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

Vinpocetine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

Cavinton Forte 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 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 retina and choroid of the eye.
• treatment of hearing disorders of vascular origin.

2. Important information before taking Cavinton Forte

When not to take Cavinton Forte

• 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 starting treatment with Cavinton Forte, discuss it with your doctor or pharmacist.
If you have certain heart diseases, your doctor will recommend regular ECG checks
(electrocardiogram - a test of heart function). This is especially important for patients with a prolonged QT interval or patients taking medications that prolong the QT interval.

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

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Cavinton Forte 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);
• anti-arrhythmic medicines (medicines used to treat heart 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 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 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 (milk sugar)

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

3. How to take Cavinton Forte

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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.
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 Forte than recommended

If you have taken more than the recommended dose of Cavinton Forte, contact your doctor or go to the nearest hospital immediately.

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 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 (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 liver enzyme activity,
• allergic skin reactions.

Rare side effects (may affect up to 1 in 1,000 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, 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
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cavinton Forte

Keep the medicine out of the sight and reach of children.
Store in the original packaging.
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 that are no longer needed. 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 silica, talc, lactose monohydrate, corn starch.

What Cavinton Forte looks like and contents of the pack

White or almost white tablets, round, flat, with beveled edges, with the inscription "10 mg" on one side and a dividing line on the other side.
The medicine is packaged in PVC/Al blisters.
The carton pack contains 30 or 90 tablets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

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

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Hungary, the country of export: OGYI-T-3531/04
OGYI-T-3531/05

Parallel import authorization number: 76/07

Date of leaflet approval:11.10.2022
[Information about the trademark]