Cavinton forte

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 in case you 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 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 the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Cavinton Forte is and what it is used for
2. Important information before taking Cavinton Forte
3. How to take Cavinton Forte
4. Possible side effects
5. How to store Cavinton Forte
6. 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 blood circulation disorders.
Indications for Cavinton Forte:

• Treatment of chronic cerebral circulation insufficiency, including post-ischemic stroke conditions and vascular dementia.
• Relief 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 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;
• in 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, consult a 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 who have been diagnosed with QT interval prolongation or in patients concurrently taking 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 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.
Inform the doctor, especially if the patient is taking any of 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 rhythm disorders);
• 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 become pregnant, 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, administration of vinpocetine is contraindicated.
Cavinton Forte is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
There is no data available regarding the influence 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 the physician. If in doubt, consult your
doctor 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 splitting 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 than the recommended dose of Cavinton Forte
If more than the recommended dose of Cavinton Forte is taken, seek immediate medical advice
from a 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 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 headaches, 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 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 (decreased 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, 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 the sight and reach of children.
There are no special storage temperature requirements.
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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cavinton Forte contains

• The active substance is vinpocetine. Each tablet contains 10 mg of vinpocetine.
• The other ingredients are: colloidal anhydrous silica, magnesium stearate, talc, corn starch, and 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, marked with "10 mg" on one side and a score line on the other.
The medicine is packaged 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 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw, Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów, Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź, Poland
Marketing authorisation numbers in Romania, country of export: 8306/2015/01
8306/2015/02
Parallel import authorisation number: 28/23