Thrombocid Forte 5 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Thrombocid Forte 5 mg/g ointment
Sodium pentosan polysulfate
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 provided in this leaflet or as directed by your pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 5 days.
Contents of the leaflet:
- What Thrombocid Forte is and what it is used for
- What you need to know before using Thrombocid Forte
- How to use Thrombocid Forte
- Possible side effects
- How to store Thrombocid Forte
- Contents of the pack and other information
1. What THROMBOCID FORTE is and what it is used for
This medicine is a topical ointment that, when applied to the skin, improves blood flow and promotes the dissolution of clots. It belongs to the topical anti-varicose medicinal product group.
Thrombocid Forte is indicated for:
- Local symptomatic relief of superficial venous disorders such as heaviness and tightness in varicose legs in adults.
- Local symptomatic relief of superficial bruises caused by trauma 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 THROMBOCID FORTE
Do not use Thrombocid Forte
- If you are allergic to sodium pentosan polysulfate or to any of the other ingredients of this medicine (listed in section 6).
- If you have significant coagulation disorders.
- 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 Forte.
- This medicine is for cutaneous use only (on the skin).
- It should only be used on intact skin.
- Avoid contact with the eyes.
- In 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 extensive skin areas.
Children
Thrombocid Forte must not be used in children under 1 year of age, as studies have not been conducted in this population.
Other medicines and Thrombocid Forte
It is not recommended to apply other topical preparations to the same area.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to use any other medicines.
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 any medicine.
Driving and using machines
The effect of Thrombocid Forte on the ability to drive and operate machinery is none or negligible.
Thrombocid Forte contains cetyl stearyl alcohol, propylene glycol (E1520), ethyl parahydroxybenzoate (E214) and methyl parahydroxybenzoate (E218).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl stearyl alcohol.
This medicine contains 50 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 ethyl parahydroxybenzoate and methyl parahydroxybenzoate.
3. How to use THROMBOCID FORTE
Follow exactly the instructions for use provided in this leaflet or those indicated 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 Forte is not recommended for use in children under 1 year of age due to lack of information in this population.
Apply the ointment with a gentle massage to enhance penetration, and wash your hands after each application. Dressing is generally not necessary, although the area may be covered with gauze or a compress if deemed necessary.
If symptoms worsen or persist for more than 5 days, or if irritation or worsening occurs, discontinue use and consult your doctor.
If you feel that the effect of Thrombocid Forte is too strong or too weak, inform your doctor or pharmacist.
If you use more Thrombocid Forte than you should
Due to its external use, intoxication is unlikely.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 915 62 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, Thrombocid Forte can produce adverse effects, although not everyone will experience them.
Very rare (affects less than 1 in 10,000 patients) allergic reactions at the application site have been observed, which may manifest as itching and irritation and 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 mentioned 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 FORTE
Keep out of the sight and reach of children.
Keep the tube tightly closed.
Do not store above 30 °C.
Expiry
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 should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Thrombocid Forte
- The active substance is pentosan polysulfate sodium. Each gram of ointment contains 5 mg of pentosan polysulfate sodium.
- The other components (excipients) are cetyl stearyl alcohol, macrogol cetyl stearyl ether, glycerol (E422), propylene glycol (E1520), decyl oleate, phenoxyethanol, methylparaben (E218), ethylparaben (E214), sodium hydroxide (for pH adjustment) (E524) and water.
Appearance of the product and pack contents
It is presented in tubes containing 30, 60 and 100 g of ointment.
Marketing Authorization Holder and Manufacturer
LACER, S.A. – Boters, 5
08290 Cerdanyola del Vallès
Barcelona - Spain
Date of the most recent revision of this leaflet: July 2025
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.gob.es/