THROMBOCID FORTE 5 mg/g OINTMENT

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Thrombocid Forte 5 mg/g ointment

Sodium pentosan polysulfate

Read the entire package leaflet carefully before starting to use this medication,as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

Contents of the package leaflet:

1. What Thrombocid Forte is and what it is used for
2. What you need to know before using Thrombocid Forte
3. How to use Thrombocid Forte
4. Possible side effects
5. Storage of Thrombocid Forte
6. Package contents and additional information

1. What is THROMBOCID FORTE and what is it used for

This medication is a topical ointment that, when applied to the skin, improves blood flow, favoring the dissolution of clots. It belongs to the pharmacotherapeutic group of topical antivaricose agents.

Thrombocid Forte is indicated for:

• Local symptomatic relief of superficial venous disorders such as heaviness and tightness in legs with varices in adults.
• Local symptomatic relief of superficial hematomas caused by blows in adults and children over 1 year of age.

You should consult a doctor if your 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 any of the other components of this medication (listed in section 6).
• If you have significant coagulation disorders.
• Do not apply to mucous membranes, ulcers, or open or infected wounds.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Thrombocid Forte.

• This medication is for external use only (on the skin).
• It should only be used on intact skin.
• Eye contact should be avoided.
• In case of venous problems caused by blood clots (such as thromboembolism), it is recommended to apply the product gently and without massage.
• It should not be used for prolonged periods or on very extensive areas of the skin.

Children:

Thrombocid Forte should not be used in children under 1 year of age, as no studies have been conducted in this population.

Other medications and Thrombocid Forte

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 may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

Driving and using machines

The influence of Thrombocid Forte on the ability to drive and use machines is nil or insignificant.

Thrombocid Forte contains cetearyl alcohol, propylene glycol (E1520), ethyl parahydroxybenzoate (E214), and methyl parahydroxybenzoate (E218).

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol.

This medication contains 50 mg of propylene glycol per 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 the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask 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 skin area, 3 or 4 times a day.
• 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 preparation by gently massaging to facilitate penetration and wash your hands after each application. Generally, no dressing is needed, although it can be covered with a gauze or compress if necessary.

If your symptoms worsen or last more than 5 days, or if irritation or worsening occurs, discontinue application and consult your doctor.

If you think 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, it is unlikely to cause intoxication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 62 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, Thrombocid Forte may cause side effects, although not everyone will experience them.

Very rare (affects less than 1 in 10,000 patients) allergic reactions have been observed at the application site, which can manifest as itching and irritation and disappear upon discontinuation of treatment.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of THROMBOCID FORTE

Keep out of sight and reach of children.

Keep the tube perfectly closed.

Do not store at a temperature above 30 °C.

Expiry date

Do not use this medication after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Thrombocid Forte

• The active ingredient is sodium pentosan polysulfate. Each gram of ointment contains 5 mg of sodium pentosan polysulfate.
• The other ingredients (excipients) are cetearyl alcohol, cetearyl ether of macrogol, glycerol (E422), propylene glycol (E1520), decyl oleate, phenoxyethanol, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), sodium hydroxide (for pH adjustment) (E524), and water.

Appearance of the product and package 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 last revision of this package leaflet:July2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/