this medicine (listed in section 6).
Hirudoid gel contains isopropyl alcohol and therefore contact with open wounds,
mucous membranes and eyes should be avoided.
Warnings and precautions
Before starting treatment with Hirudoid, discuss this with your doctor or pharmacist.
Hirudoid and other medicines
Tell your 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 baby, she should consult her doctor or pharmacist before using this medicine.
This medicine can be used during pregnancy and breastfeeding.
Driving and operating machinery
Hirudoid has no influence on the ability to drive motor vehicles or operate mechanical equipment.
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 physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Hirudoid gel is a topical medicine for application to the skin.
Recommended dose
Hirudoid should be applied 2 to 3 times daily to affected areas, or more frequently if necessary.
Depending on the size of the area being treated, application of 3 to 5 cm of gel is usually sufficient.
Hirudoid gel should be gently rubbed into the affected areas. The medicine should not be used under a dressing.
In cases of blunt injuries, treatment usually lasts up to 10 days, and in cases of superficial phlebitis,
from 1 to 2 weeks. Hirudoid may also be used for phonophoresis and iontophoresis.
During iontophoresis, the gel is administered under the cathode.
Use of more than the recommended dose of Hirudoid
Due to the method of administration, overdose of Hirudoid is unlikely.
If symptoms of overdose occur, consult a physician.
Following accidental ingestion of Hirudoid, no overdose symptoms related to the active substance
are expected to occur.
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
physician or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 medicine.
Hirudoid gel contains propylene glycol, which may cause skin irritation.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the package leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.
5. How to store Hirudoid medicine
Keep this medicine out of 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.
After first opening, the medicine remains stable for 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer in use. This will help protect the environment.
6. Contents of the pack and other information
What Hirudoid contains
The active substance is mucopolysaccharide polysulphate. 100 g of gel contains: mucopolysaccharide polysulphate 0.3 g, corresponding to 25,000 IU*
(* International Units established based on the determination of activated partial thromboplastin time (APTT)).
The other ingredients are: sodium hydroxide, propylene glycol, carbomers, isopropyl alcohol, purified water.
What Hirudoid looks like and contents of the pack
Aluminium tube in a cardboard box.
Pack size: 40 g or 100 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, 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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Austrian Marketing Authorisation number (country of export): 14.830
Parallel Import Licence number: 860/12