VICEBROL BIO

Package leaflet: Information for the patient

Vicebrol Bio
5 mg, tablets
Vinpocetinum
Please read this leaflet carefully before using 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, 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 effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Vicebrol Bio is and what it is 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. Contents of the pack and other information

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

Vicebrol Bio contains vinpocetine as the active substance.
Vinpocetine enhances cerebral metabolism, improves cerebral blood flow, dilates blood vessels, and inhibits platelet aggregation.
Indications:
Vicebrol Bio is used as adjunctive therapy in alleviating psychological and neurological symptoms of cerebral circulatory insufficiency (e.g. with symptoms of dizziness, impaired mental concentration, and memory problems).
Before using Vicebrol Bio, other causes of brain dysfunction should be excluded by a doctor.
If no improvement occurs or if the patient feels worse, contact a doctor.

2. Important information before using Vicebrol Bio

When not to use Vicebrol Bio

• 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 is suspected of having central nervous system bleeding, i.e. intracerebral haemorrhage (acute phase of haemorrhagic stroke);
• if the patient has severe ischemic heart disease (characterized by: pain radiating often to the left arm, feeling of tightness or pressure behind the breastbone);
• 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 lack of sufficient data on use of the medicine in this age group).

Warnings and precautions
Symptoms such as dizziness, difficulty concentrating, memory problems may be associated with various diseases affecting brain function, including neurodegenerative diseases, psychiatric disorders, tumour diseases or metabolic disorders. Before starting treatment with Vicebrol Bio, other causes of brain dysfunction should be ruled out.
If symptoms worsen before or during treatment with Vicebrol Bio, or if new symptoms appear, such as headache (severe or chronic), nausea, vomiting, drowsiness or sensation of limb numbness, consult a physician to rule out other causes of brain dysfunction.
Before starting treatment with Vicebrol Bio, discuss with your doctor:

• if the patient has previously experienced brain function disorders or head injuries;
• if the patient has had or still has increased tendency to bleeding (e.g. blood coagulation disorders, prolonged clotting time, or a hereditary condition called haemophilia) or tendency to develop bruises;
• if the patient has kidney disease (especially advanced renal failure);
• if the patient has been diagnosed with hypotension or orthostatic hypotension (sudden drop in blood pressure upon rapid standing or prolonged standing, leading to fainting), as vinpocetine may cause a slight reduction in blood pressure (both systolic and diastolic);
• if the patient has been diagnosed with abnormal ECG findings (so-called long QT syndrome) or the patient is taking medicines that prolong the QT interval – the doctor will recommend regular ECG monitoring (electrocardiographic examination – heart function test).

If the patient experiences a drop in blood pressure or cardiac arrhythmias, discontinue use of Vicebrol Bio and contact a physician immediately.
Children and adolescents
Vicebrol Bio should not be used in children and adolescents.
Vicebrol Bio and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• medicines that lower blood pressure (e.g. alpha-methyldopa), as Vicebrol Bio may enhance their effect. The patient should regularly monitor blood pressure;
• anticoagulant medicines (medicines that reduce blood clotting), e.g. heparin, warfarin;
• antiarrhythmic medicines (medicines used for cardiac arrhythmias), e.g. quinidine, propranolol, verapamil;
• medicines acting on the central nervous system, e.g. sedatives, antidepressants.

Vicebrol Bio with food and drink
The medicine should be taken after meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Vicebrol Bio is contraindicated during pregnancy and while breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of vinpocetine on the ability to drive or operate machinery. The decision on whether driving or operating machinery is safe should be made by the physician.
Vicebrol Bio contains lactose (a sugar present in milk).
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 Vicebrol Bio

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Dosage
Adults (including elderly patients)
Initial treatment phase (first month): 2 (two) tablets three times daily, i.e. 30 mg/day.
Maintenance treatment: 1 (one) tablet three times daily, i.e. 15 mg/day.
The medicine should be taken regularly.
Patients with impaired liver and/or kidney function
The dose of Vicebrol Bio should be reduced in patients with advanced renal impairment.
In patients with mild or moderate kidney disease, dosage adjustment is not necessary, but a doctor should be consulted before using the medicine.
There is no need to adjust the dose in patients with impaired liver function.
Use in children and adolescents
This medicine should not be used in children and adolescents due to insufficient data on the use of vinpocetine in this patient group.
Duration of treatment
The effect of vinpocetine begins approximately after one week, while the full therapeutic effect is achieved within three months.
Method of administration
The medicine should be taken orally, after meals.
Tablets should be swallowed whole, with water.
Taking more Vicebrol Bio than recommended
If more medicine has been taken than recommended, consult a doctor or pharmacist.
Missing a dose of Vicebrol Bio
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.

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 (may occur in fewer than 1 in 100 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 Bio.
• 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 the use of vinpocetine.
• Changes in blood pressure (mainly low blood pressure);
• Flushing, manifesting as redness of the facial skin;
• Nausea, heartburn;
• Dryness of the oral cavity;
• Abnormal liver function tests (increased liver enzyme activity);
• Allergic skin reactions, e.g. rash, urticaria.

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):

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

Very rare adverse reactions (may occur in fewer 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 of Monitoring of Adverse Drug Reactions 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
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 Bio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date (EXP)"/"EXP".
The expiry date refers to the last day of the stated month.
No special storage instructions for this medicine.
Medicines must 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 pack and other information

What Vicebrol Bio 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 Bio looks like and contents of the pack
Vicebrol Bio tablets are white, round, and biconvex.
The tablets are packed in PVC/Aluminum blisters, placed in a cardboard box.
The pack contains 10, 20, 30, 40, 50 or 60 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
e-mail address: [email protected]