HIRUDOID Gel 300 mg/100 g

Important notes (mandatory information)

Hirudoid forte Gel 300 mg/100 g. Active ingredient: Chondroitin polysulfate from bovine trachea. Areas of application: for local treatment of blunt injuries (trauma) with and without bruising (hematoma) and superficial phlebitis, provided that this cannot be treated by external pressure (compression).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hirudoid Gel 300 mg/100 g
Active ingredient: Chondroitin polysulfate from bovine trachea

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 14 days, talk to your doctor.

What this leaflet contains

1. WHAT IS HIRUDOID GEL AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HIRUDOID GEL?
3. HOW TO USE HIRUDOID GEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HIRUDOID GEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HIRUDOID GEL AND WHAT IS IT USED FOR?

Hirudoid Gel is a decongestant and anti-inflammatory medicine. Hirudoid Gel is used for local treatment of blunt injuries (trauma) with and without bruising (hematoma) and superficial phlebitis, provided that this cannot be treated by external pressure (compression).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE HIRUDOID GEL?

Hirudoid Gel must not be used if you are allergic to chondroitin polysulfate or any of the other ingredients of this medicine (listed in section 6). Do not apply Hirudoid Gel to open wounds or injured skin.

Warnings and precautions

Please talk to your doctor or pharmacist before using Hirudoid Gel: see under "Hirudoid Gel must not be used" and "4. What side effects are possible?"

Using Hirudoid Gel with other medicines

No interactions are known. Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Previous experience with local application of chondroitin polysulfate to the skin in pregnant and breast-feeding women has not provided any evidence of harmful effects on the unborn child or the infant.

Driving and using machines

No special precautions are necessary.

Hirudoid Gel contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW TO USE HIRUDOID GEL?

Always use Hirudoid Gel exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is

Apply Hirudoid Gel 2 to 3 times a day, or more often if necessary, to the affected area. Depending on the size of the area to be treated, a gel strand of 3 to 5 cm is generally sufficient.

Note

The primary treatment for superficial phlebitis of the lower extremities is external pressure (compression treatment).

Type of application

Application to the skin. Apply Hirudoid Gel evenly to the affected area and spread it lightly. Use Hirudoid Gel only on unbroken skin, avoid contact with eyes or mucous membranes and with open wounds or injured skin. As with all alcohol-based gels, you should not cover the area treated with Hirudoid Gel with a bandage. Hirudoid Gel is also suitable for physical treatment methods, such as iontophoresis and phonophoresis. In iontophoresis, the gel is applied under the cathode.

Duration of use

The use of Hirudoid Gel should be continued until the symptoms have subsided. The treatment period is usually up to 10 days for blunt injuries and one to two weeks for superficial phlebitis. If the symptoms have not improved after 14 days of regular use of Hirudoid Gel or if the symptoms recur after the end of treatment, please consult your doctor.

If you have used more Hirudoid Gel than you should

Overdosage is not known when Hirudoid Gel is used as directed. In case of accidental ingestion of Hirudoid Gel, overdose symptoms due to the active ingredient are not to be expected. Due to the content of 2-propanol, especially in children, accidental ingestion of larger amounts of Hirudoid Gel can lead to symptoms of acute alcohol poisoning. In the event of possible alcohol poisoning, a doctor should be consulted immediately, who will initiate special treatment measures immediately.

If you forget to use Hirudoid Gel

Do not use twice the amount of gel if you forget the previous application.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Skin and subcutaneous tissue disorders

Very rarely, hypersensitivity reactions, such as reddening of the skin, can occur when using Hirudoid Gel, which usually subside quickly after discontinuation of the preparation.

If any of the possible side effects mentioned occur, stop treatment and consult your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE HIRUDOID GEL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the tube. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Note on shelf life after opening: Shelf life after opening: 12 months. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hirudoid Gel contains

The active ingredient is chondroitin polysulfate from bovine trachea. 100 g of gel contain 300 mg of chondroitin polysulfate from bovine trachea corresponding to 25,000 U (units determined via the activated partial thromboplastin time (APTT)). The other ingredients are sodium hydroxide, polyacrylic acid, 2-propanol (Ph.Eur.), propylene glycol, purified water.

What Hirudoid Gel looks like and contents of the pack

Clear, colorless gel. Hirudoid Gel is available in packs of 100 g gel.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

Mobilat Produktions GmbH
Luitpoldstraße 1
85276 Pfaffenhofen

This leaflet was last revised in September 2019.

Source: Information from the package leaflet
Status: 09/2020
Active ingredient: Chondroitin polysulfate from bovine trachea. Areas of application: for local treatment of blunt injuries (trauma) with and without bruising (hematoma) and superficial phlebitis, provided that this cannot be treated by external pressure (compression).