Cavinton Forte

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language

Cavinton Forte

10 mg,tablets
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 Consult a Doctor or a Pharmacist.
• This Medicinal Product Has Been Prescribed to You Personally. Do Not Pass it on to Others. The Medicinal Product May Harm Another Person, Even if Their Symptoms are the Same.
• If the Patient Experiences Any Side Effects, Including Any Side Effects Not Mentioned in This Leaflet, They Should Inform Their Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet:

• 1. What is Cavinton Forte and What is it Used For
• 2. Important Information Before Using Cavinton Forte
• 3. How to Use Cavinton Forte
• 4. Possible Side Effects
• 5. How to Store Cavinton Forte
• 6. Contents of the Packaging and Other Information

1. What is Cavinton Forte and What is it Used For

Cavinton Forte Contains the Active Substance Vinpocetine.
Vinpocetine is a Compound Used in the Treatment of Diseases or Relief of Symptoms Associated with
Disorders of Blood Circulation in the Brain.
Indications for Use of Cavinton Forte:

• Treatment of Chronic Cerebral Circulatory Insufficiency, Including Post-Ischemic Stroke and Vascular Dementia;
• Relief of Mental and Neurological Symptoms of Cerebral Circulatory Insufficiency;
• Treatment of Chronic Circulatory Disorders in the Retina and Choroid of the Eye;
• Treatment of Hearing Disorders of Vascular Origin.

2. Important Information Before Using Cavinton Forte

When Not to Use Cavinton Forte

• If the Patient is Hypersensitive to Vinpocetine or Any of the Other Ingredients of This Medicinal Product (Listed in Section 6);
• If the Patient is Pregnant or 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 Ischemic Heart Disease or 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 Forte, You Should Discuss it with Your Doctor or Pharmacist.
If the Patient Has Certain Heart Diseases, the Doctor Will Recommend Performing Control ECG Exams
(Electrocardiologic Examination - Examination of Heart Function). This is Especially Important in Patients Who Have Been Diagnosed with Prolonged QT Interval or in Patients Who Are Taking Medicines that Prolong the QT Interval.

Children and Adolescents

The Use of This Medicinal Product is Contraindicated in Children and Adolescents Due to the Lack of Sufficient Clinical Trial Data in This Age Group.

Cavinton Forte 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 Any Medicinal Products You Plan to Take.
Cavinton Forte May Interfere with the Action of Other Medicinal Products or Other Medicinal Products May Affect Its Action.
You Should Tell Your Doctor, Especially if You Are Taking the Following Medicinal Products:

• Alpha-Methyldopa (a Medicinal Product Used to Treat High Blood Pressure);
• Anticoagulant Medicinal Products (Medicinal Products Used to Prevent Excessive Blood Coagulation);
• Anti-Arrhythmic Medicinal Products (Medicinal Products Used to Treat Heart Rhythm Disorders);
• Medicinal Products Acting on the Central Nervous System.

Cavinton Forte with Food and Drink

Cavinton Forte Should Be Taken After Meals.

Pregnancy and Breastfeeding

If You Are Pregnant or Breastfeeding, Think You May Be Pregnant or Are Planning to Have a Baby, You Should Consult Your Doctor or Pharmacist Before Using This Medicinal Product.
If You Are of Childbearing Age, You Must Use Effective Contraceptive Methods During Treatment with Cavinton Forte. Otherwise, the Administration of Vinpocetine is Contraindicated.
Cavinton Forte is Contraindicated During Pregnancy and Breastfeeding.

Driving and Using Machines

There is No Data on the Effect of Vinpocetine on the Ability to Drive and Use Machines.

Cavinton Forte Contains Lactose Monohydrate (Milk Sugar)

If You Have Been Diagnosed with Intolerance to Some Sugars, You Should Consult Your Doctor Before Taking the Medicinal Product.

3. How to Use Cavinton Forte

This Medicinal Product Should Always Be Used in Accordance with the Doctor's Recommendations. In Case of Doubt, You Should Consult a Doctor or a Pharmacist.
The Usual Dose of Cavinton Forte is 1 Tablet (10 mg) Three Times a Day (30 mg).
Tablets Should Be Taken After Meals.
The Break Line on the Tablet is Not Intended for Breaking the Tablet.
There is No Need to Change the Dose if the Patient Has Kidney or Liver Function Disorders.
There is No Need to Change the Dose if the Patient is Over 65 Years Old.

Use of a Higher Than Recommended Dose of Cavinton Forte

In Case of Taking a Higher Than Recommended Dose of Cavinton Forte, You Should Immediately Consult a Doctor or Go to the Nearest Hospital.

Missing a Dose of Cavinton Forte

You Should Not Take a Double Dose to Make Up for a Missed Dose. The Next Dose Should Be Taken at the Usual Time.
In Case of Any Further Doubts Related to the Use of This Medicinal Product, You Should Consult a Doctor or a Pharmacist .

4. Possible Side Effects

Like All Medicinal Products, This Medicinal Product Can Cause Side Effects, Although Not Everybody Gets Them.
The Side Effects Listed Below Are Grouped by Frequency of Occurrence.
Uncommon Side Effects (May Occur in Up to 1 in 100 People):

• Sleep Disorders (Insomnia, Drowsiness);
• Dizziness and Headaches, Weakness - These Symptoms May Be Related to the Underlying Disease;
• Changes in the ECG Record (Decrease in the ST Segment, Prolongation of the QT Interval), Tachycardia and Extra Heartbeats; These Symptoms Occurred Spontaneously, So it is Not Certain Whether the Use of Cavinton Forte Could Have Been the Cause of These Symptoms;
• Changes in Blood Pressure (Mainly Lower Blood Pressure Than Usual), Hot Flashes;
• 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, Which Can Cause Frequent Infections),
• Abdominal Pain.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Side Effects Not Mentioned in This Leaflet, You Should Inform 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,
Jerozolimskie Avenue 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 Gather More Information on the Safety of the Medicinal Product.

5. How to Store Cavinton Forte

The Medicinal Product Should Be Stored in a Place Invisible and Inaccessible to Children.
There are No Special Recommendations for the Storage Temperature of the Medicinal Product.
Store in the Original Packaging to Protect from Light.
Do Not Use This Medicinal Product After the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month.
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 Protect the Environment.

6. Contents of the Packaging and Other Information

What Cavinton Forte Contains

• The Active Substance of the Medicinal Product is Vinpocetine.
• The Other Ingredients Are: Colloidal Silica, Magnesium Stearate, Talc, Corn Starch, Lactose Monohydrate.

What Cavinton Forte Looks Like and What the Packaging Contains

White or Almost White Tablets, Flat in the Shape of a Disk, with Cut Edges with a Diameter of About 8 mm, with the Engraving "10 mg" on One Side and a Break Line on the Other Side.
The Medicinal Product is Packaged in PVC/Al Blisters.
The Carton Packaging Contains 30 or 90 Tablets.
For More Detailed Information, You Should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Romania, the Country of Export:

Gedeon Richter România S.A.
Cuza Vodă Street No. 99-105
540306 Târgu-Mureş, Romania

Manufacturer:

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

Parallel Importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska Street 249
04-458 Warsaw
Marketing Authorization Number in Romania, the Country of Export:8306/2015/01

Parallel Import Authorization Number: 299/22 Date of Approval of the Leaflet: 03.08.2022

[Information About the Trademark]