Patient Information Leaflet

Rostil, 250 mg tablets
Calcii dobesilas monohydricus
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so 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 your symptoms do not improve or if you feel worse, contact your doctor.

Table of Contents

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

1. What Rostil is and what it is used for

Rostil is a medicine in tablet form. It contains the active substance calcium dobesilate monohydrate, which
acts on the capillary endothelium, venous walls, and lymphatic vessels. The drug reduces
capillary permeability, increases their resistance, prevents exudation, and improves microcirculation.
It increases venous wall tone, thereby preventing venous stasis and thrombosis.
It enhances collagen synthesis and reduces plasma viscosity, improving its flow through peripheral tissues.
It exerts a sealing effect on vessels within the lymphatic system, reducing edema, thus alleviating pain and the sensation of heaviness in the limbs.

Indications
Treatment of symptoms of chronic venous insufficiency of the lower limbs (varicose veins): pain,
cramps, tingling, edema, and skin changes due to blood stasis.

2. Important information before taking Rostil

When not to take Rostil

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Rostil, consult a doctor or pharmacist:

if the patient has severe renal insufficiency;
if the patient has chronic recurrent gastritis;
if the patient has peptic ulcer disease of the stomach and (or) duodenum.

Rostil 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.
There are no data regarding interactions of calcium dobesilate with other medicines.
Rostil 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 a doctor or pharmacist before using this medicine.
Pregnancy
The medicine must not be used during the first trimester of pregnancy.
The medicine may be used during pregnancy only if the physician considers it absolutely necessary.
Breastfeeding
The medicine should not be used during breastfeeding.
Driving and operating machinery
Rostil has no influence on the ability to drive or operate machinery.
Rostil contains monohydrate lactose and sodium
Monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
The medicine contains 0.319 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to take Rostil

This medicine should always be taken exactly as described in the patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Recommended dose
Adults: from 500 mg (2 tablets) to 1000 mg (4 tablets) per day, i.e. 2 tablets 1–2 times daily.
The medicine should be taken during a meal.
Duration of treatment
Treatment may last from several weeks to several months.
Taking more Rostil than recommended
If you take more Rostil than recommended, contact your doctor or pharmacist immediately.
Missed dose of Rostil
Continue taking the medicine as prescribed; do not increase the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur
Rare (occur in 1 to 10 people in 10,000):

nausea and diarrhoea;
drug fever;
dizziness.

Very rare (occur in less than 1 person in 10,000):

agranulocytosis (reduction in granulocytes - a type of white blood cells, leading to increased susceptibility to infections);
itchy rash with redness.

The above side effects usually resolve after dose reduction or discontinuation of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor or pharmacist.
Adverse reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rostil medicine

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date refers to the last day of the month indicated.
Lot is the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the package and other information

What Rostil contains

The active substance is calcium dobesilate monohydrate. Each tablet contains 250 mg of calcium dobesilate monohydrate.
Other ingredients are: lactose monohydrate, potato starch, microcrystalline cellulose, talc, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate, crospovidone.

What Rostil looks like and contents of the pack
Rostil is a tablet.
The pack contains 30 or 60 tablets. The blisters are packed in a cardboard box with a leaflet.
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