Omeprazole and Sodium Bicarbonate gastro-resistant capsules USP 40mg/1100mg Taj Pharma

1. Name of the medicinal product

Omeprazole and Sodium Bicarbonate gastro-resistant capsules USP 20mg/1100mg Taj Pharma
Omeprazole and Sodium Bicarbonate gastro-resistant capsules USP 40mg/1100mg Taj Pharma

2. Qualitative and quantitative composition

a) Omeprazole and Sodium Bicarbonate gastro-resistant capsules USP 20mg/1100mg Taj Pharma
Each hard gelatin gastro-resistant capsule contains:
Omeprazole USP 20mg
Sodium Bicarbonate USP 1100mg
Excipents: Q.S.

b) Omeprazole and Sodium Bicarbonate gastro-resistant capsules USP 40mg/1100mg Taj Pharma
Each hard gelatin gastro-resistant capsule contains:
Omeprazole USP 40mg
Sodium Bicarbonate USP 1100mg
Excipents: Q.S.

Excipients with known effect:

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard gelatin, Gastro-resistant capsules
Each hard shell gelatin capsule filled with white to off-white pellets.

4. Clinical particulars

• Therapeutic indications

Omeprazole and Sodium Bicarbonate Taj Pharma is indicated in adults and children over 1 year of age and ≥ 10kg.
Omeprazole and Sodium Bicarbonate Taj Pharma gastro-resistant capsules are indicated in:

Adults:

• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics,Helicobacter pylori ( pylori) eradication in peptic ulcer disease
• Treatment of NSAID associated gastric and duodenal ulcers
• Prevention of NSAID associated gastric and duodenal ulcers in patients at risk
• Treatment of reflux esophagitis
• Long term management of patients with healed reflux esophagitis
• Treatment of symptomatic gastro-esophageal reflux disease
• Treatment of Zollinger-Ellison syndrome

Paedriatric population:

Children over 1 year of age and ≥10 kg

• Treatment of reflux esophagitis,
• Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease
• Children and adolescents over 4 years of age
• In combination with antibiotics in the treatment of duodenal ulcer caused by  pylori

Posology and method of administration

Posology in adults

Treatment of duodenal ulcers
The recommended dose in patients with an active duodenal ulcer is Omeprazole and Sodium Bicarbonate Taj Pharma 20mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with a poorly responsive duodenal ulcer Omeprazole and Sodium Bicarbonate Taj Pharma 40mg once daily is recommended and healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcers

For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. pylori eradication is not possible the recommended dose is Omeprazole and Sodium Bicarbonate Taj Pharma 20mg once daily. In some patients a daily dose of 10mg may be sufficient. In case of therapy failure, the dose can be increased to 40mg.

Treatment of gastric ulcers

The recommended dose is 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period. In patients with a poorly responsive gastric ulcer Omeprazole and Sodium Bicarbonate Taj Pharma 40mg once daily is recommended and healing is usually achieved within eight weeks.

Prevention of relapse of gastric ulcers

For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is Omeprazole and Sodium Bicarbonate Taj Pharma 20mg once daily. If needed the dose can be increased to Omeprazole and Sodium Bicarbonate Taj Pharma 40mg once daily.

1. pylorieradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the individual patient’s drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.

• Omeprazole and Sodium Bicarbonate Taj Pharma 20mg + clarithromycin 500mg + amoxicillin 1000mg, each twice daily for 1 week or
• Omeprazole and Sodium Bicarbonate Taj Pharma 20mg + clarithromycin 250mg (alternatively 500mg) + metronidazole 400mg-(or 500mg or tinidazole 500mg) each twice daily for one week or
• Omeprazole and Sodium Bicarbonate Taj Pharma 40mg once daily with amoxicillin 500mg + metronidazole 400mg (or 500mg or tinidazole 500mg) both three times a day for one week

In each regimen, if the patient is still H. pylori positive, therapy may be repeated.

Treatment of NSAID – associated gastric and duodenal ulcers:

For the treatment of NSAID -associated gastric and duodenal ulcers, the recommended dose is Omeprazole and Sodium Bicarbonate Taj Pharma 20mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

Prevention of NSAID -associated gastric and duodenal ulcers in patients at risk

For the prevention of NSAID -associated gastric ulcers and duodenal ulcers in patients at risk (age >60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is 20mg Omeprazole and Sodium Bicarbonate Taj Pharma once daily.

