VINPOCETINE COVEX 10 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Vinpocetina Covex 10 mg tablets

vinpocetina

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this summary of product characteristics. See section 4.

Contents of the Summary of Product Characteristics

1. What is Vinpocetina Covex and what is it used for
2. What you need to know before taking Vinpocetina Covex
3. How to take Vinpocetina Covex
4. Possible side effects
5. Storage of Vinpocetina Covex
6. Package contents and additional information

1. What is Vinpocetina Covex and what is it used for

Vinpocetina Covex is indicated for the treatment of cognitive impairment symptoms related to cerebral vascular pathology. Before starting treatment, non-vascular degenerative disease (Alzheimer's disease) should be ruled out.

2. What you need to know before taking Vinpocetina Covex

Do not take Vinpocetina Covex

• if you are allergic to vinpocetina or any other vinca alkaloid (e.g., vincamine, vinblastine, vincristine, vindesine, vinflunine, or vinorelbine) or to any of the other components of the medication (listed in section 6);
• if you have recently suffered a cerebral hemorrhage;
• if you have cranial hypertension (increased blood pressure inside the skull);
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vinpocetina Covex:

• if you have heart problems.
• if you are being treated with medications that have anti-aggregant or anticoagulant effects (such as aspirin, clopidogrel, diclofenac, ibuprofen, naproxen, dalteparin, enoxaparin, heparin, acenocoumarol, or warfarin), anti-arrhythmics (medications to prevent heart rhythm disorders), or anti-hypertensives (medications to lower blood pressure) (see "Other medications and Vinpocetina Covex").
• if you have liver problems.
• if you have experienced intolerance to other vinca alkaloids (such as vinblastine, vincristine, vindesine, vinorelbine).

Children and adolescents

The use of Vinpocetina Covex is not recommended in children and adolescents under 18 years of age.

Other medications and Vinpocetina Covex

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In particular, inform your doctor if you are taking any of the following medications:

• medications with anti-aggregant or anticoagulant effects, such as aspirin, clopidogrel, diclofenac, ibuprofen, naproxen, dalteparin, enoxaparin, heparin, acenocoumarol, or warfarin, and similar medications, due to the risk of bleeding.
• anti-arrhythmics (medications to prevent heart rhythm disorders) or anti-hypertensives (medications to lower blood pressure).
• medications such as phenytoin, acenocoumarol, warfarin, or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac, celecoxib), as vinpocetina may increase the blood levels of these medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Vinpocetina Covex should not be administered to pregnant or breastfeeding women (see section 2 - "Do not take Vinpocetina Covex").

Driving and using machines

This medication may affect your reaction ability, which can impair your ability to drive and use machinery, especially when taken with alcohol.

Vinpocetina Covex contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Vinpocetina Covex

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is half or one tablet (5 or 10 mg) of vinpocetina three times a day orally. It is recommended to take the tablets during meals, without chewing them.

If you take more Vinpocetina Covex than you should

There are no known cases of intoxication due to overdose with Vinpocetina Covex.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vinpocetina Covex

Do not take a double dose to make up for forgotten doses. If you forget a dose, wait for the next scheduled dose.

If you stop taking Vinpocetina Covex

Do not stop treatment unless your doctor tells you to. Consult your doctor or pharmacist before stopping treatment with Vinpocetina Covex.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon(may affect up to 1 in 100 people):

• headache,
• dizziness (feeling of spinning),
• low blood pressure (hypotension),
• skin rash and itching.

Rare(may affect up to 1 in 1,000 people):

• sleep disturbances,
• nervousness,
• anxiety,
• anguish,
• numbness or tingling sensation,
• rapid heart rate (tachycardia),
• palpitations,
• electrocardiogram changes,
• abdominal pain
• nausea.

Very rare(may affect up to 1 in 10,000 people):

• dyspepsia (feeling of fullness).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics.

You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Vinpocetina Covex

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Vinpocetina Covex

• The active ingredient is vinpocetina.
• The other components are lactose monohydrate, low-substitution hydroxypropyl cellulose, magnesium stearate, and talc.

Appearance and packaging of the product

White, round tablets with the Covex logo on one side and a score line on the other. The tablet can be divided into equal doses.

Packaging: The tablets are packaged in PVC/aluminum blisters of 15 tablets and presented in boxes of 45 or 90 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

COVEX, S.A.

C/ Acero nº 25, Pol. Ind. Sur, 28770

Colmenar Viejo (Madrid) - Spain

Tel: 91 845 02 00

e-mail: info@covex.com

Manufacturer:

COVEX, S.A.

C/ Acero nº 25, Pol. Ind. Sur, 28770

Colmenar Viejo (Madrid) - Spain

Date of the last revision of this summary of product characteristics: September 2020.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/.