Cavinton

Package Leaflet: Information for the User

Cavinton, 5 mg/ml, concentrate for solution for infusion
Vinpocetine
You should read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

• You should keep this leaflet, so you can read it again later.
• 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 or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What is Cavinton and what is it used for
• 2. Before you take 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 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 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. Before you take Cavinton

When not to take 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 arrhythmias;
• during the acute phase of haemorrhagic stroke;
• in children, due to the lack of sufficient clinical 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 in arrhythmias) and patients with atrioventricular block and prolonged QT interval (changes in 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 medicines

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

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 taking 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 (E 420)

The medicine contains 160 mg of sorbitol in each ampoule. Sorbitol is a source of fructose. If hereditary fructose intolerance has been previously diagnosed in the patient, a rare genetic disease, the patient cannot 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.
You should inform your doctor before taking this medicine if you have hereditary fructose intolerance, and you should not take it if you have been advised to avoid sugary 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 contact their doctor or pharmacist before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Cavinton contains sodium metabisulfite (E 223)

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 take Cavinton

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Medicine to be taken only on medical prescription.

The medicine should be administered only by slow intravenous infusion (the 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 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 medicine is too strong or too weak, talk to 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.

Overdose of Cavinton

If you have taken more than the prescribed dose of the medicine, contact your doctor or pharmacist 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.

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

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
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.
The infusion solution should be used within 3 hours of preparation.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). 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 is vinpocetine
• The other ingredients are: ascorbic acid, sodium metabisulfite (E223), 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
Ampoules made of orange glass in a cardboard box.
The pack contains 10 ampoules of 2 ml each.

Marketing authorization holder and manufacturer

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

For more detailed information, please contact your local representative of the marketing authorization holder.

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
Fax: +48 (22) 755 96 24

Date of last revision of the leaflet:

Information intended for healthcare professionals only

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