Package leaflet: information for the patient

Diosminex, 500 mg, film-coated tablets
Diosminum
Please read carefully the entire leaflet before using this medicine, as 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 physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, 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 your condition does not improve or worsens, contact your doctor.

Table of contents of the leaflet:

What Diosminex is and what it is used for
Important information before taking Diosminex
How to take Diosminex
Possible side effects
How to store Diosminex
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 exerts 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 lower limbs
venous leg ulcers
telangiectasias (spider veins) and varicose veins/reticular veins
sensation of leg heaviness, fatigue, discomfort, or restless legs
leg pain or burning sensation in the legs
sensation of cold legs
nocturnal leg cramps
swelling of the lower limbs
itching and paresthesia (tingling, pricking, or itching of the skin of the lower limbs)
redness (erythema) or bluish discoloration of the skin.

Diosminex is used as monotherapy in the early stages of chronic venous insufficiency or as an adjunct to other therapies in all stages of venous insufficiency (C0 to C6 according to CEAP classification).
Diosminex is indicated for the treatment of severe symptoms associated with hemorrhoids in adults.
If there is no improvement or if the patient feels worse, consult a doctor.

2. Important information before taking Diosminex

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When not to take Diosminex:

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

Warnings and precautions
Before starting treatment with Diosminex, discuss it with your doctor or pharmacist.
In cases of severe hemorrhoidal symptoms, it should be noted that treatment with Diosminex is symptomatic only and should be short-term.
If symptoms persist, a proctological examination should be performed by a physician who will determine the appropriate treatment.
The use of this medicine for symptomatic treatment during an acute flare-up of hemorrhoidal symptoms does not exclude the use of other rectal medications.
Diosminex is not effective in treating edema associated with congestive heart failure. Diosminex must not be used in patients with heart failure.
In cases of venous circulation disorders in the lower limbs, the therapeutic effect of Diosminex can be enhanced by adopting an appropriate lifestyle:

avoiding exposure to sunlight;
avoiding prolonged standing;
maintaining appropriate body weight;
wearing compression stockings.

Diosminex with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Diosmin may increase blood levels and reduce elimination of metronidazole (an antibacterial and antiprotozoal agent) and diclofenac (a pain-relieving and anti-inflammatory drug).
Diosmin may inhibit platelet aggregation (inhibit blood clotting). This may increase the risk of adverse reactions in patients taking antithrombotic medicines (blood thinners).
Diosminex with food and drink
Take this medicine during meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Diosminex medicinal product is not recommended during pregnancy.
Breastfeeding
Due to lack of available data on the passage of the drug into breast milk, breastfeeding is not recommended during treatment with Diosminex.
Fertility
There are no controlled studies on the potential effect of diosmin on fertility.
Driving and operating machinery
Diosminex has no effect or negligible effect on the ability to drive and operate machinery.
Diosminex contains lactose
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If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Diosminex contains sunset yellow FCF, lake (E 110)
This medicine may cause allergic reactions.
Diosminex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning 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 advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 2 tablets per day, one tablet in the morning and one tablet in the evening, taken during meals.
Acute flare-up of haemorrhoidal symptoms: 6 tablets per day for the first 4 days, followed by 4 tablets per day for the next 3 days.
Do not take more medicine than recommended.
Taking more Diosminex than recommended
No cases of overdose have been reported.
In case of overdose, contact your doctor.
If you forget to take Diosminex
Do not take a double dose to make up for a missed dose.
Stopping Diosminex
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should inform your doctor if any of the following symptoms occur:
Rare adverse effects (affects less than 1 in 1,000 people): diarrhoea, indigestion,
nausea, vomiting, dizziness, headache, malaise, rash, itching, urticaria;
Adverse effects with unknown frequency (frequency cannot be estimated
from available data): insomnia.
In the case of mild gastrointestinal effects and autonomic nervous system disturbances (e.g. increased anxiety, palpitations, excessive sweating, nervousness), discontinuation of the medicine is not required.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 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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Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Diosminex
Keep the medicine out of sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton after "Expiry date" or "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 packaging and other information

What Diosminex contains

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

What Diosminex looks like and contents of the pack
The coated tablets are green, biconvex, elongated.
Diosminex is available in packs containing 60 coated tablets.
The tablets are packed in PVC/Aluminium blisters and cardboard boxes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
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