Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Cavinton Forte
10 mg, tablets
Vinpocetine
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any 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 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 contraceptive methods;
if the patient has certain heart diseases, i.e. severe ischemic heart disease or severe cardiac arrhythmias;
during the acute phase of hemorrhagic stroke;
in children, due to lack of sufficient 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 diseases, the doctor may recommend regular ECG examinations
(electrocardiographic testing – heart function testing). This is particularly important in patients
who have been diagnosed with QT interval prolongation or in patients concurrently taking medicines
which cause QT interval prolongation.
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
Tell 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.
Tell your doctor, especially if the patient is taking the following medicines:

alpha 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 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 using machines
There is no data available regarding 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 taken as prescribed by your doctor. If you have any doubts, 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 break line on the tablet is not intended for splitting the tablet.
There is no need to adjust the dose in patients with renal or hepatic impairment.
There is no need to adjust the dose in patients over 65 years of age.
Taking more Cavinton Forte than prescribed
If you have taken more Cavinton Forte than prescribed, seek immediate medical advice from your doctor or go to the nearest hospital.
Missing a 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 doubts 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 findings (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 reactions 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

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Cavinton Forte

Keep this medicine out of the sight and reach of children.
There are no special requirements regarding the storage temperature of the medicinal product.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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, lactose monohydrate.

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 the marking "10 mg" on one side and a score line on the other side.
The medicine is packed in PVC/Al blisters.
The cardboard carton contains 30 or 90 tablets.
For further 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Romania, country of export: 8306/2015/01
Parallel import authorisation number: 299/22