Venotrex

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

VENOTREX200 mg, hard capsules
VENOTREX300 mg, hard capsules
(Troxerutinum)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is VENOTREX and what is it used for
• 2. Important information before taking VENOTREX
• 3. How to take VENOTREX
• 4. Possible side effects
• 5. How to store VENOTREX
• 6. Contents of the pack and other information

1. What is VENOTREX and what is it used for

VENOTREX is a mixture of four different o-β-hydroxyethyl-rutosides (troxerutin). They have a protective effect on blood vessels and lymphatic vessels.

Indications

VENOTREX is used for the symptomatic treatment of:

• venous and lymphatic insufficiency, especially in the lower limbs (feeling of heavy legs, pain, nocturnal cramps, varicose veins);
• in case of exacerbation of symptoms associated with hemorrhoids.

2. Important information before taking VENOTREX

Do not take VENOTREX:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have intolerance to some sugars.

Warnings and precautions:
In case of edema in the ankle area caused by heart, liver, or kidney diseases, do not take VENOTREX.
VENOTREX with food and drink:
It is recommended to take the medicine during a meal.
Children:
Do not recommend the use of the medicine in children.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
There are no data on the potential harmful effects of the medicine on the fetus.
There are no data on the potential harmful effects of the medicine on the newborn during breastfeeding.
Driving and using machines
VENOTREX does not affect the ability to drive and use machines.
Important information about some ingredients of VENOTREX:
The medicine contains lactose
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains sodium
This 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 (E110)
The medicine may cause allergic reactions.
Use of other medicines:
There are no known interactions between troxerutin and other medicines. VENOTREX does not change the effect of other medicines and does not affect (significantly) the results of basic laboratory tests.

3. How to take VENOTREX

Unless your doctor has prescribed otherwise, the usual dosage is:

• 2 hard capsules of 200 mg 3 times a day or 1 hard capsule of 300 mg 4 times a day, for 2 to 4 weeks. For maintenance treatment or in case of relapse, the recommended dosage is:
• 2 hard capsules of 200 mg 2 times a day or 1 hard capsule of 300 mg 3 times a day. Maintenance treatment should last 3 to 4 weeks.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Overdose of VENOTREX:
There have been no reported cases of troxerutin overdose.
In case of overdose, consult your doctor, who will recommend stomach emptying and symptomatic treatment.
Missed dose of VENOTREX:
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, VENOTREX can cause side effects.
Side effects are listed below with the following frequency of occurrence:
Bardzo często: more than 1 in 10 treated patients.
Często: less than 1 in 10, but more than 1 in 100 patients.
Niezbyt często: less than 1 in 100, but more than 1 in 1000 patients.
Rzadko: less than 1 in 1000, but more than 1 in 10,000 patients.
Bardzo rzadko: less than 1 in 10,000 patients and in individual cases.
Disorders of the skin and subcutaneous tissue:
Rzadko: skin rash, itching, urticaria
Bardzo rzadko: hypersensitivity to light, hair loss
Disorders of the stomach and intestines:
Rzadko: bloating, diarrhea, abdominal pain, nausea, discomfort in the stomach
Bardzo rzadko: nausea, vomiting
Nervous system disorders
Bardzo rzadko: headache, dizziness, fatigue.
Immune system disorders:
Bardzo rzadko: anaphylactic shock, pseudo-anaphylactic reaction, hypersensitivity
Vascular disorders:
Bardzo rzadko: hot flashes
General disorders and administration site conditions:
Bardzo rzadko: fatigue, exhaustion
Musculoskeletal disorders:
Bardzo rzadko: joint pain
In case of the above side effects, it is recommended to reduce the dose by half or temporarily discontinue the medicine.
In some people, other side effects may occur during the use of VENOTREX.
If you experience any other side effects not listed in this leaflet, please inform your doctor.
If you experience any side effects, including those not listed in the leaflet, please tell your doctor, 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
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store VENOTREX

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use VENOTREX after the expiry date stated on the packaging.

6. Contents of the pack and other information

What VENOTREX contains:

1 hard capsule of VENOTREX 200 mghard capsules contains as an active substance: 200 mg of troxerutin (O-β-hydroxyethyl-rutosides).
Excipients are: lactose monohydrate, potato starch, sodium lauryl sulfate, colloidal silica anhydrous.
The composition of the hard capsule is: erythrosine (E127), orange yellow (E110), titanium dioxide (E171), gelatin.
1 hard capsule of VENOTREX 300 mghard capsules contains as an active substance: 300 mg of troxerutin (O-β-hydroxyethyl-rutosides).
Excipients are: lactose monohydrate, potato starch, sodium lauryl sulfate, colloidal silica anhydrous.
The composition of the hard capsule is: quinoline yellow (E104), orange yellow (E110), titanium dioxide (E171), gelatin.

What VENOTREX looks like and contents of the pack:

VENOTREX 200 mg hard capsules: 64 hard capsules in the pack.
VENOTREX 300 mg hard capsules: 50 hard capsules in the pack.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o. o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of last revision of the leaflet: