Vicebrol forte

Package leaflet: Information for the patient

VICEBROL FORTE
10 mg, tablets
Vinpocetinum
Please read the entire 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, please consult your doctor or pharmacist.
• This medicine has been prescribed strictly 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:

1. What Vicebrol Forte is and what it is 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 as the active substance vinpocetine.
Vinpocetine is a compound used in the treatment of diseases or relief of symptoms associated with cerebral circulation disorders.

Indications for Vicebrol Forte

• Relief of symptoms of chronic cerebral circulation disorders following stroke, such as memory impairment, reduced intellectual performance, motor incoordination;
• Relief of psychological and neurological symptoms associated with cerebral circulation disorders due to cerebral arteriosclerosis, including vascular dementia;
• Adjunctive treatment of visual disturbances of vascular origin;
• Adjunctive treatment of hearing disturbances of vascular origin.

2. IMPORTANT INFORMATION BEFORE TAKING VICEBROL FORTE

When not to use Vicebrol Forte:

• if the patient is allergic to vinpocetine or to any of the other components of this medicine (listed in section 6);
• if the patient has or is suspected of having bleeding into the central nervous system;
• if the patient has severe ischemic heart disease;
• if the patient has cardiac arrhythmias;
• during pregnancy;
• during breastfeeding;
• in children and adolescents (due to lack of sufficient data on use in this age group).

Warnings and precautions
Before starting treatment with Vicebrol Forte, discuss with your doctor or pharmacist:

• if the patient has advanced renal insufficiency; in such cases, the dose should be reduced;
• if a drop in blood pressure or cardiac arrhythmias occur during treatment, the use of the medicine should be discontinued;
• if the medicine is administered to patients with prolonged QT interval syndrome or to patients concurrently taking medicines that prolong the QT interval; in such cases, periodic ECG monitoring is recommended.

Children and adolescents
Vicebrol Forte should not be used in children and adolescents.

Vicebrol Forte and other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
No interactions have been observed when vinpocetine was administered concomitantly with beta-blockers (one of the most important drug groups used in cardiology, especially in ischemic heart disease), such as chloranolol and pindolol, with clopamide (a diuretic) or hydrochlorothiazide (a diuretic). In rare cases, vinpocetine enhanced the hypotensive (blood pressure-lowering) effect of α-methyldopa (an antihypertensive agent). Vinpocetine administered simultaneously with adenosine increases the neuroprotective (protective effect on nervous tissue) action of the latter. No interactions were observed with digoxin (used in heart failure and ventricular fibrillation) and acenocoumarol. Combined treatment with vinpocetine did not pose a potential risk of interactions with other drugs when treating diabetes with glibenclamide (an oral antidiabetic agent).
Caution should be exercised when administering vinpocetine concomitantly with drugs acting on the central nervous system, as well as with antiarrhythmic and anticoagulant drugs.

Vicebrol Forte with food and drink
The medicine should be taken orally after meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Vicebrol Forte is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of this product on the ability to drive mechanical vehicles or operate moving machinery.

Vicebrol Forte contains lactose (a sugar found in milk)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. HOW TO USE VICEBROL FORTE

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Dosage
Adults
1 tablet three times daily (30 mg/day).
The therapeutic effect begins after approximately one week; maximum therapeutic effect
is achieved within three months, and improvement in the patient's condition may be observed
after 6–12 months of treatment.
If you feel that the effect of Vicebrol Forte is too strong or too weak, consult your doctor.
Patients with impaired liver and/or kidney function
In patients with advanced renal insufficiency, the dose should be reduced – the physician
will determine the appropriate dose individually for each patient.
Elderly patients
Dosage adjustment is not necessary.
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.
Method of administration
The medicine should be taken orally, after meals, with water.
The tablet may be divided into two equal doses.
Use of a higher than recommended dose of Vicebrol Forte
Do not use a dose higher than that recommended by your treating physician.
If you have taken more than the recommended dose, seek immediate medical advice from
your doctor or pharmacist.
Missed dose of Vicebrol Forte
If you miss a dose, take it 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 Forte
Do not discontinue treatment without consulting your doctor. If discontinuation is necessary,
your doctor will gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed during treatment with vinpocetine:
Uncommon adverse reactions (occurring in 1 to 10 out of 1,000 patients):

• Sleep disturbances (insomnia, drowsiness);
• Dizziness and headache;
• Weakness;
• Tingling in limbs;
• Increased sweating;
• Hyperkinesia;
• Cardiac rhythm disturbances: ST segment depression, QT interval prolongation, tachycardia, and extrasystoles;
• Blood pressure changes (mainly hypotension);
• Facial skin redness;
• Nausea, heartburn;
• Dryness of the oral mucosa;
• Increased liver enzyme activity;
• Allergic skin reactions.

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

• Decrease in white blood cell count (leukopenia).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE VICEBROL FORTE

Store below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Vicebrol Forte contains

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

What Vicebrol Forte looks like and contents of the pack
Vicebrol Forte tablets are white, round, biconvex, with a breakline on one side.
The tablets are packed in blisters made of PVC/PVDC/Aluminium, 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 Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań