Panum tablets p / o 20mg, No. 14

Treating mild gastroesophageal reflux disease symptoms (such as heartburn, sour belching) in adults.

PanumЃ is taken orally, before meals, without chewing or crushing, drinking a sufficient amount of liquid, 20 mg per day.
To achieve positive dynamics in the elimination of symptoms, it may be necessary to take the drug for 2-3 days, however, to completely eliminate the symptoms, it may be necessary to use the drug for 7 days. If the condition worsens during the first 3 days of treatment, it is recommended to consult a doctor.
The drug should be discontinued as soon as symptoms disappear.
Taking the drug without consulting a doctor should not exceed 4 weeks. If there is no positive dynamics within 2 weeks of continuous use of the drug, you should consult your doctor.
You should not take PanumЃ for prophylaxis.
No dose adjustment is required in elderly patients and patients with renal or hepatic impairment.

Tablet 20 mg

Active ingredient: Pantoprazole sodium sesquihydrate - 22.55 mg (in terms of pantoprazole - 20.00 mg);
Excipients: mannitol - 39.95 mg, sodium carbonate anhydrous - 7.50 mg, crospovidone - 4.00 mg, povidone K-30 - 3.50 mg, calcium stearate - 2.50 mg. Coating
: Opadray II 85G68918 white - 8.00 mg, sodium hydroxide - qs *
Enteric coating: *** Acrylic-from yellow 93092052 - 11.979 mg, simethicone emulsion 30% - 0.07 mg

* Opadray II 85G68918 white:
Polyvinyl alcohol, partially hydrolyzed (E1203) - 38.60%; titanium dioxide (E171) - 30.00%; talc (E553b) - 17.50%; macrogol (E1521) - 10.90%; soy lecithin (E322) - 3.00%.
** used 1 n. sodium hydroxide solution to adjust the pH of the shell solution.
*** Acrylic-out yellow 93092052:
Methacrylic acid and ethyl acrylate copolymer - 40%; talc (E553b) - 37.250%; titanium dioxide (E171) - 14.00%; triethyl citrate 4.80%; colloidal silicon dioxide - 1.25%; sodium bicarbonate (E500 (ii)) - 1.20%; iron oxide yellow (E172) - 1.00%; sodium lauryl sulfate - 0.50%.

• hypersensitivity to any of the components of the drug, as well as to substituted benzimidazoles;

• dyspepsia of neurotic genesis;

• taking HIV protease inhibitors such as atazanavir and nelfinavir, the absorption of which depends on the acidity (pH) of gastric juice;

• age under 18;

• pregnancy, breastfeeding period.

Trade name:

PanumЃ

International Non-proprietary Name (INN):

pantoprazole

Dosage form:

Enteric film-coated tablets

Composition for 1 tablet:

Tablet 20 mg

Active ingredient: Pantoprazole sodium sesquihydrate - 22.55 mg (in terms of pantoprazole - 20.00 mg);
Excipients: mannitol - 39.95 mg, sodium carbonate anhydrous - 7.50 mg, crospovidone - 4.00 mg, povidone K-30 - 3.50 mg, calcium stearate - 2.50 mg. Coating
: Opadray II 85G68918 white - 8.00 mg, sodium hydroxide - qs *
Enteric coating: *** Acrylic-from yellow 93092052 - 11.979 mg, simethicone emulsion 30% - 0.07 mg

* Opadray II 85G68918 white:
Polyvinyl alcohol, partially hydrolyzed (E1203) - 38.60%; titanium dioxide (E171) - 30.00%; talc (E553b) - 17.50%; macrogol (E1521) - 10.90%; soy lecithin (E322) - 3.00%.
** used 1 n. sodium hydroxide solution to adjust the pH of the shell solution.
*** Acrylic-out yellow 93092052:
Methacrylic acid and ethyl acrylate copolymer - 40%; talc (E553b) - 37.250%; titanium dioxide (E171) - 14.00%; triethyl citrate 4.80%; colloidal silicon dioxide - 1.25%; sodium bicarbonate (E500 (ii)) - 1.20%; iron oxide yellow (E172) - 1.00%; sodium lauryl sulfate - 0.50%.

Tablet 40 mg

Active ingredient: pantoprazole - 40 mg (pantoprazole sodium sesquihydrate - 45.1 mg); Auxiliary components: mannitol, crospovidone, 30% simethicone emulsion, calcium stearate, anhydrous sodium carbonate, povidone, sodium hydroxide, Opadry dye acrylosis yellow 93O92052 (methacrylic acid copolymer type C, talc, titanium dioxide, triethyl citrate, sodium colloidal iron oxide yellow, sodium lauryl sulfate), Opadry YS-1R-7006 transparent dye (macrogol 400, hypromellose 5cP, macrogol 6000).

Description

Round biconvex tablets with beveled edges, coated with a light yellow color, smooth on both sides.

Pharmacotherapeutic group:

gastric glands secretion lowering agent - proton pump inhibitor.

ATX code:

A02BC02

Pharmacological properties

Pharmacodynamics
Proton pump inhibitor (H + K + ATPase). Blocks the final stage of hydrochloric acid secretion, regardless of the nature of the stimulus.
Pantoprazole is a substituted benzimidazole that suppresses the secretion of hydrochloric acid in the stomach by specifically blocking the proton pumps of parietal cells.
Pantoprazole is transformed into its active form under acidic conditions in parietal cells, where it inhibits the activity of the H + K + ATPase enzyme, i.e. blocks the final stage of the formation of hydrochloric acid in the stomach. The suppression of activity is dose dependent and, as a result, both basal and stimulated acid secretion are reduced. When treating with pantoprazole, as with other proton pump inhibitors and H2-receptor blockers, the acidity in the stomach decreases and, thereby, the level of gastrin increases in proportion to the decrease in acidity. The increase in gastrin levels is reversible. Since pantoprazole binds the enzyme distally to the cellular receptor, it can inhibit the secretion of hydrochloric acid independently of stimulation by other substances (acetylcholine, histamine, gastrin).
Also, the content of chromogranin A (CgA) in the blood serum increases due to a decrease in the secretion of hydrochloric acid. Elevated CgA levels can distort the results of diagnostic studies for the detection of neuroendocrine tumors.
Antisecretory activity. After the first oral administration of 20 mg of pantoprazole, a decrease in gastric acid secretion by 24% occurs after 2.5-3.5 hours and by 26% after 24.5-25.5 hours. After oral administration of pantoprazole once a day for 7 days antisecretory activity, measured 2.5-3.5 hours after administration, increases to 56%, and after 24.5-25.5 hours - up to 50%. In case of duodenal ulcer associated with Helicobacter pylori,a decrease in gastric secretion increases the sensitivity of microorganisms to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of the intake.
Compared to other proton pump inhibitors, pantoprazole has greater chemical stability at neutral pH, and a lower potential for interaction with the liver oxidase system, which depends on cytochrome P450. Therefore, there was no clinically significant interaction between pantoprazole and many other drugs.

Pharmacokinetics
Pantoprazole is rapidly absorbed after oral administration. The maximum concentration in blood plasma (Cmax) with oral administration is achieved after the first dose of 20 mg. On average, approximately 2-2.5 hours after administration, the maximum serum concentration is reached, about 1.0-1.5 ?g / ml and Cmax, and remains constant after repeated use of this drug.
The pharmacokinetics of pantoprazole after single and repeated use are the same. In the dose range of 10-80 mg, the pharmacokinetics of pantoprazole in blood plasma remains linear in both oral and intravenous administration.
The absolute bioavailability of pantoprazole tablets is about 77%. Co-eating does not affect the area under the concentration-time curve (AUC), the maximum serum concentration and, accordingly, the bioavailability. When taken together with food, the time of onset of action of the drug may vary. The binding of pantoprazole to blood plasma proteins is 98%. The volume of distribution is 0.15 l / kg.
It is metabolized mainly in the liver. The main metabolic pathway is demethylation by CYP2C19 followed by sulfate conjugation. Other metabolic pathways include oxidation by CYP3A4.
The terminal half-life is approximately 1 hour, and the clearance is approximately 0.1 l / h / kg. Due to the specific binding of pantoprazole to the proton pumps of parietal cells, the half-life does not correlate with a much longer duration of action (inhibition of acid secretion).
The main route of excretion is through the kidneys (about 80%) in the form of pantoprazole metabolites, the rest is excreted in the feces. The main metabolite in blood plasma and urine is desmethylpantoprazole, conjugated with sulfate. The half-life of the main metabolite is about 1.5 hours, which is slightly higher than the half-life of pantoprazole.
When using pantoprazole in patients with limited renal function (including patients on hemodialysis), dose reduction is not required. As in healthy volunteers, the half-life of pantoprazole is short. Only a very small part of the drug is dialyzed. Despite the moderately long half-life of the main metabolite (2-3 hours), its elimination occurs rather quickly, and therefore accumulation does not occur.
In patients with liver cirrhosis (classes A and B according to the Child-Pugh classification), the half-life increases to 3-6 hours, the AUC values ??increase 3-5 times, the maximum serum concentration increases insignificantly, only 1.5 times in comparison with that in healthy volunteers when using pantoprazole at a dosage of 20 mg.
A slight increase in AUC and Cmax in older people compared with the corresponding indicators in younger people is not clinically significant.

Indications for use

Treating mild gastroesophageal reflux disease symptoms (such as heartburn, sour belching) in adults.

Contraindications

• hypersensitivity to any of the components of the drug, as well as to substituted benzimidazoles;

• dyspepsia of neurotic genesis;

• taking HIV protease inhibitors such as atazanavir and nelfinavir, the absorption of which depends on the acidity (pH) of gastric juice;

• age under 18;

• pregnancy, breastfeeding period.

Use during pregnancy and breastfeeding, effects on fertility

Use during pregnancy
Due to the lack of data on the use of pantoprazole in pregnant women, as a precautionary measure, it is necessary to exclude the use of PanumЃ during pregnancy.
Breastfeeding
Pantoprazole and its metabolites have been found in breast milk. The effect of pantoprazole on neonates / infants is unknown. PanumЃ should not be used during breastfeeding. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.
Fertility There are no
data available on the effects of pantoprazole on fertility in humans. Preclinical studies have shown no effect on male or female fertility.

Method of administration and dosage

PanumЃ is taken orally, before meals, without chewing or crushing, drinking a sufficient amount of liquid, 20 mg per day.
To achieve positive dynamics in the elimination of symptoms, it may be necessary to take the drug for 2-3 days, however, to completely eliminate the symptoms, it may be necessary to use the drug for 7 days. If the condition worsens during the first 3 days of treatment, it is recommended to consult a doctor.
The drug should be discontinued as soon as symptoms disappear.
Taking the drug without consulting a doctor should not exceed 4 weeks. If there is no positive dynamics within 2 weeks of continuous use of the drug, you should consult your doctor.
You should not take PanumЃ for prophylaxis.
No dose adjustment is required in elderly patients and patients with renal or hepatic impairment.

Side effect

When taking PanumЃ in accordance with the indications and in the recommended doses, adverse reactions are extremely rare. The most common adverse reactions are diarrhea and headache, occurring in about 1% of patients. The following are data on adverse reactions depending on the frequency of their occurrence:
Very often? 1/10; often? 1/100 and <1/10; infrequently - 1/1000 and <1/100; rarely - 1/10000 and <1/1000; very rarely <1/10000, including isolated cases; the frequency is unknown (cannot be estimated from the available data).
Disturbances from the circulatory and lymphatic system:
Rare: agranulocytosis.
Very rare: thrombocytopenia, leukopenia, pancytopenia.
Nervous system disorders:
Uncommon:headache, dizziness.
Rarely: taste disturbances.
Visual impairment:
Rare: visual impairment (blurring).
Disorders from the gastrointestinal tract:
Often: polyps of the fundic glands of the stomach (benign).
Uncommon: diarrhea, nausea / vomiting, bloating and flatulence, constipation, dry mouth, abdominal discomfort and pain.
Renal and urinary tract disorders:
Frequency unknown: interstitial nephritis.
Skin and subcutaneous tissue disorders:
Uncommon: exanthema / rash, pruritus, dermatitis.
Rarely: urticaria, angioedema.
Frequency unknown:malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity, subacute cutaneous lupus erythematosus.
Musculoskeletal and connective tissue disorders:
Uncommon: fracture of the wrist, hip and spine.
Rarely: arthralgia, myalgia.
Metabolic disorders:
Rarely: hyperlipidemia and increased concentration of lipids (triglycerides, cholesterol), changes in body weight.
Frequency unknown: hyponatremia, hypomagnesemia.
General disorders:
Uncommon: weakness, fatigue and malaise.
Rarely: increased body temperature, peripheral edema.
Immune system disorders:
Rare: hypersensitivity (including anaphylactic reactions and anaphylactic shock).
Liver and biliary tract disorders:
Uncommon: increased activity of liver enzymes (transaminases, ?-glutamine transferase).
Rarely: increased bilirubin levels.
Frequency unknown: hepatocellular damage, jaundice, hepatic cell failure.
Genital and breast disorders:
Rare: gynecomastia.
Mental disorders :
Uncommon: sleep disturbances.
Rarely: depression (including exacerbation of existing disorders).
Rarely:disorientation (including exacerbation of existing disorders).
The frequency is unknown: hallucinations, confusion (especially in patients predisposed to this), as well as a possible exacerbation of symptoms if they exist before starting therapy.

