Vinpocetine Espefa Forte

Package Leaflet: Information for the Patient

VINPOCETINE ESPEFA 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 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Vinpocetine Espefa Forte contains the active substance vinpocetine.
Vinpocetine is used to treat diseases or alleviate symptoms associated with blood circulation disorders in the brain.

Indications:

• Supportive treatment of central nervous system function disorders associated with chronic cerebral circulatory disorders in the elderly;
• Treatment of vision, hearing, and dizziness disorders of vascular origin.

2. Important information before taking Vinpocetine Espefa Forte

When not to take Vinpocetine Espefa Forte:

• in pregnant or breastfeeding women, or those planning to become pregnant (see section: Pregnancy and breastfeeding);
• in children, due to the lack of sufficient clinical data in this age group;

Warnings and precautions

Before starting treatment with Vinpocetine Espefa Forte, 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 (sudden drop in blood pressure when standing up quickly or standing for a long time, causing fainting); vinpocetine may cause a slight decrease in blood pressure (systolic and diastolic).
• If you have been diagnosed with an abnormal ECG recording (in the form of QT interval prolongation); the doctor will order regular ECG tests.
• If you are taking another medicine that causes QT interval prolongation, it is recommended to monitor the ECG recording.

Vinpocetine Espefa Forte and other medicines

Tell your doctor or pharmacist about all 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:

• blood pressure-lowering medicines (e.g. α-methyldopa), as Vinpocetine Espefa Forte may enhance their effect; you should regularly check your blood pressure;
• anti-arrhythmic medicines (e.g. quinidine, propranolol; medicines used to regulate irregular heart rhythm);
• anticoagulant medicines (e.g. heparin, warfarin; medicines used to reduce blood clotting);
• medicines acting on the central nervous system.

Taking Vinpocetine Espefa Forte with food and drink

Vinpocetine Espefa Forte should be taken after a meal. The medicine is taken orally.
Swallow the tablet whole and drink a glass of water.

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.
Vinpocetine Espefa Forte should not be used in pregnant or breastfeeding women, as there are no adequate clinical data to confirm the safety of the medicine in pregnant women.
The medicine passes into breast milk, so it should not be used during breastfeeding.
If treatment is necessary, breastfeeding should be discontinued.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Vinpocetine Espefa Forte contains lactose

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

3. How to take Vinpocetine Espefa Forte

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
Recommended dose:

Adults

1 tablet (10 mg) 3 times a day after a meal.
The medicine is taken orally.
Swallow the tablet whole and drink a glass of water.
Take the medicine regularly.

Use in children

The medicine should not be used in children, as there are no sufficient data on the use of vinpocetine in this age group.

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

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

Taking a higher dose of Vinpocetine Espefa Forte than recommended

If you have taken a higher dose than recommended, contact your doctor or pharmacist.

Missing a dose of Vinpocetine Espefa Forte

If you miss a dose, take it as soon as possible.
If it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Vinpocetine Espefa Forte

Take Vinpocetine Espefa Forte exactly as your doctor has told you.
Do not stop treatment without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects(occurring in 1 to 10 people per 1,000):

• sleep disorders (insomnia, drowsiness), dizziness, and headaches, weakness; these symptoms may be related to the underlying disease;
• blood pressure changes (mainly decreased blood pressure), flushing;
• nausea, heartburn, and dry mouth;
• abnormal liver test results (increased liver enzyme activity);
• allergic skin reactions (e.g. skin redness);
• ECG changes (such as ST segment depression, QT interval prolongation, tachycardia, and extrasystole). These symptoms occurred spontaneously and it is not certain whether they were related to vinpocetine.

Rare side effects(occurring in 1 to 10 people per 10,000):

• arterial hypotension;
• abdominal pain;
• decreased white blood cell count (leukopenia).

Very rare side effects(occurring in less than 1 person per 10,000)

• decreased hematocrit and hemoglobin levels in peripheral blood.

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 for 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: +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 Forte

Store in a temperature below 25°C.
Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of the month stated.
Do not use Vinpocetine Espefa Forte if you notice stains and/or damage to the tablets.
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 Vinpocetine Espefa Forte contains

• The active substance is vinpocetine in a dose of 10 mg. 1 tablet contains 10 mg of vinpocetine.
• The other ingredients are: lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

What Vinpocetine Espefa Forte looks like and contents of the pack

Vinpocetine Espefa Forte is in the form of tablets.
The tablets are white, round, and slightly convex on both sides.
Vinpocetine Espefa Forte is available in packs containing 30, 90, or 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208

• 30 – 133 Kraków Phone: +48 12 639 27 27 Fax: +48 12 639 96 45

Helpline for the blind and visually impaired: 800-007-777

Date of last revision of the leaflet: