Cavinton

Patient Information Leaflet: Instructions for Use

Warning! Keep this leaflet! 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 before using the 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 specifically for the named individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of Contents:

1. What is Cavinton and what is it used for
2. Important information before using Cavinton
3. How to use Cavinton
4. Possible side effects
5. How to store Cavinton
6. Contents of the package and other information

1. What is Cavinton and what is it used for

Cavinton contains 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 indicated for the treatment of the following conditions:

• Acute cerebral ischaemia: transient ischaemic attacks (TIA), ischaemic stroke, and post-stroke states when parenteral treatment is required;
• 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, as well as 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 diseases, i.e. severe ischemic heart disease and severe cardiac arrhythmias;
• in the acute phase of hemorrhagic 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 drugs (medicines used for cardiac rhythm disorders), and in patients with arrhythmia and long QT syndrome (changes in ECG), this medicine should be used only after careful consideration by the doctor of the benefits versus the potential risks of the therapy.
Regular ECG monitoring (electrocardiographic examination - heart function test) is recommended in patients with long QT syndrome or in patients concurrently taking medicines that cause QT prolongation.

Cavinton with other medicines
Inform 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:
chloranolol (a medicine used in arterial hypertension and cardiac rhythm disorders), pindolol (a medicine used in arterial hypertension, coronary artery disease, and cardiac rhythm disorders), or clopamide (a diuretic used in arterial hypertension and edema due to circulatory failure), glibenclamide (a medicine used in diabetes), digoxin (a medicine used in cardiac-origin circulatory failure and cardiac rhythm disorders), acenocoumarol (an anticoagulant used in thromboembolic disorders and arterial embolism in heart diseases), or hydrochlorothiazide (a diuretic used in arterial hypertension and edema due to 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 drugs (medicines used in cardiac rhythm disorders) 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 taking 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 (E 420)
The medicine contains 160 mg of sorbitol per ampoule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder, the patient must not take this medicine. 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 prolonged periods due to possible nausea, vomiting, or unpleasant adverse effects such as bloating, stomach cramps, or diarrhea.

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 a 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 metabisulfite (E 223)
The medicine contains 2 mg of sodium metabisulfite per ampoule. Sodium metabisulfite may rarely cause severe allergic reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule; therefore, 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 by 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, exercising special caution, will determine the individual dose according to the
patient's clinical condition and based on body weight.
After completion of intravenous therapy, continuation of treatment orally is recommended with
Cavinton Forte tablets (10 mg tablets), one tablet three times daily, or Cavinton tablets (5 mg tablets),
two 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
insufficient clinical data in this age group.
Use of Cavinton in patients with renal and/or hepatic impairment
Dose adjustment is not necessary in patients with impaired kidney or liver function,
since the medicine does not accumulate in the body.
Use of Cavinton in elderly patients
Dose adjustment is not necessary 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the serious adverse effects 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 effects listed below are grouped by frequency of occurrence.
Common adverse effects (may affect up to 1 in 10 people):

• changes in blood pressure (mainly decreased blood pressure),
• flushing of the head,
• phlebitis.

Uncommon adverse effects (may affect up to 1 in 100 people):

• sleep disturbances (insomnia, drowsiness), dizziness and headaches, 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, therefore it is uncertain whether they were caused by the use of Cavinton.
• nausea, heartburn and dry mouth,
• increased liver enzyme activity,
• allergic skin reactions.

Rare adverse effects (may affect up to 1 in 1000 people):

• leukopenia (reduced number of white blood cells),
• abdominal pain.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects allows the collection of additional information on the safety of the medicine.

5. How to store Cavinton

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
The infusion solution should be used within 3 hours of 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 must 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 package and other information

What Cavinton medicinal product contains

• The active substance is vinpocetine.
• The other components are: ascorbic acid, sodium pyrosulfite (E 223), tartaric acid, benzyl alcohol, sorbitol (E 420), 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.
Brown glass ampoules in a cardboard box.
The pack contains 10 ampoules of 2 ml each.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Hungary, the country of export:
Richter Gedeon Nyrt.
H-1103 Budapest
Gyömrői út 19-21.
Hungary
Manufacturer:
Richter Gedeon Nyrt.
H-1103 Budapest
Gyömrői út 19-21.
Hungary
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Hungary, the country of export: OGYI-T-3531/01
Parallel Import Authorisation Number: 206/24

Information intended exclusively for healthcare professionals

How to use 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 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 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 is permissible.
Due to the incompatibility of Cavinton concentrate for preparation of infusion solution with infusion solutions containing amino acids, these components should not be mixed.