HIRUDOID 3 mg/g OINTMENT

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hirudoid 3 mg/g ointment

Sodium chondroitin sulfate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

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

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this 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 and what is it used for

1. What you need to know before you start using Hirudoid

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

1. Contents of the pack and further information

1. What is Hirudoid and what is it used for

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

This medicine is indicated for:

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

the local symptomatic relief of superficial hematomas caused by bruises 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 you start using Hirudoid

Do not use Hirudoid

• 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.

• 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 long time or on very large areas of the skin.

Using Hirudoid with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Hirudoid 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.

Hirudoidcontains propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-

218), cetearyl alcohol, and lanolin

This medicine may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218), and local reactions on the skin (such as contact dermatitis) because it contains cetearyl alcohol and lanolin.

3. How to use Hirudoid

Follow exactly the administration instructions of the medicine contained in this 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 light 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 light 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 than you should

If you have used more Hirudoid 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.

Accidental ingestion of large amounts of Hirudoid gel due to its content of isopropyl alcohol may cause symptoms of acute alcohol intoxication.

In case of possible alcohol intoxication, special therapeutic measures should be initiated immediately.

If you forget to use Hirudoid

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

You should continue treatment as normal 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 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 discontinued.

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

5. Storage of Hirudoid

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 EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Place 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

• The active ingredient is sodium chondroitin sulfate. Each gram of ointment contains 3 milligrams of sodium chondroitin sulfate.

• The other ingredients (excipients) are isopropyl alcohol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), thymol, potassium hydroxide, stearic acid, cetearyl alcohol, glycerol (E-422), myristyl alcohol, lanolin, and purified water.

Appearance of the product and pack contents

Hirudoid is available in lacquered aluminum tubes with 40 grams of ointment.

Marketing authorisation 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

or

Wagener & Co. GmbH

Lohesch 60

49525 Lengerich

Germany

Date of last revision of this leaflet:March 2012

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