THROMBOCID 1mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Thrombocid 1 mg/g Ointment

Sodium Pentosan Polysulfate

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

Contents of the Package Leaflet:

1. What Thrombocid is and what it is used for
2. What you need to know before using Thrombocid
3. How to use Thrombocid
4. Possible side effects
5. Storage of Thrombocid
6. Contents of the pack and further information

1. What THROMBOCID is and what it is used for

This medication is a topical ointment for cutaneous use that, when applied to the skin, improves blood flow. It belongs to the group of medications called topical antivaricose agents.

Thrombocid 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 bruises 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 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.

This medication is for cutaneous use (on the skin) only.

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 large areas of the skin.

Children:

Thrombocid should not be used in children under 1 year of age, as there is no information available for this population.

Other medications and Thrombocid

It is not recommended to apply other topical preparations to the same area.

Inform your doctor or pharmacist if you are using or 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

Thrombocid has no or negligible influence on the ability to drive and use machines.

Thrombocid contains cetylstearyl alcohol, polyoxyethylated castor oil, butylhydroxyanisole (E320), propylene glycol (E1520), ethyl parahydroxybenzoate (E214), and methyl parahydroxybenzoate (E218).

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

This medication may cause local skin reactions because it contains polyoxyethylated castor oil.

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxyanisole.

This medication contains 7.5 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

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 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 required, although it can be covered with a gauze or compress if necessary.

If 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 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, Thrombocid can cause side 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 application site, which can manifest as itching and irritation and disappear upon discontinuation of treatment.

If you consider any of the side effects you are experiencing to be 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of THROMBOCID

Keep this medication out of the sight and reach of children.

Keep the tube tightly closed.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration 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 medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of Thrombocid

• The active ingredient is Sodium Pentosan Polysulfate. Each gram of ointment contains 1 milligram of sodium pentosan polysulfate.
• The other ingredients (excipients) are: cetylstearyl alcohol, sodium cetylstearyl sulfate (E540i), polyoxyethylated castor oil, butylhydroxyanisole (E320), citric acid (E330), decyl oleate, sorbitol (E420i), phenoxyethanol, propylene glycol (E1520), dipotassium phosphate, potassium dihydrogen phosphate, ethyl parahydroxybenzoate (E214), methyl parahydroxybenzoate (E218), thymol, and water.

Appearance of the product and contents of the pack

It is presented in tubes containing 30 and 60 grams of ointment.

Marketing authorization holder and manufacturer

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

This package leaflet was approved: October 2001

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.es/