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
Vinpocetinum
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

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

Cavinton Forte contains the active substance vinpocetine.
Vinpocetine is a compound used in the treatment of diseases or relief of symptoms associated with
cerebral circulation disorders.
Indications for Cavinton Forte:

• treatment of chronic cerebral circulatory insufficiency, including post-ischaemic stroke states and vascular dementia;
• relief of psychological and neurological symptoms of cerebral circulatory insufficiency;
• treatment of chronic circulatory disorders in the choroid and retinal vessels;
• treatment of hearing disorders of vascular origin.

2. 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 is not using effective contraceptive methods;
• if the patient has certain heart conditions, i.e. severe ischemic heart disease or severe cardiac arrhythmias;
• in the acute phase of hemorrhagic stroke;
• in children, due to insufficient clinical data in this age group.

Warnings and precautions
Before starting treatment with Cavinton Forte, please consult your doctor or pharmacist.
If the patient has certain heart conditions, the doctor may recommend regular ECG monitoring
(electrocardiographic examination – assessment of heart function). This is particularly important for
patients with known QT interval prolongation or for patients taking concomitant medicines that may
prolong the QT interval.
Children and adolescents
Use of this medicine is contraindicated in children and adolescents due to insufficient clinical data
in this age group.
Cavinton Forte with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or
plans to take.
Cavinton Forte may interfere with the action of other medicines, or other medicines may affect its
action.
Please inform your doctor, especially if the patient is taking the following medicines:

• methyldopa (a medicine used to treat high blood pressure);
• anticoagulants (medicines used to prevent excessive blood clotting);
• antiarrhythmics (medicines used to treat cardiac arrhythmias);
• medicines acting on the central nervous system.

Cavinton Forte with food and drink
Cavinton Forte should be taken after meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient is of childbearing age, she must use an effective method of contraception during
treatment with Cavinton Forte. Otherwise, administration of vinpocetine is contraindicated.
Cavinton Forte is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
There is no data available regarding the influence of vinpocetine on the ability to drive or operate
machinery.
Cavinton Forte contains monohydrate lactose (milk sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

3. How to use Cavinton Forte

This medicine should always be used exactly as your doctor has told you. If you are unsure,
you should contact your doctor or pharmacist.
The usual dose of Cavinton Forte is 1 tablet (10 mg) three times daily (30 mg).
The tablets should be taken after meals.
The break line on the tablet is not intended for dividing the tablet.
There is no need to adjust the dosage if the patient has renal or hepatic impairment.
There is no need to adjust the dosage if the patient is over 65 years of age.
Taking more Cavinton Forte than recommended
If you take more Cavinton Forte than recommended, you should contact your doctor immediately
or go to the nearest hospital.
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 the use of this medicine, you should contact your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below are grouped according to their frequency of occurrence.
Uncommon adverse effects (may occur in up to 1 in 100 people):

• Sleep disturbances (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 extrasystoles; these symptoms occurred spontaneously, therefore it is not certain whether the use of Cavinton Forte could have caused them;
• Changes in blood pressure (mainly lower blood pressure than usual), hot flushes;
• Nausea, heartburn and dry mouth;
• Increased liver enzyme activity;
• Allergic skin reactions.

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

• Leukopenia (reduced number of white blood cells, which may lead to frequent infections),
• Abdominal pain.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cavinton Forte

Keep this medicine out of sight and reach of children.
Store the blister in the outer 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Cavinton Forte contains

• The active substance is vinpocetine. Each tablet contains 10 mg of vinpocetine.
• Other components: colloidal anhydrous silica, magnesium stearate, talc, corn starch, monohydrate lactose.

What Cavinton Forte looks like and contents of the pack
White or almost white tablets, flat disc-shaped with bevelled edges, approximately 8 mm in diameter, embossed with "10 mg" on one side and a dividing line on the other.
The medicine is packed in PVC/Aluminium blisters.
The cardboard pack contains 30 or 90 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Bulgaria, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw

Marketing Authorization number in Bulgaria, country of export: 20010989
Parallel import authorization number: 154/20