TROXERUTINE KERN PHARMA 100 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Troxerutina KERN PHARMA 100 mg/ml oral solution EFG

Read the package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What is Troxerutina Kern Pharma and what is it used for
2. Before taking Troxerutina Kern Pharma
3. How to take Troxerutina Kern Pharma
4. Possible side effects of Troxerutina Kern Pharma
5. Storage of Troxerutina Kern Pharma
6. Further information

1. What is TROXERUTINA KERN PHARMA and what is it used for

Troxerutina Kern Pharma belongs to the group of capillary protective medicines.

It is indicated for short-term relief (for two to three months) of edema and symptoms related to chronic venous insufficiency (pain, heaviness of legs, swelling, etc.).

2. BEFORE TAKING TROXERUTINA KERN PHARMA

Do not take Troxerutina Kern Pharma

• if you are allergic (hypersensitive) to troxerutina or any of the other ingredients of Troxerutina Kern Pharma.

Take special care with Troxerutina Kern Pharma

• if you have or have had gastric or duodenal ulcers, severe bleeding, or a decrease in the number of platelets (blood cells involved in blood coagulation processes).

Use of other medicines

Tell your doctor if you are using or have recently used any other medicines, including those obtained without a prescription.

No interactions with food or other medicines are known. In any case, never use another medicine on your own initiative without your doctor's recommendation.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medicine.

There is no suitable experience regarding the safety of Troxerutina Kern Pharma in pregnancy. Its use in pregnant women will always be done weighing the benefit against the possible risk of administration.

Troxerutina does not pass into breast milk in significant amounts. No harmful effects have been described for the breastfed child.

Driving and using machines

It is unlikely that this medicine will negatively affect your ability to drive vehicles or use hazardous machinery.

Important information about some of the ingredients of Troxerutina Kern Pharma

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

3. HOW TO TAKE TROXERUTINA KERN PHARMA

Follow the administration instructions of Troxerutina Kern Pharma exactly as indicated by your doctor.

Oral use only.

Adults:

The usual dose is 10 milliliters per day, in one 10 ml dose or two 5 ml doses.

This medicine can be taken mixed with a little cold milk with or without sugar, fruit juice or soda, or sugared water.

If you take more Troxerutina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Troxerutina Kern Pharma

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Troxerutina Kern Pharma can cause side effects, although not everyone gets them.

The side effects of this medicine are, in general, infrequent, mild, and transient. The most characteristic side effects are digestive disorders, such as dyspepsia (heavy digestion, heartburn, and acidity), nausea, abdominal discomfort, headache, and skin rashes.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

5. Storage of TROXERUTINA KERN PHARMA

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Troxerutina Kern Pharma after the expiration date stated on the packaging after Exp. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Troxerutina Kern Pharma

• The active ingredient is troxerutina. Each milliliter of the solution contains 100 mg of Troxerutina.
• The other ingredients are: propylene glycol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), potassium sorbate, sodium saccharin, lemon flavor, lime flavor, and purified water.

Appearance of the product and packaging contents

Troxerutina Kern Pharma is an oral solution and is presented in a 200 ml amber glass bottle with a dosing cup.

Marketing authorization holder and manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

This package leaflet was approved in May 2009.

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