Vinpocetine Covex 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Vinpocetina Covex 10 mg tablets

vinpocetina

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

1. What Vinpocetina Covex is and what it is used for
2. What you need to know before taking Vinpocetina Covex
3. How to take Vinpocetina Covex
4. Possible adverse effects
5. How to store Vinpocetina Covex
6. Contents of the pack and other information

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

Vinpocetina Covex is indicated for the treatment of cognitive impairment symptoms related to cerebral vascular disease. Before starting treatment, degenerative disease of non-vascular origin (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 vinpocetine or to any other vinca alkaloid (for example, vincamine, vinblastine, vincristine, vindesine, vinflunine or vinorelbine) or to any of the other ingredients of this medicine (listed in section 6);
• if you have recently had a cerebral haemorrhage;
• if you have increased intracranial pressure (elevated blood pressure within the skull);
• if you are pregnant or breastfeeding.

Warnings and precautions

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

• if you have heart problems.
• if you are being treated with medicines that have antiplatelet or anticoagulant effects (for example, aspirin, clopidogrel, diclofenac, ibuprofen, naproxen, dalteparin, enoxaparin, heparin, acenocoumarol or warfarin), antiarrhythmics (medicines to prevent heart arrhythmias) or antihypertensives (medicines to lower blood pressure) (see “Other medicines and Vinpocetina Covex”).
• if you have liver problems.
• if you have experienced intolerance to other vinca alkaloids (for example, 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 medicines and Vinpocetina Covex

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

Specifically, inform your doctor if you are taking any of the following medicines:

• medicines with antiplatelet or anticoagulant effects, such as aspirin, clopidogrel, diclofenac, ibuprofen, naproxen, dalteparin, enoxaparin, heparin, acenocoumarol or warfarin, and similar medicines due to the risk of bleeding.
• antiarrhythmics (medicines to prevent heart arrhythmias) or antihypertensives (medicines to lower blood pressure).
• medicines such as phenytoin, acenocoumarol, warfarin or non-steroidal anti-inflammatory drugs (for example, ibuprofen, diclofenac, celecoxib), because vinpocetine could increase blood levels of these medicines.

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 medicine.

Vinpocetina Covex must not be administered to pregnant women or during the breastfeeding period (see section 2 – “Do not take Vinpocetina Covex*”).

Driving and using machines

This medicine may affect reaction ability, impairing your capacity to drive or operate machinery, especially if taken together with alcohol.

Vinpocetina Covex contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Vinpocetina Covex

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

If you take more Vinpocetina Covex than you should

There are no reported cases of poisoning 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 at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vinpocetina Covex

Do not take a double dose to make up for missed doses. If you forget a dose, wait until the next scheduled dose at its usual time.

If you stop taking Vinpocetina Covex

Do not interrupt the treatment unless your doctor instructs you to do so. Consult your doctor or pharmacist before stopping treatment with Vinpocetina Covex.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• headache,
• dizziness (sensation that everything is spinning),
• low blood pressure (hypotension),
• skin rashes and itching.

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

• sleep disturbances,
• nervousness,
• anxiety,
• distress,
• sensation of numbness or tingling,
• tachycardia (increased heart rate),
• palpitations,
• changes in electrocardiogram,
• abdominal pain,
• nausea.

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

• dyspepsia (feeling of fullness).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

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

5. Storage of Vinpocetine Covex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vinpocetine Covex

• The active substance is vinpocetine.
• The other components are monohydrate lactose, low-substituted hydroxypropylcellulose, magnesium stearate and talc.

Appearance of the product and contents of the pack

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

Pack: The tablets are packed in PVC/aluminum blisters containing 15 tablets and presented in cartons 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: [email protected]

Manufacturer:

COVEX, S.A.

C/ Acero nº 25, Pol. Ind. Sur, 28770
Colmenar Viejo (Madrid) - Spain

Date of the most recent revision of this leaflet: September 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/.