Rostil max

Package Leaflet: Information for the Patient

Rostil max, 500 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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 side effects not listed in this package 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 Package Leaflet

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

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

Rostil max contains the active substance calcium dobesilate monohydrate, which acts on the capillary endothelium, vein walls, and lymphatic vessels. The medicine reduces capillary permeability, increases their resistance, preventing the formation of exudates and improving microcirculation.
The medicine increases the tension of the vein walls, which prevents the formation of stasis and thrombi in the venous vessels. It enhances collagen synthesis, reduces blood viscosity, and increases its flow through peripheral tissues.
It has a sealing effect on the vessels in the lymphatic system, resulting in reduced swelling, leading to the relief 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 (pain, cramps, feeling of heaviness in the legs, tingling, numbness, swelling, skin changes due to blood stasis), varicose veins of the lower limbs.
Symptomatic treatment of hemorrhoids.
The 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, 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.

Very rarely, after administration of the medicine, agranulocytosis may occur (see section 4: "Possible side effects"), the symptoms of which may include fever, sore throat, infection in the oral cavity, or other symptoms of an ongoing infection. If these symptoms occur, the patient should consult their doctor.

Children and Adolescents

The medicine should not be used in children and adolescents under 18 years of age.

Rostil max and Other Medicines

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

Rostil max 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 taken 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 taken during breastfeeding.

Driving and Operating Machinery

The medicine does not affect the ability to drive and operate machinery. If dizziness occurs after taking the medicine, the patient should not drive or operate machinery.

Rostil max Contains Lactose

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

3. How to Take Rostil max

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

Recommended Dose

Adults: 1 tablet 1-2 times a day (corresponding to a daily dose of 500 mg to 1000 mg).
The medicine should be taken during meals.

Duration of Treatment

Treatment may last from several weeks to several months.

Taking a Higher Dose of Rostil max Than Recommended

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

Missing a Dose of Rostil max

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.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible Side Effects

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

The Following Side Effects May Occur

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

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

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

• agranulocytosis (reduced number of granulocytes - a type of white blood cell, resulting in increased susceptibility to infections), the symptoms of which may include fever, sore throat, infection in the oral cavity, or other symptoms of an ongoing infection;
• pruritic rash with erythema.

These adverse reactions disappear after reducing the dose or discontinuing the medicine.

Reporting Side Effects

If any side effects occur, including any side effects not listed in this package leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 max

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiration date stated on the blister pack and carton after:
EXP. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Rostil max Contains

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

What Rostil max Looks Like and Contents of the Package

The medicine is in the form of elongated, oval, biconvex tablets with dimensions of 18.5 mm x 8.5 mm, white or almost white in color.
The package contains 30 or 60 tablets. Aluminum/PVC/PVDC blisters are packed in a cardboard box with a package 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 Package Leaflet: