Cavinton

Package Leaflet: Information for the User

Cavinton, 5 mg, tablets

Vinpocetine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Cavinton and what is it used for
• 2. Important information before taking Cavinton
• 3. How to take Cavinton
• 4. Possible side effects
• 5. How to store Cavinton
• 6. Contents of the pack and other information
• 1.

What is Cavinton and what is it used for

Cavinton contains the active substance vinpocetine.
Vinpocetine is a compound used to treat diseases or alleviate symptoms associated with
blood circulation disorders in the brain.
Indications for the use of Cavinton:

• treatment of chronic cerebral circulatory insufficiency, including post-ischemic stroke and vascular dementia.
• alleviation of mental and neurological symptoms of cerebral circulatory insufficiency.
• treatment of chronic circulatory disorders in the retina and choroid of the eye.
• treatment of hearing disorders of vascular origin.

2. Important information before taking Cavinton

When not to take Cavinton

• if you are allergic to vinpocetine or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if you are of childbearing age and do not use effective contraceptive methods;
• if you have certain heart diseases, such as severe coronary heart disease or severe heart rhythm disorders;
• during the acute phase of hemorrhagic stroke;
• in children, due to the lack of sufficient clinical trial data in this age group.

Warnings and precautions

Before taking Cavinton, discuss it with your doctor or pharmacist.
If you have certain heart diseases, your doctor will recommend performing control ECG tests
(electrocardiologic examination - examination of heart function). This is especially important for patients
who have been diagnosed with QT interval prolongation or patients who are taking medications that
cause QT interval prolongation.

Children and adolescents

The use of this medicine is contraindicated in children and adolescents due to the lack of sufficient
clinical trial data in this age group.

Cavinton and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, as well as
any medicines you plan to take.
Cavinton may interfere with the action of other medicines, or other medicines may affect its action.
Tell your doctor, especially if you are taking the following medicines:

• alpha-methyldopa (a medicine used to treat high blood pressure);
• anticoagulant medicines (medicines used to prevent excessive blood clotting);
• antiarrhythmic medicines (medicines used to treat heart rhythm disorders);
• medicines acting on the central nervous system.

Cavinton with food and drink

The medicine should be taken after meals

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your
doctor or pharmacist before taking this medicine.
If you are of childbearing age, you must use effective contraception during treatment with Cavinton.
Otherwise, the administration of vinpocetine is contraindicated.
Cavinton is contraindicated during pregnancy and breastfeeding.

Driving and using machines

There is no data on the effect of vinpocetine on the ability to drive and use machines.

Cavinton contains lactose (milk sugar)

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before
taking the medicine.

3. How to take Cavinton

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your
doctor or pharmacist.
The usual dose of Cavinton is 1 or 2 tablets (5-10 mg) three times a day (15-30 mg).
Maintenance dose: 1 tablet 3 times a day.
Tablets should be taken after meals.
No dose adjustment is necessary if you have kidney or liver function disorders.
No dose adjustment is necessary if you are over 65 years old.

Taking a higher dose of Cavinton than recommended

If you have taken more tablets of Cavinton than the recommended dose, seek medical attention
immediately or go to the nearest hospital.

Missing a dose of Cavinton

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 taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below are grouped by frequency of occurrence.
Uncommon side effects (may affect up to 1 in 100 people):

• sleep disorders (insomnia, drowsiness);
• dizziness and headaches, weakness - these symptoms may be related to the underlying disease;
• changes in ECG recording (ST segment depression, QT interval prolongation), tachycardia and extra heartbeats; these symptoms occurred spontaneously, so it is not certain whether the use of Cavinton could have been the cause of these symptoms;
• changes in blood pressure (mainly lower blood pressure than usual), hot flashes;
• nausea, heartburn, and dry mouth;
• increased liver enzyme activity;
• allergic skin reactions.

Rare side effects (may affect up to 1 in 1000 people):

• leukopenia (decreased white blood cell count, which can cause frequent infections),
• abdominal pain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cavinton

Keep the medicine out of the sight and reach of children.
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 specified month.
Medicines should 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 contains

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

What Cavinton looks like and contents of the pack

Flat tablets in the shape of a disk, with beveled edges, white or almost white in color, with a diameter of about 9 mm with the inscription "CAVINTON" on one side of the tablet.
The medicine is packaged in aluminum/PVC blisters.
The carton pack contains 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest, Hungary.