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, 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 any 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
disorders of blood circulation 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 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 data in this age group.

Cavinton Forte 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 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 are planning to have a baby, ask your doctor or pharmacist for advice 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 are 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, you should consult your doctor before taking this 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 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 have taken more than the recommended dose of Cavinton Forte, seek medical attention 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 following side effects are grouped by frequency:

• 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, 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 the blister pack in the outer packaging to protect it 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.
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: magnesium stearate, colloidal silica, talc, lactose monohydrate, maize starch.

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 PVC/Aluminum blisters in a cardboard box.
The cardboard box contains 30 or 90 tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Number of the permit in Bulgaria, the country of export: 20010989

Number of the parallel import permit: 134/20

Date of approval of the leaflet:23.05.2025
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