Pantoprazole Sodium Tablets 40mg Taj Pharma

Pantoprazole Sodium Tablets 40mg Taj Pharma

  1. Name of the medicinal product

Pantoprazole Sodium Tablets 20mg
Pantoprazole Sodium Tablets 40mg

  1. Qualitative and quantitative composition
    a) Each enteric coated tablet contains:
    Pantotrazole sodium USP
    Equivalent to Pantoprazole                      20mg
    Excipients                                                  q.s
    b) Each enteric coated tablet contains:
    Pantotrazole sodium USP
    Equivalent to Pantoprazole                      40mg
    Excipients                                                  q.s
  2. Pharmaceutical form

Enteric-coated tablets.

  1. Clinical particulars

4.1 Therapeutic indications

Pantoprazole 40mg Tablet is indicated for use in adults and adolescents 12 years of age and above for:

  • Reflux oesophagitis.

Pantoprazole 40mg Tablet is indicated for use in adults for:

  • Eradication of Helicobacter pylori(H. pylori) in combination with appropriate antibiotic therapy in patients with H. pyloriassociated ulcers.
  • Gastric and duodenal ulcer.
  • Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

4.2 Posology and method of administration

Posology:

Adults and adolescents 12 years of age and above

Reflux oesophagitis

One tablet of Pantoprazole sodium 40mg per day. In individual cases the daily dose may be doubled (increase to 2 tablets Pantoprazole sodium 40mg daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

Adults:

Eradication of H. pylori in combination with two appropriate antibiotics

In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:

The following combinations have been shown to be effective:

(a) Pantoprazole sodium 40 mg twice daily,

plus 1000 mg amoxicillin twice daily

and 500 mg clarithromycin twice daily

(b) Pantoprazole sodium 40 mg twice daily,

plus 400-500 mg metronidazole (or 500 mg tinidazole) twice daily

and 250-500 mg clarithromycin twice daily

(c) Pantoprazole sodium 40 mg twice daily

plus 1000 mg amoxicillin twice-daily

and 400-500 mg metronidazole (or 500 mg tinidazole) twice-daily

In combination therapy for eradication of H. pylori infection, the second Pantoprazole sodium tablet should be taken 1 hour before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged for a further 7 days to a total duration of up to two weeks. If, to ensure healing of the ulcers, further treatment with Pantoprazole is indicated, the dose recommendations for duodenal and gastric ulcers should be considered.

If combination therapy is not an option, e.g. if the patient has tested negative for H. pylori, the following dose guidelines apply for Pantoprazole sodium monotherapy:

Treatment of gastric ulcer

One tablet of Pantoprazole sodium 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets of Pantoprazole sodium daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.

Treatment of duodenal ulcer

One tablet of Pantoprazole sodium 40mg per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole sodium daily) especially when there has been no response to other treatment. A duodenal ulcer generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.

Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80mg (2 tablets of Pantoprazole sodium 40mg). Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160mg pantoprazole per day is possible but should not be applied longer than required for adequate acid control.

Treatment duration in Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.

Elderly:

No dose adjustment is necessary in elder people (see section 5.2).

Paediatric population :

Pantoprazole sodium 40 mg is not recommended for use in children below twelve years of age because of limited data on safety and efficacy in this age group (see section 5.2).

Renal Impairment

No dose adjustment is necessary in patients with impaired renal function. Pantoprazole sodium 40mg must not be used in combination treatment for eradication of H. pylori in patients with impaired renal function since currently no data are available on the efficacy and safety of Pantoprazole sodium 40mg in combination treatment for these patients (see section 5.2).

Hepatic Impairment

A daily dose of 20 mg Pantoprazole (1 tablet of 20 mg Pantoprazole) should not be exceeded in patients with severe liver impairment. Pantoprazole sodium 40mg must not be used in combination treatment for eradication of H. pylori in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of Pantoprazole sodium 40mg in combination treatment of these patients (see section 4.4).

Method of administration

Oral use

Tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.

4.3 Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the other excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Hepatic Impairment

In patients with severe liver impairment, the liver enzymes should be monitored regularly during treatment with Pantoprazole, particularly on long-term use. In the case of a rise in liver enzymes, Pantoprazole therapy should be discontinued (see section 4.2).

Combination therapy

In the case of combination therapy, the summaries of product characteristics of the respective medicinal products should be observed.

Gastric malignancy

Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.

Further investigation is to be considered if symptoms persist despite adequate treatment.

Co-administration with HIV protease inhibitors

Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).

Influence on vitamin B12 absorption

In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.

Long term treatment

In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Bone Fracture

Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

Gastrointestinal infections caused by bacteria

Treatment with Pantoprazole sodium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter and C. difficile.

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like Pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Pantoprazole sodium 40mg. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Pantoprazole treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

4.5 Interaction with other medicinal products and other forms of interaction

Medicinal products with pH-Dependent Absorption Pharmacokinetics

Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of medicinal products where gastric pH is an important determinant of oral availability, e.g some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib.

HIV protease inhibitors

Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir due to significant reduction in their bioavailability (see section 4.4).

If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A pantoprazole dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted.

Coumarin anticoagulants (phenprocoumon or warfarin)

Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with pantoprazole and warfarin or phenprocoumon may need to be monitored for increase in INR and prothrombin time.

Methotrexate

Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may need to be considered.

Other interactions studies

Pantoprazole is extensively metabolised in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4.

Interaction studies with medicinal products also metabolized with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.

An interaction of pantoprazole with other medicinal products or compounds, which are metabolized using the same enzyme system, cannot be excluded.

Results from a range of interaction studies demonstrate that pantoprazole does not effect the metabolism of active substances metabolized by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or does not interfere with p-glycoprotein related absorption of digoxin.

There were no interactions with concomitantly administered antacids.

Interaction studies have also been performed administering pantoprazole concomitantly with the respective antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically relevant interactions were found.

Medicinal products that inhibit or induce CYP2C19:

Inhibitors of CYP2C19 such as fluvoxamine could increase the systemic exposure of pantoprazole. A dose reduction may be considered for patients treated long-term with high doses of pantoprazole, or those with hepatic impairment.

Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St John´s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.

4.6 Fertility, pregnancy and lactation

Pregnancy

A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Pantoprazole.

Animal studies have shown reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Pantoprazole during pregnancy.

Breast-feeding

Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from Pantoprazole sodium therapy taking into account the benefit of breast-feeding for the child, and the benefit of Pantoprazole sodium therapy for the women.

Fertility

There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).

4.7 Effects on ability to drive and use machines

Pantoprazole has no or negligible influence on the ability to drive and use machines.

Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machines.

4.8 Undesirable effects

Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1 % of patients.

The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience

Frequency Common Uncommon Rare Very rare Not known
System Organ Class
Blood and lymphatic system disorders Agranulocytosis Thrombocytopenia;

Leukopenia;

Pancytopenia

Immune system disorders Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Metabolism and nutrition disorders Hyperlipidaemias and lipid increases (triglycerides, cholesterol);

Weight changes

Hyponatraemia, hypomagnesaemia.

(See section 4.4);

Hypocalcaemia(1), hypokalaemia

Psychiatric disorders Sleep disorders Depression (and all aggravations) Disorientation (and all aggravations) Hallucination, Confusion, (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
Nervous system disorders Headache;

Dizziness

Taste disorder Parasthesia
Eye disorders Disturbances in vision/ blurred vision
Gastrointestinal Disorders Fundic gland polyps (benign) Diarrhoea;

Nausea/Vomiting;

Abdominal distension and bloating;

Constipation;

Dry mouth;

Abdominal pain and discomfort

Hepatobiliary disorders Liver enzymes increased (transaminases, γ-GT) Bilirubin increased Hepatocellular injury;

Jaundice;

Hepatocellular failure

Skin and subcutaneous tissue disorders Rash/exanthema/eruption;

Pruritus

Urticaria;

Angioedema

Stevens- Johnson Syndrome, Lyell Syndrome;

Erythema multiforme;

Photosensitivity;

Subacute cutaneous lupus erythematosus (see section 4.4).

