Leaflet: information for the user

VINPOCETINA COVEX 5 mg tablets

vinpocetine

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Vinpocetina Covex 5 mg tablets is indicated for the treatment of symptoms of cognitive decline related to cerebral vascular pathology. Before starting treatment, a non-vascular degenerative disease (Alzheimer's disease) should be ruled out.

Do not take Vinpocetina 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 a cerebral hemorrhage.
• If you have increased intracranial pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vinpocetina Covex 5 mg tablets

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

Taking Vinpocetina Covex 5 mg tablets with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine.

Although not described, it cannot be ruled out that there may be an interaction between vinpocetine and antiarrhythmic, antihypertensive or anticoagulant drugs. If treatment with vinpocetine is considered necessary in patients being treated with the mentioned drugs, it is advisable to monitor the treatment.

Pregnancy and breastfeeding

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

Vinpocetina Covex 5 mg tablets are not recommended for use during pregnancy and lactation.

Driving and operating machinery

This medicine may affect your ability to react, which may impair your ability to drive and operate machinery, especially when taken with alcohol.

Vinpocetina Covex 5 mg tablets contain lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Vinpocetina Covex 5 mg tablets are administered orally. The dosage of Vinpocetina Covex 5 mg tablets is 1 or 2 tablets three times a day. It is recommended to ingest the tablets during meals, without chewing them.

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

If you or another person has ingested an overdose of vinpocetine, please inform your doctor who will instruct you on the measures to take.

No cases of intoxication due to overdosing with Vinpocetina Covex 5 mg tablets have been reported. In case of overdose or accidental poisoning, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Vinpocetina Covex 5 mg tablets

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Mild episodes of blood pressure drop, gastrointestinal discomfort (feeling of fullness or nausea), and skin alterations (rash or pruritus) due to hypersensitivity to the preparation have been described.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the sight and reach of children.

This medication does not require any special temperature for conservation.

Do not use Vinpocetina Covex 5 mg tablets after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so,you will help protect the environment.

Composition of Vinpocetina Covex 5 mg tablets:

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

Appearance of the product and content of the packaging:

White, rounded tablets with the Covex logo ( ) on one face and a groove on the other.

Package: the tablets are packaged in PVC/aluminum blisters of 25 tablets and are presented in boxes of 25 and 50 tablets.

Holder of the marketing authorization:

COVEX, S.A.

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

Tel: 91 845 02 00

Telefax: 91 845 02 08

e-mail: [email protected]

Responsible for manufacturing:

KERN PHARMA, S.L.

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

Tel: 93 700 25 25

Telefax: 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

Telefax: 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

Telefax: 91 845 02 08

e-mail: [email protected]

Last review date of this leaflet: June 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .