Patient Information Leaflet: Instructions for the User

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Cavinton, 5 mg/ml, concentrate for solution for infusion
Vinpocetinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are identical.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

What is Cavinton and what is it used for
Important information before using Cavinton
How to use Cavinton
Possible side effects
How to store Cavinton
Contents of the package and other information

1. What is Cavinton and what is it used for

Cavinton contains vinpocetine as the active substance.
Vinpocetine is a compound with a complex mechanism of action, used in the treatment or alleviation of symptoms of diseases associated with impaired cerebral blood circulation.

Therapeutic indications:
Cavinton is used in the treatment of the following conditions:

Acute cerebral ischemia: transient ischemic attacks (TIA), ischemic stroke, and post-stroke states when parenteral treatment is required;
Chronic circulatory disorders in the choroid and retina of the eye (e.g., thrombosis, obstruction of the central retinal artery or vein);
Age-related hearing loss of vascular origin or caused by toxic drug effects, as well as other types of age-related hearing loss (idiopathic, noise-induced), Meniere's disease, and tinnitus.

2. Important information before using Cavinton

When not to use Cavinton

if the patient is allergic to vinpocetine or any of the other ingredients of this medicine (listed in section 6);
during pregnancy;
during breastfeeding;
if the patient is of childbearing age and is not using effective contraceptive methods;
if the patient has certain heart conditions, i.e. severe ischaemic heart disease and severe cardiac arrhythmias;
in the acute phase of haemorrhagic stroke;
in children, due to lack of sufficient clinical data in this age group.

Warnings and precautions
Before starting treatment with Cavinton, discuss this with your doctor.
In patients with increased intracranial pressure, in those taking antiarrhythmic medicines (medicines used for cardiac arrhythmias), and in patients with arrhythmia and long QT syndrome (changes in ECG), this medicine should only be used after careful consideration by the doctor of the benefits versus the possible risks of treatment.
Regular ECG monitoring (electrocardiographic examination – heart function test) is recommended in patients with long QT syndrome or in patients simultaneously taking medicines that prolong the QT interval.

Cavinton 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 clinical studies, no interactions were observed with beta-blocking agents such as:
chloranilol (a medicine used in arterial hypertension and cardiac arrhythmias), pindolol (a medicine used in arterial hypertension, coronary artery disease, and cardiac arrhythmias), and clopamide (a diuretic used in arterial hypertension and oedema in circulatory failure),
glibenclamide (a medicine used in diabetes), digoxin (a medicine used in cardiac-origin circulatory failure and cardiac arrhythmias), acenocoumarol (an anticoagulant used in thrombotic disorders, arterial embolism in heart diseases), or
hydrochlorothiazide (a diuretic used in arterial hypertension and oedema in heart failure).
In isolated cases, vinpocetine may enhance the hypotensive effect (blood pressure-lowering effect) of α-methyldopa (a medicine used in arterial hypertension). Therefore, systematic monitoring of blood pressure is recommended when these medicines are used concomitantly.
Caution is advised when using Cavinton together with medicines acting on the central nervous system, as well as with antiarrhythmic medicines (used in cardiac arrhythmias) and anticoagulants (medicines that reduce blood clotting).

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
If the patient is of childbearing age, she must use an effective method of contraception during treatment with Cavinton. Otherwise, administration of vinpocetine is contraindicated.
Cavinton is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
There is no data available on the effect of vinpocetine on the ability to drive or operate machinery.

Cavinton contains sorbitol
The medicine contains 160 mg of sorbitol per ampoule. Sorbitol is a source of fructose. If hereditary fructose intolerance, a rare genetic disorder, has been previously diagnosed in the patient, this medicine must not be taken. In patients with hereditary fructose intolerance, the body cannot break down the fructose contained in this medicine, which may lead to severe adverse reactions.
Inform your doctor before taking this medicine if you have hereditary fructose intolerance. You should avoid consuming sweet foods or drinks for a prolonged period due to possible nausea, vomiting or unpleasant adverse effects such as bloating, stomach cramps, or diarrhoea.

Cavinton contains benzyl alcohol
The medicine contains 20 mg of benzyl alcohol per ampoule. Benzyl alcohol may cause allergic reactions. Patients with kidney disease should contact their doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse reactions (so-called metabolic acidosis).