Treatment of reflux esophagitis

The recommended dose is Omeprazole and Sodium Bicarbonate Taj Pharma 20mg once daily. In most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

In patients with severe esophagitis Omeprazole and Sodium Bicarbonate Taj Pharma 40mg once daily is recommended and healing is usually achieved within eight weeks.

Long-term management of patients with healed reflux esophagitis

For the long-term management of patients with healed reflux esophagitis the recommended dose is Omeprazole and Sodium Bicarbonate Taj Pharma 10mg once daily. If needed, the dose can be increased to Omeprazole and Sodium Bicarbonate Taj Pharma 20-40mg once daily.

Treatment of symptomatic of gastro-esophageal reflux disease

The recommended dose is Omeprazole and Sodium Bicarbonate Taj Pharma 20mg daily. Patients may respond adequately to 10mg daily, and therefore individual dose adjustments should be considered. If symptom control has not be achieved after four weeks treatment with Omeprazole and Sodium Bicarbonate Taj Pharma 20mg daily, further investigation is recommended.

Treatment of Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated. The recommended initial dose is Omeprazole and Sodium Bicarbonate Taj Pharma 60mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of Omeprazole and Sodium Bicarbonate Taj Pharma 20-120mg daily. When the dose exceeds Omeprazole and Sodium Bicarbonate Taj Pharma 80mg daily, the dose should be divided and given twice daily.

Paediatric population

The safety and efficacy of Omeprazole and Sodium Bicarbonate Taj Pharma in children aged 0-12 months and < 10kg has not yet been established.

Children over 1 year of age and ≥ 10 kg

Treatment of Reflux esophagitis

Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease

The posology recommendations are as follows:

Reflux esophatitis

The treatment time is 4-8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease

The treatment time is 2-4 weeks. If symptom control has not been achieved after 2-4 weeks the patient should be investigated further.

Children and adolescents over 4 years of age

Treatment of duodenal ulcer caused by H pylori.

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidelines regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days) and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.

The posology recommendations are as follows:

Special Populations:

Renal impairment

Dose adjustment is not required in patients with impaired renal function (see section 5.2).

Hepatic impairment

In patients with impaired hepatic function a daily dose of 10-20mg may be sufficient (see section 5.2).

Elderly

Dose adjustment is not required in the elderly (see section 5.2).

Method of administration:

It is recommended to take Omeprazole and Sodium Bicarbonate Taj Pharma capsules in the morning, preferably without food, swallowed whole with half a glass of water.

The capsules must not be crushed or chewed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food:

Patients can open the capsule and swallow the contents with half a glass of water or after mixing the contents in a slightly acidic fluid e.g. fruit juice or apple sauce, or in non-carbonated water. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes) and always be stirred just before drinking and rinsed down with half a glass of water.

Alternatively patients can suck the capsule and swallow the pellets with half a glass of water. The enteric-coated pellets must not be chewed.

• Contraindications

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

Omeprazole and Sodium Bicarbonate Taj Pharma like other proton pump inhibitors (PPIs) must not be used concommitantly with nelfinavir (see section 4.5).

• Special warnings and precautions for use

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

Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400mg with 100mg of ritonavir; Omeprazole and Sodium Bicarbonate Taj Pharma 20mg should not be exceeded.

Omeprazole and Sodium Bicarbonate Taj Pharma as with 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.

Omeprazole and Sodium Bicarbonate Taj Pharma is a CYP2C19 inhibitor. When starting or ending treatment with Omeprazole and Sodium Bicarbonate Taj Pharma, the potential for interactions with drugs metabolized through CYP2C19 should be considered. An interaction is observed between clopidogrel and Omeprazole and Sodium Bicarbonate Taj Pharma (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of Omeprazole and Sodium Bicarbonate Taj Pharma and clopidogrel should be discouraged.

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like Omeprazole and Sodium Bicarbonate Taj Pharma 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 other medicines that may cause hypomagnesaemia (e.g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment;

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 fractures 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.

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 healthcare professional should consider stopping Omeprazole and Sodium Bicarbonate Taj Pharma. 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, Omeprazole and Sodium Bicarbonate Taj Pharma treatment should be stopped for at least five 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.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients possibly also Clostridium difficile (see section 5.1).

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

Paediatric population:

Some children with chronic illnesses may require long-term treatment although it is not recommended.

• Interaction with other medicinal products and other forms of interaction

Effects of Omeprazole and Sodium Bicarbonate Taj Pharma on the pharmacokinetics of other active substances

Active substances with pH dependent absorption

The decreased intragastric acidity during treatment with Omeprazole and Sodium Bicarbonate Taj Pharma might increase or decrease the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, atazanavir

The plasmas levels of nelfinavir and atazanavir are decreased in case of co-administration with Omeprazole and Sodium Bicarbonate Taj Pharma.

