Troxerutin Sinteza

Leaflet attached to the packaging: patient information

Troxerutin Synteza, 200 mg, hard capsules

• O- -hydroxyethylrutosidae

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
­ You should keep this leaflet, so you can read it again if you need to.
­ If you need advice or additional information, you should consult a pharmacist.
­ If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
See section 4.
­ If you do not feel better or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

1.

What is Troxerutin Synteza and what is it used for

2.

Important information before taking Troxerutin Synteza

3.

How to take Troxerutin Synteza

4.

Possible side effects

5.

How to store Troxerutin Synteza

6.

Contents of the packaging and other information

1. What is Troxerutin Synteza and what is it used for

The active substances of the medicine are hydroxyethylrutosides, which have a protective effect on liver cells,
inhibit aggregation, and increase the plasticity of red blood cells. Taking hydroxyethylrutosides improves
tension and elasticity of blood and lymphatic capillaries, reduces their permeability. It improves blood and lymph flow.
During treatment with Troxerutin Synteza, the oxygen saturation of venous blood improves, which has a beneficial effect on
gas exchange and the delivery of nutrients, as well as on cellular metabolism.
Based on the morphological image of blood, no negative effect on the blood coagulation system was found.
Troxerutin Synteza is used to treat symptoms of venous and lymphatic circulation disorders, especially in the lower limbs with symptoms of heaviness and leg pain, nocturnal cramps, varicose veins.

2. Important information before taking Troxerutin Synteza

When not to take Troxerutin Synteza

If you are allergic to O-β-hydroxyethylrutoside or any of the other ingredients of this medicine (listed in section 6).
Do not take Troxerutin Synteza during pregnancy.

Warnings and precautions

Before starting to take Troxerutin Synteza, you should discuss it with your doctor, pharmacist, or nurse.

Children and adolescents

Troxerutin Synteza is not recommended for use in children.

Troxerutin Synteza and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Troxerutin Synteza can be taken with other medicines. It does not affect the results of basic laboratory tests. The medicine limits the procoagulant activity of blood plasma.

Taking Troxerutin Synteza with food and drink

The medicine is recommended to be taken during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Do not take Troxerutin Synteza during pregnancy. The medicine should not be taken by breastfeeding women.

Driving and using machines

Troxerutin Synteza does not affect the ability to drive and use machines.

The medicine contains lactose monohydrate

One capsule contains 16.5 mg of lactose monohydrate.
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

The medicine contains orange yellow (E 110) and erythrosine (E 127)

One capsule contains 0.27 mg of orange yellow and 0.10 mg of erythrosine.
The medicine may cause allergic reactions.

3. How to take Troxerutin Synteza

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor. In case of doubt, you should consult your doctor or pharmacist.
Oral administration.
The medicine is recommended to be taken during meals. The initial dose is 2 to 3 times a day, 2 capsules for a period of 2 to 4 weeks. Your doctor may recommend continuing therapy with the same dosage or recommend taking 2 capsules 2 times a day for several more weeks.

Use in children and adolescents

Troxerutin Synteza is not recommended for use in children.

Use in elderly patients

There are no specific data on dosing in elderly patients.

Taking a higher dose of Troxerutin Synteza than recommended

There are no reports of cases of overdose. If you have taken a significant amount of the medicine, you should induce vomiting and consult your doctor.

Missing a dose of Troxerutin Synteza

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Troxerutin Synteza can cause side effects, although not everybody gets them. The medicine is well tolerated. Uncommon (may affect up to 1 in 100 people):
skin itching, rash, transient nausea, and gastrointestinal disorders, headaches, sleep disorders.
It is recommended to reduce the dose or temporarily discontinue the medicine. The medicine may cause allergic reactions due to the presence of dyes in the capsule shell.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Troxerutin Synteza

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Troxerutin Synteza contains

• The active substance of the medicine is O-β-hydroxyethylrutoside (O- -hydroxyethylrutosidae). One capsule contains 200 mg of O-β-hydroxyethylrutoside.
• The other excipients are: lactose monohydrate, potato starch, sodium lauryl sulfate, colloidal anhydrous silica, gelatin, titanium dioxide (E 171), orange yellow (E 110), erythrosine (E 127).

What Troxerutin Synteza looks like and what the packaging contains

Troxerutin Synteza is hard capsules, orange in color, packaged in aluminum/PVC blisters and a cardboard box.
Packaging:
Aluminum/PVC blisters in a cardboard box.
64 pieces (4 blisters of 16 pieces each)
A PP container in a cardboard box.
64 pieces (1 container of 64 pieces)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

SYNTEZA Pharmaceutical and Chemical Company Ltd.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

Date of last revision of the leaflet: