Diosmina Colfarm Max

Package Leaflet: Information for the Patient

Diosmina Colfarm Max

1000 mg, tablets

Diosminum

Read the package leaflet carefully before taking the 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, you may need to read it again.
• If you need advice or further information, consult 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 Diosmina Colfarm Max and what is it used for
• 2. Important information before taking Diosmina Colfarm Max
• 3. How to take Diosmina Colfarm Max
• 4. Possible side effects
• 5. How to store Diosmina Colfarm Max
• 6. 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 the tone of venous vessels and has a protective effect on vessels. It increases lymphatic drainage by enhancing the peristalsis (motility) of lymphatic vessels and lymph flow. The medicine affects microcirculation, reducing the permeability of small blood vessels, perivascular inflammation, and stasis in microcirculation. It also reduces the fragility of small blood vessels.
Diosmina Colfarm Max is indicated:

• for the treatment of symptoms associated with chronic venous and lymphatic insufficiency of the lower limbs:
• feeling of heaviness in the legs;
• leg pain;
• nocturnal leg cramps;
• spider veins - caused by the dilation and branching of superficial skin blood vessels;
• for the symptomatic treatment of exacerbations of hemorrhoidal disease.

If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before taking Diosmina Colfarm Max

When not to take Diosmina Colfarm Max

• 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 Diosmina Colfarm Max, you should discuss it with your doctor or pharmacist. In case of exacerbation of hemorrhoidal disease, remember that the therapy with Diosmina Colfarm Max is only symptomatic and should be short-term. If the symptoms do not subside, you should undergo an examination by a proctologist who will choose the appropriate treatment method.
In case of venous circulation disorders in the lower limbs, the therapeutic effect of Diosmina Colfarm Max can be increased by an appropriate lifestyle:

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

Diosmina Colfarm Max and other medicines

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 administered simultaneously with diclofenac or metronidazole may increase their maximum concentration in serum and prolong their elimination from the body.
Diosmin inhibits platelet aggregation. This mechanism may affect the accumulation of adverse effects in patients taking anticoagulant medications.

Diosmina Colfarm Max 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
It is not recommended to use Diosmina Colfarm Max during pregnancy.
Breastfeeding
It is not recommended to use Diosmina Colfarm Max during breastfeeding.

Driving and using machines

Diosmina Colfarm Max has no influence or negligible influence on the ability to drive and use machines.
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 directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 tablet once a day, during a meal.
In case of exacerbation of hemorrhoidal disease, the dose is 1 tablet three times a day for 4 days, and then for the next 3 days 1 tablet twice a day, during meals.
Do not take a higher dose than recommended.

Taking a higher dose of Diosmina Colfarm Max than recommended

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

Missing a dose of Diosmina Colfarm Max

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

Stopping treatment with Diosmina Colfarm Max

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects have been described according to their frequency of occurrence as follows:
Very common (occurring in 1 in 10 people or more), common (occurring in 1 to 10 people in 100),
uncommon (occurring in 1 to 10 people in 1,000), rare (occurring in 1 to 10 people in 10,000),
very rare (occurring in less than 1 person in 10,000), frequency not known (frequency cannot be estimated from the available data).
Rare: diarrhea, indigestion, nausea, vomiting, dizziness, headache, malaise, rash, itching, hives.
Frequency not known: insomnia, increased anxiety.
In case of mild side effects, such as gastrointestinal disorders, and disturbances such as increased anxiety, rapid heartbeat, excessive sweating, anxiety, insomnia, 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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
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 Diosmina Colfarm Max

Keep the medicine out of the 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 and blister.
The expiry date refers to the last day of the month.
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 Diosmina Colfarm Max contains

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

What Diosmina Colfarm Max looks like and contents of the pack

Tablets - oblong, biconvex, beige, with a score line.
The score line on the tablet is only to facilitate breaking, for easier swallowing, and not to divide into equal doses.
Diosmina Colfarm Max is available in packs containing: 30, 60, or 90 tablets.
Tablets are packaged in PVC/PVDC/Aluminum blisters, in a cardboard box.

Marketing authorization holder and manufacturer

COLFARM Pharmaceutical Works S.A.
ul. Wojska Polskiego 3
39-300 Mielec
tel.: 17 788 58 11
email: [email protected]

Date of the last revision of the leaflet: