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Betaserc® (Betahistine Dihydrochloride) 24 mg, 60 tablets

$64.00

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Description

The instruction
for medical use

of Betaserk® medicine

the Trade name
of Betaserk®

the International unlicensed

name Betagistin Lekarstvennaya a form
of the Tablet of 8 mg, 16 mg and 24 mg

Structure
One tablet contains
active agent – a betagistin dihydrochloride of 8 mg, either 16 mg, or 24 mg,
excipients: microcrystalline cellulose, Mannitolum, citric acid monohydrate, silicon dioxide colloidal anhydrous, talc.

The description
of the Tablet of round shape, flat, white or almost white color, with slanted edges with the inscription 256 on one party of a tablet (for a dosage of 8 mg).
Tablets of round shape, with a biconvex surface, white or almost white color, with slanted edges, from a tablet, risky on one party, and with the inscription 267 on both sides from risks (for a dosage of 16 mg). The tablet is divided into two equal half.
Tablets of round shape, with a biconvex surface, white or almost white color, with slanted edges, with risky on one party and with the inscription 289 on both sides from risks (for a dosage of 24 mg). Dividing risk it is intended for a tablet razlamyvaniye for the purpose of swallowing simplification, but not for division into two equal doses.
Pharmacotherapeutic group
of Means for elimination of dizziness. Betagistin.
The ATX N07CA01 code

the Pharmacological

Pharmacokinetics At properties intake betagistin is soaked up from digestive tract and metabolized quickly and almost completely. The main metabolite – 2-PAA (2-pyridylacetic acid) which has no pharmacological activity. Levels of a betagistin in plasma very low. Therefore all pharmacokinetic analysis is based on determination of level 2-PAA in blood plasma and urine.
The maximum concentration 2-PAA at Betaserk’s reception together with food
below, than at reception on an empty stomach. However meal does not influence extent of absorption of a betagistin, and only slows down it as the indicator of the general absorption is identical under both conditions.
Extent of linking of a betagistin with blood plasma proteins less than 5%.
The maximum concentration 2-PAA in blood plasma is reached in 1 hour
after Betaserk’s reception. Elimination half-life about 3.5 hours.
2-PAA it is quickly removed by kidneys. In the range of doses between 8 and 48 mg about 85% of the entered dose are removed with urine. A renal or fecal way of excretion of a betagistin have small value.
Clearance rate which remains to a constant at intake of a dose
of a betagistin from 8 to 48 mg indicates the linear nature of its pharmacokinetics and that the involved ways of metabolism are not saturated.
A pharmacodynamics
the Mechanism of action of a betagistin is studied insufficiently. There are several convincing hypotheses which are confirmed by data of clinical and preclinical trials.
Betagistin influences a gistaminergichesky system:
In biochemical researches it is established what betagistin is weak N1-agonist and the strong antagonist of H3 receptors as in tissue of nervous system and has practically no affinity to H2 receptors. Бетасерк® increases development and emission of a histamine by means of blocking presynaptic H3 receptors and also reducing quantity of H3 receptors.
Betagistin improves microcirculation both in cochlear area, and in tissue of all brain:
Pharmacological data confirm improvement of microcirculation in a vascular stripe of an inner ear, perhaps, by means of relaxation of a precapillary sphincter of microvessels of an inner ear. It is shown also that Betaserk® raises a cerebral blood stream at the person.
Betagistin facilitates vestibular compensation:
Betagistin accelerates restoration of vestibular function after unilateral neurectomy at animals, facilitating and accelerating processes of the central vestibular compensation. This effect is characterized by increase in a vypabotka and emission of a histamine and carried out thanks to antagonism of H3 receptors. At the person the restoration period after vestibular neurectomy decreases at treatment of Betaserkom®.
Betagistin changes excitement of neurons in vestibular nuclei:
Бетасерк® renders dose-dependent overwhelming effect on generation of peaks in neurons of lateral and medial vestibular nuclei.
The Pharmakodinamichesky properties shown in preclinical trials can explain therapeutic advantages of a betagistin at treatment of vestibular disorders. The efficiency of Betaserka® was proved in clinical trials at treatment of patients with vestibular dizziness and Menyer’s disease with improvement of indicators of weight and frequency of attacks of a golovkruzheniye.

