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

Before Using the Medication, You Should Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any further doubts, you should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 packaging 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 related to cerebral blood circulation disorders.
Indications for use:
Cavinton is used to treat the following diseases:

• acute conditions of cerebral hypoperfusion: transient ischemic attack (TIA) and ischemic stroke, as well as post-stroke conditions, when parenteral treatment is necessary;
• chronic circulatory disorders in the vascular and retinal vessels of the eye (e.g., thrombosis, occlusion of the central artery or vein of the retina);
• age-related hearing loss of vascular origin or caused by toxic effects of medications, 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 the patient is allergic to vinpocetine or any of the other ingredients of this medication (listed in section 6);
• -during pregnancy;
• -during breastfeeding;
• -if the patient is of childbearing age and does not use effective contraceptive methods;
• -if the patient has certain heart diseases, such as severe coronary heart disease and severe heart rhythm disorders;
• -in the acute phase of hemorrhagic stroke;
• -in children, due to the lack of sufficient clinical trial data in this age group.

Warnings and precautions

Before starting treatment with Cavinton, you should discuss it with your doctor.
In patients with increased intracranial pressure, patients taking antiarrhythmic medications (medications used to treat heart rhythm disorders), and patients with arrhythmia and prolonged QT interval (changes in the ECG recording), the medication 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 medications that cause QT interval prolongation.

Cavinton and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
In clinical trials, no interactions were observed with beta-adrenergic blockers, such as chloranolol (a medication used to treat hypertension, heart rhythm disorders), pindolol (a medication used to treat hypertension, coronary heart disease, heart rhythm disorders), and clopamide (a diuretic medication used to treat hypertension, edema in heart failure), glibenclamide (a medication used to treat diabetes), digoxin (a medication used to treat heart failure of cardiac origin, heart rhythm disorders), acenocoumarol (a medication that reduces blood clotting, used to treat thrombotic disease, arterial thrombosis in heart disease), or hydrochlorothiazide (a diuretic medication used to treat hypertension, edema in heart failure).
In individual cases, vinpocetine enhances the hypotensive effect (reducing blood pressure) of α-methyldopa (a medication used to treat hypertension), so during concurrent use of these medications, systematic blood pressure monitoring is recommended.
Caution should be exercised when using Cavinton concurrently with medications acting on the central nervous system, as well as with antiarrhythmic (medications used to treat heart rhythm disorders) and anticoagulant (medications that reduce blood clotting) medications.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medication.
If you are of childbearing age, you must use effective contraception 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 medication contains 160 mg of sorbitol in each ampoule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder, the patient should not take this medication. In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medication, which can cause severe side effects.
You should inform your doctor before taking this medication if you have hereditary fructose intolerance, and you should not consume sweet foods or drinks due to nausea, vomiting, or unpleasant side effects such as bloating, stomach cramps, or diarrhea.

Cavinton contains benzyl alcohol

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

Cavinton contains sodium metabisulfite

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

3. How to use Cavinton

This medication should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Medication to be used only on a doctor's prescription.

The medication should be administered only by slow intravenous drip (the infusion rate should not exceed 80 drops/minute).
Do not administer the medication by intramuscular injection.
Do not administer the medication 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 1 tablet of Cavinton Forte (10 mg tablets) or 2 tablets of Cavinton (5 mg tablets) three times a day.
If you feel that the effect of the medication is too strong or too weak, you should consult a doctor or pharmacist.

Use in children

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

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

There is no need to adjust the dosage in patients with renal or hepatic impairment, as the medication 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

In case of taking a higher dose of the medication than recommended, you should immediately consult a 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, the doctor should not administer such doses to patients.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.
In case of experiencing any of the following serious side effects, you should stop taking the medication and contact your doctor immediately:

• feeling of rapid or irregular heartbeat,
• significant changes in blood pressure. The following side effects are grouped by frequency of occurrence.

Common side effects (may occur in up to 1 in 10 people):

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

Uncommon side effects (may occur in 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 the ECG recording (depression of the ST segment, prolongation of the QT interval), tachycardia and extra systoles. 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 occur in up to 1 in 1000 people):

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medication.

5. How to store Cavinton

The medication should be stored out of sight and reach of children.
Store at a temperature below 25°C.
The infusion solution should be used within 3 hours of preparation.
Store in the original packaging to protect from light.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.
Medications should not be disposed of in wastewater or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cavinton contains

• -The active substance of the medication 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 what the packaging contains

Concentrate for solution for infusion, colorless to slightly greenish.
Ampoules made of brown glass (I hydrolytic class) in a cardboard box.
The packaging contains 10 ampoules of 2 ml each.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, country of export, and manufacturer:

Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Parallel importer

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Cesky Tesin, Czech Republic

Repackaged by

Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY,
ul. Wł. Żeleńskiego 45, 31-353 Krakow
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 authorization number in Bulgaria, country of export: 9700335

Parallel import authorization number: 368/19

Date of approval of the leaflet: 24.09.2024

Information intended exclusively for healthcare professionals

How to use Cavinton
Recommended dosage
Intravenous drip, 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 medication.
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 modify the dose in patients with liver or kidney disease.
The concentrate for solution for infusion Cavinton can be diluted with physiological infusion solutions containing sodium chloride or glucose.
The infusion solution should be used within 3 hours of preparation.
Incompatibilitiespharmaceutical
The concentrate for solution for infusion Cavinton is chemically incompatible with heparin, so these medications should not be mixed in the same syringe. However, concurrent treatment with anticoagulant medications is possible.
Due to the incompatibility of Cavinton concentrate for solution for infusion with infusion solutions containing amino acids, these components should not be mixed.
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