Concomitant administration of Omeprazole and Sodium Bicarbonate Taj Pharma with nelfinavir is contraindicated (see section 4.3) Co-administration of Omeprazole and Sodium Bicarbonate Taj Pharma (40mg once daily) reduced mean nelfinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75-90%. The interaction may also involve CYP2C19 inhibition.

Concomitant administration of Omeprazole and Sodium Bicarbonate Taj Pharma with atazanavir is not recommended (see section 4.4). Concomitant administration of Omeprazole and Sodium Bicarbonate Taj Pharma (40mg once daily) and atazanavir 300mg/ rintonavir 100mg to healthy volunteers resulted in a 75% decrease in atazanavir exposure. Increasing the atazanavir dose to 400mg did not compensate for the effect of Omeprazole and Sodium Bicarbonate Taj Pharma on atazanavir exposure. The co-administration of Omeprazole and Sodium Bicarbonate Taj Pharma (20mg once daily) with atazanavir 400mg/ritonavir 100mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300mg/ ritonavir 100mg once daily.

Digoxin

Concomitant treatment with Omeprazole and Sodium Bicarbonate Taj Pharma (20mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported. However caution should be exercised when Omeprazole and Sodium Bicarbonate Taj Pharma is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should then be reinforced.

Clopidogrel

Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300mg loading dose/75mg daily maintenance dose) and Omeprazole and Sodium Bicarbonate Taj Pharma (80mg p.o. daily) resulting in a decreased exposure to the active metabolite of clopidogrel by an average of 46% and a decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 16%. Inconsistent data on the clinical implications of a PK/PD interaction of Omeprazole and Sodium Bicarbonate Taj Pharma in terms of major cardiovascular events have been reported from both observational and clinical studies. As a precaution, concomitant use of Omeprazole and Sodium Bicarbonate Taj Pharma and clopidogrel should be discouraged (see section 4.4)

Other active substances

The absorption of posaconazole, erlotinib, ketoconazol and itraconazol is significantly reduced and thus clinical efficacy may be impaired. For posaconazol and erlotinib concomitant use should be avoided.

Active substances metabolised by CYP2C19

Omeprazole and Sodium Bicarbonate Taj Pharma is a moderate inhibitor of CYP2C19, the major Omeprazole and Sodium Bicarbonate Taj Pharma metabolising enzyme. Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol

Omeprazole and Sodium Bicarbonate Taj Pharma, given in doses of 40mg to healthy subjects in a cross-over study, increased the C_MAX and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.

Phenytoin

Monotoring phenytoin plasma concentration is recommended during the first two weeks after initiating Omeprazole and Sodium Bicarbonate Taj Pharma treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending Omeprazole and Sodium Bicarbonate Taj Pharma treatment.

Unknown Mechanism

Saquinavir

Concomitant administration of Omeprazole and Sodium Bicarbonate Taj Pharma with sequinavir/ritonavir resulted in increased plasma levels up to 70% for saquinavir associated with good tolerability in HIV-infected patients.

Tacrolimus

Concomitent administration of Omeprazole and Sodium Bicarbonate Taj Pharma has been reported to increase the serum levels of tacrolimus. A reinforced montoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and dosage of tacrolimus adjusted if needed.

Methotrexate

When given together with proton-pump inhibitors, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of Omeprazole and Sodium Bicarbonate Taj Pharma may need to be considered.

Effects of other active substances on the pharmacokinetics of Omeprazole and Sodium Bicarbonate Taj Pharma

Inhibitors of CYP2C19 and/or CYP3A4

Since Omeprazole and Sodium Bicarbonate Taj Pharma is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 and CYP3A4 (such as clarithromycin and voriconazole) may lead to increased Omeprazole and Sodium Bicarbonate Taj Pharma serum levels by decreasing Omeprazole and Sodium Bicarbonate Taj Pharma’s rate of metabolism. Concomitant voriconazole treatment resulted in more than doubling of the Omeprazole and Sodium Bicarbonate Taj Pharma exposure. As high doses of Omeprazole and Sodium Bicarbonate Taj Pharma have been well-tolerated adjustment of the Omeprazole and Sodium Bicarbonate Taj Pharma dose is not generally required. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4

Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampacin and St John’s Wort) may lead to decreased Omeprazole and Sodium Bicarbonate Taj Pharma serum levels by increasing Omeprazole and Sodium Bicarbonate Taj Pharma’s rate of metabolism.

