Package leaflet: Information for the patient

DIH
500 mg, coated tablets
Diosminum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used 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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or if the patient feels worse, contact your doctor.

Table of contents

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

1. What DIH is and what it is used for

DIH coated tablets contain diosmin, a compound belonging to the so-called bioflavonoids.
DIH improves venous tone and exerts a protective effect on blood vessels.

Indications

Symptoms of chronic venous insufficiency of the lower limbs:
- leg pain and nocturnal leg cramps,
- burning sensation in legs,
- feeling of cold legs,
- sensation of leg heaviness, fatigue, discomfort or restless legs,
- varicose veins of the lower limbs,
- venous ulcers,
- dilation of very small venous vessels, so-called capillary veins (spider veins) and reticular veins,
- leg swelling (edema / puffiness of legs),
- itching, paresthesia (tingling),
- redness (erythema) or bluish discoloration of the skin.
Symptomatic treatment of hemorrhoidal disease.
Monotherapy in the early stages of chronic venous insufficiency or as an adjunct to other therapies in all stages of chronic venous disease (C0–C6 according to CEAP classification).

2. Important information before using DIH

When not to use DIH

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

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Warnings and precautions
Before starting treatment with DIH, consult your doctor or pharmacist.
In cases of worsening symptoms caused by hemorrhoidal varices, it should be remembered that treatment with DIH is only symptomatic and should be short-term. If symptoms do not improve, a comprehensive assessment of the patient's condition by a physician is required.
DIH and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No studies on interactions have been conducted.
DIH with food and drink
The medicine should be taken during a meal.
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 her doctor or pharmacist before using this medicine.
Due to insufficient data, DIH should be used during pregnancy only if clearly necessary.
It is not known whether the drug passes into human breast milk; therefore, breastfeeding is not recommended during treatment.
Driving and operating machinery
Taking DIH has no effect on the ability to drive or operate machinery.

3. How to use DIH medicine

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
The usual dose is two tablets daily taken with meals, i.e. one tablet in the morning and one tablet in the evening (corresponding to a total daily dose of 1000 mg of diosmin, administered as two divided doses of 500 mg each).
Only in cases of acute flare-ups of hemorrhoidal symptoms is a higher dose recommended, up to 6 tablets daily: 3 tablets twice daily for 4 days, followed by a reduced dose over the next 3 days: 4 tablets daily, i.e. 2 tablets twice daily.
Taking a higher than recommended dose of DIH
If a significantly higher than recommended dose is taken, consult a doctor or pharmacist.
Symptoms of overdose are unknown.
Missed dose of DIH
Do not take a double dose to make up for a missed dose.
If a dose of DIH is missed, take the dose with the next meal: if the morning dose was forgotten, take it at lunchtime, and take the next dose according to schedule, i.e. in the evening.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Rare (in 1 to 10 patients per 10,000):
dyspepsia,
nausea,
vomiting,
dizziness, headache,
malaise,
rash, itching, urticaria.
In case of mild gastrointestinal adverse reactions and neuropsychiatric disturbances (insomnia, difficulty falling asleep, dizziness and headache, anxiety), discontinuation of the medicine is not required.
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 of 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the DIH medicine

Store in the original packaging at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What DIH contains

The active substance is micronized diosmin. Each coated tablet contains 500 mg of micronized diosmin.
The other ingredients (excipients) are: microcrystalline cellulose, povidone, sodium carboxymethyl starch, magnesium stearate, and Opadry II 85F24220 Pink coating [polyvinyl alcohol, titanium dioxide (E 171), macrogol - PEG 3350, talc, yellow iron oxide (E 172), and red iron oxide (E 172)].

What DIH looks like and contents of the pack
DIH are oval, pink, film-coated tablets with a smooth surface.
One pack contains 30, 60 or 90 tablets in a cardboard box.
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Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel.: 22 742 00 22
e-mail: [email protected]
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