Vinpoven
Poland
Table of Contents
Patient Information Leaflet
VINPOVEN, 5 mg, tablets
VINPOVEN FORTE, 10 mg, tablets
Vinpocetine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- 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. It may harm someone else, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
Leaflet Contents:
- What Vinpoven/Vinpoven Forte is and what it is used for
- Important information before taking Vinpoven/Vinpoven Forte
- How to take Vinpoven/Vinpoven Forte
- Possible side effects
- How to store Vinpoven/Vinpoven Forte
- Contents of the pack and other information
1. What Vinpoven/Vinpoven Forte is and what it is used for
Vinpoven/Vinpoven Forte contains the active substance vinpocetine.
Vinpocetine is a substance used in the treatment of diseases or in alleviating symptoms associated with disturbances in cerebral blood circulation.
Indications for Vinpoven/Vinpoven Forte:
treatment of chronic cerebral circulatory insufficiency, including post-ischemic stroke conditions and vascular dementia;
alleviation of psychological and neurological symptoms of cerebral circulatory insufficiency;
treatment of vascular-origin hearing disorders.
2. Information before using Vinpoven/Vinpoven Forte
When not to use Vinpoven/Vinpoven Forte:
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 has certain heart diseases, i.e. severe ischemic heart disease
and severe cardiac arrhythmias;
in the acute phase of hemorrhagic stroke;
in children.
Warnings and precautions
Before starting treatment with Vinpoven/Vinpoven Forte, consult a doctor or
pharmacist.
If the patient has certain heart diseases, the doctor may recommend regular ECG monitoring
(electrocardiographic examination – heart function test). This particularly applies to patients with QT prolongation syndrome or patients concurrently taking medicines that may cause QT interval prolongation.
Children and adolescents
This medicine is not intended for use in children. The medicine should not be used due to insufficient clinical data in this age group.
Vinpoven/Vinpoven Forte and other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Tell your doctor if the patient is taking any of the following medicines:
alpha-methyldopa (a medicine used for arterial hypertension);
anticoagulants (medicines that reduce blood clotting);
antiarrhythmics (medicines used for heart rhythm disorders);
glibenclamide (a medicine used in diabetes);
medicines acting on the central nervous system.
Vinpoven/Vinpoven Forte with food and drink
This medicine should be taken after food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Vinpoven/Vinpoven Forte is contraindicated during pregnancy and breastfeeding.
Driving and using machines
There is no data available on the influence of vinpocetine on the ability to drive or operate machinery.
Vinpoven/Vinpoven Forte contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Vinpoven/Vinpoven Forte
This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
Recommended dose
The usual dose of Vinpoven is 1 or 2 tablets (5-10 mg) three times daily (15-30 mg/day).
Maintenance dose: 1 tablet three times daily.
The usual dose of Vinpoven Forte is ½ - 1 tablet (5-10 mg) three times daily (15-30 mg/day).
Maintenance dose: ½ tablet three times daily.
The tablets should be taken after meals.
Use of Vinpoven/Vinpoven Forte in patients with renal and/or hepatic impairment
Dose adjustment is not required in patients with impaired renal or liver function.
Use of Vinpoven/Vinpoven Forte in elderly patients
Dose adjustment is not required in elderly patients.
Taking more than the recommended dose of Vinpoven/Vinpoven Forte
If more than the recommended dose is taken, seek immediate advice from a doctor or
pharmacist.
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 adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions are grouped according to frequency of occurrence as follows:
very common: may affect more than 1 in 10 people
common: may affect less than 1 in 10 people
uncommon: may affect less than 1 in 100 people
rare: may affect less than 1 in 1,000 people
very rare: may affect less than 1 in 10,000 people
Uncommon:
| sleep disturbances (insomnia, drowsiness), dizziness and headache, weakness. These symptoms may be | |
| related to the underlying disease; | |
| changes in ECG recording (ST segment depression, QT interval prolongation), tachycardia | |
| and extrasystoles; | |
changes in blood pressure (mainly decrease in blood pressure), flushing to the head;
| nausea, heartburn, and dry mouth; | ||
| increased activity of liver enzymes; | ||
| allergic skin reactions. | ||
Rarely:
leukopenia (reduced white blood cell count);
abdominal pain.
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 provide more information on the safety of this medicinal product.
5. How to store Vinpoven/Vinpoven Forte
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicinal product.
Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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: monohydrate lactose, corn starch, magnesium stearate, colloidal anhydrous silica, talc.
What Vinpoven/Vinpoven Forte looks like and contents of the pack
Vinpoven: white or almost white, elongated, biconvex tablets.
Vinpoven Forte: white or almost white, elongated, biconvex tablets with a division line on one side. The tablet can be divided into equal doses.
Packaging of Vinpoven contains 50, 100 or 200 tablets.
Packaging of Vinpoven Forte contains 30, 60, 90 or 180 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]