Cavinton Forte

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Cavinton Forte

10 mg, tablets

Vinpocetine

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Cavinton Forte and what is it used for

Cavinton Forte contains the active substance vinpocetine.
Vinpocetine is a compound used in the treatment of diseases or alleviation of symptoms related to
blood circulation disorders in the brain.
Indications for use of Cavinton Forte:

• 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 retinal and choroidal 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 does not use effective contraceptive methods;
• if the patient has 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 starting to use Cavinton Forte, you should discuss it with your doctor or pharmacist.
If the patient has certain heart diseases, the doctor will recommend performing control ECG tests
(electrocardiologic examination - examination of heart function). This is especially important in patients who have been diagnosed with QT interval prolongation or in patients who are also 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 Forte and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Cavinton Forte may interfere with the action of other medicines or other medicines may affect its action.
You should 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 that act on the central nervous system.

Cavinton Forte with food and drink

Cavinton Forte should be taken after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
If you are of childbearing age, you must use an effective contraceptive method during treatment with Cavinton Forte. Otherwise, the administration of vinpocetine is contraindicated.
Cavinton Forte 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 Forte contains lactose monohydrate (milk sugar)

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

3. How to use Cavinton Forte

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
The usual dose of Cavinton Forte is 1 tablet (10 mg) three times a day (30 mg).
Tablets should be taken after meals.
The dividing line on the tablet is not intended for breaking the tablet.
There is no need to change the dose if the patient has kidney or liver function disorders.
There is no need to change the dose if the patient is over 65 years old.

Using a higher dose of Cavinton Forte than recommended

If you have taken a higher dose of Cavinton Forte than recommended, you should immediately consult your doctor or go to the nearest hospital.

Missing a dose of Cavinton Forte

You should not take a double dose to make up for a missed dose. The next dose of the medicine should be taken at the usual time.
If you have any further doubts about using this medicine, you should consult 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 occur in 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 (depression of the ST segment, prolongation of the QT interval), tachycardia and extra heartbeats; these symptoms occurred spontaneously, so it is not certain whether the use of Cavinton Forte 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 activity of liver enzymes,
• allergic skin reactions.

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

• leukopenia (decrease in the number of white blood cells, which can cause frequent infections),
• abdominal pain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Cavinton Forte

The medicine should be stored out of sight and reach of children.
There are no special recommendations for 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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Cavinton Forte contains

• The active substance of the medicine is vinpocetine. Each tablet contains 10 mg of vinpocetine.
• The other ingredients are: colloidal silica, magnesium stearate, talc, corn starch, and lactose monohydrate.

What Cavinton Forte looks like and what the package contains

White or almost white tablets, flat in the shape of a disc, with beveled edges, approximately 8 mm in diameter, with the inscription "10 mg" on one side and a dividing line on the other side.
The medicine is packaged in PVC/Al blisters in a cardboard box.
The cardboard box contains 30 or 90 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 8306/2015/01
8306/2015/02

Parallel import authorization number: 28/23 Date of approval of the leaflet: 28.02.2023

[Information about the trademark]