ROSTIL MAX

Patient Information Leaflet

Rostil max, 500 mg, tablets
Calcii dobesilas monohydricus
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
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 that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, contact your doctor.

Leaflet Contents

1. What Rostil max is and what it is used for
2. What you need to know before taking Rostil max
3. How to take Rostil max
4. Possible side effects
5. How to store Rostil max
6. Contents of the pack and other information

1. What Rostil max is and what it is used for

Rostil max contains the active substance calcium dobesilate monohydrate, which acts on the capillary endothelium, venous walls, and lymphatic vessels. The medicine 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, reduces plasma viscosity, and improves its flow through peripheral tissues.
It exerts a sealing effect on vessels within the lymphatic system, reducing edema, which in turn alleviates pain and the sensation of heaviness in the limbs.

Indications
Treatment of symptoms of chronic venous insufficiency of the lower limbs (pain, cramps, sensation of heaviness in the legs, tingling, numbness, swelling, skin changes due to blood stasis), varicose veins of the lower limbs.
Symptomatic treatment of anal varices (haemorrhoids).
This medicine is indicated for use in adults.

2. Important information before taking Rostil max

When not to take Rostil max

• if the patient is allergic to calcium dobesilate monohydrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Rostil max, discuss with your doctor or pharmacist:

• if the patient has severe renal insufficiency;
• if the patient has chronic recurrent gastritis;
• if the patient has gastric and/or duodenal ulcer disease.

Very rarely, agranulocytosis may occur after taking the medicine (see section 4: "Possible adverse reactions"), which may present with symptoms such as fever, sore throat, oral cavity infection, or other signs of infection. If any of these symptoms occur, the patient should consult a doctor immediately.
Children and adolescents
Rostil max should not be used in children and adolescents under 18 years of age.
Rostil max 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 the patient intends to take.
There is no data available on interactions between calcium dobesilate monohydrate and other medicines.
Rostil max with food and drink
This medicine should be taken during a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the first trimester of pregnancy.
This medicine may be used during pregnancy only if the physician considers it absolutely necessary.
Breastfeeding
This medicine should not be used during breastfeeding.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery. However, if dizziness occurs after taking the medicine, the patient should not drive or operate machinery.
Rostil max contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Rostil max

This medicine should always be taken exactly as described in this patient information leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This is an oral medicine.
Recommended dose
Adults: 1 tablet 1–2 times daily (corresponding to a daily dose of 500 mg to 1000 mg).
The medicine should be taken during a meal.
Duration of treatment
Treatment may last from several weeks to several months.
Overdose of Rostil max
In case of taking more than the recommended dose, seek immediate advice from a doctor or pharmacist.
Missed dose of Rostil max
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse effects may occur
Rare (occur in 1 to 10 out of 10,000 people):

• nausea and diarrhoea;
• dizziness;
• drug fever.

Very rare (occur in less than 1 out of 10,000 people):

• agranulocytosis (reduction in the number of granulocytes - one type of white blood cells, causing increased susceptibility to infections), which may manifest as fever, sore throat, infection in the oral cavity, or other signs of infection;
• itchy rash with redness.

The above symptoms subside 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, 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 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 max

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the blister and carton after:
EXP. 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 pack and other information

What Rostil max contains

• The active substance is calcium dobesilate monohydrate. Each tablet contains 500 mg of calcium dobesilate monohydrate.
• The other ingredients are: microcrystalline cellulose, monohydrate lactose, colloidal anhydrous silica, talc, magnesium stearate.

What Rostil max looks like and contents of the pack
Rostil max is in the form of elongated, oval, biconvex tablets, 18.5 mm x 8.5 mm in size, white or almost white in colour.
The pack contains 30 or 60 tablets. Aluminium/PVC/PVDC blisters are packed in a cardboard box together with the 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