Musculoskeletal, connective tissue disorders Fracture of the hip, wrist or spine (see section 4.4) Athralgia;

Myalgia

Muscle spasm (2)
Renal and urinary disorders Interstitial nephritis (with possible progression to renal failure)
Reproductive system and breast disorders Gynaecomastia
General disorders and administration site conditions Asthenia, fatigue and malaise Body temperature increased;

Oedema peripheral

  1. Hypocalcemia in association with hypomagnesemia
  2. Muscle spasm as a consequence of electrolyte disturbance

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

There are no known symptoms of over dosage in man.

Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated.

As pantoprazole is extensively protein bound, it is not readily dialysable.

In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Proton Pump Inhibitors.

Mechanism of action

Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.

Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.

Pharmacodynamic effects

The fasting gastrin values increase under pantoprazole. On short-term use, in most cases they do not exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. An excessive increase, however, occurs only in isolated cases. As a result, a mild to moderate increase in the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during long-term treatment (simple to adenomatoid hyperplasia). However, according to the studies conducted so far, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as were found in animal experiments (see section 5.3) have not been observed in humans.

An influence of a long term treatment with pantoprazole exceeding one year cannot be completely ruled out on endocrine parameters of the thyroid according to results in animal studies.

During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours.

Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.

5.2 Pharmacokinetic properties

Absorption

Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 40 mg oral dose. On average at about 2.5 h p.a. the maximum serum concentrations of about 2-3 μg/ml are achieved, and these values remain constant after multiple administration.

Pharmacokinetics does not vary after single or repeated administration. In the dose range of 10-80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration.

The absolute bioavailability from the tablet was found to be about 77 %. Concomitant intake of food had no influence on AUC, maximum serum concentration and thus bioavailability. Only the variability of the lag-time will be increased by concomitant food intake.

Distribution

Pantoprazole’s plasma protein binding is about 98%. Volume of distribution is about 0.15 l/kg

Biotransformation

The substance is almost exclusively metabolised in the liver. The main metabolic pathway is demethylation by CYP2C19 with subsequent sulphate conjugation, other metabolic pathway include oxidation by CYP3A4.

Elimination

Terminal half-life is about 1 hour and clearance is about 0.1 l/h/kg. There were a few cases of subjects with delayed elimination. Because of the specific binding of pantoprazole to the proton pumps of the parietal cell the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secretion).

Renal elimination represents the major route of excretion (about 80%) for the metabolites of pantoprazole; the rest are excreted in the faeces. The main metabolite in both the serum and urine is desmethylpantoprazole, which is conjugated with sulphate. The half-life of the main metabolites (about 1.5 hours) is not much longer than that of pantoprazole.

Special populations

Poor metabolisers

Approximately 3 % of the European population lack a functional CYP2C19 enzyme and are called poor metabolisers. In these individuals the metabolism of pantoprazole is probably mainly catalysed by CYP3A4. After a single-dose administration of 40 mg pantoprazole, the mean area under the plasma concentration-time curve was approximately 6 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were increased by about 60 %. These findings have no implications for the posology of pantoprazole.

Renal impairment

No dose reduction is recommended when pantoprazole is administered to patients with impaired renal function (including dialysis patients). As with healthy subjects, pantoprazole’s half-life is short. Only very small amounts of pantoprazole are dialyzed. Although the main metabolite has a moderately delayed half-life (2 – 3 h), excretion is still rapid and thus accumulation does not occur.

Hepatic impairment

Although for patients with liver cirrhosis (classes A and B according to Child) the half-time values increased to between 7 and 9 hours and the AUC values increased by a factor of 5 to 7, the maximum serum concentration only increased slightly by a factor of 1.5 compared with healthy subjects.

