1. Name of the Medicinal
Vinpocetine Covex 5 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of vinpocetine.
Each tablet contains 66.55 mg lactose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White and rounded tablets with Covex logo on one side and a groove in the other.
The groove is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4. CLINICAL DATA
4.1 Therapeutic indications
Treating the symptoms of cognitive impairment associated with cerebrovascular disease.
Before starting treatment should not be ruled degenerative disease of vascular cause (Alzheimer’s disease).
4.2 Dosage and method of administration
For oral use:
1-2 tablets 3 times daily for a maximum period of 30 days, followed by 1 tablet 3 times daily for a period of two months. The potential benefit of longer treatment is unknown.
Tablets should be taken during meals, without chewing.
Hypersensitivity to vinpocetine and / or any of its excipients.
Recent brain hemorrhage.
4.4 Special warnings and precautions for use
Should be used with caution in patients with cardiac arrhythmias, should be avoided as far as possible the use of vinpocetine Covex 5 mg tablets in patients with prolonged QT interval, because in them the risk of ventricular arrhythmias is greater; likewise, it should be administered with caution in those who are treated with antihypertensive drugs or drugs that may prolong the QT interval, which have a history of intolerance during treatment with other vinca alkaloids and in patients with liver failure.
Patients with rare hereditary problems of galactose, with Lapp lactase deficiency (insufficiency observed in certain populations of Lapland) or malabsorption of glucose or galactose should not take this medicine intolerance.
4.5 Interaction with other medicinal products and other forms of interaction
You can not rule out interaction with antihypertensive, antiarrhythmic or anticoagulant drugs. Therefore it must be closely monitored in patients treated with 5 mg tablets Vinpocetine Covex and any of these medicines.
4.6 Pregnancy and lactation
It should not be administered during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Vinpocetine Covex 5 mg tablets may impair reaction which impairs the ability to drive and use machines. Especially in cases of ingestion of the drug with alcohol.
4.8 Undesirable effects
Adverse reactions are listed below by frequency, beginning with the most common, using the MedDRA convention:
While using Vinpocetine Covex 5 mg tablets described the following adverse reactions:
Rare (≥1/10.000 a <1/1.000): sleep disturbances, nervousness, anxiety.
Nervous system disorders
Uncommon (≥1/1.000 a <1/100): tension headache.
Rare (≥1/10.000 a <1/1.000): anxiety, paresthesia.
Disorders of the ear and labyrinth
Uncommon (≥1/1.000 a <1/100): dizziness.
Rare (≥1/10.000 a <1/1.000): tachycardia or premature and prolongs ventricular excitability (QT interval).
Uncommon (≥1/1.000 a <1/100): slight reduction in blood pressure.
Rare (≥1/10.000 a <1/1.000): abdominal pain or nausea.
Very rare (<1/10.000): gastrointestinal disorders such as dyspepsia.
Disorders of the skin and subcutaneous tissue
Uncommon (≥1/1.000 a <1/100): rash or itching.
There is no evidence so far of overdosage. Accidental poisoning general measures of elimination of the drug, symptomatic and supportive treatment is recommended, focusing primarily on cardiorespiratory function.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other psychostimulants and nootropics, N06BX.
ATC code: N06BX18.
Vinpocetine is a synthetic derivative of vincamine nootropics medications included among its vasodilator and activator of cerebral metabolism level effect.
Its effects have been studied in animals preferably: vasodilating action mediated inhibition of phosphodiesterase activity and increase cAMP levels, with increased blood flow by decreasing vascular resistance; antiplatelet action; hemorheological improvement of microcirculatory conditions to increase the deformability of erythrocytes; increased tolerance of brain cells to hypoxia and / or ischemia; Increased levels of oxygen and glucose utilization by neurons; improvement of the production of neurotransmitters like dopamine and noradrenaline, which has been attributed its nootropic effect.
None of these effects have been associated with clinical benefit observed.
5.2 Pharmacokinetic properties
Vinpocetine Covex 5 mg tablets are rapidly absorbed after oral administration, reaching peak concentration in 1.5 hours. Its bioavailability is highly variable, ranging from 7-57%, and increases with simultaneous food intake.
The volume of distribution is approximately 3 L / kg in young adults and higher values have been reported in the elderly (about 7 l / kg).
Vinpocetine is extensively metabolized in the liver, with the apovincamínico acid (VPA), the main metabolite resulting apparently devoid of pharmacological activity.
Its elimination half-life is about 2 hours. AVA vinpocetine and excreted by the kidneys.
5.3 Preclinical safety data
Preclinical data support the safety profile of this product is suitable for use in humans, except in pregnant women.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Lactose, hydroxypropyl cellulose low substituted, magnesium stearate and talc.
6.3 Shelf life
The drug has a validity period of five years from the date of manufacture.
6.4 Special precautions for storage
This medicine does not require any special storage conditions.
6.5 Nature and contents of container
Vinpocetine Covex 5 mg tablets is presented in a cardboard box containing one or two PVC-aluminum blisters. Each blister contains 25 tablets.
6.6 Special precautions for disposal
No special conditions for use and handling, except those of any medicine.
7. HOLDER OF THE MARKETING AUTHORIZATION
C/ Acero 25, Poligono Industrial Sur
28770 – Colmenar Viejo (Madrid)
Phone:(+34) 91 845 02 00
Fax:(+34) 91 845 02 08
8. NUMBER (S) MARKETING AUTHORIZATION
9. DATE OF FIRST AUTHORIZATION
10. DATE OF REVISION OF THE TEXT