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 before taking this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Cavinton Forte is and what it is used for
2. What you need to know 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 disturbances in cerebral blood circulation.
Indications for Cavinton Forte:

• Treatment of chronic cerebral circulatory insufficiency, including post-ischaemic 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 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;
• 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, discuss it with 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 who have been diagnosed with QT interval prolongation or in patients concurrently taking medicines that cause QT 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
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 on the influence of vinpocetine on the ability to drive vehicles 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 used as directed by the physician. In case of 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 splitting the tablet.
There is no need to adjust the dosage in patients with renal or hepatic impairment.
There is no need to adjust the dosage in patients over 65 years of age.
Use of a higher than recommended dose of Cavinton Forte
If an overdose of Cavinton Forte has been taken, 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.
In case of any further doubts concerning 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 everybody will experience them.
The adverse reactions listed below are grouped according to frequency of occurrence.

Uncommon adverse reactions (may affect 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 affect up to 1 in 1000 people):

• leukopenia (decrease in white blood cell count, 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 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 safe use of the medicine.

5. How to store Cavinton Forte

Keep the medicine out of the sight and reach of children.
Store the blister pack 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 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 pack and other information

What Cavinton Forte contains

• The active substance is vinpocetine.
• The other ingredients are: magnesium stearate, colloidal anhydrous silica, talc, lactose monohydrate, maize 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, marked with "10 mg" on one side and a break line on the other side.
The medicine is packaged in PVC/Aluminium blisters in a cardboard box.
The cardboard pack 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., Gyömrői út 19-21., 1103 Budapest, Hungary
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
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Bulgaria, the country of export: 20010989
Parallel Import Licence Number: 134/20