Product Information for the User

Thrombocid 1 mg/g Cream

Pentosan Polysulfate Sodium

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

1. What is Thrombocid and what it is used for

2. What you need to know before starting to use Thrombocid

3. How to use Thrombocid

4. Possible adverse effects

5. Storage of Thrombocid

6. Contents of the pack and additional information

This medication is a topical cream that, when applied to the skin, improves blood flow. It belongs to a group of medications called topical anti-varicose medications.

Thrombocid is indicated for:

Local symptomatic relief of superficial venous disorders such as heaviness and tightness in legs with varicose veins in adults.

Local symptomatic relief of superficial hematomas produced by trauma in adults and children over 1 year old.

No use Thrombocid

If you are allergic (hypersensitive) to pentosan polysulfate sodium or to any of the other components of this medication (listed in section 6).

If you have significant blood clotting disorders.

Do not apply on mucous membranes, open or infected wounds.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Thrombocid.

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

It should only be used on intact skin.

Avoid contact with the eyes.

In case of blood clots caused by venous problems (such as thromboembolism), it is recommended to apply the product gently and without massaging.

Do not use for a prolonged period or on large areas of the skin.

Children:

Thrombocid should not be used in children under 1 year, as there have been no studies conducted on them.

Other Medications and Thrombocid

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

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Operating Machines

The influence of Thrombocid on the ability to drive and operate machines is negligible or insignificant.

Thrombocid contains cetostearyl alcohol, polyoxylated ricinoleate, butylhydroxyanisole (E230), propylene glycol (E1520), ethyl parahydroxybenzoate (E214), and methyl parahydroxybenzoate (E218).

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

This medication may cause local skin reactions because it contains polyoxylated ricinoleate.

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 in each gram of ointment.Propylene glycolmay cause skin irritation.

This medication may cause allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate and methyl parahydroxybenzoate.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 1 year: Apply a thin layer of ointment to the affected skin area, 3 or 4 times a day.

Children under 1 year: Thrombocid is not recommended for children under 1 year due to a lack of information in this population.

Apply the preparation by performing a gentle massage to facilitate penetration and wash your hands after each application. Generally, no bandage is needed, although it may be covered with a gauze or compress if necessary.

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

If you estimate that the action of Thrombocid is too strong or 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, Thrombocid may produce adverse effects, although not all people will experience them.

It has been observed that very rarely (affects less than 1 in 10,000 patients), allergic reactions at the application site, which may manifest as itching and irritation and disappear upon interrupting treatment.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Keep the tube perfectly closed.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Thrombocid

• The active ingredient is Pentosan polysulfate sodium. Each gram of ointment contains 1 milligram of pentosan polysulfate sodium.
• The other components (excipients) are: cetearyl alcohol, sodium cetearyl sulfate (E540i), polyoxylated ricinoleate, butylhydroxyanisole (E320), citric acid (E330), decyl oleate, sorbitol (E420i), phenoxethanol, 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 packaging

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

Holder of the marketing authorization and responsible manufacturer

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

This leaflet has been approved: October 2001

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