PATIENT INFORMATION LEAFLET

Troxerutina KERN PHARMA 100 mg/ml Oral Solution EFG

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any 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. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. What Troxerutina Kern Pharma is and what it is 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. Additional information

Troxerutina Kern Pharma belongs to the group of capillary-protecting medications.

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

Do not take Troxerutina Kern Pharma

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

Be especially careful with Troxerutina Kern Pharma

• if you have or have had a stomach or duodenal ulcer, severe bleeding, or a decrease in the number of platelets (blood cells involved in blood clotting).

Use of other medications

Inform your doctor if you are using or have recently used any other medication, including those purchased without a prescription.

No interactions with food or other medications are known, but never use another medication on your own initiative without your doctor's recommendation.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medication.

No appropriate experience is available regarding the safety of Troxerutina Kern Pharma during pregnancy. Its use in pregnant women will always be made by weighing the relationship between the benefits provided and the possible risk of its administration.

Troxerutina does not pass into breast milk in significant amounts. No adverse effects have been described for the breastfeeding infant.

Driving and operating machinery

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

Important information about some of the components of Troxerutina Kern Pharma

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

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

Oral administration only.

Adults:

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

This medication can be taken mixed with a little cold milk with or without sugar, fruit juice or sugar-sweetened soda.

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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Troxerutina Kern Pharma

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Troxerutina Kern Pharma may produce adverse effects, although not all people will experience them.

The adverse effects of this medication are generally infrequent, mild, and transient. The most characteristic adverse effects are gastrointestinal disturbances, such as dyspepsia (heavy digestion, burning, and acidity), nausea, abdominal discomfort, headache, and skin eruptions.

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 the reach and sight of children.

No special storage conditions are required.

Do not use Troxerutina Kern Pharma 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 packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Troxerutina Kern Pharma Composition

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

Product Appearance and Packaging Contents

Troxerutina Kern Pharma is an oral solution and is presented in a 200 ml amber glass bottle accompanied by a measuring cup.

Marketing Authorization Holder and Responsible Manufacturer

KERN PHARMA, S.L.

Colón II Industrial Estate

Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in May 2009.

The 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.gob.es/.