Vinpoton

Package Leaflet: Information for the User

VINPOTON, 5 mg, tablets

Vinpocetine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Vinpoton and what is it 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 is Vinpoton and what is it used for

Vinpoton contains the active substance vinpocetine.
Vinpocetine is a compound used to treat diseases or alleviate symptoms associated with certain blood circulation disorders in the brain.
Indications for use of Vinpoton:

• Treatment of chronic cerebral circulation disorders, including post-ischemic stroke and vascular dementia.
• Alleviation of mental 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 hearing disorders of vascular origin.

2. Important information before taking Vinpoton

When not to take Vinpoton

• in children

Warnings and precautions

Before taking Vinpoton, discuss it with your doctor or pharmacist.
It is especially important to inform your doctor:

In such a case, or if you are taking medicines that cause prolongation of this interval, there may be a need for control ECG examinations.

Children and adolescents

The use of Vinpoton is contraindicated in children due to the lack of sufficient clinical trial data.

Vinpoton and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.
Tell your doctor, especially if you are taking the following medicines:

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

Vinpoton 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, consult your doctor or pharmacist before taking this medicine.
Vinpoton is contraindicated during pregnancy and breastfeeding. If you are of childbearing age, you must use effective contraception during therapy with Vinpoton. Otherwise, the administration of vinpocetine is contraindicated.

Driving and using machines:

There are no data on the effect of vinpocetine on the ability to drive and use machines. The most important side effects that may have such an effect are: headaches, dizziness, drowsiness, irregular heartbeat, agitation, and restlessness, which occur not very often or rarely. If you experience any of these side effects, contact your doctor.

Vinpoton contains lactose (milk sugar)

Vinpoton contains approximately 93.94 mg of lactose monohydrate in each tablet. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Vinpoton

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult your doctor or pharmacist.
The recommended dose of Vinpoton is 1 or 2 tablets (5-10 mg) three times a day (15-30 mg).
The maintenance dose is 1 tablet 3 times a day.
Tablets should be taken after meals.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Renal and/or hepatic impairment

There is no need to change the dosage in patients with renal or hepatic impairment.

Elderly patients

There is no need to change the dosage in elderly patients.

Overdose of Vinpoton

In case of taking a higher dose of Vinpoton than recommended, immediately consult your doctor or go to the emergency department of the 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.
In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below have been grouped by frequency, defined as follows:
Uncommon side effects (may occur less frequently than 1 in 100 patients):

• low blood pressure;
• hypotension;
• high cholesterol levels;
• headache, dizziness;
• nausea, dry mouth, abdominal discomfort.

Rare side effects (may occur less frequently than 1 in 1,000 patients):

• loss of appetite, decreased appetite, diabetes;
• insomnia, sleep disorders, agitation, restlessness;
• dizziness, taste disorders, hemiparesis, physical and mental numbness, drowsiness, memory disorders;
• changes in the fundus of the eye (in the back of the eye),
• hearing disorders, hypersensitivity to sounds, tinnitus (ringing in the ears);
• changes in liver enzyme activity;
• changes in ECG recording (depression of the ST segment);
• insufficient blood flow (ischemia) to the heart muscle, angina pectoris, slow heart rate, rapid heart rate, extrasystoles, palpitations;
• high blood pressure, facial flushing, phlebitis;
• high blood pressure;
• abdominal pain, constipation, diarrhea, nausea, vomiting;
• skin redness, excessive sweating, itching, rash, urticaria;
• weakness, fatigue, feeling of heat;
• changes in blood test results (increased triglyceride levels, decreased white blood cell count, decreased or increased count of some leukocytes (eosinophils, decreased platelet count).

Very rare side effects (may occur less frequently than 1 in 10,000 patients):

• anemia, red blood cell aggregation;
• hypersensitivity (allergy to the medicine);
• euphoria, depression;
• tremors, seizures;
• redness of the thin membrane covering the eye (conjunctival congestion);
• heart rhythm disorders (arrhythmia, atrial fibrillation);
• blood pressure fluctuations;
• difficulty swallowing, oral mucositis;
• 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 side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or 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 181C,
02-222 Warsaw,
Phone: 22 49-21-301,
Fax: 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 Vinpoton

Keep the medicine out of the 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 month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vinpoton contains

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

What Vinpoton looks like and contents of the pack

White, round, flat tablets with the letter V embossed on one side.
The pack contains 50, 90, or 100 tablets.

Marketing authorization holder and manufacturer:

GEDEON RICHTER POLSKA Sp. z o. o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
To obtain more detailed information, contact:
GEDEON RICHTER POLSKA Sp. z o. o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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