Pelethrocin

1. What is Pelethrocin and what is it used for

Pelethrocin is a medicine that contains micronized diosmin.
The active substance of the medicine has a protective effect on blood vessels.
Pelethrocin increases venous tone and enhances lymphatic drainage by increasing the peristalsis of lymphatic vessels and lymph flow.
Pelethrocin acts on microcirculation, reducing capillary permeability, perivascular inflammation, stasis in microcirculation, and increasing vascular resistance.
If there is no improvement or the patient feels worse, they should consult their doctor.

Indications for use

Treatment of symptoms associated with venous insufficiency of the lower limbs:

• feeling of heavy legs
• pain
• night cramps
• Symptomatic treatment in case of exacerbation of hemorrhoid-related symptoms.

2. Important information before using Pelethrocin

When not to use Pelethrocin

Warnings and precautions

Before starting to use Pelethrocin, you should consult a pharmacist or doctor.
In case of circulatory disorders in the lower limbs, the therapeutic effect can be increased by an appropriate lifestyle: avoiding sun exposure, avoiding standing for long periods, maintaining a suitable body weight, wearing special stockings.
In case of exacerbation of hemorrhoid-related symptoms, you should remember that therapy with Pelethrocin is only symptomatic and should be short-term.
If the symptoms do not disappear, the doctor will perform a proctological examination and choose an appropriate treatment method.
The use of Pelethrocin for symptomatic treatment of hemorrhoid-related symptoms does not exclude the administration of other rectal medications.

Pelethrocin and other medicines

No interactions have been found between Pelethrocin and other medicines.
You should 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 a prescription.

Using Pelethrocin with food and drink

Pelethrocin should be taken during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your pharmacist or doctor before using this medicine.
Due to the lack of sufficient data, Pelethrocin may be used during pregnancy only if necessary.
It has not been studied whether the medicine passes into breast milk, so it is not recommended to use the medicine during breastfeeding.

Driving and using machines

Pelethrocin has no effect on driving or using machines.

3. How to use Pelethrocin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, you should consult a doctor or pharmacist.
Recommended dose: 2 tablets per day (1 tablet in the morning and 1 tablet in the evening) during meals.
In case of exacerbation of hemorrhoid-related symptoms, the dose is 6 tablets per day (2 tablets three times a day) for the first 4 days, then - for the next 3 days - 4 tablets (2 tablets twice a day).
Pelethrocin is a medicine in the form of film-coated tablets for oral administration.
The dividing line on the tablet is not intended for breaking the tablet.

Using a higher than recommended dose of Pelethrocin

In known cases of overdose, no side effects have been observed.
Overdose may cause gastrointestinal disorders, vomiting, and nausea.
In case of worrying symptoms, you should consult a doctor.

Missing a dose of Pelethrocin

If you miss a dose, you should take it as soon as possible.
However, if it is almost time for the next dose, you should skip the missed dose and continue treatment as scheduled.
You should not take a double dose to make up for the missed dose.

Stopping the use of Pelethrocin

In case of any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Pelethrocin can cause side effects, although not everybody gets them.
Side effects have been described with regard to their frequency of occurrence in accordance with the following 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 1000 people, but less than 1 in 100 people),
rare (more than 1 in 10,000 people, but less than 1 in 1000 people),
very rare (less than 1 in 10,000 people).
Side effects reported rarely during the use of diosmin include:

• gastrointestinal disorders: diarrhea, indigestion, nausea, vomiting;
• nervous system disorders: dizziness, headache, malaise;
• skin and subcutaneous tissue disorders: rash, itching, urticaria
• In case of mild side effects related to the stomach and intestines, as well as neurovegetative disorders, it is not necessary to discontinue the medicine.
  If any of the side effects worsen or if you experience any side effects not listed in the leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your 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, e-mail: ndl@urpl.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Pelethrocin

Store in a temperature below 25°C.
The medicine should be stored out of 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers.
You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Package contents and other information

What Pelethrocin contains

The active substance of the medicine is micronized diosmin.
Each tablet contains 500 mg of micronized diosmin.
The other ingredients are:
Tablet core: carboxymethylcellulose sodium, 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 what the package contains

The carton contains 2 PVC/Aluminum blisters, each with 15 film-coated tablets - oval, biconvex tablets, pink-beige in color with a dividing line.

Responsible entity 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: info@help.com.gr
To obtain more detailed information, you should contact the local representative of the responsible entity:
BLUBIT sp. z o.o., ul. Wolska 84/86
PL-01 141 Warsaw
Correspondence address:
BLUBIT sp. z o.o., Pharmaceutical Warehouse ul. Szeligowska 75A
PL-01 320 Warsaw
Tel.: +48 22 664 27 27, Fax: 22 665 92 72
e-mail: blubit@blubit.com.pl

Date of the last update of the leaflet

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