VINPOCETINE COVEX 5 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VINPOCETINE COVEX 5 mg tablets

vinpocetine

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 must not be given to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Vinpocetine Covex 5 mg tablets are and what they are used for.
2. What you need to know before taking Vinpocetine Covex 5 mg tablets.
3. How to take Vinpocetine Covex 5 mg tablets.
4. Possible adverse effects.
5. How to store Vinpocetine Covex 5 mg tablets.
6. Contents of the pack and other information.

1. What VINPOCETINE COVEX 5 mg tablets are and what they are used for

Vinpocetine Covex 5 mg tablets are 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 starting to take VINPOCETINE COVEX 5 mg tablets

Do not take Vinpocetine Covex 5 mg tablets:

• If you are allergic to vinpocetine or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have cerebral hemorrhage.
• If you have increased intracranial pressure.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vinpocetine Covex 5 mg tablets:

• If you have heart problems.
• If you are being treated with antiarrhythmics, antihypertensives, or anticoagulants.
• If you have hepatic impairment.
• If you have experienced intolerance to other vinca alkaloids.

Taking Vinpocetine Covex 5 mg tablets with other medicines

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

Although no interactions have been reported, the possibility of interaction between vinpocetine and antiarrhythmic, antihypertensive, or anticoagulant drugs cannot be ruled out. If treatment with vinpocetine is considered necessary in patients receiving the aforementioned medications, careful monitoring of therapy is advisable.

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.

The use of Vinpocetine Covex 5 mg tablets is not recommended during pregnancy and breastfeeding.

Driving and using machines

This medicine may impair reaction ability, thereby affecting the capacity to drive or operate machinery, especially if taken together with alcohol.

Vinpocetine Covex 5 mg tablets contain lactose

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

3. How to take VINPOCETINE COVEX 5 mg tablets

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

Vinpocetine Covex 5 mg tablets are administered orally. The dosage of Vinpocetine Covex 5 mg tablets is 1 or 2 tablets three times daily. It is recommended to take the tablets during meals without chewing them.

If you take more Vinpocetine Covex 5 mg tablets than you should

If you or someone else has ingested an overdose of vinpocetine, please inform your doctor, who will advise you on the necessary measures to take.

There are no reported cases of poisoning due to overdose with Vinpocetine Covex 5 mg tablets. In case of overdose or accidental intoxication, contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Vinpocetine Covex 5 mg tablets

Do not take a double dose to make up for missed doses. Simply skip the dose you forgot and take the next dose at your usual time.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Episodes of mild drop in blood pressure, gastric and intestinal discomfort (feeling of fullness or nausea), and skin reactions (rash or pruritus) due to hypersensitivity to the preparation have been reported.

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 through 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. Conservation of VINPOCETINE COVEX 5 mg tablets

Keep out of sight and reach of children.

This medicine does not require any special storage temperature.

Do not use Vinpocetine Covex 5 mg tablets after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vinpocetine Covex 5 mg tablets:

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

Appearance of the product and contents of the pack

Tablets are white, rounded, with the Covex logo () on one side and a score line on the other.

Pack: The tablets are packaged in PVC/aluminum blisters containing 25 tablets and presented in cartons of 25 and 50 tablets.

Marketing Authorization Holder

COVEX, S.A.

C/ Acero nº 25, Pol. Ind. Sur, 28770 COLMENAR VIEJO (Madrid).

Tel: 91 845 02 00

Fax: 91 845 02 08

e-mail: [email protected]

Manufacturer responsible

KERN PHARMA, S.L.

C/ Venus nº 72, Pol. Ind. Colón II, 08228 TERRASSA (Barcelona).

Tel: 93 700 25 25

Fax: 93 700 25 00

e-mail: [email protected]

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II, 28923, ALCORCÓN, (Madrid).

Tel: 91 486 29 90

Fax: 91 486 29 91

e-mail: [email protected]

COVEX, S.A.

C/ Acero nº 25, Pol. Ind. Sur, 28770 COLMENAR VIEJO (Madrid).

Tel: 91 845 02 00

Fax: 91 845 02 08

e-mail: [email protected]

Date of the most recent revision of this leaflet: June 2020

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