TROMBOBEN FORTE 5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Tromboben Forte 5 mg/g cream

sodium pentosan polysulfate

Read the package leaflet carefully before starting to use this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the package leaflet:

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

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

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

Tromboben 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.

2. What you need to know before taking Tromboben Forte

Do not use Tromboben Forte

• If you are allergic to sodium pentosan polysulfate or any of the other components of this medicine (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 Forte.

• This medicine is for cutaneous 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 medicines and Tromboben Forte

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

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

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

Do not use Tromboben Forte during pregnancy or breastfeeding unless your doctor advises you to do so.

Driving and using machines

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

Tromboben Fortecontains cetearyl alcohol, sorbic acid, and propylene glycol.

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

This medicine contains 50 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.

3. How to use Tromboben Forte

Follow the instructions for administration of the medicine contained in this package 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 Forteis not recommended for use in children under 1 year of age due to the 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 action of Tromboben Forte is too strong or too weak, tell your doctor or pharmacist.

If you use more Tromboben Forte 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. Telephone 915 62 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the available data).

Disorders of the immune system.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tromboben Forte

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

Keep the tube perfectly closed.

Do not use this medicine after the expiry date stated on the carton or tube after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tromboben Forte

• The active ingredient is sodium pentosan polysulfate. Each gram of cream contains 5 mg of sodium pentosan polysulfate.
• The other ingredients (excipients) are: cetearyl alcohol, cetomacrogol 1000, glycerol (E-422), propylene glycol (E-1520), decyl oleate, phenoxyethanol, levulinic acid, sorbic acid (E-200), and purified water.

Appearance of the product and contents of the pack

White or yellowish-white cream with characteristic odor

It is presented in tubes containing 60 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

Anabel Segura 11,

Albatros Building B, 1st floor

28108 Alcobendas, Madrid,

Spain

Manufacturer

Infarmade, S.L.

Torre de los Herberos 35,

Carretera de la Isla Industrial Estate

41703 Dos Hermanas, Seville

Spain

Date of last revision of this package leaflet:June 2018

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