Overdose

To date, overdose phenomena as a result of the use of pantoprazole have not been noted. Doses up to 240 mg were administered intravenously over 2 minutes and were well tolerated.
In case of an overdose in the presence of clinical manifestations of intoxication, symptomatic and supportive therapy is performed.
Pantoprazole is not excreted by hemodialysis.

Interaction with other medicinal products

The simultaneous use of other proton pump inhibitors or H2-histamine receptor blockers is not recommended without consulting a doctor.
The simultaneous use of PanumЃ can reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach environment (for example, ketoconazole, itraconazole, posaconazole and other drugs such as erlotinib).
The combined use of pantoprazole and HIV protease inhibitors, the absorption of which depends on the acidity (pH) of gastric juice, such as atazanavir, nelfinavir, significantly reduces their bioavailability.
During drug interaction studies, there were no clinically significant interactions when using pantoprazole in the following cases:

• in patients with diseases of the cardiovascular system, taking cardiac glycosides (digoxin), blockers of slow calcium channels (nifedipine), beta-blockers (metoprolol);

• in patients with diseases of the gastrointestinal tract taking antacids, antibiotics (amoxicillin, clarithromycin);

• in patients taking oral contraceptives containing levonorgestrel and ethinyl estradiol;

• in patients taking non-steroidal anti-inflammatory drugs (diclofenac, naproxen, piroxicam);

• in patients with diseases of the endocrine system, taking glibenclamide, levothyroxine;

• in patients with anxiety and sleep disorders taking diazepam;

• in patients with epilepsy taking carbamazepine and phenytoin;

• in patients taking indirect anticoagulants, such as warfarin and phenprocoumon, under the control of prothrombin time and INR at the beginning and at the end of treatment, as well as during irregular administration of pantoprazole.

At the same time, it should be noted that there are cases of increased INR and prothrombin time in patients who received proton pump inhibitors together with warfarin or with phenprocoumon. An increase in INR and prothrombin time can lead to pathological life-threatening bleeding. In this regard, such patients should be monitored for the timely detection of an increase in INR and prothrombin time.
The absence of clinically significant drug interactions with caffeine, ethanol, and theophylline was also noted.
There are reports of an increase in the level of methotrexate in the blood in some patients when it is used together in high doses (for example, 300 mg) with proton pump inhibitors. Therefore, when using high doses of methotrexate, for example, for cancer or psoriasis, it may be necessary to consider temporarily discontinuing pantoprazole.

special instructions

Before starting treatment with PanumЃ, the possibility of a malignant neoplasm should be excluded, since the drug can mask symptoms and delay the correct diagnosis.
Patients should consult a physician if they are to undergo an endoscopy or urea breath test.
Patients should consult a doctor if the following cases occur:

• unintentional weight loss, anemia, gastrointestinal bleeding, trouble swallowing, persistent vomiting or vomiting of blood. In these cases, taking the drug can partially alleviate the symptoms and delay the correct diagnosis;

• previous surgery on the gastrointestinal tract or stomach ulcer;

• continuous symptomatic treatment of dyspepsia and heartburn for 4 weeks or more;

• liver disease, including jaundice and liver failure;

• other serious illnesses that worsen general health.

ѕациенты в возрасте старше 55 лет, при наличии новых или недавно изменившихс¤ симптомов, должны проконсультироватьс¤ с врачом.
ѕациентам не следует рассчитывать на мгновенное устранение симптомов недомогани¤. ќблегчение симптомов возможно после приблизительно одного дн¤ приема пантопразола, также необходимо учитывать, что дл¤ полного устранени¤ изжоги может понадобитьс¤ приблизительно 7 дней.
ѕри приеме препаратов, снижающих кислотность желудочного сока, незначительно повышаетс¤ риск желудочно-кишечных инфекций, возбудител¤ми которых ¤вл¤ютс¤ бактерии рода Salmonella spp., Campylobacter spp. или —. difficile.
ѕри лечении ингибиторами протонного насоса очень редко отмечаетс¤ развитие подострой кожной красной волчанки (ѕ  ¬). ѕри возникновении поражений кожи, особенно на участках, подвергшихс¤ воздействию солнечных лучей, а также при наличии сопутствующей артралгии, пациент должен немедленно обратитьс¤ за медицинской помощью, и врачу следует оценить необходимость прекращени¤ лечени¤ препаратом ѕанумЃ. ¬озникновение ѕ  ¬ после предшествующего лечени¤ ингибитором протонного насоса может повысить риск развити¤ ѕ  ¬ при лечении другими ингибиторами протонного насоса.
ѕри проведении лабораторных исследований необходимо учитывать, что повышенное содержание CgA в сыворотке крови может искажать результаты диагностических исследований дл¤ вы¤влени¤ нейроэндокринных опухолей. ¬ св¤зи с этим применение препарата ѕанумЃ следует прекратить не менее чем за 5 дней до проведени¤ исследовани¤ содержани¤ CgA. ?сли содержание CgA и гастрина не возвратилось к нормальным значени¤м после первого определени¤, то исследование следует повторить через 14 дней после прекращени¤ приема ингибитора протонного насоса.
ѕрепарат предназначен дл¤ краткосрочного применени¤ (до 4 недель).
ѕри длительном приеме препарата могут возникать дополнительные риски, и необходимо обратитьс¤ к врачу дл¤ назначени¤ препарата с последующим регул¤рным медицинским наблюдением.
—ледующие дополнительные риски считаютс¤ значительными при продолжительном приеме препарата.
¬ли¤ние на абсорбцию ¬итамина ¬12
ѕантопразол, как все ингибиторы протонного насоса может снизить абсорбцию витамина ¬12 (цианокобаламин) в результате гипо- или ахлоргидрии. Ёто следует учитывать у пациентов со сниженными запасами в организме или факторами риска снижени¤ абсорбции витамина ¬12 при длительной терапии или при наличии соответствующих клинических симптомов.
¬ли¤ние на переломы костей
»нгибиторы протонного насоса, особенно в больших дозах и при продолжительной терапии (>1 года), могут незначительно увеличивать риск перелома бедра, зап¤сть¤ и позвоночника, преимущественно у пожилых людей или при наличии других известных факторов риска. Ќаблюдени¤ показали, что ингибиторы протонного насоса могут увеличить общий риск переломов на 10-40%. Ёто увеличение частично может быть обусловлено другими факторами риска. ѕациенты с риском развити¤ остеопороза должны получать лечение в соответствии с действующими клиническими рекомендаци¤ми, и у них должно быть соответствующее поступление витамина D и кальци¤ в организм.
vипомагниеми¤:
” пациентов, принимающих ингибиторы протонного насоса (»ѕЌ), в том числе пантопразол, в течении как минимум трех мес¤цев, и, в большинстве случаев, в течение года наблюдалась т¤жела¤ гипомагниеми¤. ѕри этом возможно развитие т¤желых про¤влений гипомагниемии, таких как утомл¤емость, тетани¤, бред, судороги, головокружение и желудочкова¤ аритми¤, они могут начинатьс¤ незаметно и быть пропущены. ” большинства пациентов с подобными нарушени¤ми гипомагниеми¤ была скорректирована после заместительной терапии магнием и прекращени¤ приема »ѕЌ.
” пациентов, которым предстоит длительное лечение, или пациентам, принимающим »ѕЌ совместно с дигоксином или другими препаратами, которые могут вызвать гипомагниемию (например, диуретики), следует провести исследование содержани¤ магни¤ в сыворотке крови перед началом лечени¤ »ѕЌ и периодически осуществл¤ть его контроль во врем¤ лечени¤.

¬ли¤ние на способность управлени¤ транспортными средствами/механизмами.

—ледует воздержатьс¤ от управлени¤ транспортными средствами и другими механизмами, требующими повышенного внимани¤, из-за веро¤тности головокружений и нарушени¤ зрени¤.

‘орма выпуска

Tablets enteric, film-coated, 20 mg.
10 tablets in blister Al / Al; 1 blister (10 tablets) or 2 blisters (20 tablets) or 3 blisters (30 tablets) together with instructions for use in a cardboard box.
14 tablets in blister Al / Al; 1 blister (14 tablets) or 2 blisters (28 tablets) or 4 blisters (56 tablets) together with instructions for use in a cardboard box.

Shelf life

2 years.
Do not use after the expiration date.

Storage conditions

Store in a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Vacation conditions

Available without a prescription.