Dih max comfort

Package leaflet: Information for the patient

DIH MAX COMFORT
1000 mg, coated tablets
Diosminum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the physician or pharmacist. See section 4.
• If symptoms do not improve or the patient feels worse, contact the physician.

Table of contents

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

1. What DIH MAX COMFORT is and what it is used for

DIH MAX COMFORT coated tablets contain diosmin, a compound belonging to the group of so-called
bioflavonoids.
DIH MAX COMFORT increases 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 the 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 veins, i.e. telangiectasias (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 hemorrhoids (anal varices).
• 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 MAX COMFORT

When not to use DIH MAX COMFORT

• if the patient is allergic to the active substance – diosmin – or to any of the other ingredients of this medicine (listed in section 6). 1/4

Warnings and precautions
Before starting treatment with DIH MAX COMFORT, discuss it with your doctor or pharmacist.
If symptoms related to haemorrhoids do not improve or worsen despite using the medicine, consult your doctor.
In case of symptoms related to haemorrhoids, treatment with DIH MAX COMFORT should be symptomatic and short-term.

DIH MAX COMFORT with other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No studies on interactions have been conducted.

DIH MAX COMFORT 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 baby, she should consult her doctor or pharmacist before using this medicine.
Due to insufficient data, DIH MAX COMFORT may be used during pregnancy only if clearly necessary.
It is not known whether the medicine passes into breast milk; therefore, breastfeeding should be avoided during treatment.

Driving and operating machinery
Taking DIH MAX COMFORT has no effect on the ability to drive or operate machinery.

DIH MAX COMFORT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use DIH MAX COMFORT

This medicine should always be taken exactly as described in this patient 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 1 coated tablet per day during a meal.
Only in cases of exacerbation of symptoms caused by haemorrhoids, temporary administration of higher doses is recommended: 1 coated tablet 3 times a day for 4 days, followed by 1 coated tablet twice daily (in the morning and evening) for the next 3 days.
If symptoms related to haemorrhoids do not improve or worsen despite treatment, consult a doctor.
Use of a higher than recommended dose of DIH MAX COMFORT
If a significantly higher than recommended dose is taken, consult a doctor or pharmacist.
Symptoms of overdose are unknown.
Missed dose of DIH MAX COMFORT
Do not take a double dose to make up for a missed dose.
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If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets 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 neurovegetative 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 Reactions of Medicinal Products, 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.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store DIH MAX COMFORT

Store in the original packaging, at a temperature not exceeding 25°C.
Keep the medicine out of the 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 should not be disposed of via wastewater 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 DIH MAX COMFORT contains

• The active substance is micronized diosmin. Each film-coated tablet contains 1000 mg of micronized diosmin.
• The other ingredients (excipients) are: microcrystalline cellulose, povidone K 30, sodium carboxymethyl starch (type A), magnesium stearate, and the coating Opadry II Pink 85F24220, which consists of: polyvinyl alcohol, partially hydrolyzed, polyethylene glycol/PEG MW 3350, polyethylene glycol 4000 JP, talc, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171).

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What DIH MAX COMFORT looks like and contents of the pack
DIH MAX COMFORT is an oval, biconvex, smooth, pink film-coated tablet.
One pack contains 30 or 60 film-coated tablets, placed in a cardboard box.
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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