PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging in a foreign language
Cavinton Forte
10 mg, tablets
Vinpocetinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, please consult your doctor or pharmacist. – This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Cavinton Forte is and what it is used for

Cavinton Forte contains the active substance vinpocetine.
Vinpocetine is a compound used in the treatment of diseases or in alleviating symptoms associated with disturbances in cerebral blood circulation.

Indications for Cavinton Forte:

Treatment of chronic cerebral circulatory insufficiency, including post-ischaemic stroke states and vascular dementia.
Alleviation of psychological and neurological symptoms of cerebral circulatory insufficiency.
Treatment of chronic circulatory disorders in the choroid and retinal vessels.
Treatment of hearing disorders of vascular origin.

2. Important information before using Cavinton Forte

When not to use Cavinton Forte

if the patient is allergic to vinpocetine or to any of the other ingredients of this medicine (listed in section 6);
if the patient is pregnant or breastfeeding;
if the patient is of childbearing age and is not using effective contraceptive methods;
if the patient has certain heart conditions, i.e. severe ischemic heart disease or severe cardiac arrhythmias;
during the acute phase of hemorrhagic stroke;
in children, due to insufficient clinical data in this age group.

Warnings and precautions
Before starting treatment with Cavinton Forte, consult your doctor or pharmacist.
If the patient has certain heart conditions, the doctor may recommend regular ECG monitoring
(electrocardiographic examination – heart function test). This is particularly important in patients
with known QT interval prolongation or in patients concurrently taking medicines that may prolong
the QT interval.

Children and adolescents
Use of this medicine is contraindicated in children and adolescents due to insufficient clinical data
in this age group.

Cavinton Forte 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 plans to take.
Cavinton Forte may interfere with the action of other medicines, or other medicines may affect its
action.
Please inform your doctor, especially if the patient is taking any of the following medicines:

methyldopa (a medicine used to treat high blood pressure);
anticoagulants (medicines used to prevent excessive blood clotting);
antiarrhythmics (medicines used to treat heart rhythm disorders);
medicines acting on the central nervous system.

Cavinton Forte with food and drink
Cavinton Forte should be taken after food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient is of childbearing age, she must use an effective method of contraception during
treatment with Cavinton Forte. Otherwise, administration of vinpocetine is contraindicated.
Cavinton Forte is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
There is no data available on the effect of vinpocetine on the ability to drive or operate machinery.

Cavinton Forte contains lactose (milk sugar)
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 use Cavinton Forte

This medicine should always be taken as directed by a physician. In case of doubt, consult a
physician or pharmacist.
The usual dose of Cavinton Forte is 1 tablet (10 mg) three times daily (30 mg).
Tablets should be taken after meals.
The division line on the tablet is not intended for breaking the tablet.
There is no need to adjust the dosage if the patient has renal or hepatic impairment.
There is no need to adjust the dosage if the patient is over 65 years of age.
Taking more than the recommended dose of Cavinton Forte
If more than the recommended dose of Cavinton Forte is taken, seek immediate medical advice
from a physician or go to the nearest hospital.
Missed dose of Cavinton Forte
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below are grouped according to their frequency of occurrence.

Uncommon adverse effects (may occur in up to 1 in 100 people):

sleep disturbances (insomnia, drowsiness);
dizziness and headaches, weakness – these symptoms may be related to the underlying disease;
changes in ECG findings (depression of the ST segment, prolongation of the QT interval), tachycardia, and extrasystoles; these symptoms occurred spontaneously, therefore it is not certain whether the use of Cavinton Forte could have caused them;
changes in blood pressure (mainly lower blood pressure than usual), hot flushes;
nausea, heartburn, and dry mouth;
increased liver enzyme activity;
allergic skin reactions.

Rare adverse effects (may occur in up to 1 in 1000 people):

leukopenia (decreased number of white blood cells, which may lead to frequent infections);
abdominal pain.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Cavinton Forte

Keep this medicine out of the sight and reach of children.
Store the blister in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Cavinton Forte contains

The active substance is vinpocetine. Each tablet contains 10 mg of vinpocetine.
The other components are: colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate.

What Cavinton Forte looks like and contents of the pack
White or almost white tablets, flat disc-shaped with bevelled edges, approximately 8 mm in diameter, embossed with "10 mg" on one side and a division line on the other side.
The medicine is packed in PVC/Aluminum blisters.
The cardboard package contains 30 or 90 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Bulgaria, the country of export:
Gedeon Richter Plc.
Gyomrői ut 19-21
1103 Budapest
Hungary

Manufacturer:
Gedeon Richter Plc.
Gyomrői ut 19-21
1103 Budapest
Hungary

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
02-234 Warsaw
Poland

Bulgaria (country of export) Marketing Authorisation Number: 20010989
Parallel Import Licence Number: 121/24