Instructions Panocid 40 enteric-coated tablets 40 mg No. 30
Composition
active ingredient: 1 tablet contains pantoprazole sodium hemihydrate equivalent to 40 mg of pantoprazole;
excipients: mannitol (E 421), sodium carbonate anhydrous, crospovidone, hydroxypropylmethylcellulose, calcium stearate, dye IC-S-329 (hydroxypropylmethylcellulose, polyethylene glycol), dye ENS-II-041 (methacrylate copolymer (type C), polyethylene glycol, talc, titanium dioxide (E 171), iron oxide yellow (E 172)).
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: yellow round biconvex tablets in an enteric-coated shell.
Pharmacotherapeutic group
Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. Proton pump inhibitors.
ATX code A02B C02.
Pharmacological properties
Pharmacodynamics
The inhibitor of H+-K+-ATPase of parietal cells disrupts the transfer of hydrogen ions from the parietal cell into the lumen of the stomach and blocks the final stage of hydrophilic secretion of hydrochloric acid. Reduces basal and stimulated (regardless of the type of stimulus - acetylcholine, histamine, gastrin) secretion of hydrochloric acid. In duodenal ulcer disease associated with Helicobacter pylori, such a decrease in gastric secretion increases the sensitivity of the microorganism to antibiotics. Pantoprazole has antimicrobial activity against Helicobacter pylori and contributes to the manifestation of the antihelicobacter effect of other drugs.
Pharmacokinetics
After oral administration, the drug is rapidly and completely absorbed; approximately 90-95% of the drug binds to plasma proteins. Pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system. The maximum concentration in the blood serum is reached after 2.5 hours. The effect persists for 24 hours. Approximately 71% of the drug is excreted by the kidneys and 18% - with feces.
Indication
Adults and children aged 12 and over.
- Reflux esophagitis.
Adults.
- Eradication of Helicobacter pylori (H. pylori) in patients with H. pylori-associated gastric and duodenal ulcers in combination with appropriate antibiotics.
- Duodenal ulcer.
- Stomach ulcer.
- Zollinger-Ellison syndrome and other hypersecretory pathological conditions.
Contraindication
Hypersensitivity to the active substance, benzimidazole derivatives and any component of the drug.
Interaction with other medicinal products and other types of interactions
Effect of pantoprazole on the absorption of other medicinal products: Pantoprazole may reduce the absorption of medicinal products whose bioavailability depends on the pH of the gastric juice (e.g. some antifungals such as ketoconazole, itraconazole, posaconazole, or other medicinal products such as erlotinib).
Anti-HIV drugs (atazanavir). Concomitant use of proton pump inhibitors with atazanavir and other anti-HIV drugs whose absorption depends on gastric pH may significantly reduce the bioavailability of the latter and affect their efficacy. Therefore, concomitant use of proton pump inhibitors with atazanavir is not recommended.
Coumarin anticoagulants (phenprocoumon and warfarin). Although no interaction was observed with concomitant administration of phenprocoumon and warfarin in clinical trials, isolated cases of changes in INR (International Normalized Ratio) have been reported in the post-marketing period. Therefore, in patients taking coumarin anticoagulants (e.g. phenprocoumon and warfarin), it is recommended that prothrombin time/INR be monitored after initiation, discontinuation or irregular administration of pantoprazole.
Methotrexate: Concomitant use of high doses of methotrexate (e.g. 300 mg) and proton pump inhibitors has been reported to increase blood levels of methotrexate in some patients. Patients receiving high doses of methotrexate, e.g. for cancer or psoriasis, are advised to temporarily discontinue pantoprazole treatment.
Other interactions. Pantoprazole is extensively metabolised in the liver via the cytochrome P450 enzyme system. The main route of metabolism is demethylation by CYP2C19 and other metabolic pathways, including oxidation by CYP3A4. Studies with medicinal products also metabolised by these pathways, such as carbamazepine, diazepam, glibenclamide, nifedipine and oral contraceptives containing levonorgestrel and ethinylestradiol, have not revealed any clinically significant interactions.
The results of a number of studies on possible interactions indicate that pantoprazole does not affect the metabolism of active substances metabolized by CYP1A2 (e.g. caffeine, theophylline), CYP2C9 (e.g. piroxicam, diclofenac, naproxen), CYP2D6 (e.g. metoprolol), CYP2E1 (e.g. ethanol), and does not affect p-glycoprotein, which is associated with the absorption of digoxin.
No interactions with concomitantly administered antacids were identified.
Studies have been conducted to study the interaction of pantoprazole with certain antibiotics (clarithromycin, metronidazole, amoxicillin) administered concomitantly. No clinically significant interactions between these drugs have been identified.
Application features
Hepatic impairment: Patients with severe hepatic impairment should have their liver enzymes monitored regularly, especially during long-term treatment. If liver enzymes increase, treatment with the drug should be discontinued.
Combination therapy. During combination therapy, the instructions for medical use of the respective medicinal products must be followed.
Alarming symptoms present. In the presence of alarming symptoms (e.g. significant weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia, melena), as well as in the presence or suspicion of gastric ulcer, malignant disease should be excluded, as treatment with pantoprazole may mask symptoms and delay diagnosis.
If symptoms persist despite adequate treatment, further examination is necessary.
Concomitant use with atazanavir. Concomitant use of atazanavir with proton pump inhibitors (PPIs) is not recommended (see section 4.5). If the combination of a PPI with atazanavir is necessary, close clinical monitoring (e.g. viral load measurement) should be performed in conjunction with an increase in the dose of atazanavir to 400 mg with 100 mg ritonavir. The dose of pantoprazole should not exceed 20 mg daily.
Vitamin B12 absorption: In patients with Zollinger-Ellison syndrome and other hypersecretory pathological conditions requiring long-term treatment, pantoprazole, like all drugs that block hydrochloric acid production, may reduce the absorption of vitamin B12 (cyanocobalamin) due to the occurrence of hypo- and achlorhydria. This should be taken into account in patients with low body weight or in the presence of risk factors for reduced absorption of vitamin B12 during long-term treatment, or in the presence of relevant clinical symptoms.
Long-term treatment. With long-term treatment, especially more than 1 year, patients should be under regular medical supervision.
Gastrointestinal infections caused by bacteria. Pantoprazole, like other proton pump inhibitors, may increase the number of bacteria normally present in the upper gastrointestinal tract. Treatment with Panocid 40 may slightly increase the risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. Difficile.
Hypomagnesemia: Severe hypomagnesemia has been reported in patients treated with PPIs such as pantoprazole for at least three months, and in most cases for a year. The following serious clinical manifestations of hypomagnesemia may occur and may initially be insidious: fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmias. In the case of hypomagnesemia, the majority of patients improved after magnesium replacement therapy and discontinuation of the PPI.
Patients requiring long-term therapy or patients taking PPIs concomitantly with digoxin or drugs that may cause hypomagnesemia (e.g., diuretics) should have their magnesium levels measured before starting PPI treatment and periodically during treatment.
Bone fractures. Long-term treatment (more than 1 year) with high doses of proton pump inhibitors may slightly increase the risk of hip, wrist and spine fractures, mainly in the elderly or in the presence of other risk factors. Observational studies suggest that the use of proton pump inhibitors may increase the overall risk of fractures by 10-40%. Some of these may be due to other risk factors. Patients at risk of osteoporosis should be treated according to current clinical guidelines and consume adequate amounts of vitamin D and calcium.
Use during pregnancy or breastfeeding
Pregnancy. Experience with pantoprazole in pregnant women is limited. In animal reproduction studies, embryotoxicity was observed at doses above 5 mg/kg. The potential risk to humans is unknown. The drug should be used during pregnancy only if clearly needed.
Breastfeeding. There is evidence of excretion of pantoprazole into breast milk. The decision to use the drug during breastfeeding should be made after a careful benefit/risk assessment.
Ability to influence reaction speed when driving or using other mechanisms
Use with caution when driving vehicles and performing work that requires attention. It is necessary to take into account the possible development of adverse reactions, such as dizziness and visual disturbances.
Method of administration and doses
Treatment of reflux esophagitis.
The recommended dose for children aged 12 years and over and adults is 1 tablet (40 mg) once a day. In some cases, the dose can be doubled (2 tablets of 40 mg per day), especially if other drugs for the treatment of reflux esophagitis are ineffective.
