Hirudoid 3 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Hirudoid 3 mg/g gel
Chondroitin sodium sulfate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those provided by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
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You should consult a doctor if your condition worsens or if you do not improve after 5 days.
Contents of the leaflet:
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What Hirudoid is and what it is used for
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What you need to know before using Hirudoid
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How to use Hirudoid
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Possible side effects
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How to store Hirudoid
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Contents of the pack and other information
1. What Hirudoid is and what it is used for
Hirudoid is a medicine containing sodium chondroitin sulfate as the active substance, and has properties that promote blood flow.
This medicine is indicated for:
the local symptomatic relief of superficial venous disorders such as heaviness and tightness in legs with varicose veins in adults
the local symptomatic relief of superficial bruises caused by blows in adults and children over 1 year of age.
You should consult a doctor if symptoms worsen or do not improve after 5 days.
2. What you need to know before using Hirudoid
Do not use Hirudoid
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If you are allergic to sodium chondroitin sulfate or to any of the other components of this medicine (listed in section 6).
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If you have significant coagulation disorders.
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On mucous membranes, ulcers, or open or infected wounds.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Hirudoid.
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Should be used only on intact skin.
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Contact with the eyes should be avoided.
In case of venous problems caused by blood clots (such as thromboembolism, obstruction of a blood vessel impairing blood flow), it is recommended to apply the product gently without massage.
- Should not be used for prolonged periods or over large areas of skin.
Using Hirudoid with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use Hirudoid during pregnancy or breastfeeding unless your doctor advises otherwise.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Hirudoid contains propylene glycol
This medicine contains 5 mg of propylene glycol in each gram of gel. Propylene glycol may cause skin irritation.
This medicine 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
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is for cutaneous use (for external use only 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 daily, spreading it with gentle massage to facilitate 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, consult your doctor.
Children under 18 years: do not use without medical supervision.
Bruises (contusions):
Adults and children over 1 year of age: apply a thin layer of gel or ointment to the affected area 2 to 3 times daily, spreading it with gentle massage to facilitate penetration.
Wash your hands after each application to avoid accidental contact with eyes and mucous membranes. The average duration of treatment for bruises is usually less than 10 days. If symptoms worsen or persist after 5 days of treatment, consult your doctor.
Children under 1 year of age: 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, contact the Toxicology Information Service at telephone number 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 suspected alcohol intoxication, specific therapeutic measures should be initiated immediately.
If you forget to use Hirudoid
Do not apply a double dose to make up for missed doses.
Continue treatment as usual without the need to take any special action.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Hirudoid may cause adverse effects, although not everyone experiences them.
Very rarely (affects less than 1 in 10,000 patients), allergic-type reactions at the application site have been observed, which may manifest as itching and irritation; these reactions disappear upon discontinuation of treatment.
Reporting of 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 leaflet. You may also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicinal Products at the website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Hirudoid
Keep this medicine out of 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.
The tube should be discarded 12 months after first opening. Write the date of opening in the space provided on the carton.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Hirudoid
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The active substance is sodium chondroitin sulfate. Each gram of gel contains 3 milligrams of sodium chondroitin sulfate.
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The other components (excipients) are isopropyl alcohol, sodium hydroxide, propylene glycol, polyacrylic acid, and purified water.
Appearance of the product and contents of the pack
Hirudoid is available in lacquered aluminum tubes containing 40 grams of gel.
Marketing Authorization Holder
Laboratorio STADA S.L. Frederic Mompou, 5
08960 Sant Just Desvern (Spain) [email protected]
Manufacturer
STADA Arzneimittel AG Stadastrasse 2-18
61118 - Bad Vilbel
Germany
or
Wagener & Co. GmbH
Lohesch 60
49525 Lengerich
Germany
Date of the most recent revision of this leaflet: September 2021
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”