Package leaflet: information for the patient

Diohespan, 1000 mg, tablets
Diosminum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms appear identical.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Diohespan is and what it is used for

Diohespan increases venous vessel tone and exerts a protective effect on blood vessels. It also 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 to rupture of small blood vessels.

Indications

Treatment of symptoms of chronic venous insufficiency of the lower limbs such as: sensation of heavy legs, leg pain, nocturnal cramps, oedema.
Treatment of venous ulcers associated with chronic venous insufficiency of the lower limbs as an adjunct to other therapeutic methods.
Symptomatic treatment during exacerbations of haemorrhoidal symptoms (haemorrhoids).

2. Important information before taking Diohespan

When not to take Diohespan:

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 to take Diohespan, consult a doctor.
If symptoms related to haemorrhoids persist or worsen despite treatment with the medicine,
consult a doctor.
Treatment of symptoms associated with haemorrhoids should be short-term.
Diohespan 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.
Taking Diohespan with food and drink
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 child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Diohespan 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 the passage of Diohespan into breast milk, the use of the medicine during breastfeeding is not recommended.
Driving and operating machinery
Diohespan has no influence on the ability to drive or operate machinery.

3. How to take Diohespan

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is for oral use.
Recommended dose
Chronic venous insufficiency of the lower limbs:
1 tablet once daily, taken with a meal.
Ulceration associated with chronic venous insufficiency of the lower limbs:
1 tablet once daily, taken with a meal.
Acute haemorrhoidal attack:
3 tablets daily for 4 days, followed by 2 tablets daily for the next 3 days.
The tablet break line is only intended to facilitate splitting the tablet for easier swallowing.
Do not take more than the recommended dose.
Taking more than the recommended dose of Diohespan
If more tablets have been taken 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.
Missing a dose of Diohespan
Continue taking the medicine as prescribed, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Diohespan treatment
There is no available data on the consequences of stopping treatment.
In case of 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 everyone will experience them.
The following adverse effects may occur
Rarely (occur in 1 to 10 out of 10,000 people):

diarrhoea, indigestion, nausea, vomiting;
dizziness, headache, malaise;
itching, rash (itchy, red bumps on the skin), urticaria (pinkish, itchy wheals on the skin).

The occurrence of any of the above adverse effects does not necessarily require discontinuation of the medicine.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Adverse effects 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,
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather additional information on the safety of the medicine.

5. How to store Diohespan

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

6. Contents of the packaging and other information

What Diohespan 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 looks like and contents of the pack
Diohespan is a tablet with a score line. The score line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing.
Tablets are packed in blisters of 10 tablets and placed in cardboard boxes.
Pack sizes: 30 tablets, 60 tablets, 90 tablets or 120 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