Package leaflet: Information for the patient

OTREX 600; tablets, 600 mg
(Diosminum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or if you feel worse, consult your doctor.

Contents of the package leaflet

What Otrex 600 is and what it is used for
Important information before taking Otrex 600
How to take Otrex 600
Possible side effects
How to store Otrex 600
Contents of the pack and other information

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

Each Otrex 600 tablet contains 600 mg of diosmin. The medicine increases venous wall tone, normalizes capillary permeability, and exerts a protective effect on blood vessel walls (increases resistance of small blood vessels).
Indications for Otrex 600:

Reduction of symptoms related to chronic venous insufficiency of the lower limbs, e.g., sensation of heavy legs, leg pain, and discomfort caused by stasis dermatitis;
Symptomatic treatment of acute haemorrhoidal attacks.

2. Information before using Otrex 600

When not to use Otrex 600

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

Warnings and precautions:

if the medicine is administered during an acute flare-up of haemorrhoidal symptoms, additional treatment as used for other anorectal disorders may be necessary. Treatment should be short-term – up to 15 days.
if haemorrhoid-related symptoms persist or worsen despite treatment, consult a doctor.

Children and adolescents
No data available.
Otrex 600 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Interactions between Otrex 600 and other medicines are not known.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Otrex 600 may be used during pregnancy only if clearly necessary.
Due to lack of data on passage of Otrex 600 into breast milk, use during breastfeeding is not recommended.
Driving and operating machinery
Otrex 600 has no influence on the ability to drive or operate machinery.

3. How to use Otrex 600

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Chronic venous insufficiency of the lower limbs:
the usual dose is 1 tablet daily, taken in the morning on an empty stomach.
Acute flare-up of haemorrhoidal disorders:
the usual dose is 2 to 3 tablets daily, taken during meals.
Taking more Otrex 600 than prescribed
If you take more than the recommended dose, consult a doctor or pharmacist.
Symptoms of overdose with Otrex 600 are not known.
If you miss a dose of Otrex 600
Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Gastrointestinal disturbances (nausea, vomiting) may rarely occur.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported
directly to: Department for Monitoring Adverse Drug Reactions
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: [email protected]
Reporting adverse effects allows more information on the safety of the medicine to be collected.

5. How to store Otrex 600

Keep this medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Otrex 600 contains

The active substance is semi-synthetic diosmin. One 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 contents of the pack
Otrex 600 tablets are oblong, greyish-yellow or light yellow, with a score line on both sides.
The tablets are packed in blisters placed in cardboard cartons. The packs contain 15 or 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Stragen France SAS
30 rue Edouard Nieuport
69008 Lyon
France
Manufacturer:
Phyteo Laboratoire
11, rue de Montbazon
37260 Monts
France
Date of preparation of the leaflet: February 2020