Package leaflet: Information for the patient

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

Keep this leaflet for future reference.
If you have any further questions, 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 you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 relief of symptoms associated with cerebral circulation disorders.
Indications for use of Cavinton Forte:

Treatment of chronic cerebral circulatory insufficiency, including post-ischemic stroke states and vascular dementia.
Relief of psychological and neurological symptoms of cerebral circulatory insufficiency.
Treatment of chronic circulatory disorders in the choroid and retinal vessels of the eye.
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 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 methods of contraception;
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, discuss this with your doctor or pharmacist.
If the patient has certain heart conditions, the doctor may recommend periodic ECG monitoring
(electrocardiographic examination – heart function test). This is particularly important in patients
who have QT interval prolongation or who are 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 with other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Cavinton Forte may interfere with the action of other medicines, or other medicines may affect its action. Inform your doctor, especially if the patient is taking 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 cardiac arrhythmias);
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 may 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 regarding the effect of vinpocetine on the ability to drive or operate machinery.

Cavinton Forte contains lactose (milk sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Cavinton Forte

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual dose of Cavinton Forte is 1 tablet (10 mg) three times daily (30 mg total).
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 impaired kidney or liver function.
There is no need to adjust the dosage if the patient is over 65 years of age.
Taking more Cavinton Forte than recommended
If more than the recommended dose of Cavinton Forte has been taken, consult a doctor immediately
or go to the nearest hospital.
Missing a dose of Cavinton Forte
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
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 can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below are grouped according to frequency of occurrence.

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

sleep disturbances (insomnia, drowsiness);
dizziness and headache, weakness – these symptoms may be related to the underlying disease;
changes in ECG recording (ST segment depression, QT interval prolongation), 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 reactions (may occur in up to 1 in 1000 people):

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

Reporting of adverse reactions
If any adverse symptoms 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, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cavinton Forte

Keep the medicine out of sight and reach of children.
Store in the original packaging.
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 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 packaging and other information

What Cavinton Forte contains

The active substance is vinpocetine.
The other ingredients are: colloidal anhydrous silica, magnesium stearate, talc, corn starch, monohydrate lactose.

What Cavinton Forte looks like and contents of the pack
White or almost white, flat, disc-shaped tablets with bevelled edges, approximately 8 mm in diameter, embossed with "10 mg" on one side and a score line on the other side.
The medicine is packed in PVC//Al blisters, in a cardboard box.
The cardboard pack contains 30 or 90 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Hungary, country of export:
Richter Gedeon Nyrt.
H-1103 Budapest
Gyömrői út 19-21.
Hungary
Manufacturer:
Richter Gedeon Nyrt.
H-1103 Budapest
Gyömrői út 19-21.
Hungary
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Hungary Marketing Authorisation numbers: OGYI-T-3531/04
OGYI-T-3531/05
Parallel Import Authorisation number: 130/19