Diosminex Max

Package Leaflet: Information for the Patient

Diosminex Max, 1000 mg, Film-Coated Tablets

Diosminum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Diosminex Max and what is it used for

Diosminex Max contains micronized diosmin. Diosminex Max increases venous tone and has a protective effect on blood vessels.
Diosminex Max is indicated for the treatment of symptoms of chronic venous insufficiency in adults, such as:

• varicose veins of the legs
• venous ulcers
• telangiectasias (spider veins) and reticular veins
• feeling of heavy legs, tiredness, discomfort, or restless legs
• pain or burning sensation in the legs
• feeling of cold legs
• nocturnal cramps in the legs
• swelling of the legs
• itching and paresthesia (tingling, prickling, or itching sensation in the skin of the legs)
• redness (erythema) or discoloration of the skin.

Diosmin is used as monotherapy in the initial stages of chronic venous insufficiency or as a supplement to other therapies in all stages of chronic venous insufficiency (C0 – C6 according to the CEAP classification).
Diosminex Max is indicated for the treatment of exacerbated symptoms associated with hemorrhoids in adults.
If there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Diosminex Max

When not to take Diosminex Max

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

Warnings and precautions

Before starting to take Diosminex Max, the patient should discuss it with their doctor or pharmacist.
In case of exacerbated symptoms associated with hemorrhoids, it should be remembered that the therapy with Diosminex Max is only symptomatic and should be short-term.
If the symptoms do not improve, a proctologist should be consulted to choose the appropriate treatment method.
Taking this medication for symptomatic treatment in case of exacerbated symptoms associated with hemorrhoids does not exclude the concurrent use of other medications rectally.
Diosminex Max is not effective in treating edema associated with congestive heart failure. Diosminex Max should not be used in patients with heart failure.
In case of venous circulation disorders in the legs, the therapeutic effect of Diosminex Max can be increased by an appropriate lifestyle:

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

If the disease symptoms worsen, i.e., skin inflammation, phlebitis, hardening of the subcutaneous tissue, severe pain, skin ulcers, or atypical symptoms such as immediate swelling of one or both legs occur, the patient should immediately consult their doctor.
Diosminex Max does not work if leg swelling is caused by heart, kidney, or liver diseases.

Diosminex Max and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Diosmin may increase the blood concentration and reduce the excretion of metronidazole (an antibacterial and antiprotozoal medication) and diclofenac (a pain reliever and anti-inflammatory medication), fexofenadine (an antihistamine), warfarin (an anticoagulant), and carbamazepine (an antiepileptic medication).

Diosminex Max with food and drink

The medication should be taken during meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. As a precaution, it is recommended to avoid taking Diosminex Max during pregnancy.
Pregnancy
Before taking Diosminex Max during pregnancy or if the patient becomes pregnant while taking this medication, they should consult their doctor.
Breastfeeding
It is not known whether diosmin or its metabolites pass into breast milk.
A risk to the breastfed child cannot be excluded.
Diosminex Max should not be taken during breastfeeding.

Driving and using machines

Diosminex Max has no influence or negligible influence on the ability to drive and use machines.

Diosminex Max contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medication.

Diosminex Max contains orange yellow S (E 110)

The medication coating contains orange yellow S (E 110). The medication may cause allergic reactions.

Diosminex Max contains sodium

The medication contains less than 1 mmol of sodium (23 mg) per tablet, which means the product is considered "sodium-free".

3. How to take Diosminex Max

This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Treatment of chronic venous insufficiency symptoms
The recommended dose is 1 tablet once a day, during a meal.
To achieve improvement, the medication should be taken for at least several weeks. If after five weeks of treatment the disease symptoms have worsened or not changed, the patient should consult their doctor.
Treatment of exacerbated hemorrhoid symptoms
The recommended dose is 3 tablets a day for the first 4 days, then 2 tablets a day for the next 3 days.
If after seven days of treatment the disease symptoms have worsened or not changed, the patient should consult their doctor.
A higher dose of the medication than recommended should not be taken.

Taking a higher dose of Diosminex Max than recommended

No cases of overdose have been reported.
In case of overdose, the patient should consult their doctor.

Missing a dose of Diosminex Max

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Diosminex Max

If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Diosminex Max can cause side effects, although not everybody gets them.
Side effects have been described according to their frequency of occurrence as follows:
very common(more than 1 in 10 people),
common(more than 1 in 100 people, but less than 1 in 10 people),
uncommon(more than 1 in 1000 people, but less than 1 in 100 people),
rare(more than 1 in 10,000 people, but less than 1 in 1000 people),
very rare(less than 1 in 10,000 people).
Rare: diarrhea, nausea, vomiting, dizziness, headache, malaise, rash, itching, urticaria.
In case of mild side effects related to the stomach and intestines, as well as neurovegetative disorders (e.g., increased anxiety, rapid heartbeat, excessive sweating, nervousness), it is not necessary to stop taking the medication.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 medication.

5. How to store Diosminex Max

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medication after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Diosminex Max contains

• The active substance of the medication is diosmin (Diosminum). Each tablet contains 1000 mg of micronized diosmin.
• The other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate. coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, quinoline yellow lake (E 104), indigo carmine lake (E 132), orange yellow S lake (E 110), iron oxide black (E 172).

What Diosminex Max looks like and contents of the pack

The film-coated tablets are green, oblong, biconvex, with a smooth surface, without spots and damage.
Diosminex Max is available in packs containing:
30 or 60 film-coated tablets.
The tablets are packaged in PVC/Aluminum blisters, in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: