Pantap 28's 40 mg coated tablets

The instruction for use
To medical use

of Pantap medicine ® 40

Trade name
Pantap ® 40

International unlicensed


name Pantoprazol Lekarstvennaya
the Tablet form, covered with a kishechnorastvorimy cover, 40 mg

Structure
One tablet contains
active agent - a pantoprazol of sodium of sexivihydrat
(40 mg are equivalent to a pantoprazol) 45.30 mg,
excipients: sodium of a kroskarmelloz, microcrystalline PH 102 cellulose, corn starch (dry), magnesium carbonate, silica gel colloidal (aerosil), talc, magnesium stearate,
provisional cover: a hydroksipropilmetiltsellyuloza (pharmakoat 603), talc, alcohol of 96% (36, 43 ml) *, the water purified *,
a kishechnorastvorimy covering: eydragit L 30 D-55 (30%), triethyl citrate (tsitroflex), a macrogoal 6000 (PEG 6000), sepispers AP 3232 John yellow (a hydroksipropilmetiltsellyuloza, the titan dioxide (E171), ferrous oxide yellow (E 172), propilparagidroksibenzoat, methylparahydroxybenzoate, Natrium benzoicum), the emulsion of a simetikon of 30%, water purified *.
* - evaporates in the course of production.

The description
the Oblong tablets covered with a kishechnorastvorimy cover of pale yellow color.

Pharmacotherapeutic group
Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux. Inhibitors of the protonew pump.
The code of automatic telephone exchange A02BC02

the Pharmacological

Pantoprazol Pharmacokinetics properties is quickly soaked up in digestive tract after single or repeated oral administration. Absolute bioavailability about 77%. The maximum concentration (Cmax) in blood of 2.09 mkg/ml, time of achievement of the maximum concentration (tmax) in blood 2.8 hours.
Serumal proteinaceous binding of a pantoprazol makes about 98%, mainly with albumine.
Elimination half-life of a pantoprazol about 1.2-1.3 hours. Despite short elimination half-life after pantoprazol covalently communicates with (N + - K+) ATP-ase, the anti-secretory activity remains more than 24 hours.
Volume of distribution of a pantoprazol near 0.34l kg. Pantoprazol is metabolized in the main metabolite desmetilpantoprazol and other substances in a liver by means of P450 system CYP2C19 isoenzyme with the subsequent sulphation. Metabolites of a pantoprazol have no significant pharmakodinamichesky activity. About 80% of an oral dose are removed with urine and 20% with excrements. In urine comes to light changed pantoprazol.
The plasma clearance of a pantoprazol can decrease slightly or moderately at elderly people.
The pharmacodynamics
Pantap ® 40 contains active agent pantoprazol which belongs to group of the substituted benzamidazol inhibiting a final stage in producing hydrochloric acid by means of formation of a covalent bond with (N + - K+) ATF-aznoy a fermental system on the secretory surface of covering cells.
Duration of suppression of activity of hydrochloric acid of pantoprazoly more than 24 hours. Acid secretion is normalized within 3-5 days after reception of the last dose ПАНТАП®.
At use of drug the increased level of serumal gastrin which is normalized after the treatment termination is observed.

Indications
- a peptic ulcer of a stomach and duodenum, in t. h assotsii-
rovanny with Helicobacter pylori
- the prevention and treatment of erosive cankers of a gastro intestinal path associated with intake of non-steroidal anti-inflammatory drugs
- a gastroesophageal reflux disease
- Zollingera-Ellison's syndrome

the Route of administration and doses
the Adult:
A peptic ulcer of a stomach and duodenum
the Recommended oral dose of drug of 40 mg once a day within 4 weeks. Depending on a condition of the patient it is possible to continue a course of treatment up to 8 weeks.
A peptic ulcer of a stomach and duodenum, an assotion rovanny with Helicobacter pylori.The recommended oral dose of drug of 40 mg twice a day as a part of complex therapy within 7 - 14 days.
A gastroesophageal reflux disease
the Recommended oral dose of 40 mg once a day during 4 weeks. Depending on a condition of the patient it is possible to continue
a course of treatment up to 8 weeks.
Prevention and treatment of erosive cankers zheludochno - an intestinal path associated with intake of non-steroidal anti-inflammatory drugs.
The recommended dose on 40 mg of 1 times a day within 4 - 8 weeks.
To take the drug to food, in the first half of day, tablets cannot be chewed or split up. To wash down each dose with a glass of water, swallowing tablets entirely.

Side effects
Seldom:
- nausea, an abdominal pain, a meteorism, temporary diarrhea,
- an indisposition, a headache, illegibility of sight
- skin rash, an itching, heat, hypostasis.
The reactions observed at less than 1% of patients are given below, but connection of these reactions with use of Pantap® is not established:
- concern, an asthenia, nervousness, a sleep disorder, emotional
lability, drowsiness
- disorder of vision and hearing (an amblyopia, a diplopia, an ear-ache, a ring
in ears)
- aphthous stomatitis, dryness in a mouth, a food faddism, anorexia, colitis
- bronchitis, laryngitis, asthma, nasal bleedings, a hiccups
- a retrosternal pain
- renal pains, a glucosuria, a dysuria, urination disturbance
- a dysmenorrhea, impotence
- an alopecia, an acne, exfoliative dermatitis
- arthritises, dorsodynias
- anemia (iron deficiency, hypochromia)
- changes of laboratory indicators (hyperbilirubinemia, increase
in alkaline phosphatase, increase in a gammaglyutamiltranspeptidaza,
a gipergastrinemiya)

of the Contraindication
- hypersensitivity to any making
drug component
- a renal failure

Medicinal interactions
Is compatible to the drugs which are metabolized with the participation of the fermental system of P450 cytochrome (Phenazepamum, diazepam, digoxin, theophylline, carbamazepine, diclofenac, Naproxenum, piroxicam, Phenytoinum, warfarin, nifedipine, metoprolol, ethanol). ПАНТАП® renders deep and long inhibition of secretion of hydrochloric acid therefore drug can reduce absorption of some drugs, such as ketokonazol, ethers of ampicillin, iron salt where it is necessary defined rn a stomach for their bioavailability.

Special instructions
correction of doses is not required to Patients with a liver failure.
Before an initiation of treatment it is necessary to exclude a possibility of a malignant new growth in a stomach and a gullet.
Use in pediatrics
the Efficiency and safety of drug for children is not established.
Pregnancy and a lactation
In need of use of drug at pregnancy it is necessary to estimate expected advantage for mother and potential risk for a fruit.
It is not established whether it is allocated pantoprazol with milk.
In need of prescribing of drug it is asked about the feeding termination by a breast.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug it is necessary to be careful during the driving and work with potentially dangerous mechanisms.


Overdose
Symptoms: a disorder of vision, drowsiness, excitement, a headache, increase in sweating, dryness in a mouth, nausea, tachycardia.
Treatment: symptomatic treatment.

The form of release and packing
of the Tablet covered with a kishechnorastvorimy cover of 40 mg. On 10, 14 or 28 tablets in a polyethylene bottle with the self-adhesive label.
On 14 tablets in blister strip packaging from aluminum foil.
On 1 bottle or on 1, 2 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a cardboard pack.



To Store storage conditions at a temperature not above 25 °C in the dry, protected from light place.
To store out of children's reach!

A period of storage
2 years
not to apply after a period of storage

Prescription status
According to the prescription


JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer

Republic of Kazakhstan. Almaty, Shevchenko St. 162 E.