PATIENT INFORMATION LEAFLET

Hirudoid Forte 4.45 mg/g cream

Sodium chondroitin sulfate

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

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

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

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

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 additional information

Hirudoid Forte is a medication that contains sodium chondroitin sulfate as the active ingredient, and has properties that promote 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 produced by blows in adults and children over 1 year old.

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

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 blood clotting disorders.

• On mucous membranes, ulcers, or 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.

• It should be avoided in contact with the eyes.

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

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

Use of Hirudoid Forte with other medications

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use Hirudoid Forte during pregnancy or breastfeeding unless your doctor tells you otherwise.

Driving and operating machinery

No effects on the ability to drive vehicles and operate machinery have been described.

Follow exactly the administration instructions of the medication contained in this leaflet or those 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 its penetration.

Wash your hands after each application to avoid accidental 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 must consult your doctor.

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

Haematomas:

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 its penetration.

Wash your hands after each application to avoid accidental contact with eyes and mucous membranes. The average duration of treatment for haematomas is usually less than 10 days. If symptoms worsen or persist after 5 days of treatment, you must consult your 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 Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Hirudoid Forte

Do not apply a double dose to compensate for the missed doses.

You must continue treatment normally without taking any particular action.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Hirudoid may cause adverse effects, although not all people will experience 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 may manifest as itching and irritation, and disappear upon interrupting treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in the Spanish System for Pharmacovigilance of Medicinal Products for Human Use Website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

You must 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 thrown down the drains or in the trash. Deposit the packaging and the

medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. In this way, you will help protect the environment.

Composition of HirudoidForte

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

• The other components (excipients) are monostearate of glycerol, medium-chain triglycerides, myristic alcohol, isopropyl myristate, bentonite, isopropyl alcohol, imidurea, phenoxethanol, rosemary essence, and purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

Laboratorio STADA S.L. Frederic Mompou, 5

08960 Sant Just Desvern (Spain) [email protected]

Responsible for manufacturing

Mobilat Produktions GmbH Luitpoldstrasse 1

85276 Pfaffenhofen Germany

or

STADA Arzneimittel AG Stadastrasse 2-18

61118 - Bad Vilbel

Germany

Last review date of this leaflet:March 2012

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