In adult patients with gastric and duodenal ulcers and positive for Helicobacter pylori, eradication of the organism should be achieved using combination therapy. Depending on the susceptibility of the microorganisms, the following therapeutic combinations can be prescribed for eradication of Helicobacter pylori in adults:
- 1 tablet of Panocide 40 (40 mg) 2 times a day + 1000 mg of amoxicillin 2 times a day + 500 mg of clarithromycin 2 times a day;
- 1 tablet of Panocide 40 (40 mg) 2 times a day + 400-500 mg of metronidazole (or 500 mg of tinidazole) 2 times a day + 250-500 mg of clarithromycin 2 times a day;
- 1 tablet of Panocide 40 (40 mg) 2 times a day + 1000 mg of amoxicillin 2 times a day + 400-500 mg of metronidazole (or 500 mg of tinidazole) 2 times a day.
When using combination therapy for eradication of H. pylori, the second tablet of Panocid 40 should be taken in the evening 1 hour before a meal. The treatment period is 7 days and can be extended for another 7 days with a total duration of treatment not exceeding two weeks. If further treatment with pantoprazole is indicated to ensure ulcer healing, the dosage recommendations for gastric and duodenal ulcers should be considered.
If combination therapy is not indicated, for example, in patients with a negative result for Helicobacter pylori, for monotherapy of gastric and duodenal ulcers with Panocid 40, the recommended dose is 1 tablet of 40 mg once a day. In some cases, the dose can be doubled (2 tablets of 40 mg per day), especially in the absence of effect from the use of other drugs.
For long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the initial daily dose is 80 mg (2 tablets of the drug). If necessary, the dose can then be changed, increasing or decreasing, depending on the indicators of acid secretion in the stomach. Doses exceeding 80 mg per day should be divided into two doses. A temporary increase in the dose above 160 mg of pantoprazole is possible, but the duration of use should be limited only to the period necessary for adequate control of acid secretion.
The duration of treatment for Zollinger-Ellison syndrome and other pathological hypersecretory conditions is not limited and depends on clinical need.
Patients with severe liver dysfunction should not exceed a daily dose of 20 mg. Patients with moderate and severe liver dysfunction should not use Panocid 40 for the eradication of H. pylori in combination therapy, as there is currently no data on the efficacy and safety of such use for this category of patients.
No dose adjustment is required for patients with impaired renal function. Patients with impaired renal function should not use Panocid 40 for the eradication of H. pylori in combination therapy, as there is currently no data on the efficacy and safety of such use in this category of patients.
Elderly patients do not require dose adjustment.
General instructions.
Panocid 40, film-coated tablets, enteric-coated, should be swallowed whole 1 hour before breakfast, without chewing or crushing, with water. In combination therapy, the purpose of which is the eradication of Helicobacter pylori, the second tablet of the drug should be taken before dinner. The duration of combination therapy is usually 7 days, but it can be extended to a maximum of 2 weeks. If further treatment with pantoprazole is indicated for the treatment of ulcers, the dosage recommendations for gastric and duodenal ulcers should be considered.
Duodenal ulcers usually heal within 2 weeks. If two weeks is not enough, healing can be expected within a further 2 weeks.
Gastric ulcers and reflux esophagitis usually require 4 weeks to heal. If this is not enough, healing can be expected within a further 4 weeks.
Children
Panocide 40 is indicated in children aged 12 years and older for the treatment of reflux esophagitis. The drug is not recommended for use in children under 12 years of age, as data on the safety and efficacy of the drug in this age group are limited.
Overdose
Symptoms of overdose are unknown.
Doses up to 240 mg administered intravenously over 2 minutes have been well tolerated. Since pantoprazole is extensively protein bound, it is not a drug that can be readily dialyzed.
In case of overdose with clinical signs of intoxication, symptomatic and supportive therapy is used. There are no specific therapy recommendations.
Adverse reactions
General disorders: fever, facial edema, peripheral edema, generalized edema, malaise, asthenia, abscess, heat stroke, chills, cyst, hernia, laboratory abnormalities, candidiasis, neoplasm, nonspecific drug reactions, photosensitivity reactions, allergic reactions, fatigue.
Gastrointestinal disorders: epigastric pain, abdominal pain and discomfort, diarrhea, constipation or flatulence, nausea, vomiting, dry mouth, pancreatitis, anorexia, aphthous stomatitis, cardiospasm, colitis, duodenitis, dysphagia, enteritis, esophageal hemorrhages, esophagitis, gastrointestinal carcinoma, gastrointestinal hemorrhages, rectal hemorrhages, gastrointestinal candidiasis, gingivitis, glossitis, halitosis, hematemesis, increased appetite, melena, oral mucosal ulcers, stomatitis, bowel disorders, tongue discoloration, ulcerative colitis, periodontitis, periodontal abscess, gastric ulcers, rectal hemorrhages, oral candidiasis.
