Diosminex

PATIENT INFORMATION LEAFLET

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Information leaflet included in the packaging: information for the patient

Diosminex, 500 mg, film-coated tablets

Diosminum

Read the leaflet carefully before taking this medicine, as it contains

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Diosminex and what is it used for

Diosminex contains micronized diosmin. Diosminex increases venous tone and has a protective effect on blood vessels.
Diosminex is indicated for the treatment of symptoms of chronic venous insufficiency in adults, such as:

• varicose veins of the legs
• venous ulcers
• telangiectasias (spider veins) and reticular veins
• feeling of heavy legs, fatigue, discomfort or restless legs
• pain or burning sensation in the legs
• feeling of cold legs
• nocturnal cramps in the legs
• swelling of the legs
• itching and paresthesia (tingling, pricking or itching of the skin of the legs)
• redness (erythema) or cyanosis of the skin.

Diosminex is used as monotherapy in the initial stages of chronic venous insufficiency or as a supplement to other therapies in all stages of chronic venous insufficiency (C0 to C6 according to the CEAP classification).
Diosminex is indicated for the treatment of exacerbated symptoms associated with hemorrhoids in adults.
If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before taking Diosminex

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When not to take Diosminex:

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

Warnings and precautions

Before taking Diosminex, you should discuss it with your doctor or pharmacist.
In case of exacerbated symptoms associated with hemorrhoids, you should remember that the therapy with Diosminex is only symptomatic and should be short-term.
If the symptoms do not disappear, you should undergo an examination by a proctologist who will choose the appropriate treatment method.
Taking this medicine for symptomatic treatment in case of exacerbated symptoms associated with hemorrhoids does not exclude the rectal administration of other medicines.
Diosminex is not effective in the treatment of edema associated with congestive heart failure. Diosminex should not be used in patients with heart failure.
In case of venous circulation disorders in the legs, the therapeutic effect of Diosminex can be increased by an appropriate lifestyle:

• avoiding sun exposure;
• avoiding standing for long periods of time;
• maintaining a healthy body weight;
• wearing special stockings.

Diosminex and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Diosmin may increase the blood levels and reduce the excretion of metronidazole (an antibacterial and antiprotozoal medicine) and diclofenac (a pain reliever and anti-inflammatory medicine).
Diosmin may inhibit platelet aggregation (inhibit blood clotting). This may increase the risk of side effects in patients taking medicines that prevent the formation of blood clots (anticoagulant medicines).

Diosminex with food and drink

The medicine should be taken during meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Diosminex is not recommended during pregnancy.
Breastfeeding
Due to the lack of available data on the passage of the medicine into breast milk, breastfeeding is not recommended during treatment with Diosminex.
Fertility
There are no controlled studies on the potential impact of diosmin on fertility.

Driving and using machines

Diosminex has no influence or negligible influence on the ability to drive and use machines.

Diosminex contains lactose

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If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Diosminex contains orange yellow S (E 110)

The medicine may cause allergic reactions.

Diosminex contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Diosminex

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose is 2 tablets per day, one tablet in the morning and one tablet in the evening during meals.
Exacerbation of hemorrhoid symptoms: 6 tablets per day for the first 4 days, then 4 tablets per day for the next 3 days.
Do not take a higher dose of the medicine than recommended.

Taking a higher dose of Diosminex than recommended

No cases of overdose have been reported.
In case of overdose, you should contact your doctor.

Missing a dose of Diosminex

Do not take a double dose to make up for a missed dose.

Stopping treatment with Diosminex

If you have any further doubts about the use of this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should tell your doctor about the following symptoms:
rare side effects (affecting less than 1 in 1,000 people):diarrhea, nausea, vomiting, dizziness, headache, malaise, rash, itching, urticaria;
side effects with unknown frequency (frequency cannot be estimated from the available data):insomnia.
In case of mild gastrointestinal side effects and neurovegetative disorders (e.g. increased anxiety, rapid heartbeat, excessive sweating, nervousness), it is not necessary to discontinue the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
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Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Diosminex

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton after the words "Expiry date" or "EXP".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diosminex contains

• The active substance is diosmin. One film-coated tablet contains 500 mg of diosmin (in micronized form).
• The other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal silica anhydrous, magnesium stearate; coating: talc, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, quinoline yellow, lake (E 104), indigo carmine, lake (E 132), orange yellow S, lake (E 110), iron oxide black (E 172).

What Diosminex looks like and contents of the pack

The film-coated tablets are green, biconvex, and oblong.
Diosminex is available in packs containing 60 film-coated tablets.
The tablets are packaged in PVC/Aluminum blisters and a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra

Date of last revision of the leaflet:

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