Cavinton Forte

Package Leaflet: Information for the User

Cavinton Forte, 10 mg, Tablets

Vinpocetine

Read the Leaflet Carefully Before Taking the Medication, 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. 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 any not listed in this leaflet, please tell your 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 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 in the treatment of diseases or alleviation of symptoms related to
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 retinal and choroidal vessels 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 not using 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 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
(electrocardiologic examination - examination of heart function). This is especially important in patients
with a prolonged QT interval or in 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 data in this age group.

Cavinton Forte and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently,
as well as about the medicines you 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);
• antiarrhythmic 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 Operating Machines

There are no data on the effect of vinpocetine on the ability to drive and operate machines.

Cavinton Forte Contains Lactose (Milk Sugar)

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

3. How to Take Cavinton Forte

This medicine should always be taken exactly as advised by your doctor. If you are unsure, 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 score 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.

Overdose of Cavinton Forte

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

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.
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 activity of liver enzymes,
• allergic skin reactions.

Rare side effects (may affect up to 1 in 1,000 people):

• leukopenia (decrease in white blood cell count, which may cause frequent infections),
• abdominal pain.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 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. 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: colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate.

What Cavinton Forte Looks Like and Contents of the Pack

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 score line on the other side.
The medicine is packaged in aluminum/PVC blisters.
The carton pack contains 30 or 90 tablets.

Marketing Authorization Holder and Manufacturer

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

For More Detailed Information, Please Contact the Local Representative of the Marketing Authorization Holder.

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
Fax: +48 (22) 755 96 24

Date of Last Revision of the Leaflet: