Thrombocid 1 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Thrombocid 1 mg/g ointment
Pentosan polysulfate sodium
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
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Contents of the package leaflet:
- What Thrombocid is and what it is used for
- What you need to know before using Thrombocid
- How to use Thrombocid
- Possible side effects
- Storage of Thrombocid
- Contents of the pack and other information
1. What THROMBOCID is and what it is used for
This medicine is a topical ointment that, when applied to the skin, improves blood flow. It belongs to the group of medicines known as topical anti-varicose agents.
Thrombocid is indicated for:
Local symptomatic relief of superficial venous disorders such as heaviness and tightness in the legs with varicose veins in adults.
Local symptomatic relief of superficial bruising caused by blows in adults and children over 1 year of age.
2. What you need to know before using THROMBOCID
Do not use Thrombocid
If you are allergic (hypersensitive) to sodium pentosan polysulfate or to any of the other components of this medicine (listed in section 6).
If you have significant disorders of blood coagulation.
Do not apply on mucous membranes, ulcers, or open or infected wounds.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Thrombocid.
This medicine is for cutaneous use only (on the skin).
It should only be used on intact skin.
Avoid contact with the eyes.
In cases of venous problems caused by blood clots (such as thromboembolism), it is recommended to apply the product gently without massage.
It should not be used for prolonged periods or over large areas of skin.
Children:
Thrombocid should not be used in children under 1 year of age, as studies have not been conducted in this population.
Other medicines and Thrombocid
It is not recommended to apply other topical preparations to the same area.
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
Driving and using machines
The effect of Thrombocid on the ability to drive and use machines is none or negligible.
Thrombocid contains cetostearyl alcohol, polyoxyl 35 castor oil, butylhydroxyanisole (E230), propylene glycol (E1520), ethylparaben (E214) and methylparaben (E218).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
This medicine may cause local skin reactions because it contains polyoxyl 35 castor oil.
This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole.
This medicine contains 7.5 mg of propylene glycol in each gram of ointment. Propylene glycol may cause skin irritation.
It may cause allergic reactions (possibly delayed) because it contains ethylparaben and methylparaben.
3. How to use THROMBOCID
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 1 year of age: Apply a thin layer of ointment to the affected area of skin, 3 or 4 times daily.
Children under 1 year of age: Thrombocid is not recommended for use in children under 1 year of age due to lack of information in this population.
Apply the preparation with a gentle massage to enhance penetration, and wash your hands after each application. A dressing is generally not necessary, although the area may be covered with gauze or a compress if considered necessary.
If symptoms worsen or persist beyond 5 days, or if irritation or worsening occurs, discontinue use and consult your doctor.
If you feel that the effect of Thrombocid is too strong or too weak, inform your doctor or pharmacist.
If you use more Thrombocid than you should
Using more ointment than recommended may cause skin irritation.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, Thrombocid may produce adverse 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 site of application, which may manifest as itching and irritation, and which disappear upon discontinuation of treatment.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of THROMBOCID
Keep this medicine out of the sight and reach of children.
Keep the tube tightly closed.
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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Thrombocid
- The active substance is Pentosan polysulfate sodium. Each gram of ointment contains 1 milligram of pentosan polysulfate sodium.
- The other components (excipients) are: cetostearyl alcohol, sodium cetostearyl sulfate (E540i), polyoxyethylene castor oil, butylhydroxyanisole (E320), citric acid (E330), decyl oleate, sorbitol (E420i), phenoxyethanol, propylene glycol (E1520), dipotassium phosphate, potassium dihydrogen phosphate, ethylparaben (E214), methylparaben (E218), thymol and water.
Appearance of the medicinal product and contents of the pack
It is presented in tubes containing 30 and 60 g of ointment.
Marketing Authorization Holder and Manufacturer
LACER, S.A. – Boters, 5
08290 Cerdanyola del Vallès
Barcelona - Spain
This patient information leaflet was approved: October 2001
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/