VINPOTON

Package leaflet: Information for the user

VINPOTON, 5 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 further questions, please 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Vinpoton is and what it is used for

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

• Treatment of chronic cerebral circulation disorders, including post-ischaemic stroke states and vascular dementia.
• Relief of psychological and neurological symptoms associated with cerebral circulation disorders.
• Treatment of certain eye diseases (retinal and choroidal disorders) associated with chronic blood circulation disorders.
• Treatment of vascular-origin hearing disorders.

2. Important information before taking Vinpoton

When not to use Vinpoton

• 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,
• in children

Warnings and precautions
Before starting to take Vinpoton, discuss it with your doctor or pharmacist.
It is especially important to inform your doctor:

• if the patient has increased intracranial pressure,
• if the patient has irregular heart rhythm,
• if the patient knows they have changes in the ECG called prolonged QT interval.

In such cases, or if the patient is taking medicines that cause QT interval prolongation, periodic ECG monitoring may be required.

Children and adolescents
The use of Vinpoton is contraindicated in children due to insufficient clinical data.

Vinpoton and 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 use in the future.
Especially inform your doctor if the patient is taking the following medicines:

• medicines containing alpha-methyldopa (used in arterial hypertension),
• anticoagulant medicines (medicines preventing blood clots),
• antiarrhythmic medicines (used in heart rhythm disorders),
• medicines acting on the central nervous system.

Vinpoton with food and drink
This medicine should be taken after a meal.

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

Driving and operating machinery
There is a lack of data on the influence of vinpocetine on the ability to drive vehicles and operate machinery. The most relevant adverse effects that may affect these abilities are: headache, dizziness, drowsiness, irregular heartbeat, excitement, and restlessness, which occur uncommonly or rarely. If any of these adverse effects occur, the patient should contact their doctor.

Vinpoton contains lactose (milk sugar)
Vinpoton contains approximately 93.94 mg of monohydrate lactose per tablet. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Vinpoton

This medicine should always be taken as directed by a physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Vinpoton is 1 or 2 tablets (5–10 mg) three times daily (15–30 mg).
The maintenance dose is 1 tablet three times daily.
The tablets should be taken after meals.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or
pharmacist.
Impaired kidney and/or liver function
There is no need to adjust the dosage in patients with impaired kidney or liver function.
Elderly patients
There is no need to adjust the dosage in elderly patients.
Taking more than the recommended dose of Vinpoton
If you take more than the recommended dose of Vinpoton, seek immediate medical advice
from your doctor or go to the emergency department of your nearest hospital.
Missed dose of Vinpoton
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, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below are grouped according to frequency of occurrence,
defined as follows:

Uncommon adverse reactions (may occur in less than 1 out of 100 patients):

• blood pressure lower than usual;
• low arterial blood pressure;
• high cholesterol levels;
• headache, sensation of spinning (vertigo);
• nausea, dry mouth, abdominal discomfort.

Rare adverse reactions (may occur in less than 1 out of 1,000 patients):

• loss of appetite, decreased appetite, diabetes;
• insomnia, sleep disturbances, restlessness, anxiety;
• dizziness, disturbances in taste sensation, muscle weakness on one side of the body, physical and mental lethargy, somnolence, memory disturbances;
• changes in the fundus of the eye (at the back of the eye);
• hearing disturbances, hypersensitivity to sounds, tinnitus (ringing in the ears);
• changes in liver enzyme activity;
• changes in ECG recording (ST segment depression);
• inadequate blood flow (ischaemia) to the heart muscle, constricting chest pain, slow heartbeat, rapid heartbeat, extra heartbeats, palpitations;
• increased blood pressure, facial flushing, phlebitis;
• high blood pressure;
• abdominal pain, constipation, diarrhoea, indigestion, vomiting;
• skin redness, excessive sweating, itching, rash, urticaria;
• weakness, fatigue, sensation of heat;
• changes in blood test results (increased triglyceride levels, decreased white blood cell count, decreased or increased numbers of certain leukocytes (eosinophilia), decreased platelet count).

Very rare adverse reactions (may occur in less than 1 out of 10,000 patients):

• anaemia, red blood cell agglutination;
• hypersensitivity (allergic reaction to the medicine);
• euphoria, depression;
• tremor, seizures;
• redness of the thin membrane covering the eye (conjunctival hyperaemia);
• heart rhythm disorders (arrhythmia, atrial fibrillation);
• fluctuations in arterial blood pressure;
• difficulty in swallowing, inflammation of the oral mucosa;
• skin inflammation;
• chest discomfort;
• abnormally low body temperature;
• changes in blood test results (changes in white blood cell count, decreased red blood cell count, shortened prothrombin time);
• weight gain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
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,
Tel.: 22 49-21-301,
Fax: 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 the medicine.

5. How to store the medicine Vinpoton

Keep this 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.
Do not store above 25°C.
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 pack and other information

What Vinpoton contains

• The active substance is vinpocetine, 5 mg in each tablet.
• The other components are: potato starch, Ludipress (monohydrate lactose, povidone, crospovidone), magnesium stearate.

What Vinpoton looks like and contents of the pack
White, round, biconvex tablets with the letter V embossed on one side.
The pack contains 50, 90 or 100 tablets.
Marketing Authorisation Holder and Manufacturer:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
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