PROSPECTO: INFORMATION FOR THE USER

Thrombocid Forte 5 mg/g cream

Pentosan polysulfate sodium

Read this prospect carefully because it contains important information for you.

This medication can be purchased without a prescription. However, for the best results, it must be used properly.

-Keep this prospect, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If symptoms worsen or persist after 5 days, you must consult a doctor.

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

1.What is Thrombocid Forte and what it is used for

2.Before using Thrombocid Forte

3.How to use Thrombocid Forte

4.Possible adverse effects

5.Storage of Thrombocid Forte

6.Additional information

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

Thrombocid Forte 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.

Do not use Thrombocid Forte

• If you are allergic (hypersensitive) to pentosan polysulfate sodium or to any of the components of Thrombocid Forte.
• If you have significant coagulation disorders.
• Do not apply on mucous membranes, ulcers, or open or infected wounds.

Be especially careful with Thrombocid Forte because

• 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 venous problems caused by blood clots (such as thromboembolism), it is recommended to apply the product gently and without massaging.
• Do not use it for a prolonged period or on large areas of the skin.

Use of other medications

Do not apply other topical preparations in the same area.

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not use Thrombocid Forte during pregnancy or breastfeeding unless your doctor tells you otherwise.

Driving and operating machines

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

Important information about some of the components of Thrombocid Forte

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

It may cause allergic reactions (possibly delayed) because it contains Ethyl Parahydroxybenzoate (E214) and Methyl Parahydroxybenzoate (E218).

This medication may cause skin irritation because it contains Propylene Glycol as an excipient. This medication contains 50 mg of Propylene Glycol in each gram of ointment.

Follow these instructions unless your doctor has given you different instructions.Consult your doctor or pharmacist if you have any doubts.

• 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 Forte is not recommended for children under 1 year due to a lack of information in this population.

Apply the preparation by gently massaging it into the skin 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 if irritation or worsening occurs, discontinue application and consult your doctor.

If you estimate that the action 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 that poisoning will occur.

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

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

The following adverse effects have been reported in post-marketing experience. Frequency is defined as follows: (frequent: affects between 1 and 10 of every 100 patients, infrequent: affects between 1 and 10 of every 1,000 patients, rare: affects between 1 and 10 of every 10,000 patients; very rare: affects fewer than 1 of every 10,000 patients).

Immune system disorders.

Very rare: allergic reactions, at the application site, which may manifest as itching and irritation, and disappear upon discontinuing treatment.

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

Keep out of reach and sight of children.

Keep the tube perfectly closed.

Do not store at a temperature above 30 °C.

Expiration Date

Do not use Thrombocid Forte after the expiration date that appears on the box and the tube. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Thrombocid Forte

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

Appearance of the product and content of the packaging

It is presented in tubes containing 30, 60 and 100 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona -Spain

This leaflet was approved inNovember 2001

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