Troxerutin synteza

Package leaflet: Information for the patient

Troxerutin Synteza, 200 mg, hard capsules
O- -hydroxyethylrutosides
Please read this leaflet carefully 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 a
physician or pharmacist.
­ Keep this leaflet, so that you can read it again if necessary.
­ If you need advice or further information, consult your pharmacist.
­ If you experience any adverse reactions, including any adverse reactions not listed in this leaflet,
inform your doctor, pharmacist or nurse.
See section 4.
­ If you do not feel better or if your condition worsens, contact your doctor.

Table of contents

1. What Troxerutin Synteza is and what it is used for
2. What you need to know before taking Troxerutin Synteza
3. How to take Troxerutin Synteza
4. Possible side effects
5. How to store Troxerutin Synteza
6. Contents of the pack and other information

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

The active substances in this medicine are hydroxyethylrutosides, which exert a protective effect on liver cells, inhibit aggregation and increase the plasticity of red blood cells. Administration of hydroxyethylrutosides improves the tone and elasticity of capillary blood and lymphatic vessels and reduces their permeability. It enhances blood and lymph flow. During treatment with Troxerutin Synteza, venous blood oxygenation improves, which positively affects gas exchange and the delivery of nutrients, as well as cellular metabolism. Based on morphological blood analysis, no negative effect on the blood coagulation system has been observed.
Troxerutin Synteza is used in the treatment of symptoms related to venous and lymphatic circulation disorders, particularly in the lower limbs, associated with sensations of heaviness and leg pain, nocturnal cramps, and varicose veins.

2. Important information before using Troxerutin Synteza

When not to use Troxerutin Synteza
Do not use Troxerutin Synteza if the patient is allergic to O-β-hydroxyethylrutoside or any of the other
ingredients of this medicine (listed in section 6).
Do not use Troxerutin Synteza during pregnancy.

Warnings and precautions
Before starting treatment with Troxerutin Synteza, consult a doctor, pharmacist, or nurse.

Children and adolescents
Troxerutin Synteza is not recommended for use in children.

Troxerutin Synteza and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Troxerutin Synteza may be used with other medicines. It does not affect the results of basic laboratory tests. The medicine reduces the procoagulant activity of blood plasma.

Taking Troxerutin Synteza with food and drink
It is recommended to take the medicine during meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Troxerutin Synteza during pregnancy. The medicine should not be used in breastfeeding women.

Driving and operating machinery
Troxerutin Synteza has no influence on the ability to drive or operate machinery.

The medicine contains lactose monohydrate
One capsule contains 16.5 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

The medicine contains sunset yellow (E 110) and erythrosine (E 127)
One capsule contains 0.27 mg of sunset 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 prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Oral administration.
It is recommended to take the medicine during meals. The initial dose is 2 capsules 2 to 3 times daily for a period of 2 to 4 weeks. Your doctor may recommend continuing the therapy with the same dosage or may advise taking 2 capsules twice daily 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 dosage recommendations for elderly patients.
Taking more Troxerutin Synteza than recommended
There are no reports of overdose cases. If a significant amount of the medicine has been ingested, induce gastric emptying and consult a doctor immediately.
If you miss a dose of Troxerutin Synteza
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them. The medicine is well tolerated.
Not common (may affect up to 1 in 100 patients):
skin itching, rash, transient nausea and gastrointestinal disturbances, headache, sleep disturbances.
Reduction of dose or temporary discontinuation of the medicine is recommended. The medicine may cause allergic reactions due to the presence of dyes in the capsule coating.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Troxerutin Synteza

Store below 25°C.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Troxerutin Synteza contains

• The active substance is O-β-hydroxyethylrutoside (O- -hydroxyethylrutoside). Each capsule contains 200 mg of O-β-hydroxyethylrutoside.
• The other ingredients are: monohydrate lactose, potato starch, sodium lauryl sulfate, anhydrous colloidal silicon dioxide, gelatin, titanium dioxide (E 171), sunset yellow (E 110), erythrosine (E 127).

What Troxerutin Synteza looks like and contents of the pack
Troxerutin Synteza is orange hard capsules packed in aluminum/PVC foil blisters and cardboard boxes.
Packaging:
Aluminum/PVC foil blisters in a cardboard box.
64 pieces (4 blisters with 16 pieces each)
PP container in a cardboard box.
64 pieces (1 container with 64 pieces)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Pharmaceutical-Chemical Enterprise „SYNTEZA” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81