Troxerutin Kern Pharma 100 mg/ml oral solution EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Troxerutin KERN PHARMA 100 mg/ml oral solution EFG
Read the entire 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 give it to others, even if they have the same symptoms as you, because it could harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor.
Leaflet Contents:
- What Troxerutin KERN PHARMA is and what it is used for
- Before you take Troxerutin KERN PHARMA
- How to take Troxerutin KERN PHARMA
- Possible side effects of Troxerutin KERN PHARMA
- How to store Troxerutin KERN PHARMA
- Further information
1. What TROXERUTIN KERN PHARMA is and what it is used for
Troxerutin Kern Pharma belongs to the group of capillary protective medications.
It is indicated for the short-term relief (for two to three months) of edema and symptoms related to chronic venous insufficiency (pain, leg heaviness, swelling, etc.).
2. BEFORE TAKING TROXERUTIN KERN PHARMA
Do not take Troxerutin Kern Pharma
- if you are allergic (hypersensitive) to troxerutin or to any of the other components of Troxerutin Kern Pharma.
Take special care with Troxerutin Kern Pharma
- if you have or have had gastric or duodenal ulcer, severe bleeding, or a reduced platelet count (blood cells involved in blood coagulation processes).
Use of other medicines
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
No interactions with food or other medicines are known. Nevertheless, you should never take another medicine on your own initiative without your doctor having recommended it.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using this medicine.
There is no adequate experience regarding the safety of Troxerutin Kern Pharma during pregnancy. Its use in pregnant women should always be based on a careful assessment of the benefit provided versus the potential risks of administration.
Troxerutin does not pass into breast milk in significant amounts. No harmful effects on the breastfed infant have been reported.
Driving and operating machinery
It is unlikely that this medicine will negatively affect your ability to drive vehicles or operate machinery.
Important information about some of the components of Troxerutin Kern Pharma
May cause allergic reactions (possibly delayed) as it contains methyl and propyl parahydroxybenzoate.
3. HOW TO TAKE TROXERUTIN KERN PHARMA
Follow exactly the administration instructions for Troxerutin Kern Pharma provided by your doctor.
For oral use only.
Adults:
The usual dose is 10 milliliters per day, taken either as a single 10 ml dose or in two divided doses of 5 ml each.
This medicine may be taken mixed with a small amount of cold milk with or without sugar, fruit juice, soft drink, or sugared water.
If you take more Troxerutin Kern Pharma than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Troxerutin Kern Pharma
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Troxerutina Kern Pharma can produce adverse effects, although not everyone will experience them.
The adverse effects of this medicine are generally infrequent, mild, and transient. The most characteristic adverse effects are gastrointestinal disturbances, such as dyspepsia (indigestion, heartburn, and acid reflux), nausea, abdominal discomfort, headache, and skin rashes.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 expiry date stated on the packaging following Exp. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Troxerutina Kern Pharma
- The active substance is troxerutin. Each ml of solution contains 100 mg of troxerutin.
- The other components are: propylene glycol, methyl p-hydroxybenzoate (E-218), propyl p-hydroxybenzoate (E-216), potassium sorbate, sodium saccharin, lemon flavor, lime flavor, and purified water.
Appearance of the product and contents of the pack
Troxerutina Kern Pharma is an oral solution and is supplied 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 leaflet was last approved in May 2009.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.