Package leaflet: information for the patient

VICEBROL
5 mg, tablets
Vinpocetinum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What is Vicebrol and for what is it used
Important information before taking Vicebrol
How to take Vicebrol
Possible adverse reactions
How to store Vicebrol
Contents of the package and other information

1. What is Vicebrol and for what is it used

Vicebrol contains vinpocetine as the active substance.
Vinpocetine is a compound used in the treatment of diseases or relief of symptoms associated with cerebral circulation disorders.
Indications for Vicebrol:

Treatment of chronic cerebral circulatory insufficiency and vascular dementia, including post-ischemic stroke states.
Relief of psychological and neurological symptoms of cerebral circulatory insufficiency.
Treatment of chronic circulatory disorders in the retinal and choroidal vessels.
Treatment of hearing disorders of vascular origin.

2. Important information before using Vicebrol

When not to use Vicebrol

if the patient is allergic to vinpocetine or any of the other ingredients of this medicine (listed in section 6);
if the patient has been diagnosed with or suspected cerebral haemorrhage (acute phase of haemorrhagic stroke);
if the patient has severe ischaemic heart disease (characterised by pain often radiating to the left arm, feeling of tightness or pressure in the chest);
if the patient has cardiac arrhythmias (sensation of rapid or irregular heartbeat, or the heart momentarily "stopping");
during pregnancy;
during breastfeeding;
in children and adolescents (due to insufficient data on the use of this medicine in this age group).

Warnings and precautions
Before starting treatment with Vicebrol, the doctor should exclude other possible causes of cerebral dysfunction.
Before starting treatment with Vicebrol, discuss the following with your doctor or pharmacist:

if the patient has kidney disease (particularly advanced renal insufficiency);
if the patient has been diagnosed with hypotension or orthostatic hypotension (sudden drop in blood pressure upon standing up quickly or prolonged standing, which may lead to fainting), as vinpocetine may cause a slight decrease in systolic and diastolic blood pressure;
if the patient has been diagnosed with abnormal ECG findings (so-called QT prolongation syndrome) or is taking medicines causing QT prolongation – the doctor will order regular ECG monitoring (electrocardiographic examination – heart function test).

If the patient experiences a drop in blood pressure or cardiac arrhythmias, treatment with Vicebrol should be discontinued and the patient should contact their doctor immediately.
Children and adolescents
Vicebrol must not be used in children and adolescents.
Vicebrol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.
In particular, inform your doctor if the patient is taking any of the following medicines:

medicines that lower blood pressure (e.g. methyldopa), as Vicebrol may enhance their effect. The patient should regularly monitor blood pressure;
anticoagulants (medicines that reduce blood clotting), e.g. heparin, warfarin;
antiarrhythmics (medicines used in cardiac arrhythmias), e.g. quinidine, propranolol, verapamil;
medicines acting on the central nervous system;
medicines used in diabetes, e.g. glibenclamide.

Taking Vicebrol with food and drink
This medicine should be taken after meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Vicebrol is contraindicated during pregnancy and breastfeeding.
Driving and using machines
No studies on the effect of vinpocetine on the ability to drive and operate machinery have been conducted. The decision on whether driving or operating machinery is permitted should be made by the doctor.
Vicebrol contains lactose (a sugar found in milk).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Vicebrol

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
Dosage
Adults
Initial treatment phase: 2 (two) tablets three times daily, i.e. 30 mg per day.
Maintenance treatment: 1 (one) tablet three times daily, i.e. 15 mg per day.
In particularly justified cases, the daily dose may be gradually increased up to a maximum of
1 mg/kg body weight.
The medicine should be taken regularly.
Patients with impaired liver and/or kidney function
In patients with advanced renal insufficiency, the dose should be reduced – the physician will determine
the dose individually for each patient.
Use in children and adolescents
This medicine should not be used in children and adolescents, as there is insufficient data
on the use of vinpocetine in this patient group.
Method of administration
The medicine should be taken orally, after meals.
Tablets should be swallowed whole, with water.
Taking a higher than recommended dose of Vicebrol
Do not take a higher dose than recommended by the treating physician.
If a higher than recommended dose is taken, consult a physician or pharmacist immediately.
Missed dose of Vicebrol
If a dose is missed, 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 a missed dose.
Stopping treatment with Vicebrol
Do not discontinue treatment without consulting your physician. If discontinuation of the
medicine is necessary, the physician will gradually reduce the dose.
If you have any further doubts regarding the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of vinpocetine:

Uncommon adverse reactions (in 1 to 10 of 1000 patients):

Sleep disturbances (insomnia, drowsiness);
Dizziness and headache;
Weakness;
Tingling of limbs;
Increased sweating;
Motor hyperactivity.

The above symptoms may be related to the underlying disease, i.e. the condition for which the patient is being treated with Vicebrol.

Changes in ECG findings, such as ST-segment depression, QT-interval prolongation;
Tachycardia and extrasystoles. The above symptoms have also occurred spontaneously, and it is uncertain whether they were related to vinpocetine administration.
Changes in blood pressure (mainly low blood pressure);
Flushing of the facial skin due to blood rushing to the head;
Nausea, heartburn;
Dry mouth;
Abnormal liver function tests (increased liver enzyme activity);
Allergic skin reactions, e.g. rash, urticaria.

Rare adverse reactions (in 1 to 10 of 10,000 patients):

Decrease in white blood cell count (leukopenia);
Abdominal pain.

Very rare adverse reactions (less than 1 in 10,000 patients):

Changes in blood test results, such as decreased hematocrit and hemoglobin concentration in peripheral blood.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vicebrol

Store below 25°C.
Keep in the original packaging to protect from light.
Keep out of 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Vicebrol contains

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

What Vicebrol looks like and contents of the pack
Vicebrol tablets are white, round, biconvex.
The tablets are packed in PVC/Aluminum blisters, placed in a cardboard box.
The pack contains 50, 100 or 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
[email protected]