Package leaflet: Information for the patient

Diovemin
1000 mg, tablets
Diosminum
Please read carefully the entire leaflet before taking 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 advised 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 your symptoms do not improve or if you feel worse, contact your doctor.

Table of contents:

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

1. What Diovemin is and what it is used for

Diovemin contains micronized diosmin. Diosmin increases venous tone and exerts a protective effect on blood vessels. It enhances lymphatic drainage by stimulating peristalsis (motility) of lymphatic vessels and lymph flow. Diovemin affects microcirculation by reducing permeability of small blood vessels, perivascular inflammatory reactions, and stasis in the microcirculation. It also reduces fragility of small blood vessels.

Diovemin is indicated:

for the treatment of symptoms related to chronic venous and lymphatic insufficiency of the lower limbs:
- sensation of heavy legs;
- leg pain;
- nocturnal leg cramps;
- capillary varicosities (spider veins) – caused by dilation and branching of superficial skin blood vessels;
for symptomatic treatment during exacerbations of haemorrhoidal disease – in this indication, the medicine is intended for short-term use.

If there is no improvement or if you feel worse, consult your doctor.

2. Important information before taking Diovemin

When not to take Diovemin

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 to take Diovemin, consult your doctor or pharmacist.
In case of worsening symptoms related to haemorrhoids, remember that treatment with Diovemin is only symptomatic and should be short-term. If symptoms do not improve, a medical examination by a proctologist should be performed to determine the appropriate treatment method.
In case of venous circulation disorders in the lower limbs, the therapeutic effect of Diovemin can be enhanced by adopting an appropriate lifestyle:

avoiding exposure to sunlight,
avoiding prolonged standing,
maintaining a healthy body weight,
wearing special compression stockings,
engaging in physical activity and performing appropriate exercises.

Diovemin and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant administration of diosmin with diclofenac or metronidazole may increase their maximum plasma concentration and prolong their elimination from the body.
Diosmin inhibits platelet aggregation. This mechanism may contribute to an increased risk of adverse effects in patients taking anticoagulant medicines.
Concomitant administration of diosmin with fexofenadine may increase the absorption and bioavailability of fexofenadine.
Diosmin inhibits the action of carbamazepine in the body.

Diovemin with food and drink
Take this medicine during meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
The use of Diovemin is not recommended during pregnancy.

Breastfeeding
The use of Diovemin is not recommended during breastfeeding.

Driving and operating machinery
Diovemin has no effect or has a negligible effect on the ability to drive motor vehicles and operate mechanical equipment.

3. How to take Diovemin

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet once daily, taken during a meal.
In case of an acute flare-up of haemorrhoidal symptoms, the dose is 1 tablet three times daily for 4 days, followed by 1 tablet twice daily for the next 3 days, taken during meals.
Do not take a higher than recommended dose of the medicine.
Taking more Diovemin than recommended
No cases of overdose have been reported.
If you take more than the recommended dose, contact your doctor.
Missing a dose of Diovemin
Do not take a double dose to make up for a missed dose.
Stopping Diovemin
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody experiences them.
Rarely occurring: diarrhoea, dyspepsia, nausea, vomiting, dizziness, headache, malaise, rash, itching, urticaria.
In case of mild gastrointestinal adverse reactions, and disturbances such as increased restlessness, palpitations, excessive sweating, anxiety, insomnia, discontinuation of the medicine is not required.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine, contributing to enhanced patient safety.

5. How to store Diovemin

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 and blister pack.
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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Diovemin contains

The active substance is diosmin (Diosminum). One tablet contains 1000 mg of micronized diosmin.
Other ingredients: polyvinyl alcohol, sodium croscarmellose, magnesium stearate.

What Diovemin looks like and contents of the pack
Tablets – elongated, biconvex, beige in colour, with a score line.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, and does not guarantee an equal division into doses.
Diovemin is available in packs containing: 30, 60 or 90 tablets.
The tablets are packed in blisters made of PVC/PVDC/Aluminium, in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne COLFARM S.A.
ul. Wojska Polskiego 3
39-300 Mielec