Vincetan Forte

Package Leaflet: Information for the Patient

Vincetan 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Vincetan Forte and what is it used for
• 2. Important information before taking Vincetan Forte
• 3. How to take Vincetan Forte
• 4. Possible side effects
• 5. How to store Vincetan Forte
• 6. Contents of the pack and other information

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

Vincetan Forte contains vinpocetine as the active substance.
Vinpocetine is a compound used to treat diseases or alleviate symptoms associated with
blood circulation disorders in the brain.

Indications:

• 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 Vincetan Forte

When not to take Vincetan Forte:

• if the patient is allergic to vinpocetine or any of the other ingredients of this medication (listed in section 6),
• if the patient is pregnant or breastfeeding,
• if the patient is of childbearing age and does not use effective contraceptive methods,
• if the patient has certain heart diseases, such as severe coronary heart disease and severe cardiac arrhythmias,
• during the acute phase of hemorrhagic stroke,
• in children.

Warnings and precautions

Before starting treatment with Vincetan Forte, discuss it with your doctor or pharmacist.
If the patient has certain heart diseases, it is recommended to perform control ECG examinations
(electrocardiologic examination - examination of heart function). Especially in patients with
prolonged QT interval or in patients taking medications that cause QT interval prolongation.

Children

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

Vincetan Forte and other medications

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Tell your doctor if the patient is taking the following medications:

• alpha-methyldopa (a medication used to treat hypertension),
• anticoagulant medications (medications that reduce blood clotting),
• antiarrhythmic medications (medications used to treat heart rhythm disorders),
• medications that act on the central nervous system.

Vincetan Forte with food and drink

The medication should be taken after meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
If the patient is of childbearing age, they must use effective contraception during vinpocetine therapy.
Otherwise, vinpocetine administration is contraindicated.
Vinpocetine is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

There is no data on the effect of vinpocetine on the ability to drive and operate machinery.

Vincetan Forte contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

Vincetan Forte contains sodium

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

3. How to take Vincetan Forte

This medication should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The usual dose of Vincetan Forte is 1 tablet (10 mg) three times a day (30 mg).
Tablets should be taken after meals.
Administration of Vincetan Forte in patients with renal and/or hepatic impairment
There is no need to adjust the dosage in patients with renal or hepatic impairment.
Administration 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 a higher dose of Vincetan Forte than recommended

In case of taking a higher dose of the medication than recommended, seek medical attention immediately or go to the nearest hospital.

Missing a 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 side effects

Like all medications, Vincetan Forte can cause side effects, although not everybody gets them.
The side effects listed below are grouped by frequency of occurrence.
Uncommon(may occur in less than 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 extrasystole. These symptoms occurred spontaneously and therefore it is not certain whether they were caused by vinpocetine.
• Changes in blood pressure (mainly decreased blood pressure), flushing.
• Nausea, heartburn, and dry mouth.
• Increased activity of liver enzymes.
• Allergic skin reactions.

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

• Leukopenia (decreased white blood cell count).
• Abdominal pain.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, inform a 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 181 C, 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 gather more information on the safety of the medication.

5. How to store Vincetan Forte

Store in the original packaging to protect from light.
Store at a temperature below 25°C.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
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Medications should not be disposed of via wastewater or household waste containers. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Vincetan Forte contains

• The active substance of the medication is vinpocetine. 1 tablet contains 10 mg of vinpocetine.
• The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethylcellulose (type A), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

What Vincetan Forte looks like and what the pack contains

White to light yellow tablets, smooth, in the shape of a biconvex disk.
One pack of the medication contains 30 or 90 tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

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

Date of last update of the leaflet:

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