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

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

• You Should Keep this Leaflet, so that You can Read it Again if Necessary.
• If You have any Further Questions, You Should Ask Your Doctor or Pharmacist.
• This Medicinal Product has been Prescribed to You Personally. You Should not Pass it on to Others. The Medicinal Product may Harm Another Person, even if their Symptoms are the Same.
• If You Experience any Side Effects, including those not Mentioned in this Leaflet, You Should Tell Your Doctor or Pharmacist. 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 the Active Substance Vinpocetine.
Vinpocetine is a Compound with a Complex Mechanism of Action, Used in the Treatment or Relief of Symptoms of Diseases Related to Blood Circulation Disorders in the Brain.
Indications for Use:
Cavinton is Used in the Treatment of 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 Vessels 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 Medicinal Products, 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 Medicinal Product (Listed in Section 6);
• During Pregnancy;
• During Breast-Feeding;
• If You are of Childbearing Age and do not Use Effective Contraceptive Methods;
• If You have Certain Heart Diseases, such as Severe Ischemic Heart Disease and Severe Heart Rhythm Disorders;
• In 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, You Should Discuss it with Your Doctor. In Patients with Increased Intracranial Pressure, Patients Taking Anti-Arrhythmic Medicinal Products (Medicinal Products Used in Heart Rhythm Disorders) and Patients with Atrial Fibrillation and Prolonged QT Interval (Changes in the ECG Recording), the Medicinal Product 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 who are also Taking Medicinal Products that Prolong the QT Interval.

Cavinton and Other Medicinal Products

You Should Tell Your Doctor or Pharmacist about all Medicinal Products You are Currently Taking or have Recently Taken, as well as about Medicinal Products You Plan to Take.
In Clinical Trials, no Interactions have been Observed with Beta-Adrenergic Blocking Agents, such as: Chloranolol (a Medicinal Product Used in Arterial Hypertension, Heart Rhythm Disorders), Pindolol (a Medicinal Product Used in Arterial Hypertension, Coronary Artery Disease, Heart Rhythm Disorders) and Clopamide (a Diuretic Used in Arterial Hypertension, Edema in Heart Failure), Glibenclamide (a Medicinal Product Used in Diabetes), Digoxin (a Medicinal Product Used in Heart Failure of Cardiac Origin, Heart Rhythm Disorders), Acenocoumarol (a Medicinal Product that Reduces Blood Coagulability, Used in Thrombotic Disease, Arterial Thrombosis in Heart Diseases) or Hydrochlorothiazide (a Diuretic Used in Arterial Hypertension, Edema in Heart Failure).
In Individual Cases, Vinpocetine Enhances the Hypotensive Effect (Lowering Blood Pressure) of Alpha-Methyldopa (a Medicinal Product Used in Arterial Hypertension), therefore, During Concomitant Use of these Medicinal Products, Systematic Blood Pressure Monitoring is Recommended.
Caution Should be Exercised when Using Cavinton Concomitantly with Medicinal Products that Act on the Central Nervous System, as well as with Anti-Arrhythmic (Medicinal Products Used in Heart Rhythm Disorders) and Anti-Coagulant Medicinal Products (Medicinal Products that Reduce Blood Coagulability).

Pregnancy, Breast-Feeding, and Fertility

If You are Pregnant or Breast-Feeding, Think You may be Pregnant, or are Planning to have a Child, You Should Ask Your Doctor or Pharmacist for Advice Before Taking this Medicinal Product.
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 Breast-Feeding.

Driving and Using Machines

There are no Data on the Influence of Vinpocetine on the Ability to Drive and Use Machines.

Cavinton Contains Sorbitol

The Medicinal Product Contains 160 mg of Sorbitol in each Ampoule. Sorbitol is a Source of Fructose. If You have been Diagnosed with Hereditary Fructose Intolerance, a Rare Genetic Disease, You Should not Take this Medicinal Product. In Patients with Hereditary Fructose Intolerance, the Body does not Break Down the Fructose Contained in this Medicinal Product, which can Cause Serious Side Effects.
You Should Inform Your Doctor Before Taking this Medicinal Product if You have Hereditary Fructose Intolerance, and You Should not Take it if You have Experienced Nausea, Vomiting, or Unpleasant Side Effects such as Abdominal Distension, Abdominal Cramps, or Diarrhea.

Cavinton Contains Benzyl Alcohol

The Medicinal Product 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 Medicinal Product, as a Large Amount of Benzyl Alcohol may Accumulate in their Body and Cause Side Effects (Metabolic Acidosis).

