Hirudoid Forte 4.45 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Hirudoid Forte 4.45 mg/g ointment
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 use of this medicine as described in this leaflet or as directed 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 further 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 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 side 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 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 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.
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Should be used only on intact skin.
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Contact with the eyes should be avoided.
In cases 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.
The application of other topical preparations on the same area is not recommended 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 Forte should not be used during pregnancy or breastfeeding unless your doctor advises otherwise.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported.
3. How to use Hirudoid Forte
Follow exactly the instructions for use provided in this leaflet or those indicated 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 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 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 Forte than you should
If you have used more Hirudoid Forte than you should, or in case of accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Hirudoid Forte
Do not apply a double dose to make up for missed doses.
Continue treatment as normal, without needing 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 produce adverse effects, although not everyone will experience them.
Very rarely (affects less than 1 in 10,000 patients), allergic-type reactions at the site of application 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 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.
The tube should be discarded 12 months after first opening. Write down 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 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 ointment contains 4.45 milligrams of sodium chondroitin sulfate.
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The other components (excipients) are glyceryl monostearate, medium-chain triglycerides, myristyl alcohol, isopropyl myristate, bentonite, isopropyl alcohol, imidurea, phenoxyethanol, rosemary essence, 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 ointment.
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 review of this leaflet: March 2012
“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”