HIRUDOID FORTE 4.45 mg/g OINTMENT

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hirudoid Forte 4.45 mg/g ointment

Sodium chondroitin sulfate

Read the package leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the package leaflet:

1. What is Hirudoid Forte and what is it used for

1. What you need to know before using Hirudoid Forte

1. How to use Hirudoid Forte
2. Possible side effects
3. Storage of Hirudoid Forte

1. Contents of the pack and further information

1. What is Hirudoid Forte and what is it used for

Hirudoid Forte is a medicine that contains sodium chondroitin sulfate as the active ingredient and has properties that favor blood flow.

This medicine is indicated for:

local symptomatic relief of superficial venous disorders such as heaviness and tightness in legs with varices in adults

local symptomatic relief of superficial hematomas caused by blows in adults and children over 1 year of age.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before using Hirudoid Forte

Do not use Hirudoid Forte

• If you are allergic to sodium chondroitin sulfate or any of the other components of this medicine (listed in section 6).

• If you have significant coagulation disorders.

• On mucous membranes, ulcers, and open or infected wounds.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hirudoid Forte.

• It should only be used on intact skin.

• Eye contact should be avoided.

In case of venous problems caused by blood clots (such as thromboembolism, obstruction of a blood vessel that hinders blood flow), it is recommended to apply the product gently and without massage.

• It should not be used for a prolonged period or on very extensive areas of the skin.

Using Hirudoid Forte with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

It is not recommended to apply other topical preparations to the same area without consulting your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Hirudoid Forte during pregnancy or breastfeeding unless your doctor advises you to do so.

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described.

3. How to use Hirudoid Forte

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is for topical use (exclusively on the skin). The recommended dose is:

Superficial venous disorders

Adults:apply a thin layer of gel or ointment to the affected area 2 to 3 times a day, distributing it with a gentle massage to facilitate penetration.

Wash your hands after each application to avoid unintentional contact with eyes and mucous membranes.

The average duration of treatment is usually between 1 and 2 weeks. If symptoms worsen or persist after 5 days of treatment, you should consult a doctor.

Children under 18 years:do not use without medical supervision.

Hematomas:

Adults and children over 1 year:apply a thin layer of gel or ointment to the affected area 2 to 3 times a day, distributing it with a gentle massage to facilitate penetration.

Wash your hands after each application to avoid unintentional contact with eyes and mucous membranes. The average duration of treatment for hematomas is usually less than 10 days. If symptoms worsen or persist after 5 days of treatment, you should consult a doctor. Children under 1 year:do not use without medical supervision.

If you use more Hirudoid Forte than you should

If you have used more Hirudoid Forte than you should or in case of accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Hirudoid Forte

Do not apply a double dose to make up for forgotten doses.

You should continue treatment as usual without taking any particular action.

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

4. Possible side effects

Like all medicines, Hirudoid Forte can cause side effects, although not everybody gets them.

It has been observed that very rarely (affects less than 1 in 10,000 patients), allergic reactions may appear at the application site, which can manifest as itching and irritation, and which disappear when treatment is interrupted.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in the Spanish Medicines Monitoring System Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hirudoid Forte

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

You should discard the tube 12 months after first opening. Write the opening date in the space provided on the carton.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Hirudoid Forte

• The active ingredient is sodium chondroitin sulfate. Each gram of ointment contains 4.45 milligrams of sodium chondroitin sulfate.

• The other ingredients (excipients) are glycerol monostearate, medium-chain triglycerides, myristyl alcohol, isopropyl myristate, bentonite, isopropyl alcohol, imidurea, phenoxyethanol, rosemary essential oil, and purified water.

Appearance of the product and contents of the pack

Hirudoid Forte is available in lacquered aluminum tubes containing 30, 60, and 100 grams of ointment.

Marketing authorization holder

Laboratorio STADA S.L. Frederic Mompou, 5

08960 Sant Just Desvern (Spain) [email protected]

Manufacturer

Mobilat Produktions GmbH Luitpoldstrasse 1

85276 Pfaffenhofen Germany

or

STADA Arzneimittel AG Stadastrasse 2-18

61118 - Bad Vilbel

Germany

Date of last revision of this package leaflet:March 2012

"Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"