Cavinton Contains Sodium Metabisulfite

The Medicinal Product Contains 2 mg of Sodium Metabisulfite in each Ampoule. Sodium Metabisulfite may Rarely Cause Severe Allergic Reactions and Bronchospasm.
The Medicinal Product Contains Less than 1 mmol (23 mg) of Sodium per Ampoule, which Means that the Medicinal Product is Considered "Sodium-Free".

3. How to Use Cavinton

This Medicinal Product Should Always be Used in Accordance with the Doctor's Recommendations. If You have any Doubts, You Should Ask Your Doctor or Pharmacist.

The Medicinal Product is Used Only on the Doctor's Prescription.

The Medicinal Product Should be Administered Exclusively by Slow Intravenous Infusion (the Infusion Rate Should not Exceed 80 Drops/Minute).
The Medicinal Product Should not be Administered by Intramuscular Injection.
The Medicinal Product Should not be Administered Undiluted Intravenously.
The Doctor will Determine the Individual Dose with Particular Caution, Depending on the Patient's Clinical Condition, Based on their Body Weight.
After Completing the Intravenous Therapy, it is Recommended to Continue the 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 Medicinal Product is too Strong or too Weak, You Should Ask Your Doctor or Pharmacist.

Use in Children

Cavinton is not Intended for Use in Children. The Medicinal Product 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 Change the Dose in Patients with Renal or Hepatic Impairment, as the Medicinal Product does not Accumulate in the Body.

Use of Cavinton in Elderly Patients

There is no Need to Change the Dose in Elderly Patients.

Use of a Higher than Recommended Dose of Cavinton

If You have Taken a Higher Dose of the Medicinal Product than Recommended, You Should Immediately Ask Your Doctor or Pharmacist for Advice.
Administration of Vinpocetine at a Dose of 1 mg/kg Body Weight is Safe. There is no Clinical Experience with the Use of 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 Medicinal Products, this Medicinal Product can Cause Side Effects, although not Everybody gets them.
If any of the Following Serious Side Effects Occur, You Should Stop Taking the Medicinal Product 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 Decrease in Blood Pressure),
• Flushes,
• 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 (Decrease in the ST Segment, Prolongation of the QT Interval), Tachycardia and Extra Systoles. These Symptoms have Occurred Spontaneously and therefore it is not Certain whether they are Caused by the Use of Cavinton,
• Nausea, Heartburn, and Dryness in the Mouth,
• Increased Activity of Liver Enzymes,
• Allergic Skin Reactions.

Rare Side Effects (may Occur in up to 1 in 1000 People):

• Leukopenia (Decrease in the Number of White Blood Cells),
• Abdominal Pain.

Reporting of Side Effects

If You Experience any Side Effects, including those not Mentioned in this Leaflet, You Should Tell Your Doctor or Pharmacist. 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.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
By Reporting Side Effects, You can Help to Gather more Information on the Safety of the Medicinal Product.

5. How to Store Cavinton

The Medicinal Product Should be Stored in a Place that is Inaccessible to Children.
Store at a Temperature Below 25°C. Store in the Original Packaging to Protect from Light.
The Solution for Infusion Should be Used Immediately After Preparation.
Do not Use this Medicinal Product after the Expiry Date Stated on the Packaging. The Expiry Date refers to the Last Day of the Month Stated.
Medicinal Products Should not be Disposed of via Wastewater or Household Waste. You Should Ask Your Pharmacist how to Dispose of Medicinal Products that are no Longer Needed. This will Help to Protect the Environment.

6. Contents of the Packaging and Other Information

What Cavinton Contains

• The Active Substance of the Medicinal Product 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

Ampoules Made of Brown Glass (Hydrolytic Class I), in a Cardboard Box.
The Packaging Contains 10 Ampoules of 2 ml Each.
For more Detailed Information, You Should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Bulgaria, the Country of Export:9700335
Parallel Import Authorization Number:300/19

Date of Approval of the Leaflet: 15.07.2024

[Information on the Trademark]

Information Intended for Healthcare Professionals Only

How to Use Cavinton
Recommended Dosage
Intravenous Infusion, the Initial Daily Dose is Usually 20 mg (2 Ampoules) Diluted in 500 ml of Solution for Infusion. 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 Medicinal Product.
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 Solution for Infusion).
There is no Need to Modify 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 Solution for Infusions Should be Used within 3 Hours of Preparation.
Incompatibilities
The Concentrate for Solution for Infusion Cavinton is Chemically Incompatible with Heparin, therefore these Medicinal Products Should not be Mixed in the Same Syringe. However, Concomitant Treatment with Anti-Coagulant Medicinal Products is Possible.
Due to the Incompatibility of Cavinton Concentrate for Solution for Infusion with Solutions for Infusion Containing Amino Acids, these Components Should not be Mixed.