• Fertility, pregnancy and lactation

Pregnancy

Results from three prospective epidemiologic studies (more than 1000 exposed outcomes) indicate no adverse effects of Omeprazole and Sodium Bicarbonate Taj Pharma on pregnancy or on the health of the foetus/ newborn child.

Omeprazole and Sodium Bicarbonate Taj Pharma can be used during pregnancy.

Breast-feeding

Omeprazole and Sodium Bicarbonate Taj Pharma is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

• Effects on ability to drive and use machines

Omeprazole and Sodium Bicarbonate Taj Pharma has no or negligible influence on the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbance may occur (see section 4.8). If affected, patients should not drive or operate machinery.

• Undesirable effects

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

The following adverse drug reactions have been identified or suspected in the clinical trials programme for Omeprazole and Sodium Bicarbonate Taj Pharma and post-marketing. None was found to be dose-related.

Adverse reactions listed below are classified according to the frequency and System Organ Class (SOC). Frequency categories are defined according to the following convention:

• 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)

Paediatric Population

The safety of Omeprazole and Sodium Bicarbonate Taj Pharma has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of Omeprazole and Sodium Bicarbonate Taj Pharma during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long term data regarding the effects of Omeprazole and Sodium Bicarbonate Taj Pharma treatment on puberty and growth.

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.

Overdose

There is limited information available on the effects of overdoses of Omeprazole and Sodium Bicarbonate Taj Pharma in humans. In literature, doses of up to 560mg have been described, and occasional reports have been received when single oral doses have been reached of up to 2,400mg Omeprazole and Sodium Bicarbonate Taj Pharma (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.

The symptoms described in connection with Omeprazole and Sodium Bicarbonate Taj Pharma overdose have been transient, and no serious outcome has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is symptomatic.

5. Pharmacological properties

• Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors,

Mechanism of Action:

Omeprazole and Sodium Bicarbonate Taj Pharma, a racemic mixture of two enantiomers, reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

Omeprazole and Sodium Bicarbonate Taj Pharma is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+, K+-ATPase – the acid pump. This effect on the final step of gastric acid formation process is dose-dependent and provides for highly effective inhibition of both basal acid secretion and stimulated acid secretion, irrespective of stimulus.

Pharmacodynamic effects:

All pharmacodynamic effects observed can be explained by the effect of Omeprazole and Sodium Bicarbonate Taj Pharma on acid secretion.

Clinical Efficacy and Safety:

Effect on gastric acid secretion:

Oral dosing with Omeprazole and Sodium Bicarbonate Taj Pharma once daily provides for rapid and effective inhibition of daytime and night-time gastric acid secretion with maximum effect being achieved within 4 days of treatment. With Omeprazole and Sodium Bicarbonate Taj Pharma 20mg, a mean decrease of at least 80% in 24-hour intragastric acidity is then maintained on duodenal ulcer patients, with the mean decrease in peak acid output after pentagastrin stimulation being about 70% 24 hours after dosing.

Oral dosing with Omeprazole and Sodium Bicarbonate Taj Pharma 20mg maintains an intragastric pH of ≥ 3 for a mean time of 17 hours of the 24-hour period in duodenal ulcer patients.

As a consequence of reduced acid secretion and intragastric acidity, Omeprazole and Sodium Bicarbonate Taj Pharma dose-dependently reduces/normalizes acid exposure of the esophagus in patients with gastro-esophageal reflux disease. The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) of Omeprazole and Sodium Bicarbonate Taj Pharma and not the actual plasma concentration at a given time.

No tachyphylaxis has been observed during treatment with Omeprazole and Sodium Bicarbonate Taj Pharma.

Effect on H. pylori

1. pyloriis associated with peptic ulcer disease, including duodenal and gastric ulcer disease. H. pyloriis a major factor in the development of gastritis. H. pylori together with gastric acid are major factors in the development of peptic ulcer disease. H. pylori is a major factor in the development of atrophic gastritis which is associated with an increased risk of developing gastric cancer.

Eradication of H. pylori with Omeprazole and Sodium Bicarbonate Taj Pharma and antimicrobials is associated with high rates of healing and long-term remission of peptic ulcers.

Dual therapies have been tested and have been found to be less effective than triple therapies. They could however be considered in cases where known hypersensitivity precludes the use of any triple combination.

Other effects related to acid inhibition

During long-term treatment gastric glandular cysts have been reported in somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric count of bacteria normally present in the gastrointestinal tract. Treatment with acid reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile..

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.

An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in some patients (both children and adults) during long term treatment with Omeprazole and Sodium Bicarbonate Taj Pharma. The findings are considered to be of no clinical significance.

Paediatric population

In a non-controlled study in children (1 to 16 years of age) with severe reflux esophagitis, Omeprazole and Sodium Bicarbonate Taj Pharma at doses of 0.7 to 1.4mg/kg improved esophagitis level in 90 % of the cases and significantly reduced reflux symptoms. In a single-blind study, children aged 0-24 months with clinically diagnosed gastro-esophageal reflux disease were treated with 0.5, 1.0 or 1.5mg Omeprazole and Sodium Bicarbonate Taj Pharma/kg. The frequency of vomiting/regurgitation episodes decreased by 50 % after 8 weeks of treatment irrespective of the dose.

Eradication of Helicobacter pylori in children

A randomised, double-blind clinical study (Heliot study) concluded that Omeprazole and Sodium Bicarbonate Taj Pharma in combination with two antibiotics (amoxicillin and clarithromycin) was safe and effective in the treatment of H. pylori infection in children of 4 years old and above with a gastritis: H. pylori eradication rate: 74 % (23/31 patients) with Omeprazole and Sodium Bicarbonate Taj Pharma + amoxicillin + clarithromycin versus 9.4 % (3/32 patients) with amoxicillin + clarithromycin. However, there was no evidence of clinical benefit demonstrated regarding dyspeptic symptoms. This study does not support any information for children aged less than 4 years old.

• Pharmacokinetic properties

Absorption

Omeprazole and Sodium Bicarbonate Taj Pharma is acid labile and is therefore administered orally as enteric-coated granules in hard-gelatin capsules. Absorption of Omeprazole and Sodium Bicarbonate Taj Pharma is rapid, with peak-plasma levels occurring 1-2 hours after the dose. Absorption of Omeprazole and Sodium Bicarbonate Taj Pharma takes place in the small intestine and is usually completed within 3-6 hours. Concomitant intake of food has no influence on the bioavailability. The systemic availability (bioavailability) from a single oral dose of Omeprazole and Sodium Bicarbonate Taj Pharma is approximately 40%. After repeated once-daily administration, the bioavailability increases to about 60%.

Distribution

The apparent volume of distribution in healthy subjects is approximately 0.3l/kg body weight. Omeprazole and Sodium Bicarbonate Taj Pharma is 97% protein bound.

Biotransformation

Omeprazole and Sodium Bicarbonate Taj Pharma is completely metabolised, by the cytochrome P450 system (CYP). The major part of metabolism is dependent on the polymorphically expressed CYP 2C19 responsible for the formation of hydroxyOmeprazole and Sodium Bicarbonate Taj Pharma, the major metabolite in plasma. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of Omeprazole and Sodium Bicarbonate Taj Pharma Sulphone. As a consequence of high affinity of Omeprazole and Sodium Bicarbonate Taj Pharma to CYP 2C19, there is the potential for competitive inhibition and metabolic drug-drug interactions with other substrates for CYP 2C19. However due to low affinity to CYP3A4, Omeprazole and Sodium Bicarbonate Taj Pharma has no potential to inhibit the metabolism of other CYP3A4 substrates. In addition Omeprazole and Sodium Bicarbonate Taj Pharma lacks an inhibitory effect on the main CYP enzymes.

Approximately 3% of the Caucasian population and 15-20% of the Asian population lack a functional CYP 2C19 enzyme and are called poor metabolisers. In such individuals the metabolism of Omeprazole and Sodium Bicarbonate Taj Pharma is probably mainly catalysed by CYP3A4. After repeated once-daily administration of 20mg Omeprazole and Sodium Bicarbonate Taj Pharma the mean AUC was 5 to 10 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were also higher, by 3 to 5 times. These findings have no implications for the posology of Omeprazole and Sodium Bicarbonate Taj Pharma.

Elimination

The plasma elimination half life of Omeprazole and Sodium Bicarbonate Taj Pharma is usually shorter than one hour both after single and repeated oral once daily dosing. Omeprazole and Sodium Bicarbonate Taj Pharma is completely eliminated from plasma between doses with no tendency for accumulation during once daily administration. Almost 80% of an oral dose of Omeprazole and Sodium Bicarbonate Taj Pharma is excreted as metabolites in the urine, the remainder in the faeces, primarily originating from bile secretion.

