Vinpocetine Espefa

Package Leaflet: Information for the Patient

Vinpocetine Espefa 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. 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 tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Description of the drug:

Vinpocetine Espefa tablets contain 5 mg of vinpocetine. It is a medicine that improves blood flow through the brain vessels. This increases the tolerance of brain cells to hypoxia, increases their glucose and oxygen consumption, and their ability to produce the necessary chemical compounds for their proper functioning.

Indications for use:

Supplementary treatment of central nervous system disorders associated with chronic cerebral circulation disorders in the elderly, as well as vision, hearing, and dizziness disorders of vascular origin.

2. Important information before taking Vinpocetine Espefa

When not to take Vinpocetine Espefa:

• if you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6;
• if you have been diagnosed with or are suspected of having intracerebral hemorrhage (acute phase of hemorrhagic stroke);
• if you have been diagnosed with heart rhythm disorders;
• if you have been diagnosed with coronary heart disease;
• in pregnant or breastfeeding women,
• during breastfeeding.

Warnings and precautions

Before starting treatment with Vinpocetine Espefa, you should discuss it with your doctor.

• before starting treatment with vinpocetine, the doctor should rule out other causes of brain function disorders;
• if you have been diagnosed with hypotension or orthostatic hypotension, vinpocetine may cause a slight decrease in systolic and diastolic blood pressure;
• in patients with a prolonged QT interval or in patients taking additional medications that cause QT interval prolongation, it is recommended to monitor the ECG recording.

Use of Vinpocetine Espefa in patients with kidney and/or liver disorders

In patients with liver and/or kidney disorders, there is no need to reduce the dose.

Vinpocetine Espefa and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking α-methyldopa (a blood pressure lowering medicine), as Vinpocetine Espefa may enhance its effect. During concomitant use of these medicines, regular blood pressure monitoring is recommended.

Taking Vinpocetine Espefa with food and drink

It is recommended to take the medicine after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
This medicine should not be used during pregnancy or breastfeeding.
Vinpocetine passes into breast milk, so breastfeeding should be discontinued if the medicine is necessary.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. The decision to drive or operate machines should be made by the doctor.

Vinpocetine Espefa contains lactose (a type of sugar)

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

3. How to take Vinpocetine Espefa

This medicine should always be taken as directed by your doctor.
If you are unsure, ask your doctor.
The recommended dose is:
Initially, take 1 to 2 tablets (5 mg to 10 mg) three times a day after meals.
Maintenance dose - 1 tablet (5 mg) 3 times a day.
The medicine should be taken regularly.

Use in children and adolescents

The medicine should not be used in children, as there is insufficient data on the use of vinpocetine in this patient group.

Taking a higher dose of Vinpocetine Espefa than recommended

There is no data on overdose. If you have taken a higher dose than recommended and experience any worrying symptoms, contact your doctor or pharmacist.

Missing a dose of Vinpocetine Espefa

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Uncommon(occurring in 1 to 10 people per 1,000): tachycardia or extrasystoles, decreased blood pressure, changes in the ECG recording (depression of the ST segment, prolongation of the QT interval).
Rare(occurring in 1 to 10 people per 10,000): heartburn, abdominal pain, nausea, insomnia, headaches and dizziness, weakness.
Very rare(occurring in less than 1 person per 10,000): allergic skin reactions, decreased white blood cell count, decreased hematocrit and hemoglobin level in peripheral blood, increased liver enzyme activity.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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, Tel.: +48 22 49 21 301, Fax: +48 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 Vinpocetine Espefa

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Keep the pack tightly closed to protect from light and moisture.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of the 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, anhydrous colloidal silica, magnesium stearate.

What Vinpocetine Espefa looks like and contents of the pack

Vinpocetine Espefa is a white, round tablet.
The pack contains 50 or 100 tablets.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA, ul. J. Lea 208, 30-133 Kraków, Poland, tel. 12 639 27 27

Information for the blind and visually impaired:800-007-777
Date of last revision of the leaflet:19.04.2023