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Description
The instruction
for medical use of medicine
Tanakanum
the Trade name
Tanakanum
the International unlicensed name
Is not present
the Dosage form
of the Tablet, coated 40 mg
Structure
One tablet contains
active agent: extract of a ginkgo of a bilob of standardized (EGb 761), the ginkgo containing 24% of glycosides and 6% of ginkgolidov-bilobalid of 40 mg,
auxiliary components: lactose, cellulose microcrystalline, starch corn, silicon colloidal anhydrous, talc, magnesium stearate
structure of a cover: a macrogoal 400, a gipromeloza, a macrogoal 6000, the titan dioxide (E171), ferrous oxide red (E172)
the Description
of the Tablet of a biconvex form, round, coated brick-red color, on a break – beige color. Specific smell.
Pharmacotherapeutic group
Drugs for treatment of diseases of nervous system. Psychoanaleptics. Drugs for treatment of dementia. Other drugs for treatment of dementia. A ginkgo of a bilob
the ATX N06DX02 Code
the Pharmacological
Pharmacokinetics Later properties of oral introduction of 120 mg of extract of a ginkgo in the form of solution the average absolute bioavailability of terpenic lactones of a ginkgolid And was 80%, a ginkgolid In – 88%, a bilobalida – 79%. After intake of extract of a ginkgo in the form of tablets the peaks of plasma concentration of terpenic lactones were in range of 16-22 ng/ml for a ginkgolid And, 8-10 ng/ml for a ginkgolid In and 27-54 ng/ml for a bilobalid. Half-life periods of a ginkgolid And yes In and a bilobalida were 3-4, 4-6 and 2-3 hours respectively.
After reception of 120 mg of extract of a ginkgo in the form of solution the peaks of plasma concentration of extract made 25-33 ng/ml, 9-17 ng/ml and 19-35 ng/ml for a ginkgolid And, In and a bilobalida respectively. The connected elimination half-life for a ginkgolid And made 5 hours, for a ginkgolid In – 9-11 hours, and for a bilobalid – 3-4 hours.
The pharmacodynamics
EGb761 Tanakanum represents medicine of plant origin. The exact mechanism of effect of drug is unknown. Data of pharmacological researches showed increase in EEG of caution (vigilance) at elderly subjects, decrease in viscosity of blood and improvement of cerebral perfusion in certain areas at healthy men (60-70 years) and decrease in aggregation of thrombocytes. Besides, the vasodilating action on blood vessels of a forearm causing increase in a regional blood-groove is shown.
Indications
– symptomatic treatment of cognitive disturbances at the adult and elderly people (who are shown, mainly, following symptoms: decrease in attention, speed of thinking, memory loss, deterioration in mental abilities, speech functions, depressions, including as a result of age changes), except for patients with the confirmed dementia, the Parkinson’s disease, cognitive disturbances of iatrogenic origin or cognitive disturbances secondary in relation to a depression or metabolic diseases
– treatment of dizziness at damage of a vestibular mechanism
– symptomatic treatment of sonitus
the Route of administration and doses
Inside, on 1 tablet 3 times a day at meal time, washing down also frac12, a glass of water.
Duration of a course of treatment is from 1 to 3 months.
Side effects
by the Most frequent side reactions (& gt, 5%) received during five years’ clinical trial for assessment of efficiency and tolerance of the drug Tanakanum on 120 mg twice a day at patients are more senior than 70 years, there were in an abdominal pain, diarrhea and dizziness.
Classification of frequency of side reactions in this islledovaniye was following: often (& ge, 1/100 to & lt, 1/10), infrequently (from 1/1000 to & lt, 1/100), it is rare (& ge, 1/10000 to & lt, 1/1000).
System body
the class Frequency Side Reaction
Disturbances from the immune system
Often
Hypersensitivity, dispnoe
Infrequently
the Small tortoiseshell
Seldom
Angioedema (Quincke’s edema)
Disturbances from nervous system
the Dizziness, a headache, a faint
Disturbances is frequent from digestive tract
Often
the Abdominal pain, diarrhea, dyspepsia, nausea
Disturbances from skin and hypodermic fabric
Often
Eczema, an itching
Infrequently
Rash
Contraindications
– hypersensitivity to drug components
– pregnancy and the period of a lactation (due to the lack of data)
– to persons with hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, galactose glucose malabsorption
– to children and teenagers up to 18 years
Medicinal interactions
Simultaneous use of the drugs containing Ginkgo biloba with anticoagulants (for example, fenprokumon and warfarin) or antithrombocytic drugs (for example, klopidogrel, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs) can influence effect of the listed drugs.
The available researches with warfarin do not indicate interaction between warfarin and the drugs containing Ginkgo biloba, but adequate monitoring at drug treatment start is recommended, to the containing ginkgoes, at change of a dosage of drug of a ginkgo, at the termination of administration of drug of a ginkgo or when replacing one drug of a ginkgo by another.
The interaction research with Talinololum shows that Ginkgo biloba can inhibit a P-glycoprotein at the intestinal level. It can lead to increase in exposure of drugs on which the R-glycoprotein has considerable impact in intestines (for example, a dabigatrana eteksilat). It is recommended to show care at a combination of drugs of a ginkgo and a dabigatran.
One research of interaction showed that Ginkgo biloba can influence increase in Cmax of nifedipine. At some patients the increase by 100% was observed that led to dizziness and strengthening of weight of inflows.
Simultaneous use of drugs of a ginkgo and efavirenz is not recommended, plasma concentration of an efavirenz can be reduced because of induction of CYP3A4.
The special
instructions This Medicine contains lactose. It is contraindicated to persons with congenital intolerance of a galactose, a lactose intolerance or a syndrome of glucosic or galaktozny malabsorption.
At patients with patholologically the increased tendency to bleeding (hemorrhagic diathesis) and the accompanying anticoagulating and antithrombocytic therapy EGb761 Tanakanum should be applied only after consultation with the doctor.
The drugs containing a ginkgo can increase susceptibility to bleedings. Therefore, as a precautionary measure, intake of Tanakanum should be stopped in 3-4 weeks prior to planned operation.
At patients with epilepsy it is impossible to exclude emergence of the new attacks provoked by administration of drugs of a ginkgo.
Simultaneous use of the drugs containing a ginkgo of a bilob, and an efavirenz is not recommended.
Pregnancy and a lactation
Pregnancy
Ginkgo biloba Extracts can reduce ability of thrombocytes to aggregation, the tendency to bleeding can be as a result increased. The available data are insufficient concerning reproductive toxicity. Use of drug is contraindicated during pregnancy.
A lactation
It is unknown whether Ginkgo biloba or its metabolites with human milk is excreted. Due to the lack of sufficient data, use of drug during breastfeeding is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Researches of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms it was not carried out
Overdose
overdose Cases by drug
the Form of release and packing
On 15 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil are not known. On 2 or 6 packs together with the instruction for use in the state and Russian languages put
Storage conditions in a cardboard pack
to Store at a temperature not over 25C
to Store out of children’s reach!
A period of storage
3 years
not to apply after expiry date
Prescription status
Without prescription
the Producer Beaufour Ipsen Industrie 28100 Dreux, France Packer of Beaufour Ipsen Industrie 28100 Dreux, France
the Name and the country of the holder of the registration certificate
of Ipsen Pharma SAS, France
the Address of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine:
Representative office of JSC IPSEN PHARMA (IPSEN FARMA) in RK
050040 Almaty, Al-Farabi Ave., 45, office 2
Ph./fax: 8 (727) 2646448, 2646715
E-mail address:
To Develop pharmacovigilance.kazakhstan@ipsen.com
Additional information
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