Package leaflet: Information for the patient

Vincetan Forte, 10 mg, tablets
Vinpocetinum
Please read the entire leaflet carefully 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Vincetan Forte is and what it is used for
Important information before taking Vincetan Forte
How to take Vincetan Forte
Possible side effects
How to store Vincetan Forte
Contents of the pack and other information

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

Vincetan Forte contains as the active substance vinpocetine.
Vinpocetine is a compound used in the treatment of diseases or relief of symptoms related to
cerebral blood circulation disorders.
Indications:

Treatment of chronic cerebral circulation insufficiency, including post-ischemic stroke states and vascular dementia.
Relief of psychological and neurological symptoms of cerebral circulation insufficiency.
Treatment of chronic circulatory disorders in the retinal and choroidal vessels.
Treatment of hearing disorders of vascular origin.

2. Important information before using Vincetan Forte

When not to use Vincetan 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 diseases, i.e. severe ischemic heart disease and severe cardiac arrhythmias,
in the acute phase of hemorrhagic stroke,
in children.

Warnings and precautions
Before starting treatment with Vincetan Forte, discuss this with your doctor or pharmacist.
If the patient has certain heart conditions, periodic ECG monitoring (electrocardiographic examination – heart function test) is recommended, especially in patients with QT interval prolongation syndrome or in patients concurrently taking medicines that may cause QT interval prolongation.

Children
This medicine is not intended for use in children.
The medicine should not be used due to insufficient clinical data available in this age group.

Vincetan Forte with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Inform your doctor if the patient is taking any of the following medicines:

alpha-methyldopa (a medicine used for hypertension),
anticoagulant medicines (medicines that reduce blood clotting),
antiarrhythmic medicines (medicines used for heart rhythm disorders),
medicines acting on the central nervous system.

Vincetan Forte with food and drink
The medicine should be taken after food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
If the patient is of childbearing age, she must use an effective method of contraception during vinpocetine therapy. Otherwise, the administration of vinpocetine is contraindicated.
Vinpocetine is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
There is no data available regarding the effect of vinpocetine on the ability to drive or operate machinery.

Vincetan Forte contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Vincetan Forte contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Vincetan Forte

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
The usual dose of Vincetan Forte is 1 tablet (10 mg) three times daily (30 mg total).
Tablets should be taken after meals.
Use of Vincetan Forte in patients with renal and/or hepatic impairment
There is no need to adjust the dosage in patients with impaired kidney or liver function.
Use of Vincetan Forte in elderly patients
There is no need to adjust the dosage in patients over 65 years of age.
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Taking more Vincetan Forte than recommended
If you take more than the recommended dose, seek medical advice immediately or go to the nearest hospital.
Missed dose of Vincetan Forte
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

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 (may occur in fewer than 1 in 100 people)

Sleep disturbances (insomnia, drowsiness), dizziness and headache, fatigue. These symptoms may be related to the underlying disease.
Changes in ECG findings (ST segment depression, QT interval prolongation), tachycardia, extrasystoles. These symptoms occurred spontaneously, therefore it is uncertain whether they were caused by administration of vinpocetine.
Changes in blood pressure (mainly decreased blood pressure), sensation of hot flushes.
Nausea, heartburn and dry mouth.
Increased liver enzyme activity.
Allergic skin reactions.

Rare (may occur in fewer than 1 in 1000 people)

Leukopenia (reduction in white blood cell count).
Abdominal pain.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vincetan Forte

Keep in the original packaging to protect from light.
Store below 25°C.
Keep the medicine 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 stated month.
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Medicines must 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 packaging and other information

What Vincetan Forte contains

The active substance is vinpocetine. One tablet contains 10 mg of vinpocetine.
The other components (excipients) are: monohydrate lactose, sodium carboxymethyl starch (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Vincetan Forte looks like and contents of the pack
White to light yellow, smooth tablets in the shape of a biconvex disc.
One pack contains 30 or 90 tablets in blisters within a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicine
tel. 22 742 00 22
e-mail: [email protected]
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