Elderly

A slight increase in AUC and Cmax in elderly volunteers compared with younger counterparts is also not clinically relevant.

Paediatric population

Following administration of single oral doses of 20 or 40 mg pantoprazole to children aged 5-16 years AUC and Cmax were in the range of corresponding values in adults.

Following administration of single i.v. doses of 0.8 or 1.6 mg/kg pantoprazole to children aged 2 – 16 years there was no significant association between pantoprazole clearance and age or weight.

AUC and volume of distribution were in accordance with data from adults.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.

In the two-year carcinogenicity studies in rats neuroendocrine neoplasms were found. In addition, squamous cell papillomas were found in the fore stomach of rats. The mechanism leading to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels occurring in the rat during chronic high-dose treatment. In the two-year rodent studies an increased number of liver tumors was observed in rats and in female mice and was interpreted as being due to pantoprazole’s high metabolic rate in the liver.

A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg). The occurrence of these neoplasms is associated with the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver. As the therapeutic dose in man is low, no harmful effects on the thyroid glands are expected.

In animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg.

Investigations revealed no evidence of impaired fertility or teratogenic effects.

Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation. As a result, concentration of pantoprazole in the foetus is increased shortly before birth.

  1. Pharmaceutical particulars

6.1 List of excipients

Tablet core: Mannitol, Crospovidone, Anhydrous sodium carbonate, Hydroxypropylcellulose, Calcium stearate

Tablet coating: Hypromellose, Yellow iron oxide, Methacrylic acid-ethylacrylate -copolymer (1:1)

triethyl citrate.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

No special precautions for storage

6.5 Nature and contents of container

Packs: ALU/ALU blisters Pack.

6.6 Special precautions for disposal and other handling

No special requirements.

7.Manufactured BY:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India).

 

Pantoprazole Sodium Tablets 40 mg (Taj Pharma)

Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Pantoprazole Tablets is and what it is used for
  2. What you need to know before you take Pantoprazole Tablets
  3. How to take Pantoprazole Tablets
  4. Possible side effects
  5. How to store Pantoprazole Tablets
  6. Content of the pack and other information

 

  1. What Pantoprazole Tablets is and what it is used for

Pantoprazole Tablets contains the active substance Pantoprazole (as Pantoprazole sodium sesquihydrate). Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.

Pantoprazole Tablets are used for:

Pantoprazole is used to treat adults and adolescents 12 years of age and above for:

  • Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.

Pantoprazole is used to treat adults for:

  • An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
  • Stomach and duodenal ulcers.
  • Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
  1. What you need to know before you take Pantoprazole Tablets

Do not take Pantoprazole Tablets

  • If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
  • If you are allergic to medicines containing other proton pump inhibitors.

Warning and precautions

Talk to your doctor or pharmacist before taking Pantoprazole Tablets

  • If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently, especially when you are taking Pantoprazole Tablets as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.
  • If you have reduced body stores or risk factors for reduced vitamin B12 and receive long-term treatment with pantoprazole. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin B12.
  • If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
  • Taking a proton pump inhibitor like pantoprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
  • If you are on Pantoprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
  • if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Tablets that reduces stomach acid.
  • If you are due to have a specific blood test (Chromogranin A).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole Tablets. Remember to also mention any other ill-effects like pain in your joints.

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease:

  • an unintentional loss of weight
  • vomiting, particularly if repeated
  • difficulty in swallowing or pain when swallowing
  • vomiting blood; this may appear as dark coffee grounds in your vomit
  • you look pale and feel weak (anaemia)
  • you notice blood in your stools; which may be black or tarry in appearance
  • chest pain
  • stomach pain
  • severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.

Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.

If you take Pantoprazole Tablets on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

Children and adolescents

Pantoprazole tablet is not recommended for use in children as it has not been proven to work in children below 12 years of age.

Talk to your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.

This is because Pantoprazole may influence the effectiveness of other medicines, so tell your doctor if you are taking:

  • Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole may stop these and other medicines from working properly.
  • Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
  • Medicines used to treat HIV-infection, such as atazanavir.
  • Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your Pantoprazole Tablets treatment because pantoprazole can increase levels of methotrexate in the blood.
  • Fluvoxamine (used to treat depression and other psychiatric diseases – if you are taking fluvoxamine your doctor may reduce the dose.
  • Rifampicin (used to treat infections).
  • St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breast-feeding

There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking the medicine.

You should use this medicine, only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.

Driving and using machines

Pantoprazole has no or negligible influence on the ability to drive and use machines.

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

  1. How to take Pantoprazole Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents 12 years of age and above:

To treat reflux oesophagitis

The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take your medicine.

Adults:

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).

One tablet, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before your evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks.

For the treatment of stomach and duodenal ulcers.

The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled. Your doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.

For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too much stomach acid is produced.

The recommended starting dose is usually two tablets a day.

Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If prescribed more than two tablets a day, the tablets should be taken twice daily.

If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Patients with kidney problems

  • If you have kidney problems,, you should not take Pantoprazole tablets for eradication of Helicobacter pylori.

Patients with liver problems

  • If you suffer from severe liver problems, you should not take more than one tablet 20 mg pantoprazole a day (for this purpose tablets containing 20 mg Pantoprazole are available). If you suffer from moderate or severe liver problems, you should not take Pantoprazole Tablets for eradication of Helicobacter pylori.

Use in children and adolescents

  • These tablets are not recommended for use in children below 12 years.

Method of administration

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.

If you take more Pantoprazole Tablets than you should

Consult your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazole Tablets

Do not take a double dose to make up for the forgotten dose. Take your next, normal dose at the usual time.

If you stop taking Pantoprazole Tablets

Do not stop taking these tablets without first talking to your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:

  • Serious allergic reactions (frequency rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating.
  • Serious skin conditions (frequency not known: frequency cannot be estimated from the

available data): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.

  • Other serious conditions (frequency not known: frequency cannot be estimated from the

available data): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys), possibly leading to kidney failure.

Other side effects are:

  • Common (may affect up to 1 in 10 people) Benign polyps in the stomach
  • Uncommon (may affect up to 1 in 100 people)

headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders; fracture in the hip, wrist or spine.

  • Rare (may affect up to 1 in 1,000 people)

Distortion or complete lack of the sense of taste, disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; high fever swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males,

  • Very Rare (may affect up to 1 in 10,000 people)
  • Not known (frequency cannot be estimated from the available data)

Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood, decreased magnesium level in blood (see section 2), rash, possibly with pain in the joints, feeling of tingling, prickling, pins and needles, burning sensation or numbness;

Side effects identified through blood tests:

  • Uncommon (may affect up to 1 in 100 people) an increase in liver enzymes.
  • Rare (may affect up to 1 in 1000 people) an increase in bilirubin; increased fats levels in the blood; sharp drop in circulating granular white blood cells, associated with high fever.
  • Very Rare (may affect up to 1 in 10,000 people) a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections. Co-existing abnormal reduction in the number of red and white blood cells, as well as platelets.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. How to store Pantoprazole Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton and container after EXP. The expiry date refers to the last day of that month.

To be used within 6 months after first opening the container.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

 

  1. Content of the pack and other information

What Pantoprazole Tablets contain

  • The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole (as sodium).
  • The other ingredients are Mannitol, Crospovidone, Anhydrous sodium carbonate, hydroxypropylcellulose, calcium stearate, Hypromellose, Yellow iron oxide, Methacrylic acid-ethylacrylate -copolymer (1:1) and triethyl citrate.

 

What Pantoprazole Tablets looks like and contents of the pack

Enteric coated oval biconvex tablets plain on both the sides.

Packs: Aluminium blisters

Pantoprazole 40 mg tablets are available in the following pack sizes: 10, 20, 30, 50, 100, 150, 300, 500.

7.Manufactured BY:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India).

 

 

 

 

 

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.