Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Cavinton, 5 mg/ml, concentrate for solution for infusion
Vinpocetinum
Please read the entire leaflet 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 further questions, please 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 others, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Cavinton is and what it is 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 Cavinton is and what it is used for

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

acute cerebral ischaemia: transient ischaemic attacks (TIA), ischaemic stroke, and post-stroke states when parenteral treatment is necessary;
chronic circulatory disorders in the retinal capillaries and retina (e.g. thrombosis, obstruction of the central retinal artery or vein);
age-related hearing loss of vascular origin or caused by toxic drug effects, or other types of age-related hearing loss (idiopathic, noise-induced), Ménière’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 insufficient clinical data in this age group.

Warnings and precautions
Before starting treatment with Cavinton, please discuss this with your doctor. In patients with increased intracranial pressure, in patients taking antiarrhythmic drugs (medicines used for cardiac rhythm disorders), as well as in patients with bradycardia and long QT syndrome (changes in ECG), Cavinton should be used only after careful assessment by the physician of the benefits versus the potential risks of the therapy. Regular ECG monitoring (electrocardiographic examination – a test of heart function) is recommended in patients with long QT syndrome or in patients concurrently taking medicines that cause QT prolongation.

Cavinton with other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
In clinical studies, no interactions were observed with beta-blocking agents such as:
chloranolol (a medicine used in hypertension, cardiac rhythm disorders), pindolol (a medicine used in hypertension, coronary artery disease, cardiac rhythm disorders), and clopamide (a diuretic used in hypertension, oedema in circulatory failure), glibenclamide (a medicine used in diabetes), digoxin (a medicine used in heart failure of cardiac origin, cardiac rhythm disorders), acenocoumarol (an anticoagulant used in thrombotic disease, arterial embolism in heart diseases), or hydrochlorothiazide (a diuretic used in hypertension, oedema in heart failure).
In isolated cases, vinpocetine enhances the hypotensive effect (blood pressure lowering) of α-methyldopa (a medicine used in hypertension); therefore, systematic monitoring of blood pressure is recommended during concomitant use of these medicines.
Caution is advised when using Cavinton together with medicines acting on the central nervous system, as well as with antiarrhythmic drugs (medicines used in cardiac rhythm disorders) and anticoagulants (medicines reducing blood coagulation).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her 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 vehicles and 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 used. In patients with hereditary fructose intolerance, the body cannot metabolize 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 consult their doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (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, i.e. the medicine is considered "sodium-free".

3. How to use Cavinton

This medicine should always be used as directed by a physician. If in doubt, consult your
doctor or pharmacist.
This medicine is available only on prescription.
The medicine must be administered only by slow intravenous infusion (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 body weight.
After completion of intravenous therapy, continuation of treatment orally is recommended, using
tablets, 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 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 renal and/or hepatic impairment
Dosage adjustment is not required in patients with impaired kidney or liver function,
since the medicine does not accumulate in the body.
Use of Cavinton in elderly patients
Dosage adjustment is not required in elderly patients.
Use of a higher than recommended dose of Cavinton
If you have taken more than the recommended dose, seek immediate advice from your doctor or
pharmacist.
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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the serious adverse reactions listed below occur,
you should stop taking the medicine and contact your doctor immediately:

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

The adverse reactions listed below are grouped according to their frequency of occurrence.
Common adverse reactions (may occur in up to 1 in 10 people):

changes in blood pressure (mainly decrease in blood pressure),
flushing,
phlebitis.

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

sleep disturbances (insomnia, drowsiness), dizziness and headache, weakness and sweating. These symptoms may be related to the underlying disease.
changes in ECG recording (ST segment depression, QT interval prolongation), tachycardia and extrasystoles. These symptoms occurred spontaneously and therefore it is uncertain whether the use of Cavinton was the cause,
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 (reduced number of white blood cells),
abdominal pain.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cavinton medicine

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
The infusion solution should be used immediately after preparation.
Do not use this medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Cavinton medicinal product contains

The active substance is vinpocetine.
The other components are: ascorbic acid, sodium pyrosulfite, 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
Ampoules made of brown glass (Type I hydrolytic class), in a cardboard box.
The pack contains 10 ampoules of 2 ml each.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, country of export: 9700335
Parallel Import Authorisation Number: 300/19

Information intended exclusively for medical professionals

How to use Cavinton
Recommended dosage
The initial daily dose in intravenous infusion is usually 20 mg (2 vials) diluted in 500 ml of infusion solution. The dose may be increased to 1 mg/kg body weight per day over 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 vials in 500 ml of infusion solution).
There is no need to adjust the dose in patients with liver or kidney disease.
Cavinton concentrate for infusion solution can be diluted with physiological infusion fluids containing sodium chloride or glucose.
The infusion solution should be used within 3 hours after preparation.
Pharmaceutical incompatibilities
Cavinton concentrate for 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 of Cavinton concentrate for infusion solution with infusion solutions containing amino acids, these components should not be mixed.