HIRUDOID FORTE 4.45 mg/g GEL

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

HirudoidForte 4.45 mg/g gel

Sodium chondroitin sulfate

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

Follow the administration instructions for the medication 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 side effects not listed in this package leaflet.

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

Contents of the package leaflet:

1. What Hirudoid Forte is and what it is 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. Package contents and additional information

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

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

This medication is indicated for:

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

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

You should consult a doctor if your condition 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 medication (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 medications

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

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 medication.

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 reported.

Hirudoid Forte contains propylene glycol

This medication contains 5 mg of propylene glycol per gram of gel. Propylene glycol may cause skin irritation.

This medication contains propylene glycol; do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

3. How to use Hirudoid Forte

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

This medication 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 treatment duration 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 treatment duration 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 medication and the amount ingested.

Accidental ingestion of large amounts of Hirudoid Forte 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 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 about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Hirudoid can cause side effects, although not everyone will experience them.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in the Spanish Medicines and Healthcare Products Agency (AEMPS) Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hirudoid Forte

Keep this medication out of sight and reach of children.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Hirudoid Forte composition

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

• The other components (excipients) are isopropyl alcohol, sodium hydroxide, propylene glycol, polyacrylic acid, and purified water.

Appearance of the product and package contents

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

Marketing authorization holder

Laboratory 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 the last revision of this package leaflet: September 2021

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