Package leaflet: Information for the patient

Diosmina Colfarm Max
1000 mg, tablets
Diosminum
Please read the entire 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 leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
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 symptoms persist or worsen, contact your doctor.

Table of contents:

What is Diosmina Colfarm Max and what is it used for
Important information before taking Diosmina Colfarm Max
How to take Diosmina Colfarm Max
Possible adverse effects
How to store Diosmina Colfarm Max
Contents of the pack and other information

1. What is Diosmina Colfarm Max and what is it used for

Diosmina Colfarm Max contains micronized diosmin. Diosmina Colfarm Max 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. The drug affects microcirculation by reducing permeability of small blood vessels, perivascular inflammatory conditions, and stasis in the microcirculation. It also reduces the fragility of small blood vessels.

Diosmina Colfarm Max is indicated:

for the treatment of symptoms related to chronic venous and lymphatic insufficiency of the lower limbs:
- sensation of leg heaviness;
- leg pain;
- nocturnal leg cramps;
- capillary varicosities – caused by dilation and branching of superficial skin blood vessels;
for symptomatic treatment of acute haemorrhoidal attacks.

If symptoms do not improve or worsen, consult your doctor.

2. Important information before taking Diosmina Colfarm Max

When not to take Diosmina Colfarm Max

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 Diosmina Colfarm Max, consult your doctor or
pharmacist. In case of worsening symptoms related to haemorrhoids, it should be remembered that
treatment with Diosmina Colfarm Max 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
Diosmina Colfarm Max can be enhanced by adopting an appropriate lifestyle:

avoiding exposure to sunlight,
avoiding prolonged standing,
maintaining a healthy body weight,
wearing compression stockings.

Diosmina Colfarm Max 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 concentrations and prolong their elimination from the body.
Diosmin inhibits platelet aggregation. This mechanism may influence the accumulation of
adverse effects in patients taking anticoagulant medicines.

Diosmina Colfarm Max with food and drink
Take the 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 Diosmina Colfarm Max is not recommended during pregnancy.
Breastfeeding
The use of Diosmina Colfarm Max is not recommended during breastfeeding.

Driving and operating machinery
Diosmina Colfarm Max has no effect or has a negligible effect on the ability to drive and operate machinery.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Diosmina Colfarm Max

This medicine should always be taken exactly as described in this patient leaflet or as advised 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 exceed the recommended dose.
Taking more Diosmina Colfarm Max than recommended
No cases of overdose have been reported.
If you take more than the recommended dose, contact your doctor.
If you miss a dose of Diosmina Colfarm Max
Do not take a double dose to make up for the missed dose.
Stopping Diosmina Colfarm Max
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.
Adverse effects have been described according to the following frequency categories:
Very common (affects 1 in 10 people or more), common (affects 1 to 10 in 100 people),
uncommon (affects 1 to 10 in 1,000 people), rare (affects 1 to 10 in 10,000 people),
very rare (affects less than 1 in 10,000 people), frequency not known (cannot be estimated from the available data).
Rare: diarrhoea, dyspepsia, nausea, vomiting, dizziness, headache, malaise, rash, pruritus, urticaria.
Frequency not known: insomnia, increased anxiety.
In case of mild gastrointestinal adverse effects, or disturbances such as increased anxiety, palpitations, excessive sweating, restlessness, or insomnia, 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309; website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store the medicine Diosmina Colfarm Max

Keep this medicine out of the 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 must 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 packaging and other information

What the medicine Diosmina Colfarm Max contains

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

What Diosmina Colfarm Max looks like and contents of the pack
Tablets – oblong, biconvex, beige in colour, with a score line.
The score line on the tablet is intended only to facilitate breaking for easier swallowing, and does not allow for equal dose division.
Diosmina Colfarm Max is available in packages containing: 30, 60 or 90 tablets.
The tablets are packed in PVC/PVDC/Aluminium blisters, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne COLFARM S.A.
ul. Wojska Polskiego 3
39-300 Mielec
tel.: 17 788 58 11
email: [email protected]