Venotrex

PATIENT INFORMATION LEAFLET: USER INFORMATION

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

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 using VENOTREX
• 3. How to use 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 symptomatic treatment of:

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

2. Important information before using VENOTREX

When not to use VENOTREX:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• intolerance to certain sugars.

Warnings and precautions:
In the case of edema in the ankle area caused by heart, liver, or kidney diseases, VENOTREX should not be used.
VENOTREX with food and drink:
It is recommended to take the medicine during a meal.
Children:
It is not recommended to use the medicine in children.
Pregnancy and breastfeeding:
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using 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 baby 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 the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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.
Using other medicines:
There are no known interactions between troxerutin and other medicines. VENOTREX does not change the effect of other medicines and does not significantly affect the results of basic laboratory tests.

3. How to use VENOTREX

If the doctor does not recommend a different dosage, the medicine is usually used as follows:

• 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.

In case of feeling that the effect of the medicine is too strong or too weak, you should consult a doctor.
Using a higher dose of VENOTREX than recommended:
There are no reported cases of troxerutin overdose.
In case of overdose, you should consult a doctor, who will recommend stomach emptying and symptomatic treatment.
Missing a dose of VENOTREX:
You should 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, hives
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: headaches, 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 occurrence of the described side effects, it is recommended to reduce the dose by half or temporarily discontinue the medicine.
In some people, during the use of VENOTREX, other side effects may occur.
In case of occurrence of other side effects not listed in this leaflet, you should inform your doctor.
If you experience any side effects, including any side effects not listed in the leaflet, you should 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store VENOTREX

The medicine should be stored in a place inaccessible and invisible to 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-rutoside)
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-rutoside).
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 what the pack contains:

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
phone: (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: