Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Hirudoid (Hirudoid - Salbe)
0.3 g/100 g, ointment
Mucopolysaccharide polysulphate
Hirudoid and Hirudoid - Salbe are different trade names for the same medicinal product.
Please read the entire leaflet carefully 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 physician or pharmacist.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your doctor or pharmacist.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

What HIRUDOID is and what it is used for
What you need to know 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 for:

blunt injuries with or without bruising (haematoma),
superficial thrombophlebitis that cannot be treated with compression bandages.
Hirudoid ointment may also be used in phonophoresis and iontophoresis. In iontophoresis, the ointment is applied under the cathode.

2. Important information before using HIRUDOID

When not to use HIRUDOID
If you are hypersensitive (allergic) to mucopolysaccharide polysulphate,
methyl parahydroxybenzoate, propyl parahydroxybenzoate, or to any of the excipients.
Do not apply the ointment to open wounds or damaged skin.

When to exercise special caution when using HIRUDOID
See section 3.

Use of HIRUDOID with other medicines
You should tell your doctor about all medicines you have recently taken, including those
obtained without a prescription.
No interactions with other medicines have been reported.

Pregnancy and breastfeeding
Before using any medicine, consult your doctor or pharmacist.
HIRUDOID may be used during pregnancy and breastfeeding.

Driving and operating machinery
HIRUDOID ointment has no influence on the ability to drive or operate machinery.

HIRUDOID ointment contains cetostearyl alcohol emulsifying (type A)
This may cause local skin reactions (e.g. contact dermatitis).

HIRUDOID ointment contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
These may cause allergic reactions (delayed-type reactions possible).

3. How to use HIRUDOID

Hirudoid ointment is a medicine for topical application to the skin.
Hirudoid should be applied 2 to 3 times daily to affected areas, or more frequently if necessary.
Depending on the size of the area to be treated, application of 3 to 5 cm of ointment is usually sufficient.
Hirudoid ointment should be gently massaged into the affected areas. In case of painful inflammation, the ointment should be spread gently over the affected areas. Hirudoid ointment may also be used under a medicated 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 in phonophoresis and iontophoresis. During iontophoresis, the ointment is administered 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, consult a physician.
Following accidental ingestion of Hirudoid, no overdose symptoms related to the active substance are expected.
Missed dose of HIRUDOID
Do not apply a double dose to make up for a missed dose.
If you have any doubts concerning the use of this medicine, consult your doctor or pharmacist.
Important information about some ingredients of HIRUDOID ointment
Due to the content of cetostearyl alcohol, emulsifying (Type A), and myristyl alcohol, the ointment may cause local skin reactions (e.g. contact dermatitis).

4. Possible adverse reactions

Like all medicines, HIRUDOID may 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 medicinal product.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store HIRUDOID

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What HIRUDOID contains
The active substance is mucopolysaccharide polysulphate 0.3 g/100 g, corresponding to 25,000 IU.*
(*Units defined on the basis of APTT).
The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol
85%, stearic acid, wool fat alcohol base, cetostearyl alcohol, emulsifying
(type A), myristyl alcohol, isopropyl alcohol, thymol, potassium hydroxide, purified water.

What HIRUDOID looks like and contents of the pack
Aluminium tube containing 40 g of ointment.
For further information, please contact the responsible party or parallel importer.

Responsible party in Austria, 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, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Austrian licence number, country of export: 8.527
Parallel import licence number: 89/17