Diohespan Max

Package Leaflet: Information for the Patient

Diohespan max, 1000 mg, tablets

Diosmin

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 package leaflet for the patient or as directed 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 those 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 Diohespan max and what is it used for
• 2. Important information before taking Diohespan max
• 3. How to take Diohespan max
• 4. Possible side effects
• 5. How to store Diohespan max
• 6. Contents of the pack and other information

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

Diohespan max increases venous tone and has a protective effect on blood vessels. It increases lymphatic drainage by enhancing the peristalsis (motility) of lymphatic vessels and lymph flow. The medicine acts on microcirculation, reducing the permeability of small blood vessels, perivascular inflammation, and stasis in microcirculation. It also reduces the fragility of small blood vessels.

Indications for Use

Symptomatic treatment of chronic venous insufficiency of the lower limbs in adults, which includes:

• varicose veins,
• venous ulcers,
• telangiectasias (dilations of very small venous vessels, so-called spider veins),
• reticular veins,
• feeling of heaviness, discomfort, fatigue in the legs,
• restless legs syndrome (unpleasant sensations in the lower limbs that force movement, usually occurring at night),
• leg pain,
• burning sensation, itching of the skin on the legs,
• feeling of cold legs,
• nocturnal cramps,
• leg swelling,
• paresthesia (tingling),
• redness (erythema) of the skin,
• bluish discoloration of the skin.

Diohespan max is indicated for monotherapy (i.e., used alone) in the initial stages of chronic venous insufficiency or as a supplement to other therapies in all stages of venous insufficiency.

Symptomatic treatment in case of exacerbation of symptoms related to hemorrhoids.

If there is no improvement or the patient feels worse, they should consult their 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 hemorrhoids persist or worsen despite taking the medicine, a doctor should be consulted. Treatment of symptoms related to hemorrhoids should be short-term.

Diohespan max and Other Medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

No interactions with other medicines have been reported.

Diohespan max with Food

The medicine 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 medicine.

Pregnancy

The medicine may be used during pregnancy only if necessary, and only on a doctor's prescription. If the patient becomes pregnant during treatment, they should consult their doctor, as only the doctor can decide whether to continue treatment.

Breastfeeding

Due to the lack of data on the passage into breast milk, the use of the medicine during breastfeeding is not recommended.

Driving and Using Machines

The medicine has no influence or negligible influence on the ability to drive and use machines.

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 tablet, which means it is considered "sodium-free".

3. How to Take Diohespan max

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

The medicine is administered orally.

Recommended Dose

Chronic Venous Insufficiency of the Lower Limbs

1 tablet per day, during a meal.

Treatment should last for at least 4-5 weeks.

Exacerbation of Hemorrhoids

3 tablets per day for 4 days, then 2 tablets per day for the next 3 days, during meals.

A higher dose of the medicine than recommended should not be taken.

The dividing line on the tablet is only to facilitate breaking it for easier swallowing, not for dividing into equal doses.

Taking a Higher Dose of Diohespan max Than Recommended

No cases of poisoning due to overdose of the medicine have been reported.

Taking a higher dose of the medicine than recommended may cause gastrointestinal disorders, vomiting, and nausea.

In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.

Missing a Dose of Diohespan max

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

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Rare(occurring in 1 to 10 people out of 10,000):

• diarrhea, indigestion, nausea, vomiting;
• dizziness, headache;
• malaise;

and the following side effects:

• rash (itching, red bumps on the skin);
• itching;
• urticaria (light red, itching blisters on the skin).

The observed side effects do not require discontinuation of the medicine.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their 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 gather more information on the safety of the medicine.

5. How to Store Diohespan max

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the blister pack and carton:

EXP. The expiry date stated is the last day of the specified month.

BATCH - means batch number.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the Pack and Other Information

What Diohespan max Contains

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

What Diohespan max Looks Like and Contents of the Pack

Diohespan max is in the form of tablets with a dividing line.

The pack contains 10, 20, 30, or 60 tablets.

Marketing Authorization 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

Date of Last Revision of the Leaflet: