Vincetan

Leaflet attached to the packaging: patient information

Vincetan, 5 mg, tablets

Vinpocetine

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vincetan and what is it used for
• 2. Important information before using Vincetan
• 3. How to use Vincetan
• 4. Possible side effects
• 5. How to store Vincetan
• 6. Package contents and other information

1. What is Vincetan and what is it used for

The medicine contains vinpocetine as the active substance. Vinpocetine is a compound used in the treatment of diseases or alleviation of symptoms related to blood circulation disorders in the brain.
Vincetan is used in:

• 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 Vincetan

When not to use Vincetan:

• if the patient is allergic to the active substance (vinpocetine) or any of the other ingredients of this medicine (listed in section 6),
• in severe ischemic heart disease and severe cardiac arrhythmias,
• in the acute phase of hemorrhagic stroke,
• during pregnancy and breastfeeding,
• if the patient is of childbearing age and does not use effective contraceptive methods,
• in children due to the lack of sufficient clinical trials in this age group.

Warnings and precautions

Before starting to use Vincetan, you should discuss it with your doctor, pharmacist, or nurse.
It is recommended to monitor the ECG recording in case of prolonged QT interval syndrome (changes in the electrocardiogram) or when using additional medication that causes QT interval prolongation.
You should consult a doctor, even if the above warnings concern situations that occurred in the past.

Using Vincetan in patients with kidney and/or liver function disorders

There is no need to change the dose in patients with liver or kidney diseases.

Children

This medicine is not intended for use in children.
The medicine should not be used due to the lack of sufficient clinical trial data in this age group.

Vincetan and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
In individual cases, vinpocetine may enhance the hypotensive (blood pressure-lowering) effect of α-methyldopa, so regular blood pressure monitoring is recommended during such combined therapy.
Care should be taken when using vinpocetine in combination with medicines that act on the central nervous system, as well as with antiarrhythmic (medicines used in cardiac arrhythmias) and anticoagulant (medicines that reduce blood clotting) medicines.

Vincetan with food and drink

The medicine should be taken after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
If you are of childbearing age, you must use effective contraception during vinpocetine therapy. Otherwise, vinpocetine administration is contraindicated.
Vinpocetine 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.

Vincetan contains lactose monohydrate

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

Vincetan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Vincetan

This medicine should always be used in accordance with the recommendations of your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
The recommended dose is:
Adults: 1-2 tablets (5-10 mg) 3 times a day.
Maintenance dose: 1 tablet (5 mg) 3 times a day.
The medicine should be taken after a meal.
Using Vincetan in patients with kidney and/or liver function disorders
There is no need to change the dosage if the patient has kidney or liver function disorders.
Using Vincetan in elderly patients
There is no need to change the dosage if the patient is over 65 years old.
If you feel that the effect of Vincetan is too strong or too weak, you should consult your doctor.

Taking a higher dose of Vincetan than recommended

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

Missing a dose of Vincetan

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.

4. Possible side effects

Like all medicines, Vincetan can cause side effects, although not everybody gets them.
Uncommon(in 1 to 10 patients per 1000):

• sleep disorders (insomnia, drowsiness), dizziness, and headaches, weakness - these symptoms may be related to the underlying disease,
• blood pressure changes (mainly blood pressure lowering), flushing,
• nausea, heartburn, and dry mouth,
• increased liver enzyme activity,
• allergic skin reactions,
• ST segment depression (changes in the electrocardiogram), QT interval prolongation, tachycardia, and extrasystole - these symptoms resolved spontaneously, and it is not certain whether they were caused by vinpocetine.

Rare(in 1 to 10 patients per 10,000):

• abdominal pain,
• leukopenia (reduced white blood cell count).

In some people, other side effects may occur during the use of the medicine .

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +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 the medicine.

5. How to store Vincetan

Store in a temperature below 25°C. Protect from light and moisture.
The medicine should be stored in a place that is out of sight and reach of children.
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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vincetan contains

• The active substance of the medicine is vinpocetine. One tablet contains 5 mg of vinpocetine.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, anhydrous colloidal silica.

What Vincetan looks like and what the package contains

The medicine is a white ,flat, beveled tablet with a smooth surface.
One package of the medicine contains 50 or 100 tablets.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: