Description
Package leaflet: information for the patient
VINPOCETINE COVEX 5 mg tablets
vinpocetine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this insert, as you may need to read it again. In the case of any queries, consult your doctor or pharmacist.
This medicine has been prescribed for you only and should not be given to any other person, even if they have the same symptoms as yours, as it may be harmful for them. If you get any side effects, talk to your doctor or pharmacist even if they are not listed in this leaflet. See section 4.
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What is in this leaflet: 1. What Vinpocetine Covex 5 mg tablets is and what it is used for. 2. What you need to know before you take Vinpocetine Covex 5 mg tablets.
How to take Vinpocetine Covex 5 mg tablets. Possible side effects. How to store Vinpocetine Covex 5 mg tablets. Contents of the pack and additional information.
- 1.
What VINPOCETINE COVEX 5 mg tablets is and what it is used for
Vinpocetine Covex 5 mg tablets is indicated for the treatment of cognitive impairment symptoms related to cerebral vascular pathology. Before starting treatment, degenerative disease of non-vascular cause (Alzheimer’s disease) must be ruled out.
What you need to know before you take VINPOCETINE COVEX 5 mg tablets
Do not take Vinpocetine Covex 5 mg tablets: – If you are allergic to vinpocetine or any of the other drug components of this
medicine (listed in section 6). If you are pregnant or breastfeeding. If you suffer a cerebral hemorrhage. If you have cranial hypertension.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Vinpocetine Covex 5 mg tablets
If you suffer from heart condition. If you are under treatment with antiarrhythmic, antihypertensive or anticoagulant drugs. If you suffer from hepatic insufficiency. If you have experienced intolerance to other vinca alkaloids.
SOCIEDA ANONIMA
O COLN
Ministry of Health, Social Policy and Equality/ Spanish Agency for Medicines and Health Products
Taking Vinpocetine Covex 5 mg tablets with other medicines Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Although none has been described, the possibility of interaction between vinpocetine and antiarrhythmic, antihypertensive or anticoagulant drugs cannot be discarded. If treatment with vinpocetine is considered necessary in patients who are taking the aforementioned drugs, it is recommended that the treatment be monitored.
Pregnancy and breastfeeding If you are pregnant or breast–feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
tration of Vinpocetine Covex 5 mg tablets is not recommended during pregnancy or breastfeeding.
Driving and using machines
This medication may alter reaction capacity, which is detrimental for driving and operating machinery particularly in those cases where the drug is consumed together with alcohol.
Vinpocetine Covex 5 mg tablets contains lactose This medicine contains lactose. If your doctor has indicated that you suffer from intolerance to certain sugars, consult with him before taking this medicine.
How to take VINPOCETINE COVEX 5 mg tablets
Follow the instructions exactly regarding the administration of this medicine indicated by your doctor. If you are not sure, consult again your doctor or pharmacist.
Vinpocetine Covex 5 mg tablets are administered orally. The dosage of Vinpocetine Covex 5 mg tablets is 1 or 2 tablets three times per day. It is recommended that the tablets be taken during meals, without chewing them.
If you take more Vinpocetine Covex 5 mg tablets than you should If you or another person have taken an overdose of vinpocetine, please inform your doctor, who will indicate what measures you should take.
There is no record of cases of intoxication due to overdose with Vinpocetine Covex 5 mg tablets. In the event of an accidental intoxication or overdose consult the Toxicology
Information Service, Telephone 91 562 04 20.
If you forgot to take Vinpocetine Covex 5 mg tablets Do not take a double dose to compensate the missed doses. Simply skip the missed dose and take the next one at the normal time.
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Ministry of Health, Social Policy and Equality/ Spanish Agency for Medicines and Health Products
Possible side effects
As occurs with all medication, this medicine can cause side effects, even if not everyone has them.
Episodes of slight decrease in blood pressure, gastric and intestinal discomfort (feeling of fullness or nausea) and skin alterations (exanthema or itching) have been described as a result of hypersensitivity to the preparation.
Reporting of side effects; If you get any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store VINPOCETINE COVEX 5 mg tablets
Keep this medicine out of the sight and reach of children. This medicine does not require any special temperature for storage.
Do not use Vinpocetine Covex 5 mg tablets after the expiry date indicated on the box after CAD. The expiry date refers to the last day of that month.
Medication should not be disposed of down drains or in rubbish bins. Leave unwanted packaging and medication at the SIGRE Point at the pharmacy. If in your pharmacist how to dispose of packaging and medication that you no longer need. In this way, you will be helping to protect the environment.
Contents of the pack and additional information
Composition of Vinpocetine Covex 5 mg tablets
The active ingredient is vinpocetine The other components are lactose, low-substituted hydroxypropylcellulose, magnesium stearate and talc.
Product appearance and content of the package
White, rounded tablets, with the Covex logo ( D on one of its sides and a score line on the other side.
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Packaging: the tablets are presented in PVC/aluminium blisters containing 25 tablets in each blister and in boxes of 25 or 50 tablets.
SOGEDE ANONIMA
Marketing Authorisation Holder COVEX, S.A. C/ Acero no 25, Pol. Ind. Sur, 28770 COLMENAR VIEJO (Madrid).
Ministry of Health, Social Policy and Equality/ Spanish Agency for Medicines and Health Products
Tel.: 91 845 02 00 Fax: 91 845 02 08 E–mail: info@covex.com
Responsible for the manufacture: KERN PHARMA, S.L.
C/ Venus n° 72, Pol. Ind. Colón II, 08228 TERRASSA (Barcelona). Tel.: 93 700 25 25 Fax: 93 700 25 00 e–mail: info@kernpharma.com
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: vir@vir.es
This insert has been approved in November 2011
Detailed and up-to-date information regarding this medication is available on the website of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/.
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