Gastrosidin 30s 40 mg coated tablets

The instruction for medical use


of GASTROSIDIN medicine

the Trade name
Gastrosidin

Mezhdunarodnoye the unlicensed


name Famotidine Dosage Form
of the Tablet, film coated, 40 mg

Structure
One tablet contains
active agent - famotidine of 40 mg,
excipients: lactose (monohydrate), starch corn, silicon dioxide colloidal anhydrous, magnesium stearate,
structure of a cover: SeleCoat AQ-1257, brown: hydroksipropilmetiltsel-lyuloza, hydroxypropyl cellulose, polyethyleneglycol 6000, gland (III) oxide red (E172), gland (III) oxide yellow (E172), talc, titan dioxide (E171).

The description
of the Tablet of round shape, with a biconvex surface, film coated, light brown color, with risky on one party.

Pharmacotherapeutic group
Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux. Blockers of N2-of histamine receptors. Famotidine.
ATX A02BA03 code

the Pharmacological

Pharmacokinetics Later properties of oral administration of 40 mg of famotidine, the maximum concentration in blood plasma in 1 - 3.5 hour makes 78 mkg/l, and therapeutic level is supported within 24 hours.
The bioavailability of drug is about 45%. Extent of linking with proteins of blood plasma – 15 – 22%.
Famotidine is emitted from an organism mainly with kidneys (65-70%), 30-35% of drug are removed through intestines. 25-30% of the accepted dose are brought out of an organism with urine in not changed look.
At patients with normal function of kidneys time of semi-removal is 2.5 - 4 hours, at patients with clearance of creatine is lower, than 30ml/mines, increases till 10-12 o'clock.

Gastrosidin's pharmacodynamics – the competitive antagonist of N-2 of receptors of a histamine
of the 3rd generation of long action. Oral administration of Gastrosidin in a dose of 10 - 20 mg leads to decrease in secretion of hydrochloric acid more than for 80%, at least, within 12 hours. Concentration of famotidine in plasma, necessary for 50% of suppression of secretion of acid in a stomach, makes 13mkg/l.
After reception of 40 mg of Gastrosidin rn acids in a stomach are made by 5.0 - 6.4.
The inhibition of secretion of Gastrosidinom hydrochloric acid can increase a little concentration of gastrin in blood serum to the upper bounds of normal indicators.
Gastrosidin suppresses as basal, so stimulated Pentagastrinum secretion of hydrochloric acid.
Drug possesses the wide therapeutic index that allows to maintain its efficiency even at long reception in the raised doses.
At patients with Zollingera-Ellison's syndrome at prolonged use of Gastrosidin in a combination with the anticholinergic drugs controlling secretion of hydrochloric acid in a stomach changes from biochemical indicators of blood were not observed.
Gastrosidin is well had by patients.

Indications
- treatment and prevention of a peptic ulcer of a stomach and duodenum
- the morbid conditions connected with hypersecretion of hydrochloric acid (Zollingera-Ellison's syndrome)
- a gastroesophageal reflux disease (GERD)
- prevention of erosive cankers of digestive tract during intake of non-steroidal anti-inflammatory drugs (NPVS).

A route of administration and doses
Ulcer of stomach and duodenum in an aggravation phase -
40 mg of drug for the night. Duration of treatment of 4 - 8 weeks, depending on dynamics of healing (scarring) of an ulcer.
Prevention of a recurrence of a peptic ulcer of a stomach and duodenum
For prevention of a recurrence of stomach ulcer and a duodenum is recommended Gastrosidin's reception in a dose of 20 mg of 1 times a day before going to bed within 4-8 weeks.
Zollingera-Ellison
Bolnym's syndrome, earlier not receiving the drugs suppressing secretion is recommended Gastrosidin's use in an initial dose of 20 mg each 6 hours. It is necessary to appoint a dose depending on a condition of the patient and to continue treatment according to clinical indicators. At the same time the daily dose of drug at these patients can reach 400 mg without emergence of side effects.
In a gastroesophageal reflux disease (GERD) the recommended dose for oral administration of 20 mg twice a day, lasting treatment of 6-12 weeks. In cases when GERD is followed by an esophagitis, the recommended Gastrosidin's dose makes 20-40 mg within 12 weeks.
Prevention of erosive cankers of digestive tract during intake of non-steroidal anti-inflammatory drugs (NPVS)
On 20 mg of 1 times a day before going to bed with a duration for the term of intake of non-steroidal anti-inflammatory drugs (NPVS).
The route of administration and doses at special groups of patients
the Renal failure
As Gastrosidin is generally excreted by kidneys, it is necessary to apply him with care at patients with a renal failure. In case clearance of creatinine & lt, 30 ml/min., and the level of serumal creatinine & gt, 3 mg/ml, the maximum daily dose has to be reduced to 20 mg a day or the interval between receptions is increased till 36-48 o'clock.

