Venotrex
Poland
Table of Contents
VENOTREX 200 mg, hard capsules
VENOTREX 300 mg, hard capsules
(Troxerutinum)
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.
- Keep this leaflet for possible future reference.
- If you have any questions, please consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What VENOTREX is and what it is used for
- Important information before taking VENOTREX
- How to take VENOTREX
- Possible side effects
- How to store VENOTREX
- Contents of the pack and other information
1. What VENOTREX is and what it is used for
VENOTREX is a mixture of four different o-hydroxyethylrutosides (troxerutin).
They act protectively on blood and lymphatic vessels.
Indications
VENOTREX is indicated for symptomatic treatment of:
- venous and lymphatic circulatory insufficiency, particularly in the lower limbs (sensation of heavy legs, pain, nocturnal cramps, varicose veins);
- exacerbations of symptoms associated with haemorrhoidal disease.
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:
VENOTREX must not be used in cases of ankle swelling caused by heart, liver, or kidney diseases.
VENOTREX with food and drink:
It is recommended to take the medicine during a meal.
Children:
The use of this medicine is not recommended in children.
Pregnancy and breastfeeding:
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There are no data on a possible adverse effect of the medicine on the fetus.
There are no data on a possible adverse effect of the medicine on the breastfed newborn.
Driving and operating machinery
VENOTREX has no influence on the ability to drive and operate machinery.
Important information about certain ingredients of VENOTREX:
The medicine contains lactose
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
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".
The medicine contains sunset yellow (E110)
The medicine may cause allergic reactions.
Use with other medicines:
Interactions between troxerutin and other medicines are not known. VENOTREX does not alter the effect of other medicines, nor does it affect (in a significant way) the results of basic laboratory tests.
3. How to use VENOTREX
If the doctor has not prescribed otherwise, the usual dosage is as follows:
- 2 hard capsules of 200 mg three times daily, or 1 hard capsule of 300 mg four times daily, for 2 to 4 weeks. For maintenance treatment or in case of recurrence, the recommended dosage is:
- 2 hard capsules of 200 mg twice daily, or 1 hard capsule of 300 mg three times daily. 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.
Use of a higher than recommended dose of VENOTREX:
Cases of troxerutin overdose have not been described.
In case of overdose, consult a doctor who will recommend gastric lavage and symptomatic treatment.
Missed dose of VENOTREX:
Do not take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like any medicinal product, VENOTREX may cause adverse reactions.
The adverse reactions listed below are categorized according to the following frequency of occurrence:
Very common: affects more than 1 in 10 treated patients.
Common: affects less than 1 in 10 but more than 1 in 100 patients.
Uncommon: affects less than 1 in 100 but more than 1 in 1,000 patients.
Rare: affects less than 1 in 1,000 but more than 1 in 10,000 patients.
Very rare: affects less than 1 in 10,000 patients and in isolated cases.
Skin and subcutaneous tissue disorders:
Rare: skin rash, itching, urticaria
Very rare: photosensitivity, alopecia
Gastrointestinal disorders:
Rare: bloating, diarrhoea, abdominal pain, dyspepsia, gastric discomfort
Very rare: nausea, vomiting
Nervous system disorders:
Very rare: headache, dizziness, fatigue
Immune system disorders:
Very rare: anaphylactic shock, pseudoanaphylactic reaction, hypersensitivity
Vascular disorders:
Very rare: hot flushes
General disorders and administration site conditions:
Very rare: fatigue, exhaustion
Musculoskeletal disorders:
Very rare: joint pain
If any of the adverse reactions described above occur, it is recommended to reduce the dose by half or temporarily discontinue treatment.
In some individuals, other adverse reactions may occur during treatment with VENOTREX.
If any adverse effects not listed in this leaflet occur, inform your doctor.
If any adverse reactions occur, including those not mentioned in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store the medicine VENOTREX
Keep the medicine out of the reach and sight of children.
Store below 25°C.
Do not use the medicine 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 mg hard capsules contains as the active substance: 200 mg troxerutin (O-hydroxyethylrutosides).
Excipients: monohydrate lactose, potato starch, sodium lauryl sulfate, anhydrous colloidal silicon dioxide.
Composition of the hard capsule shell: erythrosine (E127), sunset yellow (E110), titanium dioxide (E171), gelatin.
1 hard capsule of VENOTREX 300 mg hard capsules contains as the active substance: 300 mg troxerutin (O-hydroxyethylrutosides).
Excipients: monohydrate lact游戏副本