Package leaflet: Information for the patient

Diohespan Max, 1000 mg, tablets
Diosmin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, contact your doctor.

Table of contents

What Diohespan Max is and what it is used for
What you need to know before taking Diohespan Max
How to take Diohespan Max
Possible side effects
How to store Diohespan Max
Contents of the pack and other information

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

Diohespan Max increases venous vessel tone and has a protective effect on blood vessels. It enhances lymphatic drainage by stimulating peristalsis (motility) of lymphatic vessels and lymph flow. The drug acts on microcirculation by reducing permeability of small blood vessels, perivascular inflammatory conditions, and stasis in the microcirculation. It also reduces susceptibility of small blood vessels to rupture.

Indications

Symptomatic treatment of chronic venous insufficiency of the lower limbs in adults, characterized by:

varicose veins,
venous ulcers,
telangiectasias (dilation of very small venous vessels, so-called spider veins),
reticular veins,
sensation of heaviness, discomfort, fatigue in the legs,
restless legs syndrome (unpleasant sensations in the lower limbs causing an urge to move them, usually occurring at night),
leg pain,
burning or itching of the skin of the legs,
sensation of cold legs,
nocturnal cramps,
leg swelling (edema),
paresthesia (tingling),
redness (erythema) of the skin,
cyanosis (bluish discoloration) of the skin.

Diohespan Max is indicated as monotherapy (i.e. used alone) in the early stages of chronic venous insufficiency or as an adjunct to other therapies at all stages of venous insufficiency.

Symptomatic treatment during flare-ups of symptoms associated with hemorrhoidal disease (hemorrhoids).

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

2. Important information before taking Diohespan Max

When not to take Diohespan Max

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

Warnings and precautions
If symptoms related to haemorrhoids persist or worsen despite using the medicine,
consult a doctor. Treatment of symptoms related to haemorrhoids should be short-term.
Diohespan Max and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines have been reported.
Diohespan Max and food
Take the medicine during meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The medicine may be used during pregnancy only if clearly necessary and only on a doctor's prescription. If the patient becomes pregnant during treatment, she should seek medical advice, as only a doctor can decide whether treatment should be continued.
Breastfeeding
Due to lack of data on passage into breast milk, the use of the medicine during breastfeeding is not recommended.
Driving and operating machinery
The medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
Diohespan Max contains sodium
The medicine contains 0.807 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to take Diohespan Max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
Recommended dose
Chronic venous insufficiency of the lower limbs
1 tablet per day, taken during a meal.
Treatment should last for at least 4-5 weeks.
Acute flare-up of haemorrhoidal symptoms
3 tablets per day for 4 days, followed by 2 tablets per day for the next 3 days, taken during meals.
Do not take more than the recommended dose of the medicine.
The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing and does not indicate an equal division into doses.
Accidental overdose of Diohespan Max
No cases of poisoning due to overdose have been reported.
Taking more than the recommended dose may cause gastrointestinal disturbances, vomiting and nausea.
If more than the recommended dose has been taken, consult a doctor or pharmacist immediately.
Missed dose of Diohespan Max
Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
Rare (occur in 1 to 10 out of 10,000 people):

diarrhoea, indigestion, nausea, vomiting;
dizziness, headache;
malaise;

and the following adverse reactions:

rash (itchy, red bumps on the skin);
itching;
urticaria (pinkish, itchy blisters on the skin).

Observed adverse reactions do not necessarily require discontinuation of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety.

5. How to store Diohespan Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton following:
EXP. The expiry date refers to the last day of the stated month.
Lot – means batch number.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Diohespan max contains

The active substance is diosmin. One tablet contains 1000 mg of micronized diosmin.
The other ingredients are: polyvinyl alcohol, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate.

What Diohespan max looks like and contents of the pack
Diohespan max is in the form of tablets with a division line.
The pack contains 10, 20, 30 or 60 tablets.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151,
95-200 Pabianice
Tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31,
95-054 Ksawerów