Vinpocetine espefa forte

Package leaflet: Information for the patient

VINPOCETINE ESPEFA FORTE, 10 mg, tablets
Vinpocetinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Vinpocetine Espefa Forte contains the active substance vinpocetine.
Vinpocetine is used in the treatment of diseases or relief of symptoms associated with impaired cerebral blood circulation.
Indications:

• supportive treatment of central nervous system function disorders related to chronic cerebral circulation disorders in elderly patients;
• treatment of visual, auditory, and vestibular disturbances of vascular origin.

2. Information before using Vinpocetine Espefa Forte

When not to use Vinpocetine Espefa Forte:

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has intracranial bleeding (acute phase of haemorrhagic stroke) confirmed or suspected;
• if the patient has cardiac arrhythmias (feeling of rapid or irregular heartbeat, or the heart momentarily "stopping");
• if the patient has ischaemic heart disease (manifesting as pain often radiating to the left arm, feeling of tightness or pressure behind the breastbone);
• in pregnant women or women planning pregnancy, and during breastfeeding (see section: Pregnancy and breastfeeding);
• in children, due to lack of sufficient clinical data in this age group;
• if the patient has hereditary intolerance to certain sugars (see section: Vinpocetine Espefa Forte contains lactose).

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

• Before initiating vinpocetine treatment, the doctor should rule out other causes of brain dysfunction.
• If the patient has hypotension or orthostatic hypotension (sudden drop in blood pressure upon rapid standing or prolonged standing, leading to fainting), vinpocetine may cause a slight reduction in systolic and diastolic blood pressure.
• If the patient has abnormal ECG findings (manifested as QT interval prolongation), the doctor will order regular ECG monitoring.
• If the patient is taking another medicine causing QT prolongation, ECG monitoring is recommended.

Vinpocetine Espefa Forte with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking:

• antihypertensive drugs (e.g. α-methyldopa), as Vinpocetine Espefa Forte may enhance their effect; the patient should regularly monitor blood pressure;
• antiarrhythmic drugs (e.g. quinidine, propranolol; drugs used to normalize irregular heart function);
• anticoagulant drugs (e.g. heparin, warfarin; drugs used to reduce blood clotting);
• drugs 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.
The tablet should be swallowed whole with a glass of water.

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.
Vinpocetine Espefa Forte should not be used in pregnant women or women planning pregnancy, as there are no adequate clinical studies establishing the safety of the medicine in pregnant women.
The medicine passes into breast milk; therefore, it should not be used during breastfeeding.
If treatment is necessary, breastfeeding should be discontinued.

Driving and using machines
No studies on the effect of the medicine on the ability to drive vehicles or operate machinery have been conducted.

Vinpocetine Espefa Forte contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Vinpocetine Espefa Forte

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Recommended dose:
Adults
1 tablet (10 mg) three times daily after meals.
The medicine should be taken orally.
The tablet should be swallowed whole with a glass of water.
The medicine should be taken regularly.
Use in children
This medicine should not be used in children, as there is insufficient data on the use of
vinpocetine in this patient group.
Use of Vinpocetine Espefa Forte in patients with impaired kidney and/or liver function
In patients with impaired kidney and/or liver function, there is no need to change
the dose.
Taking more Vinpocetine Espefa Forte than recommended
If you take more than the recommended dose, consult your doctor or pharmacist.
Missed 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 Vinpocetine Espefa Forte treatment
Vinpocetine Espefa Forte should be used as directed by the physician. Do not stop
treatment without consulting your doctor.
If you have any further doubts regarding the use of this medicine, consult
your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Uncommon adverse effects (occur in 1 to 10 people out of 1,000):

• Sleep disturbances (insomnia, drowsiness), dizziness, headache, fatigue; these symptoms may be related to the underlying disease;
• Changes in blood pressure (mainly low blood pressure), flushing;
• Nausea, heartburn, and dry mouth;
• Abnormal liver function tests (increased liver enzyme activity);
• Allergic skin reactions (e.g. skin redness);
• Changes in ECG recording (such as ST segment depression, QT interval prolongation, tachycardia, and extrasystoles). These symptoms occurred spontaneously, and it is uncertain whether they were related to the use of vinpocetine.

Rare adverse effects (occur in 1 to 10 people out of 10,000):

• Hypotension;
• Abdominal pain;
• Decreased white blood cell count (leukopenia).

Very rare adverse effects (occur in less than 1 person out of 10,000):

• Decreased hematocrit and hemoglobin concentration in peripheral blood.

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 of Monitoring of Adverse Drug Reactions, 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 the medicine Vinpocetine Espefa Forte

Store below 25°C.
Keep in the original packaging.
Store the medicine in a place inaccessible and out of sight of children.
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.
Do not use Vinpocetine Espefa Forte if you notice spots and/or damage on the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Vinpocetine Espefa Forte contains

• The active substance is vinpocetine in a dose of 10 mg. Each tablet contains 10 mg of vinpocetine.
• Other ingredients are: lactose, microcrystalline cellulose, colloidal anhydrous 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, slightly biconvex.
Vinpocetine Espefa Forte is available in packs containing 30, 90 or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30 – 133 Kraków
Tel.: +48 12 639 27 27
Fax: +48 12 639 96 45
Helpline for blind and visually impaired persons: 800-007-777