Cavinton contains sodium metabisulphite
The medicine contains 2 mg of sodium metabisulphite per ampoule. Sodium metabisulphite may rarely cause severe allergic reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

3. How to use Cavinton

This medicine should always be used as directed by a physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is available only on prescription.
The medicine should be administered only by slow intravenous infusion (the infusion rate must not
exceed a maximum of 80 drops/minute).
Do not administer the medicine by intramuscular injection.
Do not administer undiluted medicine intravenously.
The physician will determine the individual dose with special caution, depending on the patient's
clinical condition and based on the patient's body weight.
After completion of intravenous therapy, continuation of treatment by oral administration is recommended, using one tablet of Cavinton Forte (10 mg tablets) three times daily or two tablets of Cavinton (5 mg tablets) three times daily.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or
pharmacist.
Use in children
Cavinton is not intended for use in children. The medicine should not be used due to
lack of sufficient clinical data in this age group.
Use of Cavinton in patients with impaired renal and/or hepatic function
There is no need to adjust the dosage in patients with impaired renal or
hepatic function, as the medicine does not accumulate in the body.
Use of Cavinton in elderly patients
There is no need to adjust the dosage in elderly patients.
Use of a higher than recommended dose of Cavinton
If a higher than recommended dose of the medicine has been taken, consult a doctor or
pharmacist immediately.
Administration of vinpocetine at a dose of 1 mg/kg body weight is safe. There is no clinical experience
with doses higher than 1 mg/kg body weight, and therefore physicians should not administer such doses to patients.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the serious adverse reactions listed below occur, discontinue taking the medicine and contact your doctor immediately:

sensation of rapid or irregular heartbeat,
significant changes in blood pressure.

The adverse reactions listed below are grouped according to frequency of occurrence.

Frequent adverse reactions (may occur in up to 1 in 10 people):

changes in blood pressure (mainly decreased blood pressure),
flushing (sensation of warmth and redness in the face and head),
phlebitis (inflammation of veins).

Uncommon adverse reactions (may occur in up to 1 in 100 people):

sleep disturbances (insomnia, drowsiness), dizziness, headache, weakness, and sweating. These symptoms may be related to the underlying disease.
changes in ECG findings (ST-segment depression, QT-interval prolongation), tachycardia, and extrasystoles. These symptoms occurred spontaneously, therefore it is not certain whether they were caused by the use of Cavinton.
nausea, heartburn, and dry mouth,
increased liver enzyme activity,
allergic skin reactions.

Rare adverse reactions (may occur in up to 1 in 1000 people):

leukopenia (reduction in white blood cell count),
abdominal pain.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to enhance the information on the safety of this medicine.

5. How to store Cavinton

Keep this medicine out of sight and reach of children.
Store below 25°C.
The infusion solution should be used within 3 hours after preparation.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Cavinton contains

The active substance is vinpocetine.
The other ingredients are: ascorbic acid, sodium metabisulfite, tartaric acid, benzyl alcohol, sorbitol, water for injections.

Each 2 ml ampoule contains 10 mg of vinpocetine.
What Cavinton looks like and contents of the pack
Concentrate for solution for infusion, colourless to slightly greenish.
Ampoules made of brown glass (hydrolytic class I) in a cardboard box.
The pack contains 10 ampoules of 2 ml each.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder and manufacturer in Bulgaria, country of export:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Parallel importer
Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Český Těšín, Czech Republic
Repackaged in
Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY,
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. Komandytowa
ul. Działkowa 56, 02-234 Warsaw
Marketing authorisation number in Bulgaria, country of export: 9700335
Parallel import authorisation number: 368/19

Information intended exclusively for medical professionals

How to administer Cavinton
Recommended dosage
The initial daily dose in intravenous infusion is usually 20 mg (2 ampoules) diluted in 500 ml of infusion solution. The dose may be increased to 1 mg/kg body weight per day within 2–3 days, depending on the patient's tolerance to the drug.
The average duration of treatment is 10–14 days, and the commonly used daily dose for a patient weighing 70 kg is 50 mg/day (5 ampoules in 500 ml of infusion solution).
There is no need to adjust the dose in patients with hepatic or renal impairment.
The Cavinton concentrate for preparation of infusion solution may be diluted with physiological infusion fluids containing sodium chloride or glucose.
The infusion solution should be used within 3 hours after preparation.
Pharmaceutical incompatibilities
The Cavinton concentrate for preparation of infusion solution is chemically incompatible with heparin; therefore, these drugs should not be mixed in the same syringe. However, concomitant treatment with anticoagulant drugs may be used.
Due to incompatibility, Cavinton concentrate for preparation of infusion solution should not be mixed with infusion solutions containing amino acids.