Side effects
Often
- lack of appetite, dryness in a mouth, disorders of flavoring feelings, nausea, vomiting, an abdominal distension, diarrhea or a constipation
- a headache, dizziness, increased fatigue, sonitus, passing mental disturbances
- are possible muscular pains, joint pains
- a skin itching, a bronchospasm, fever, an allopecia, ordinary eels, xeroderma, a Quincke's disease, an acute anaphylaxis, other manifestations of a hyper sensitization
is not frequent
- spasms
- mental disorders
- a leukopenia, thrombocytopenia
- arrhythmia, the atrioventricular block
- increase in activity of liver enzymes, a hyperbilirubinemia, increase in level of urea
Is rare
- development of cholestatic jaundice
is Very rare
- an agranulocytosis, a pancytopenia
- at long reception – a giperprolaktinemiya, a gynecomastia, an amenorrhea, decrease a libido, impotence.

Contraindications
- hypersensitivity to famotidine and other components of drug
- pregnancy and the period of a lactation
- hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption
- the children's and teenage age up to 18 years


Medicinal interactions
At simultaneous use of famotidine with anticoagulants is not excluded a possibility of increase in a prothrombin time and development of bleedings.
At simultaneous use of famotidine with the antacids containing magnesium hydroxide and aluminum hydroxide the famotidine absorption reduction is possible.
At simultaneous use of famotidine with itrakonazoly reduction of concentration of an itrakonazol in blood plasma and decrease in its efficiency is possible.
At simultaneous use of famotidine with nifedipine the case of reduction of minute volume of heart and warm emission, owing to strengthening of negative ionotropny effect of nifedipine is described.
At simultaneous use of famotidine with norfloxacin the concentration of norfloxacin in blood plasma decreases, with probenetsidy – concentration of famotidine in blood plasma increases.
At simultaneous use of famotidine with cyclosporine perhaps some increase in concentration of cyclosporine in blood plasma.
At simultaneous use, famotidine reduces absorption of a ketokonazol.

Special instructions
With care apply at patients with renal failures and a liver.
Patients with a heavy renal failure (clearance of creatinine & lt, 10 ml/min.) recommend longer intervals between doses or lower doses.
Before an initiation of treatment it is necessary to exclude a possibility of presence of a malignant disease of a gullet, stomach or duodenum. Does not change activity of microsomal enzymes of a liver.
At long-term treatment of the patient has to be under observation of the doctor.
It is necessary to observe an interval between reception of antacids and Gastrosidin of 2 hours and more.
With care and under medical control appoint Gastrosidin to patients with disturbances of a warm rhythm, because of risk of development of AV of blockade.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering a possibility of development of side effects from the central nervous system (CNS), the question of a possibility of occupations potentially dangerous types of activity requiring special attention and speed of psychomotor reactions should be solved only after assessment of individual reaction of the patient to


the drug Overdose Symptoms - vomiting, motive excitement, a tremor, bradycardia, a lowering of arterial pressure, collapse, arrhythmia, tachycardia. Treatment - gastric lavage, if necessary carry out symptomatic therapy

the Form of release and packing
On 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in cardboard packing.


To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!

A period of storage
3 years
not to use drug after an expiration date!

Prescription status
According to the prescription


the Producer Zentiva Saglyk Uryunleri Sanai ve A.O. Tidzharet, Turkey
the Owner of the registration certificate
Zentiva Saglyk Uryunleri Sanai ve A.O. Tidzharet, Turkey
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP 050016 Almaty, Kunayev St. 21btelefon: 8-727-244-50-96факс:
To Develop 8-727-258-25-96e-mail:quality.info@sanofi.com