Rostil

Package Leaflet: Information for the Patient

Rostil,250 mg, tablets
Calcii dobesilas monohydricus

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Rostil and what is it used for

Rostil is a medicine in the form of tablets. It contains the active substance calcium dobesilate monohydrate, which acts on the capillary endothelium, vein walls, and lymphatic vessels. The medicine reduces the permeability of capillaries, increases their resistance, preventing the formation of exudates and improving microcirculation.
The medicine increases the tension of the vein wall, preventing the formation of stasis and thrombi in the venous vessels. It enhances collagen synthesis, reduces blood plasma viscosity, and increases its flow through peripheral tissues.
It has a sealing effect on the vessels in the lymphatic system, causing a reduction in swelling, leading to the disappearance of painful symptoms and a feeling of heaviness in the limbs.

Indications for Use

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

2. Important Information Before Taking Rostil

When Not to Take Rostil

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

Warnings and Precautions

Before starting to take Rostil, the patient should discuss it with their doctor or pharmacist:

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

Rostil and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
There is no data on the interaction of calcium dobesilate with other medicines.

Rostil with Food and Drink

The medicine should be taken during meals.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine should not be used during the first trimester of pregnancy.
The medicine may be used during pregnancy only if the doctor considers it absolutely necessary.
Breastfeeding
The medicine should not be used during breastfeeding.

Driving and Using Machines

The medicine does not affect the ability to drive or operate machines.

Rostil Contains Lactose Monohydrate and Sodium

Lactose Monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium

The medicine contains 0.319 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to Take Rostil

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is for oral use.

Recommended Dose

Adults: 500 mg (2 tablets) to 1000 mg (4 tablets) per day, i.e., 2 tablets 1-2 times a day.
The medicine should be taken during meals.

Duration of Treatment

Treatment may last from several weeks to several months.

Taking More Than the Recommended Dose of Rostil

In case of taking more than the recommended dose of the medicine, the patient should immediately consult their doctor or pharmacist.

Missing a Dose of Rostil

The patient should continue taking the medicine, without increasing the next dose.
A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Following Side Effects May Occur

Rare(occurring in 1 to 10 people out of 10,000):

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

Very Rare(occurring in less than 1 person out of 10,000):

• agranulocytosis (reduced number of granulocytes, a type of white blood cell, making the patient more susceptible to infections);
• pruritic rash with erythema.

These symptoms disappear after reducing the dose or discontinuing the medicine.

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Rostil

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°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 month.
Lot means batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Rostil Contains

• The active substance of the medicine is calcium dobesilate monohydrate. One tablet contains 250 mg of calcium dobesilate monohydrate.
• The 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

The medicine is in the form of tablets.
The pack contains 30 or 60 tablets. The blisters are packed in a cardboard box with a leaflet.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of Last Revision of the Leaflet:08.02.2021