Indications
– a syndrome of Menyer which is characterized by a triad of the main symptoms, including the dizziness (which is followed by nausea and vomiting), sonitus, the progressing decrease in hearing (relative deafness)
– symptomatic treatment of vestibular dizziness

the Route of administration and doses
mg Tablets 8 and 16:
The daily dose for adults makes 24-48 mg which is divided into 2-3 receptions:

Tablets of 8 mg

of the Tablet of 16 mg

1-2 tablets 3 times a day

1/2-1 tablet
3 times in day

of the Tablet of 24 mg:
The daily dose for adults makes 48 mg divided into 2 receptions.

Tablets of 24 mg

1 tablet
2 times a day

throughout treatment adjust a dose depending on therapeutic effect. The stable therapeutic effect occurs after two weeks of treatment. The best results are sometimes observed after several months of treatment. The early initiation of treatment warns a hearing loss at later stages of a disease.
Children and teenagers: Бетасерк® it is not recommended to persons to appoint younger than 18 years as data on safety and efficiency are not enough.
Special groups of patients: special selection of a dose of Betaserka® at elderly, patients with a renal and liver failure is not required.

Side effect
Is frequent (according to clinical trials):
– nausea, dyspepsia
– a headache (frequency is comparable with the group accepting placebo)
Frequency is unknown (according to post-marketing experience of use):
– reactions of hypersensitivity (anaphylactic reactions), including from integuments (Quincke’s edema, rash, an itching, urticaria)
– vomiting, an abdominal pain, a meteorism (it is possible to facilitate development of these symptoms if to take the drug at meal time or to reduce a dose)

Contraindications
– hypersensitivity to active or to any of auxiliary components of drug
– a pheochromocytoma

Medicinal interactions
of Special researches on studying interaction it was not carried out. On the basis of these in vitro, interaction with enzymes of in Vivo P450 cytochrome is not expected.
Results of the researches in vitro showed that metabolism of a betagistin is suppressed with drugs which suppress a monoaminooxidase (MAO), including subtype B (for example, seleginin). Therefore it is recommended to be careful at co-administration of Betaserk and MAO inhibitors (including selection MAO-B).
As betagistin is a histamine analog, at joint purpose of Betaserka®s antihistaminic drugs decrease in efficiency of one of drugs is possible.

Special instructions
Patients with bronchial asthma and/or a peptic ulcer of a stomach in the anamnesis need careful observation during treatment by Betaserk.
Pregnancy and breastfeeding
of Data on safety of use of Betaserk for pregnant women are not enough. The potential risk for a fruit of the person and newborns is unknown. Бетасерк® it is not necessary to apply during pregnancy if only the expected advantage for mother does not exceed potential risk for the fruit / child. It is not known whether gets betagistin into breast milk. In need of Betaserk’s appointment to the feeding woman, it is necessary to cancel breastfeeding.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous
Betaserk® mechanisms has no sedation and does not affect ability to drive the car or to work on machines and the mechanism.

Overdose
Symptoms: nausea, drowsiness, an abdominal pain of light and moderate expressiveness at a dose up to 640 mg. More serious complications (spasms, symptoms from lungs or heart) were observed in cases of intended overdose, especially in a combination with other drugs.
Treatment: symptomatic and maintenance therapy.

Form of release and packing
of the Tablet of 8 mg: On 30 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
Tablets of 16 mg: On 15 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack cardboard.
Tablets of 24 mg: On 20 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 or 3 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack cardboard.

To Store storage conditions at a temperature not above 25 °C, in original packing for protection against light.
To store out of children’s reach!

3 years
not to apply a period of storage after the expiration date specified on packing.

Prescription status
According to the prescription

the Producer Abbott Helscare of SAS, France
Shatiyon-sur-Shalaron, Ruth de Belvill, Mayar 01400

Owner of the registration certificate
B.V. Abbott Helscare Products, the Netherlands
S.D van Houtenlaan 36, 1381

JV Veesp Organization
the packer Abbott Helscare of SAS, France
Shatiyon-sur-Shalaron, Ruth de Belvill, Mayar 01400

Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality produktsiitoo Abbott of Kazakhstan, Almaty, Republic of Kazakhstan Dostyk Ave. 117/6, Business center Khan Tengri-2, 050059, Ph.: +7 727 244 75 44, fax: +7 727 244 76 44, e-mail:

To Develop pv.kazakhstan@abbott.com

Additional information

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