TROMBOBEN 1 mg/g CREAM

Introduction

Leaflet: Information for the user

Tromboben 1 mg/g cream

sodium pentosan polysulfate

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

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

• Keep this 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 side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the leaflet:

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

1. What is Tromboben and what is it used for

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

Tromboben 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 caused by bruises in adults and children over 1 year of age.

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

Do not use Tromboben

• 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, and open or infected wounds.

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Tromboben
• This medication is for topical 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 a long time or on very large areas of the skin.

Other medications and Tromboben

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

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take 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 this medication.

You should not use Tromboben during pregnancy or breastfeeding unless your doctor tells you to do so.

Driving and using machines

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

Tromboben contains cetyl stearyl alcohol, sorbic acid, butylhydroxyanisole, polyoxyethylene castor oil, and propylene glycol.

Cetyl stearyl alcohol and sorbic acid may cause local skin reactions (such as contact dermatitis).

Butylhydroxyanisole may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Polyoxyethylene castor oil may cause skin reactions.

This medication contains 7.5 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.

3. How to use Tromboben

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults, adolescents, and children over 1 year of age:

Apply a thin layer of cream to the affected skin area, 3 or 4 times a day.

• Children under 1 year of age.

Tromboben cream 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 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 Tromboben is too strong or too weak, tell your doctor or pharmacist.

If you use more Tromboben than you should

Using more cream than recommended may cause skin irritation.

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.

If you stop treatment with Tromboben

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been reported in post-marketing experience. The frequency is defined as: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), frequency not known (cannot be estimated from available data).

Immune system disorders

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this 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 Tromboben

Keep out of sight and reach of children.

Keep the tube perfectly closed.

Do not use this medication after the expiration date shown on the box or tube after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tromboben 1 mg/g cream

• The active ingredient is sodium pentosan polysulfate. Each gram of cream contains 1 mg of sodium pentosan polysulfate.
• The other components (excipients) are cetyl stearyl alcohol, sodium cetyl sulfate (E-540), polyoxyethylene castor oil, butylhydroxyanisole (E-320), citric acid (E-300), potassium phosphate, decyl oleate, sorbitol (E-420), propylene glycol (E-1520), sorbic acid (E-200), levulinic acid, phenoxyethanol, guaiazulene, thymol, and purified water.

Appearance of the product and package contents

White or white-yellowish cream with a bluish tint and characteristic odor.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U

Anabel Segura, 11. Edificio Albatros B - 1ª planta.

28108 Alcobendas. Madrid. Spain

Manufacturer

Infarmade, S.L

C/ Torre de los Herberos 35.

Polígono Industrial Carretera de la Isla

41703 Dos Hermanas. Sevilla

Spain

Date of the last revision of this leaflet:June 2018

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