Package leaflet: Information for the patient

Vinpocetine Espefa 5 mg tablets
Vinpocetinum
Please read carefully the entire leaflet before using this 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 doubts, 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 identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Vinpocetine Espefa and what is it used for
Important information before taking Vinpocetine Espefa
How to take Vinpocetine Espefa
Possible side effects
How to store Vinpocetine Espefa
Contents of the pack and other information

1. What is Vinpocetine Espefa and what is it used for

Mechanism of action:
Vinpocetine Espefa tablets contain 5 mg of vinpocetine. This is a medicine that improves blood flow through cerebral blood vessels. As a result, brain cells become more tolerant to hypoxia, their consumption of glucose and oxygen increases, as well as their capacity to produce chemical compounds necessary for proper functioning.
Indications:
Adjunctive treatment of central nervous system disorders associated with chronic cerebral circulation disorders in elderly patients, and vascular-origin disturbances of vision, hearing, and vertigo.

2. Important information before taking Vinpocetine Espefa

When not to take Vinpocetine Espefa:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine listed in section 6;
if intracerebral bleeding has been diagnosed or suspected (acute phase of haemorrhagic stroke);
if the patient has been diagnosed with cardiac arrhythmia;
if the patient has been diagnosed with ischemic heart disease;
in women who are pregnant or planning pregnancy;
during breastfeeding.

Warnings and precautions
Before starting Vinpocetine Espefa, discuss this with your doctor.

before initiating treatment with vinpocetine, the doctor should rule out other causes of brain dysfunction;
if the patient has hypotension or orthostatic hypotension, vinpocetine may cause a slight decrease in systolic and diastolic blood pressure;
in patients with prolonged QT interval or in patients taking additional drugs causing QT prolongation, ECG monitoring is recommended.

Use of Vinpocetine Espefa in patients with renal and/or hepatic impairment
In patients with impaired liver and/or kidney function, no dose adjustment has been found necessary.

Vinpocetine Espefa 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 the patient plans to use.
In particular, inform the doctor if the patient is taking α-methyldopa (a medicine lowering blood pressure), as Vinpocetine Espefa may enhance its effect. Regular monitoring of arterial blood pressure is recommended when these medicines are used concomitantly.

Taking Vinpocetine Espefa with food and drink
It is recommended to take the medicine after meals.

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 her doctor before using this medicine.
This medicine should not be used in women who are pregnant or planning pregnancy.
Vinpocetine passes into breast milk; therefore, breastfeeding should be discontinued if treatment with this medicine is necessary.

Driving and using machines
Studies on the effect of the medicine on the ability to drive or operate machinery have not been conducted. The decision on driving or operating machinery should be made by the doctor.

Vinpocetine Espefa contains lactose (a type of sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to take Vinpocetine Espefa

This medicine should always be taken as directed by the physician.
In case of doubt, consult your doctor.
The recommended dose is:
Initially, take 1 to 2 tablets (5 mg to 10 mg) three times daily after meals.
Maintenance dose – 1 tablet (5 mg) three times daily.
The medicine should be taken regularly.
Use in children and adolescents
This medicine must not be used in children, as there is insufficient data on the use of
vinpocetine in this patient group.
Taking more Vinpocetine Espefa than recommended
There is no data available regarding overdose. If a dose higher than recommended has been taken and any worrying symptoms occur, consult a doctor or pharmacist.
If you forget to take Vinpocetine Espefa
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur:
Not common (occur in 1 to 10 people out of 1,000): tachycardia or extrasystoles,
decrease in blood pressure, changes in ECG recording (ST segment depression, QT interval prolongation).
Rare (occur in 1 to 10 people out of 10,000): heartburn, abdominal pain, nausea, insomnia,
headache and dizziness, weakness.
Very rare (occur in less than 1 person out of 10,000): skin allergic reactions,
decrease in white blood cell count, reduced hematocrit and hemoglobin levels in peripheral blood,
increased liver enzyme activity.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vinpocetine Espefa

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in a tightly closed container to protect from light and moisture.
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.

6. Contents of the pack and other information

What Vinpocetine Espefa contains

The active substance is vinpocetine. One tablet contains 5 mg of vinpocetine.
The other ingredients are: lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Vinpocetine Espefa looks like and contents of the pack
Vinpocetine Espefa is in the form of white, round tablets.
The pack contains 50 or 100 tablets.
Marketing Authorisation Holder and Manufacturer
Chemical-Pharmaceutical Cooperative ESPEFA
J. Lea 208
30-133 Kraków, Poland
tel. 12 639 27 27

Information for the blind and partially sighted: 800-007-777