Cavinton

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Cavinton

5 mg/ml, concentrate for solution for infusion

Vinpocetine
Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 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 pack 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 related to cerebral blood circulation disorders.
Indications for use:
Cavinton is used to treat the following diseases:

• acute conditions of cerebral hypoperfusion: transient ischaemic attack (TIA) and ischaemic stroke, as well as post-stroke conditions, when parenteral treatment is necessary;
• chronic circulatory disorders in the retinal and choroidal vessels (e.g., thrombosis, occlusion of the central retinal artery or vein);
• age-related hearing loss of vascular origin or caused by toxic effects of drugs, or other types of age-related hearing loss (idiopathic, due to noise exposure), Meniere's disease, and tinnitus.

2. Important information before using Cavinton

When not to use Cavinton

• -if you are allergic to vinpocetine or any of the other ingredients of this medicine (listed in section 6);
• during pregnancy;
• during breastfeeding;
• if you are of childbearing age and do not use effective contraceptive methods;
• if you have certain heart diseases, such as severe coronary heart disease and severe cardiac arrhythmias;
• during the acute phase of haemorrhagic stroke;
• in children, due to the lack of sufficient clinical data in this age group.

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Warnings and precautions

Before starting treatment with Cavinton, discuss it with your doctor.
In patients with increased intracranial pressure, patients taking antiarrhythmic drugs (drugs used in cardiac arrhythmias) and patients with atrioventricular block and prolonged QT interval (changes in the ECG recording), the drug can be used after careful consideration by the doctor of the benefits versus the possible risk of the therapy.
It is recommended to perform control ECG examinations (electrocardiologic examination - examination of heart function) in patients with prolonged QT interval or in patients taking drugs that prolong the QT interval.

Cavinton and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
In clinical trials, no interactions were observed with beta-adrenergic blockers, such as chloranolol (a drug used in hypertension, cardiac arrhythmias), pindolol (a drug used in hypertension, coronary heart disease, cardiac arrhythmias), and clopamide (a diuretic used in hypertension, oedema in heart failure), glibenclamide (a drug used in diabetes), digoxin (a drug used in heart failure of cardiac origin, cardiac arrhythmias), acenocoumarol (a drug that reduces blood clotting, used in thrombotic disease, arterial thrombosis in heart diseases), or hydrochlorothiazide (a diuretic used in hypertension, oedema in heart failure).
In individual cases, vinpocetine enhances the hypotensive effect (reducing blood pressure) of alpha-methyldopa (a drug used in hypertension), so during concomitant use of these drugs, systematic blood pressure monitoring is recommended. Caution should be exercised when using Cavinton with drugs that act on the central nervous system, as well as with antiarrhythmic (drugs used in cardiac arrhythmias) and anticoagulant (drugs that reduce blood clotting) drugs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
If you are of childbearing age, you must use an effective contraceptive method during treatment with Cavinton. Otherwise, the administration of vinpocetine is contraindicated.
Cavinton is contraindicated during pregnancy and breastfeeding.

Driving and using machines

There are no data on the effect of vinpocetine on the ability to drive and use machines.

Cavinton contains sorbitol

The medicine contains 160 mg of sorbitol in each ampoule. Sorbitol is a source of fructose. If you have previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder, you should not take this medicine. In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medicine, which can cause severe side effects.
Tell your doctor before taking this medicine if you have hereditary fructose intolerance, and do not take sweet foods or drinks due to nausea, vomiting, or unpleasant side effects, such as bloating, stomach cramps, or diarrhoea.

Cavinton contains benzyl alcohol

The medicine contains 20 mg of benzyl alcohol in each ampoule. Benzyl alcohol may cause allergic reactions. Patients with kidney diseases should contact their doctor or pharmacist before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Cavinton contains sodium metabisulfite

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

3. How to use Cavinton

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

Medicine to be used only on medical prescription.

The medicine should be administered only by slow intravenous infusion (infusion rate should not exceed 80 drops/minute).
Do not administer the medicine by intramuscular injection.
Do not administer the medicine intravenously undiluted.
The doctor will determine the individual dose with caution, depending on the patient's clinical condition, based on their body weight.
After completing intravenous therapy, it is recommended to continue treatment orally with tablets, at a dose of one tablet of Cavinton Forte (10 mg tablets) or two tablets of Cavinton (5 mg tablets) three times a day.
If you feel that the effect of the medicine is too strong or too weak, ask your doctor or pharmacist.

Use in children

Cavinton is not intended for use in children. The medicine should not be used due to the lack of sufficient clinical data in this age group.

Use of Cavinton in patients with renal and/or hepatic impairment

There is no need to adjust the dose in patients with renal or hepatic impairment, as the medicine does not accumulate in the body.

Use of Cavinton in elderly patients

There is no need to adjust the dose in elderly patients.

Use of a higher than recommended dose of Cavinton

If you have taken more than the recommended dose of the medicine, seek medical attention 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, the doctor should not administer such doses to patients.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

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

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Side effects are grouped by frequency of occurrence.
Common side effects (may affect up to 1 in 10 people):

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

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

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

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C
02-222 Warsaw
phone: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cavinton

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store 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 carton.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cavinton contains

• -The active substance of the medicine is vinpocetine. Each 2 ml ampoule contains 10 mg of vinpocetine.

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• Other ingredients are: benzyl alcohol, tartaric acid, sorbitol, ascorbic acid, sodium metabisulfite, water for injections.

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 more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, the 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Bulgaria, the country of export: 9700335

Parallel import authorisation number: 814/12 Date of approval of the leaflet: 07.09.2022

[Information on the trademark]

Information intended exclusively for healthcare professionals

How to use Cavinton
Recommended dosage
Intravenous infusion, the initial daily dose is usually 20 mg (2 ampoules) diluted in 500 ml of infusion solution. The dose can be increased to 1 mg/kg body weight per day, within 2-3 days, depending on the patient's tolerance to the medicine.
The average duration of treatment is 10-14 days, and the usual daily dose for a patient with a body weight of 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 liver or kidney diseases.
The concentrate for solution for infusion of Cavinton can be diluted with physiological infusion solutions containing sodium chloride or glucose.
The infusion solution should be used immediately after preparation .
Incompatibilities
The concentrate for solution for infusion of Cavinton is chemically incompatible with heparin, so these medicines should not be mixed in the same syringe. However, concomitant treatment with anticoagulant drugs can be used.
Due to the incompatibility of Cavinton concentrate for solution for infusion with infusion solutions containing amino acids, these medicines should not be mixed.
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