Endocrine disorders: hyperlipoproteinemia, hyperglycemia, painful breast tenderness, diabetes mellitus, glycosuria, goiter.
Hepatobiliary disorders: liver cell damage, increased levels of liver enzymes (transaminases, gamma-GT), triglycerides, hepatocellular disorders leading to jaundice with/without liver failure, biliary pain, hyperbilirubinemia, cholecystitis, cholelithiasis, cholestatic jaundice, hepatitis, increased levels of alkaline phosphatase, SGOT.
Blood and lymphatic system disorders: leukopenia, thrombocytopenia, hypercholesterolemia, eosinophilia, hyperlipoproteinemia, anemia, ecchymosis, hypochromic anemia, iron deficiency anemia, leukocytosis, agranulocytosis, pancytopenia.
Metabolic disorders: dehydration, gout, thirst, hyperlipidemia and increased lipid levels (triglycerides, cholesterol), weight loss or gain, hyponatremia, hypomagnesemia, hypocalcemia1, hypokalemia.
Immune system disorders: anaphylactic reactions, including anaphylactic shock, angioedema.
Disorders of the musculoskeletal and connective system:
In isolated cases, arthralgia, myalgia, which resolves after discontinuation of the drug, muscle spasm2, arthritis, arthrosis, bone disorders, bone pain, bursitis, joint dysfunction, convulsions, neck stiffness, tenosynovitis, fractures of the hip, wrist, spine (see section "Special warnings and precautions for use").
Neurological disorders: headache, dizziness, tremor, paresthesia, phobia, sleep disorders, nightmares, confusion (especially in patients with a predisposition to these disorders, as well as exacerbation of these symptoms if present), taste disorders, seizures, dysarthria, emotional lability, hyperkinesia, hypoesthesia, decreased libido, nervousness, neuralgia, neuritis, neuropathy, decreased reflexes, drowsiness.
Mental disorders: depression that resolved after discontinuation of the drug, hallucinations, disorientation, confusion, thinking disorders.
Respiratory system disorders: asthma, nosebleeds, hiccups, laryngitis, lung disease, pneumonia, voice change.
Skin and subcutaneous tissue disorders: allergic reactions in the form of itching and skin rashes. In isolated cases, urticaria, erythema multiforme, Lyell's syndrome, Stevens-Johnson syndrome, photosensitivity, alopecia, exfoliative dermatitis, acne, contact dermatitis, dry skin, eczema, fungal dermatitis, hemorrhages, herpes simplex, shingles, lichenoid dermatitis, maculopapular rash, skin disorders, skin ulcer, increased sweating, exanthema, angioedema were observed.
Sense organs: visual impairment, blurred vision, amblyopia, cataract, deafness, diplopia, ear pain, extraocular paralysis, glaucoma, otitis externa, taste changes, tinnitus.
Renal and urinary disorders: in isolated cases, interstitial nephritis (with possible development of renal failure), hematuria, albuminuria, balanitis, cystitis, dysmenorrhea, dysuria, epididymitis, kidney stones, kidney pain, nocturia, prostate dysfunction, pyelonephritis, scrotal edema, urethral pain, urethritis, urinary tract disorders, urination disorders, vaginitis.
Reproductive system and breast disorders: impotence, gynecomastia.
1. Hypocalcemia simultaneously with hypomagnesemia.
2. Muscle spasm as a result of electrolyte imbalance.
Expiration date
. 3 years.
Storage conditions
Keep out of reach of children.
Store at a temperature not exceeding 30 °C in the original packaging.
Packaging
10 tablets are placed in a blister. 1 or 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
Flamingo Pharmaceuticals Ltd.
Location of the manufacturer and its business address
E-28, Opp. Fire Brigade, M.I.D.S., Taloja, Raigad District, Maharashtra, IN-410 208, India.
Applicant
Flamingo Pharmaceuticals Ltd.
Location of the applicant and/or applicant's representative
7/1, Corporate Park, Sion-Trombay Road, Chembur, Mumbai - 400 071, India.
