Vicebrol Bio

Leaflet attached to the packaging: patient information

Vicebrol Bio

5 mg, tablets

Vinpocetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vicebrol Bio and what is it used for
• 2. Important information before taking Vicebrol Bio
• 3. How to take Vicebrol Bio
• 4. Possible side effects
• 5. How to store Vicebrol Bio
• 6. Package contents and other information

1. What is Vicebrol Bio and what is it used for

Vicebrol Bio contains vinpocetine as the active substance.
Vinpocetine stimulates brain metabolism, improves blood flow in the brain, dilates blood vessels, and prevents platelet aggregation.

Indications:

Vicebrol Bio is used as a supportive treatment for alleviating mental and neurological symptoms of cerebral circulatory insufficiency (e.g., with symptoms of dizziness, impaired mental concentration, and memory problems).

Before taking Vicebrol Bio, other causes of brain function disorders should be excluded by a doctor.

If there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Vicebrol Bio

When not to take Vicebrol Bio

• if the patient is allergicto vinpocetine or any other component of this medicine (listed in section 6);
• if the patient has been diagnosed with or is suspected of having bleeding into the central nervous system, i.e., intracerebral hemorrhage(acute phase of hemorrhagic stroke);
• if the patient has severe coronary heart disease(manifested by: pain radiating to the left arm, feeling of suffocation or pressure behind the sternum);
• if the patient has heart rhythm disorders(feeling of rapid or irregular heartbeat, or "stopping" of the heart for a moment);
• during pregnancy;
• during breastfeeding;
• in children and adolescents(due to the lack of sufficient data on the use of the medicine in this age group).

Warnings and precautions

Symptoms such as: dizziness, impaired mental concentration, memory problems
may be associated with the occurrence of many different diseases affecting brain function,
including degenerative diseases of the nervous system, mental illnesses, cancer, or metabolic disorders. Before starting to take Vicebrol Bio, other causes of brain function disorders should be excluded.

If the patient experiences worsening of symptoms or new symptoms appear, such as headache (severe or chronic), nausea, vomiting, drowsiness, or a feeling of numbness in the limbs, they should contact their doctor to exclude

other causes of brain function disorders.
Before starting to take Vicebrol Bio, the patient should discuss the following with their doctor:

• if the patient has had brain function disordersor head injuriesin the past;
• if the patient has had or still has increased bleeding tendency(e.g., blood coagulation disorders, prolonged bleeding time, or a hereditary disease called hemophilia) or a tendency to bruise;
• if the patient has kidney disease(especially advanced renal failure);
• if the patient has been diagnosed with hypotensionor orthostatic hypotension(sudden drop in blood pressure when standing up or standing for a long time, causing fainting), as vinpocetine may cause a slight decrease in blood pressure (systolic and diastolic);
• if the patient has been diagnosed with an abnormal ECG recording(so-called prolonged QT interval) or is taking medicines that prolong the QT interval- the doctor will order regular ECG checks (electrocardiologic examination - examination of heart function).

If the patient experiences a drop in blood pressure or heart rhythm disorders, they should stop taking Vicebrol Bio and contact their doctor.

Children and adolescents

Vicebrol Bio should not be used in children and adolescents.

Vicebrol Bio and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor about taking the following medicines:

• blood pressure-lowering medicines(e.g., alpha-methyldopa), as Vicebrol Bio may enhance their effect. The patient should regularly check their blood pressure;
• anticoagulant medicines(medicines that reduce blood clotting), e.g., heparin, warfarin;
• antiarrhythmic medicines(medicines used for heart rhythm disorders), e.g., quinidine, propranolol, verapamil;
• medicines acting on the central nervous system, e.g., sleeping pills, antidepressants.

Vicebrol Bio with food and drink

The medicine should be taken after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Vicebrol Bio is contraindicated during pregnancy and breastfeeding.

Driving and using machines

No studies have been conducted on the effect of vinpocetine on the ability to drive and use machines. The decision to drive and use machines should be made by the doctor.
Vicebrol Bio contains lactose(a sugar found in milk).
If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Vicebrol Bio

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

Adults (including the elderly)
Initial treatment phase (first month): 2 (two) tablets three times a day, i.e., 30 mg/day.
Maintenance treatment: 1 (one) tablet three times a day, i.e., 15 mg/day.

The medicine should be taken regularly.

Patients with liver and/or kidney function disorders
The dose of Vicebrol Bio should be reduced in patients with advanced renal failure.
In the case of patients with mild or moderate kidney disease, dose adjustment is not necessary, but the patient should consult their doctor before taking the medicine.
No dose adjustment is necessary in patients with liver function disorders.
Use in children and adolescents
The medicine should not be used in children and adolescents, due to the lack of sufficient data on the use of vinpocetine in this patient group.

Duration of treatment

The effect of vinpocetine begins approximately after one week, and the full therapeutic effect is achieved within three months.

Method of administration

The medicine should be taken orally, after a meal.
Tablets should be swallowed whole, with a glass of water.

Taking a higher dose of Vicebrol Bio than recommended

In case of taking a higher dose than recommended, the patient should consult their doctor or pharmacist.

Missing a dose of Vicebrol Bio

If a dose is missed, the patient should take the medicine as soon as possible.
However, if it is almost time for the next dose, the missed dose should be skipped.
A double dose should not be taken 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 have been observed during treatment with vinpocetine:
Uncommon side effects(may occur in less than 1 in 100 patients):

• sleep disorders (insomnia, drowsiness);
• dizziness and headaches;
• weakness;
• tingling of limbs;
• increased sweating;
• hyperactivity. The above symptoms may be related to the underlying disease, i.e., the disease being treated with Vicebrol Bio.
• changes in ECG recording, such as: ST segment depression, QT interval prolongation;
• tachycardia and extra heartbeats. The above symptoms also occurred spontaneously and it is not certain whether they were related to the use of vinpocetine.
• changes in blood pressure (mainly decreased blood pressure);
• flushing of the skin on the face;
• nausea, heartburn;
• dry mouth;
• abnormal liver function test results (increased liver enzyme activity);
• allergic skin reactions, e.g., rash, urticaria.

Rare side effects(may occur in less than 1 in 1,000 patients):

• decrease in white blood cell count (leukopenia);
• abdominal pain.

Very rare side effects(may occur in less than 1 in 10,000 patients):

• changes in blood test results, such as: decreased hematocrit and hemoglobin levels in peripheral blood.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, the patient should inform their 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
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vicebrol Bio

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
“Expiry date (EXP)”/“EXP” .
The expiry date refers to the last day of the month.
No special precautions for storage are required.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vicebrol Bio contains

• The active substance of the medicine is vinpocetine (Vinpocetinum). One tablet contains 5 mg of vinpocetine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate.

What Vicebrol Bio looks like and what the package contains

Vicebrol Bio tablets are white, round, and biconvex.
The tablets are packaged in PVC/Aluminum blisters, placed in a cardboard box.
The package contains 10, 20, 30, 40, 50, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Date of last update of the leaflet: