Vinpoven

Package Leaflet: Information for the Patient

VINPOVEN, 5 mg, tablets

VINPOVEN FORTE, 10 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. 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Vinpoven/Vinpoven Forte and what is it used for

Vinpoven/Vinpoven Forte contains the active substance vinpocetine.
Vinpocetine is a substance used to treat diseases or alleviate symptoms associated with
blood circulation disorders in the brain.
Indications for the use of Vinpoven/Vinpoven Forte:
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 hearing disorders of vascular origin.

2. Important information before taking Vinpoven/Vinpoven Forte

When not to take Vinpoven/Vinpoven Forte:

if you are allergic to vinpocetine or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding;
if you have certain heart diseases, such as severe coronary heart disease and severe heart rhythm disorders;
during the acute phase of hemorrhagic stroke;
in children.

Warnings and precautions

Before taking Vinpoven/Vinpoven Forte, discuss it with your doctor or pharmacist.
If you have certain heart diseases, your doctor will recommend regular ECG checks (electrocardiogram - a test of heart function). This applies mainly to patients with a prolonged QT interval or patients taking medications that prolong the QT interval.

Children and adolescents

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

Vinpoven/Vinpoven Forte and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines:
alpha-methyldopa (a medicine used to treat high blood pressure);
anticoagulants (medicines that reduce blood clotting);
anti-arrhythmic medicines (medicines used to treat heart rhythm disorders);
glibenclamide (a medicine used to treat diabetes);
medicines that act on the central nervous system.

Vinpoven/Vinpoven Forte with food and drink

Take the medicine after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Vinpoven/Vinpoven Forte is contraindicated during pregnancy and breastfeeding.

Driving and using machines

There are no data on the effect of vinpocetine on the ability to drive and use machines.

Vinpoven/Vinpoven Forte contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Vinpoven/Vinpoven Forte

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
Usually, the recommended dose of Vinpoven is 1 or 2 tablets (5-10 mg) three times a day (15-30 mg/day).
Maintenance dose: 1 tablet 3 times a day.
Usually, the recommended dose of Vinpoven Forte is ½ - 1 tablet (5-10 mg) three times a day (15-30 mg/day).
Maintenance dose: ½ tablet 3 times a day.
Take the tablets after meals.

Using Vinpoven/Vinpoven Forte in patients with kidney or liver function disorders

No dose adjustment is necessary in patients with kidney or liver function disorders.

Using Vinpoven/Vinpoven Forte in elderly patients

No dose adjustment is necessary in elderly patients.

Taking a higher dose of Vinpoven/Vinpoven Forte than recommended

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

Missing a dose of Vinpoven/Vinpoven 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 medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are grouped by frequency as follows:
very common:
may occur in more than 1 in 10 people
common:
may occur in less than 1 in 10 people
uncommon:
may occur in less than 1 in 100 people
rare:
may occur in less than 1 in 1,000 people
very rare:
may occur in less than 1 in 10,000 people
Uncommon:

changes in blood pressure (mainly decrease in blood pressure), flushing;
Rare:
leukopenia (decrease in white blood cell count);
abdominal pain.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, please inform 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vinpoven/Vinpoven Forte

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
Store in the original packaging to protect from light.
Medicines should 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 Vinpoven/Vinpoven Forte contains

One Vinpoven tablet contains 5 mg of the active substance.
One Vinpoven Forte tablet contains 10 mg of the active substance.

• The active substance is vinpocetine.
• The other ingredients are: lactose monohydrate, corn starch, magnesium stearate, colloidal silica anhydrous, talc.

What Vinpoven/Vinpoven Forte looks like and contents of the pack

Vinpoven, white or almost white, oblong, biconvex tablets.
Vinpoven Forte, white or almost white, oblong, biconvex tablets, with a score line on one side. The tablet can be divided into equal doses.
The Vinpoven pack contains 50, 100 or 200 tablets.
The Vinpoven Forte pack contains 30, 60, 90 or 180 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: