Package leaflet: Information for the user

Pelethrocin, 500 mg, film-coated tablets
Diosminum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

This medicine should always be used according to the instructions in this patient leaflet or as directed by a doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
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.
If symptoms do not improve or worsen, contact your doctor.

Table of contents of the leaflet:

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

1. What Pelethrocin is and what it is used for

Pelethrocin is a medicine containing micronized diosmin.
The active substance has a protective effect on blood vessels.
Pelethrocin increases venous tone and enhances lymphatic drainage by stimulating lymphatic vessel peristalsis and lymph flow.
Pelethrocin acts on the microcirculation by reducing capillary permeability, perivascular inflammation, microcirculatory stasis, and by increasing vessel resistance.
If there is no improvement or if the patient feels worse, medical advice should be sought.
Indications
Treatment of symptoms related to chronic venous insufficiency of the lower limbs:

sensation of heavy legs
pain
nocturnal cramps

Symptomatic treatment of flare-ups of haemorrhoidal disease (haemorrhoids).

2. Important information before using Pelethrocin

When not to use Pelethrocin

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 use Pelethrocin, consult a pharmacist or doctor.
In case of venous circulation disorders in the lower limbs, therapeutic effect may be enhanced by adopting an appropriate lifestyle: avoiding exposure to sunlight, avoiding prolonged standing, maintaining a healthy body weight, and wearing special compression stockings.
In case of worsening symptoms related to haemorrhoids, it should be remembered that treatment with Pelethrocin is only symptomatic and should be short-term.
If symptoms do not improve, the doctor should perform a proctological examination and choose an appropriate treatment method.
The use of Pelethrocin for symptomatic treatment during exacerbation of haemorrhoid-related symptoms does not exclude the administration of other rectal medications.

Pelethrocin and other medicines
No interactions between Pelethrocin and other medicines have been reported.
Inform your pharmacist or doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without prescription.

Taking Pelethrocin with food and drink
Pelethrocin should be taken 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 a pharmacist or doctor before using this medicine.
Due to insufficient data, Pelethrocin should be used during pregnancy only if clearly necessary.
It is not known whether the drug passes into breast milk; therefore, the use of Pelethrocin is not recommended during breastfeeding.

Driving and operating machinery
Pelethrocin has no influence on the ability to drive or operate machinery.

3. How to take Pelethrocin

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose: 2 tablets per day (1 tablet in the morning and 1 tablet in the evening) with meals.
In case of an acute flare-up of haemorrhoidal symptoms, the dose is 6 tablets per day (2 tablets three times a day) for the first 4 days, followed by 4 tablets per day (2 tablets twice a day) for the next 3 days.
Pelethrocin is a medicine in the form of coated tablets for oral administration.
The break line on the tablet is not intended for splitting the tablet.
Taking more Pelethrocin than recommended
In known cases of overdose, no adverse effects have been observed.
Overdose may cause gastrointestinal disturbances, vomiting, and nausea.
If disturbing symptoms occur, medical advice should be sought.
If you miss a dose of Pelethrocin
If a dose is missed, take it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Pelethrocin
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Pelethrocin may cause adverse reactions, although not everybody experiences them.
Adverse reactions are described below according to the following frequency convention:
very common (more than 1 in 10 people),
common (more than 1 in 100 people, but less than 1 in 10 people),
uncommon (more than 1 in 1,000 people, but less than 1 in 100 people),
rare (more than 1 in 10,000 people, but less than 1 in 1,000 people),
very rare (less than 1 in 10,000 people).

Adverse reactions reported rarely during use of diosmin include:

gastrointestinal disorders: diarrhoea, indigestion, nausea, vomiting;
nervous system disorders: dizziness, headache, malaise;
skin and subcutaneous tissue disorders: rash, itching, urticaria.

In case of mild gastrointestinal or neurovegetative adverse reactions, discontinuation of the medicine is not required. If any of the adverse reactions worsen, or if any adverse reactions not listed in this leaflet occur, a doctor or pharmacist should be consulted.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pelethrocin

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use the 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pelethrocin contains
The active substance is micronized diosmin.
Each tablet contains 500 mg of micronized diosmin.
Other ingredients are:
Tablet core: sodium carboxymethyl starch, microcrystalline cellulose, gelatin,
magnesium stearate, talc;
Coating: beeswax, glycerol, hypromellose 2190, macrogol 6000, sodium lauryl sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171), magnesium stearate.
What Pelethrocin looks like and contents of the pack
The cardboard box contains 2 PVC/Aluminum blisters, each containing 15 coated tablets – oval, biconvex, pinkish-beige tablets with a division line.
Marketing Authorisation Holder and Manufacturer
HELP S.A., 10, Valaoritou Str.,
GR 144 52 Metamorphosis – Attica, Greece.
Tel: +30 210 2843479, 2815353
Fax: +30 210 2811850
e-mail: [email protected]
For more detailed information, please contact the local representative of the Marketing Authorisation Holder:
BLUBIT sp. z o.o., ul. Wolska 84/86
PL-01 141 Warsaw
Mailing address:
BLUBIT sp. z o.o., Pharmaceutical Wholesaler, ul. Szeligowska 75A
PL-01 320 Warsaw
Tel.: +48 22 664 27 27, Fax: 22 665 92 72
e-mail: [email protected]

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