Package leaflet: Information for the user

Warning! Please keep the leaflet. Information on the immediate 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 relief of symptoms associated with
cerebral circulation disorders.
Indications for 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 retina 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 contraceptive methods;
if the patient has certain heart diseases, i.e. severe ischemic heart disease or severe cardiac arrhythmias;
in 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 taking other medicines that may prolong the QT interval.

Children and adolescents
The 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 all medicines currently used or recently taken, as well as any medicines planned for future use.
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 meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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, vinpocetine administration 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 monohydrate lactose (milk sugar)
If the patient has previously been 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 used as directed by a physician. If in doubt, consult a 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 break line on the tablet is not intended for splitting 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 in patients over 65 years of age.
Taking more than the recommended dose of Cavinton Forte
In case of taking more than the recommended dose of Cavinton Forte, seek immediate medical advice from a doctor 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 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 their 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 uncertain 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 reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Cavinton Forte

Keep this medicine out of sight and reach of children.
There are no special requirements regarding storage temperature.
Store in the original 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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.
Other ingredients are: magnesium stearate, colloidal anhydrous silica, talc, lactose monohydrate, corn starch.

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 break line on the other.
The medicine is packed in PVC/Al blisters, placed in a cardboard box.
The cardboard box contains 30 or 90 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Gedeon Richter România S.A., Str. Cuza Vodă Nr. 99-105, 540306 Târgu-Mureş, Romania
Manufacturer:
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Romania, country of export: 8306/2015/01
8306/2015/02
Parallel import authorisation number: 371/22