Vicebrol Forte

Package Leaflet: Information for the Patient

VICEBROL FORTE

10 mg, tablets
Vinpocetinum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 Forte and what is it used for
• 2. Important information before taking Vicebrol Forte
• 3. How to take Vicebrol Forte
• 4. Possible side effects
• 5. How to store Vicebrol Forte
• 6. Contents of the pack and other information

• 1.

WHAT IS VICEBROL FORTE AND WHAT IS IT USED FOR

Vicebrol Forte contains the active substance vinpocetine.
Vinpocetine is a compound used in the treatment of diseases or alleviation of symptoms associated with cerebral blood circulation disorders.

Indications for the use of Vicebrol Forte

• Alleviation of symptoms of chronic cerebral circulation disorders, occurring after a stroke, such as: memory impairment, decreased intellectual performance, movement disorders,
• Alleviation of psychological and neurological symptoms associated with cerebral circulation disorders in the course of cerebral atherosclerosis, including vascular dementia,
• Supportive treatment of vision disorders of vascular origin.
• Supportive treatment of hearing disorders of vascular origin.

2. IMPORTANT INFORMATION BEFORE TAKING VICEBROL FORTE

When not to take Vicebrol Forte:

• If the patient is allergic to vinpocetine or any other ingredient of this medicine (listed in section 6);
• If the patient has been diagnosed with or is suspected of having central nervous system bleeding;
• If the patient has severe coronary heart disease;
• If the patient has heart rhythm disorders;
• During pregnancy;
• During breastfeeding;
• In children and adolescents(due to lack of sufficient data on the use of the medicine in this age group).

Warnings and precautions

Before starting to take Vicebrol Forte, discuss it with your doctor or pharmacist:

• if the patient has advanced kidney failure, in which case the dose of the medicine should be reduced,
• if during the use of the medicine a decrease in blood pressure or heart rhythm disorders are observed, the use of the medicine should be discontinued,
• if the medicine is administered to patients with a prolonged QT interval or to people taking medicines that prolong the QT interval, in such cases, it is recommended to perform control ECG examinations.

Children and adolescents

Vicebrol Forte should not be used in children and adolescents.

Vicebrol Forte with food and drink

The medicine should be taken orally after a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Vicebrol Forte is contraindicated during pregnancy and breastfeeding.
Driving and using machines
No studies have been conducted on the effect of the product on the ability to drive vehicles and operate machinery.
Vicebrol Forte contains lactose(a sugar found in milk)
If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine.

3. HOW TO TAKE VICEBROL FORTE

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Dosage

Adults
1 tablet three times a day(30 mg/day).
The therapeutic effect of the preparation starts after about a week, the maximum therapeutic effect is achieved within three months, and an improvement in the patient's condition can be observed after 6-12 months of therapy.
If you feel that the effect of Vicebrol Forte is too strong or too weak, consult a doctor.
Patient 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.
Patient in advanced age
Dose adjustment is not necessary

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, with water.
The tablet can be divided into two equal doses.

Taking a higher dose of Vicebrol Forte than recommended

Do not take a higher dose than recommended by the doctor.
In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.

Missing a dose of Vicebrol Forte

In case of missing a dose, take the medicine as soon as possible. However, if it is close to the time of taking the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping the use of Vicebrol Forte

Do not stop the treatment without consulting a doctor. If it is necessary to stop the use of the medicine, the doctor will gradually reduce the dose used.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

• 4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the use of vinpocetine, the following side effects have been observed: Not very common side effects (in 1 to 10 out of 1000 patients):

• sleep disorders (insomnia, drowsiness);
• dizziness and headaches;
• weakness;
• tingling of limbs;
• increased sweating;
• hyperactivity;
• heart rhythm disorders: ST segment depression, QT interval prolongation, tachycardia, and extrasystoles;
• blood pressure changes (mainly hypotension);
• facial flushing
• nausea, heartburn;
• dryness of the oral mucosa
• increased activity of liver enzymes;
• allergic skin reactions

Rare side effects (in 1 to 10,000 patients):

• decrease in white blood cell count (leukopenia)

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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

• 5. HOW TO STORE VICEBROL FORTE

Store in a temperature below 25°C.
Store in a place 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 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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vicebrol Forte contains

• The active substance of the medicine is vinpocetine (Vinpocetinum). One tablet contains 10 mg of vinpocetine.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate.

What Vicebrol Forte looks like and what the pack contains
The tablets of Vicebrol Forte are white, round, biconvex, with a notch on one side.
The tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
The pack contains 10, 30, 50, 60, 90, 100, or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Date of approval of the leaflet: