Vicebrol

Package Leaflet: Information for the Patient

VICEBROL

5 mg, tablets

Vinpocetine

Read the package 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Vicebrol and what is it used for

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

Indications for the use of Vicebrol:

• Treatment of chronic cerebral circulatory insufficiency and vascular dementia, including post-ischemic stroke conditions.
• Alleviation of mental and neurological symptoms of cerebral circulatory insufficiency.
• Treatment of chronic circulatory disorders in the vascular and retinal vessels of the eye.
• Treatment of hearing disorders of vascular origin.

2. Important information before taking Vicebrol

When not to take Vicebrol

• 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 ischemic 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

Before starting to take Vicebrol, the doctor should rule out other causes of brain function disorders.
Before starting to take Vicebrol, you should discuss this with your doctor or pharmacist:

• if the patient has kidney disease(especially advanced kidney 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 and contact their doctor.

Children and adolescents

Vicebrol should not be used in children and adolescents.

Vicebrol and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor about taking the following medicines:

• blood pressure-lowering medicines(e.g., alpha-methyldopa), as Vicebrol may enhance their effect. The patient should regularly check their blood pressure;
• anticoagulant medicines(medicines that reduce blood clotting), e.g., heparin, warfarin;
• anti-arrhythmic medicines(medicines used to treat heart rhythm disorders), e.g., quinidine, propranolol, verapamil;
• medicines acting on the central nervous system;
• medicines used to treat diabetes, e.g., glibenclamide.

Taking Vicebrol with food and drink

The medicine should be taken after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Vicebrol 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 contains lactose(a sugar found in milk).
If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Vicebrol

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, consult your doctor or pharmacist.

Dosage

Adults
Initial treatment phase: 2 (two) tablets three times a day, i.e., 30 mg per day.
Maintenance treatment: 1 (one) tablet three times a day, i.e., 15 mg per day.
In justified cases, the daily dose of the medicine can be gradually increased to a maximum of 1 mg/kg body weight.
The medicine should be taken regularly.
Patients with liver and/or kidney function disorders
In patients with advanced kidney failure, the dose of the medicine should be reduced - the doctor will determine the dose individually for each patient.

Use in children and adolescents

The medicine should not be used in children and adolescents, as there is a lack of sufficient data on the use of vinpocetine in this patient group.

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 than recommended

Do not take a dose higher than recommended by your doctor.
If you have taken a higher dose than recommended, consult your doctor or pharmacist.

Missing a dose of Vicebrol

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

Stopping treatment with Vicebrol

Do not stop treatment without consulting your doctor. If it is necessary to stop treatment, the doctor will gradually reduce the dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

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(in 1 to 10 out of 1000 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.

• 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(in 1 to 10 out of 10,000 patients):

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

Very rare side effects(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 you experience any side effects, including those not listed in this leaflet, 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Vicebrol

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 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 looks like and what the package contains

Vicebrol tablets are white, round, and biconvex.
The tablets are packaged in PVC/Aluminum blisters, placed in a cardboard box.
The package contains 50, 100, or 200 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
biofarm@biofarm.pl

Date of the last update of the leaflet: