Vincetan

Patient Information Leaflet

Vincetan, 5 mg, tablets
Vinpocetinum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• 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 you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

1. What Vincetan is and what it is used for

The medicine contains vinpocetine as the active substance. Vinpocetine is a compound used in the treatment of diseases or relief of symptoms associated with impaired cerebral blood circulation.
Vincetan is used for:

• Treatment of chronic cerebral circulation insufficiency, including post-ischaemic stroke conditions and vascular dementia.
• Relief of psychological and neurological symptoms of cerebral circulation insufficiency.
• Treatment of chronic circulatory disorders in the choroid and retinal 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,
• during 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 lack of sufficient clinical data in this age group.

Warnings and precautions
Before starting treatment with Vincetan, discuss this with your doctor, pharmacist, or nurse.
ECG monitoring is recommended in patients with QT prolongation syndrome (changes in electrocardiogram) or when using other medicinal products that prolong the QT interval.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.

Use of Vincetan in patients with renal and/or hepatic impairment
There is no need to adjust the dose in patients with liver or kidney disease.

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

Vincetan with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In individual cases, vinpocetine may enhance the hypotensive (blood pressure-lowering) effect of α-methyldopa; therefore, regular blood pressure monitoring is recommended when these medicines are used concomitantly.
Caution is advised when using vinpocetine together with medicines acting on the central nervous system, as well as with antiarrhythmic (medicines used for cardiac rhythm disorders) and antithrombotic (medicines reducing blood clotting) agents.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, 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 vinpocetine therapy. Otherwise, vinpocetine administration is contraindicated.
Vinpocetine is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
There are no data available on the effects of vinpocetine on the ability to drive or operate machinery.

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

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

3. How to use Vincetan

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
The recommended dose is:
Adults: 1 – 2 tablets (5-10 mg) three times daily.
Maintenance dose: 1 tablet (5 mg) three times daily.
The medicine should be taken after meals.
Use of Vincetan in patients with renal and/or hepatic impairment
There is no need to adjust the dosage if the patient has impaired kidney or liver function.
Use of Vincetan in elderly patients
There is no need to adjust the dosage for patients over 65 years of age.
If you feel that the effect of Vincetan is too strong or too weak, please consult your doctor.
Taking more Vincetan than recommended
If you take more Vincetan than recommended, consult your doctor or go to the nearest hospital immediately.
Missing a dose of Vincetan
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Uncommon (in 1 to 10 patients out of 1,000):

• Sleep disturbances (insomnia, drowsiness), dizziness and headache, weakness – these symptoms may be related to the underlying disease,
• Changes in blood pressure (mainly low blood pressure), flushing,
• Nausea, heartburn and dry mouth,
• Increased liver enzyme activity,
• Allergic skin reactions,
• ST segment depression (changes in electrocardiogram), QT interval prolongation, tachycardia and extrasystoles – these symptoms resolved spontaneously, and therefore it is uncertain whether they were caused by administration of vinpocetine.

Rare (in 1 to 10 patients out of 10,000):

• Abdominal pain,
• Leukopenia (reduced white blood cell count).

Other adverse reactions may occur in some individuals during treatment with this medicine.

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

5. How to store Vincetan

Store below 25°C. Protect from light and moisture.
Keep the medicine in a place invisible and out of 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Vincetan contains

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

What Vincetan looks like and contents of the pack
Vincetan is a white, biconvex, scored tablet with a smooth, uniform surface.
One package contains 50 or 100 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]