Hirudoid Forte 4.45 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
HirudoidForte 4.45 mg/g gel
Chondroitin sulfate sodium
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always follow exactly the instructions for use of the medicine as described in this leaflet or as advised 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.
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You should consult a doctor if your condition worsens or does not improve after 5 days.
Contents of the leaflet:
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What Hirudoid Forte is and what it is used for
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What you need to know before using Hirudoid Forte
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How to use Hirudoid Forte
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Possible adverse effects
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How to store Hirudoid Forte
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Contents of the pack and other information
1. What Hirudoid Forte is and what it is used for
Hirudoid Forte 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 the 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 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
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If you are allergic to sodium chondroitin sulfate or to any of the other ingredients 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 Forte.
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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.
Use of Hirudoid Forte 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Hirudoid should not be used during pregnancy or breastfeeding unless your doctor specifically advises you to do so.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported.
Hirudoid Forte contains propylene glycol
This medicine contains 5 mg of propylene glycol per gram of gel. Propylene glycol may cause skin irritation.
This medicine contains propylene glycol; do not use on open wounds or large damaged skin areas (such as burns) without consulting your doctor or pharmacist first.
3. How to use Hirudoid Forte
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 (on the skin only). 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 a 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 1 to 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:
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 a 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: do not use without medical supervision.
If you use more Hirudoid Forte than you should
If you have used more Hirudoid Forte than recommended or in case of accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine 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, specific therapeutic measures should be initiated immediately.
If you forget to use Hirudoid Forte
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 can cause adverse effects, although not everyone will experience 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 Pharmacovigilance System for Human Medicines 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 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 EXP. The expiry date refers to the last day of the month indicated.
Dispose of the tube 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. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Hirudoid Forte
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The active substance is sodium chondroitin sulfate. Each gram of gel contains 4.45 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 Forte is available in lacquered aluminum tubes containing 30, 60, and 100 grams of gel.
Marketing Authorization Holder
Laboratorio STADA S.L. Frederic Mompou, 5
08960 Sant Just Desvern (Spain) [email protected]
Manufacturer
Wagener & Co. GmbH
Lohesch 60
49525 Lengerich
Germany
or
STADA Arzneimittel AG
Stadastrasse 2-18
61118 - Bad Vilbel
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 Health Products (AEMPS) http://www.aemps.gob.es/"