Cavinton

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cavinton

5 mg/ml, concentrate for solution for infusion

Vinpocetine

Before taking the medicine, you should read the leaflet carefully, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 taking Cavinton
• 3. How to take 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:

Cavinton is used to treat the following diseases:

• acute conditions of cerebral ischemia: transient ischemic attack (TIA) and ischemic stroke, as well as post-stroke conditions, when parenteral treatment is necessary;
• chronic circulatory disorders in the vascular system and retina 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, as well as other types of age-related hearing loss (idiopathic, due to noise exposure), Meniere's disease, and tinnitus.

2. Important information before taking Cavinton

When not to take Cavinton

• -if the patient is allergic to vinpocetine or any other component of the medicine (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 arrhythmias;
• during the acute phase of hemorrhagic stroke;
• in children, due to the lack of sufficient clinical data in this age group.

Warnings and precautions

Before starting treatment with Cavinton, the patient should discuss it with their doctor.
In patients with increased intracranial pressure, those taking antiarrhythmic medications, and those with atrioventricular block and prolonged QT interval, the medicine can be used after careful consideration by the doctor of the benefits versus the potential risks.
It is recommended to perform control ECGs (electrocardiographic examination) in patients with prolonged QT interval or those taking medications that prolong the QT interval.

Cavinton and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In clinical trials, no interactions were observed with beta-adrenergic blockers, such as chloranolol (used in hypertension, arrhythmias), pindolol (used in hypertension, coronary heart disease, arrhythmias), and clopamide (a diuretic used in hypertension, edema in heart failure), glibenclamide (used in diabetes), digoxin (used in heart failure, arrhythmias), acenocoumarol (an anticoagulant used in thrombosis, arterial embolism in heart diseases), or hydrochlorothiazide (a diuretic used in hypertension, edema in heart failure).
In individual cases, vinpocetine may enhance the hypotensive effect of alpha-methyldopa (used in hypertension), so it is recommended to monitor blood pressure systematically during concomitant use of these medicines.
Caution should be exercised when using Cavinton concomitantly with central nervous system depressants, antiarrhythmic medications, and anticoagulants.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
If the patient is of childbearing age, they must use effective contraception during treatment with Cavinton. Otherwise, the use of vinpocetine is contraindicated.
Cavinton is contraindicated during pregnancy and breastfeeding.

Driving and using machines

There are no data on the effects 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 the patient has been previously diagnosed with hereditary fructose intolerance, a rare genetic disorder, they 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.
The patient should inform their doctor before taking this medicine if they have hereditary fructose intolerance, and 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 medicine contains 20 mg of benzyl alcohol in each ampoule. Benzyl alcohol may cause allergic reactions. Patients with kidney diseases should consult their doctor or pharmacist before taking this medicine, as large amounts 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 it is considered "sodium-free".

3. How to take Cavinton

This medicine should always be taken as directed by the doctor. If there are any doubts, the patient should consult their doctor or pharmacist.

Cavinton is only used on medical prescription.

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

Overdose of Cavinton

In case of overdose, the patient should immediately consult their 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 medicines, Cavinton can cause side effects, although not everybody gets them.
In case of any of the following serious side effects, the patient should stop taking the medicine and contact their 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 affect up to 1 in 10 people):

• changes in blood pressure (mainly decreased 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 (depression of the ST segment, prolongation of the QT interval), tachycardia and extrasystoles. These symptoms occurred spontaneously and therefore it is not certain whether they were caused by Cavinton.
• nausea, heartburn, and dry mouth,
• increased liver enzyme activity,
• allergic skin reactions.

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health,
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 (22) 49 21 301, fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Cavinton

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
The concentrate for solution for infusion 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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: benzyl alcohol, tartaric acid, sorbitol, ascorbic acid, sodium metabisulfite, water for injections.

Each 2 ml ampoule contains 10 mg of vinpocetine.

What Cavinton looks like and contents of the pack

Brown glass ampoules (hydrolytic class I), in a cardboard box.
The pack contains 10 ampoules of 2 ml each.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, country of export:

Richter Gedeon Nyrt.
Gyömrői út 19-21., H-1103 Budapest, Hungary

Manufacturer:

Richter Gedeon Nyrt.
Gyömrői út 19-21., H-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
Hungarian, country of export marketing authorization number: OGYI-T-3531/01

Parallel import authorization number: 402/17 Date of approval of the leaflet: 18.11.2022

[Information on the trademark]

Information intended for healthcare professionals only

How to use Cavinton
Recommended dosage
By 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, over 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.
Cavinton concentrate for solution for infusion can be diluted with physiological infusion solutions containing sodium chloride or glucose.
The infusion solution should be used within 3 hours of preparation.
Incompatibilities
Cavinton, concentrate for solution for infusion, is chemically incompatible with heparin, and therefore these medicines should not be mixed in the same syringe. However, concomitant treatment with anticoagulants is possible.
Due to the incompatibility of Cavinton, concentrate for solution for infusion, with infusion solutions containing amino acids, these medicines should not be mixed.