Diosmax

Leaflet attached to the packaging: patient information

DiosMax, 1000 mg, film-coated tablets

Diosminum

Please read the contents of the leaflet carefully before using the medicine, as it contains

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

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is DiosMax and what is it used for

DiosMax contains micronized diosmin, which belongs to a group of substances called bioflavonoids.
Diosmin increases the tone and elasticity of venous vessels and has a protective effect on the vessels.
It reduces the permeability of blood vessel walls, which contributes to improved venous circulation.
It increases lymphatic drainage, enhances the peristalsis (movements) of lymphatic vessels and lymph flow,
and improves blood return from the venous system, reducing venous stasis and (or) hypertension in the lower limbs.
Diosmin also reduces the permeability of small blood vessels - limits inflammatory conditions, especially in perivenous inflammation.
By restoring normal permeability to the capillaries, it reduces the susceptibility to rupture of small blood vessels.
Indications for use of DiosMax :

• treatment of symptoms occurring in chronic venous insufficiency of the lower limbs, such as: swelling, feeling of fatigue, pain and heaviness of the legs, burning, nocturnal cramps, and widening of very small venous vessels (so-called "spider veins");
• symptomatic treatment of varicose veins of the lower limbs;
• exacerbation of symptoms associated with hemorrhoids (piles).

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

2. Important information before taking DiosMax

When not to use DiosMax:

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

Warnings and precautions

Before starting treatment with DiosMax, you should discuss it with your doctor or pharmacist.
Exacerbation of symptoms associated with hemorrhoids
You should remember that therapy with DiosMax is only symptomatic and should be short-term.
If symptoms persist or worsen despite treatment, you should contact your doctor.
Chronic venous insufficiency
If the symptoms of the disease worsen during treatment, i.e., skin inflammation, phlebitis, subcutaneous tissue hardening, severe pain, skin ulcers, or if atypical symptoms occur, such as sudden swelling of one or both legs, you should contact your doctor immediately.
The effectiveness of therapy can be increased by a proper lifestyle, i.e., avoiding prolonged sun exposure, avoiding standing for long periods, reducing excess weight, controlling body weight, wearing special compression stockings, and physical activity.
DiosMax is not effective if swelling of the lower limbs is caused by heart, liver, or kidney disease.

Children and adolescents

The use of this medicine is not recommended in children and adolescents.

DiosMax 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.
In particular, you should inform about the use of:

• metronidazole (antibacterial medicine) - the effect of metronidazole may be enhanced,
• diclofenac (anti-inflammatory, analgesic medicine) - the effect of diclofenac may be enhanced,
• fexofenadine (antiallergic medicine) - the effect of fexofenadine may be enhanced,
• carbamazepine (antiepileptic medicine) - the effect of carbamazepine may be enhanced.

Using DiosMax with food and drink

The tablet should be swallowed and washed down with a sufficient amount of water.
The medicine should be taken during meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of medicinal products containing diosmin is not recommended during pregnancy, unless your doctor advises otherwise.
Breastfeeding
The medicine is not recommended during breastfeeding, due to the lack of data on the penetration of the medicine into breast milk.
Fertility
There is no data indicating a possible effect of this medicine on fertility.

Driving and using machines

The medicine has no effect on the ability to drive and use machines.

3. How to take DiosMax

This medicine should always be taken exactly as described in this patient leaflet, or as directed by
your doctor or pharmacist. If you have any doubts, you should contact your doctor or pharmacist.
Chronic venous insufficiency of the lower limbs
The recommended dose is 1 tablet once a day, during a meal.
To achieve improvement, the medicine should be used for at least 4 to 5 weeks.
Exacerbation of symptoms associated with hemorrhoids
The recommended dose is 1 tablet 3 times a day for the first 4 days of treatment, and then 1 tablet 2 times a day (in the morning and evening) for the next 3 days, during meals.
If symptoms worsen or do not improve after 7 days of treatment, you should consult your doctor.

Taking a higher dose of DiosMax than recommended

In case of taking a higher dose of the medicine than recommended, you should contact your doctor.
No cases of poisoning with the medicine due to overdose have been reported. Taking a higher dose of the medicine than recommended may cause gastrointestinal disorders, vomiting, and nausea.

Missing a dose of DiosMax

You should not take a double dose to make up for a missed dose.
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.
Side effects are listed according to their frequency.

• Rare (may affect up to 1 in 10,000 people):
• gastrointestinal disorders (abdominal pain, diarrhea, dyspepsia, nausea, vomiting, constipation),
• headache and dizziness. In single cases, during the first 4 days of treatment, itching or hives may occur.

Medicines with diosmin are generally well tolerated, and the occurrence of any of the above side effects does not necessarily require discontinuation of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel: +48 22 492 13 01, fax: + 48 22 492 13 09, 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 DiosMax

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton and blister after the EXP symbol.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What DiosMax contains

• The active substance is diosmin. Each tablet contains 1000 mg of micronized diosmin.
• The other ingredients (excipients) are: tablet core (microcrystalline cellulose, sodium croscarmellose, polyvinyl alcohol, magnesium stearate, colloidal silica), coating Opadry II Clear (polyvinyl alcohol, macrogol 3350, talc).

What DiosMax looks like and contents of the pack

Film-coated tablets, oblong, biconvex, grayish-yellow or light yellow in color.
Acceptable lighter discoloration on the edge of the tablet.
PVC/PVDC/Aluminum blister in a cardboard box.
The pack contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

OLIMP Laboratories Sp. z o.o.
Pustynia 84 F
39-200 Dębica
{logo OLIMP Laboratories}

Date of last revision of the leaflet: