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Otrex 600

Otrex 600

About the medicine

How to use Otrex 600

Leaflet attached to the packaging: patient information

OTREX 600; tablets, 600 mg

( Diosmin)

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

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet, or as directed by
the doctor or pharmacist.

  • This leaflet should be kept, so that it can be read again if necessary.
  • If advice or additional information is needed, the pharmacist should be consulted.
  • If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
  • If there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

  • 1. What is Otrex 600 and what is it used for
  • 2. Important information before using Otrex 600
  • 3. How to use Otrex 600
  • 4. Possible side effects
  • 5. How to store Otrex 600
  • 6. Package contents and other information

1. What is Otrex 600 and what is it used for

Otrex 600 tablet contains 600 mg of diosmin. The medicine increases the tension of venous vessel walls,
causes normalization of vessel permeability and has a protective effect on vessel walls (increases
the resistance of small blood vessels).
Indications for use of Otrex 600:

  • reducing symptoms associated with venous circulation failure of the lower limbs, such as feelings of heaviness in the legs, leg pain, and discomfort caused by bedsores;
  • symptomatic treatment in case of exacerbation of hemorrhoid symptoms.

2. Important information before using Otrex 600

When not to use Otrex 600

  • if the patient is allergic to diosmin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

  • if the medicine is administered in the exacerbation of hemorrhoid symptoms, it may be necessary to use treatment as in other anorectal diseases. The treatment should be short-term - up to 15 days
  • if the symptoms associated with hemorrhoids persist or worsen despite the use of the medicine, the doctor should be consulted.

Children and adolescents

No data are available.
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Otrex 600 and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken by the patient
or recently taken, as well as any medicines that the patient plans to use.
Interactions between Otrex 600 and other medicines are not known.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected or planned, the doctor or pharmacist should be consulted before using this medicine.
The medicine may be used during pregnancy only if necessary.
Due to the lack of data on the penetration of Otrex 600 into breast milk, the use of the medicine during breastfeeding is not recommended.

Driving and using machines

The medicine has no effect on the ability to drive and use machines.

3. How to use Otrex 600

This medicine should always be used exactly as described in the patient leaflet, or as directed by
the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The medicine is administered orally.
Venous circulation failure of the lower limbs:
the usual dose of the medicine is 1 tablet per day, in the morning, on an empty stomach.
Exacerbation of hemorrhoid symptoms:
the usual dose of the medicine is 2 to 3 tablets per day, during meals.

Using a higher dose of Otrex 600 than recommended

In case of taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted.
Symptoms of overdose of Otrex 600 are not known.

Missing a dose of Otrex 600

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, gastrointestinal disorders (nausea, vomiting) may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products
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
e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.
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5. How to store Otrex 600

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
The medicine should not be used after the expiry date stated on the carton after "expiry date". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Otrex 600 contains

  • The active substance of the medicine is semi-synthetic diosmin. 1 tablet contains 600 mg of semi-synthetic diosmin.
  • The other ingredients are: corn starch, microcrystalline cellulose, povidone, magnesium stearate.

What Otrex 600 looks like and what the package contains

Otrex 600 tablets are oblong, gray-yellow or light yellow with a dividing groove on both sides.
The tablets are packaged in blisters placed in cardboard cartons. The packages contain 15
and 30 tablets.

Responsible entity and manufacturer

Responsible entity:
Stragen France SAS
30 rue Edouard Nieuport
69008 Lyon
France
Manufacturer:
Phyteo Laboratoire
11, rue de Montbazon
37260 Monts
France
Date of leaflet preparation: February 2020
08583

  • Country of registration
  • Active substance
  • Prescription required
    No
  • Manufacturer
  • Importer
    Phyteo Laboratoire

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