Diosmax

Patient Information Leaflet

DiosMax, 1000 mg, film-coated tablets
Diosminum
Please read the entire leaflet carefully before using this 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 the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or if you feel worse, consult your doctor.

Table of Contents

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 known as bioflavonoids.
Diosmin increases venous tone and elasticity and has a protective effect on blood vessels.
It reduces the permeability of blood vessel walls, thereby improving venous circulation.
It enhances lymphatic drainage, increases peristalsis (movement) of lymphatic vessels and lymph flow, improves blood return from the venous system, and reduces venous stasis and/or hypertension in the lower limbs. Diosmin also reduces capillary permeability—limiting inflammatory processes, particularly perivenular inflammation. By restoring normal capillary permeability, it reduces susceptibility to capillary rupture.

Indications for DiosMax:

• Treatment of symptoms associated with chronic venous insufficiency in the lower limbs, such as edema, sensation of fatigue, pain and heaviness in the legs, burning sensation, nocturnal cramps, and dilation of very small veins (so-called "spider veins");
• Symptomatic treatment of varicose veins of the lower limbs;
• Acute flare-ups of hemorrhoidal disease (piles).

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

2. Important information before taking DiosMax

When not to use DiosMax:

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

Warnings and precautions
Before starting treatment with DiosMax, consult your doctor or pharmacist.
Exacerbation of haemorrhoidal symptoms
Please note that treatment with DiosMax is symptomatic only and should be short-term.
If symptoms persist or worsen despite treatment, contact your doctor.
Chronic venous insufficiency
If disease symptoms worsen during treatment, e.g. skin inflammation, phlebitis, subcutaneous tissue induration, severe pain, skin ulceration, or if atypical symptoms occur such as sudden swelling of one or both legs, contact your doctor immediately.
The effectiveness of treatment can be enhanced by adopting an appropriate lifestyle, including avoiding prolonged sun exposure, avoiding prolonged standing, reducing excess body weight, maintaining a healthy body weight, wearing special compression stockings, and engaging in physical activity.
DiosMax is not effective if lower limb oedema is caused by heart, liver, or kidney diseases.
Children and adolescents
The use of this medicine is not recommended in children and adolescents.
DiosMax with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor 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.

Taking DiosMax with food and drink
Swallow the tablet whole with sufficient water.
Take the medicine during meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The use of medicinal products containing diosmin is not recommended during pregnancy unless otherwise advised by a doctor.
Breastfeeding
The use of this medicine is not recommended during breastfeeding due to lack of data on its passage into breast milk.
Fertility
There are no data indicating that this medicine may affect fertility.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.

3. How to take DiosMax

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.
Chronic venous insufficiency of the lower limbs
The recommended dose is 1 tablet once daily, taken with food.
To achieve improvement, this medicine should be taken for at least 4 to 5 weeks.
Acute haemorrhoidal attacks
The recommended dose is 1 tablet 3 times daily for the first 4 days of treatment, followed by 1 tablet
2 times daily (morning and evening) for the next 3 days, taken with meals.
If symptoms worsen or do not improve within 7 days of treatment, consult your doctor.
Taking more DiosMax than recommended
If you take more tablets than recommended, contact your doctor.
No cases of poisoning due to overdose have been reported. Taking more than the recommended dose
may cause gastrointestinal disturbances, vomiting and nausea.
If you forget to take DiosMax
Do not take a double dose to make up for the missed dose.
If you have any further doubts concerning 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 everybody gets them.
Adverse effects are listed according to frequency.
Rare (may affect up to 1 to 10 people in 10,000):

• gastrointestinal disorders (abdominal pain, diarrhoea, indigestion, nausea, vomiting, constipation),
• headaches and dizziness. In isolated cases at the beginning of treatment (during the first 4 days), itching or urticaria may occur.

Medicines containing diosmin are in most cases well tolerated, and occurrence of any of the above-mentioned adverse effects does not necessitate discontinuation of the medicine.
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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 492 13 01, fax: +48 22 492 13 09, website: https://smz.ezdrowie.gov.pl
Adverse effects may 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 DiosMax

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after the
symbol EXP.
The expiry date refers to the last day of the indicated month.
Medicines should 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 DiosMax contains

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

What DiosMax looks like and contents of the pack
Film-coated tablets, elongated, biconvex, greyish-yellow or light yellow in colour.
Slight lighter discolouration at the tablet edges is acceptable.
PVC/PVDC/Aluminium blister in a cardboard box.
The pack contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
OLIMP Laboratories Sp. z o.o.
Pustynia 84 F
39-200 Dębica
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