The AUC of Omeprazole and Sodium Bicarbonate Taj Pharma increases with repeated administration. This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration. This time- and dose- dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by Omeprazole and Sodium Bicarbonate Taj Pharma and /or it’s metabolites (e.g. the sulphone).

No metabolite has been found to have any effect on gastric acid secretion.

Special Populations

Impaired hepatic function

The metabolism of Omeprazole and Sodium Bicarbonate Taj Pharma in patients with liver dysfunction is impaired, resulting in an increased AUC. Omeprazole and Sodium Bicarbonate Taj Pharma has not shown any tendency to accumulate with once-daily dosing.

Impaired renal function

The pharmacokinetics of Omeprazole and Sodium Bicarbonate Taj Pharma, including systemic bioavailability and elimination rate, are unchanged in patients with reduced renal function.

Elderly

The metabolism rate of Omeprazole and Sodium Bicarbonate Taj Pharma is somewhat reduced in elderly subjects (75-79 years of age).

Paediatric patients

During treatment with the recommended doses to children from the age of 1 year, similar plasma concentrations were obtained as compared to adults. In children younger than 6 months, clearance of Omeprazole and Sodium Bicarbonate Taj Pharma is low due to low capacity to metabolise Omeprazole and Sodium Bicarbonate Taj Pharma.

• Preclinical safety data

Gastric ECL-cell hyperplasia and carcinoids have been observed in life-long studies in rats treated with Omeprazole and Sodium Bicarbonate Taj Pharma. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition. Similar findings have been made after treatment with H₂-receptor antagonists, proton pump inhibitors and after partial fundectomy. Thus, these changes are not from a direct effect of any individual active substance.

6. Pharmaceutical particulars
   • List of excipients

Capsule Content

Drug coating

Sugar spheres (sucrose, maize starch)

Hypromellose

Sodium hydroxide

Barrier coating

Hypromellose

Enteric coating

Methacrylic Acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent (methacrylic acid-ethyl acrylate (1:1), sodium lauryl sulphate, polysorbate 80)

Talc

Titanium dioxide

Macrogol 6000

Polysorbate 80

Sodium hydroxide

Capsule shell

Shell cap

Iron oxide red, Titanium dioxide, Gelatin, Sodium lauryl sulphate

Shell Body

Titanium dioxide, Gelatin, Sodium lauryl sulphate

• Incompatibilities

Not applicable.

• Shelf life

HDPE Bottle Pack

Shelf life: 24 months

Blister Pack

Shelf life: 24 months

• Special precautions for storage

Blister Pack: Do not store above 25°C. Store in original package in order to protect from moisture.

HDPE tablets container: Keep the container tightly closed in order to protect from moisture

• Nature and contents of container

Round wide mouth white coloured HDPE bottle with white opaque PP screw cap induction sealing line.

7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 112, 200, 500 in bottles 2 x 50.

Aluminium/Polyamide/PVC blister.

7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 98, 100, 112, 200, 500 in blisters 2 x 50

Not all pack sizes may be marketed.

• Special precautions for disposal and other handling

No special requirements for disposal.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com

Omeprazole and Sodium Bicarbonate gastro-resistant capsules USP 40mg/1100mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole and Sodium Bicarbonate Taj Pharma 20mg & 40mg Gastro-resistant Capsules (Omeprazole and Sodium Bicarbonate Taj Pharma)

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. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Omeprazole and Sodium Bicarbonate Taj Pharma is and what it is used for.
2. What you need to know before you take Omeprazole and Sodium Bicarbonate Taj Pharma.
3. How to take Omeprazole and Sodium Bicarbonate Taj Pharma.
4. Possible side effects.
5. How to store Omeprazole and Sodium Bicarbonate Taj Pharma.
6. Contents of the pack and other information.

1.WHAT OMEPRAZOLE AND SODIUM BICARBONATE TAJ PHARMA IS AND WHAT IT IS USED FOR

Omeprazole and Sodium Bicarbonate Taj Pharma belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Omeprazole and Sodium Bicarbonate Taj Pharma is used to treat the following conditions:

In adults:

• ‘Gastro-esophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestines (duodenal ulcer) or stomach (gastric ulcer).
• To stop ulcers in the upper part of the intestines (duodenal ulcer) or stomach (gastric ulcer) from coming back.
• Ulcers which are also infected with a bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (non-steroidal anti inflammatory drugs). Omeprazole and Sodium Bicarbonate Taj Pharma can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10kg:

• ‘Gastro-esophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

In children the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age:

• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE AND SODIUM BICARBONATE TAJ PHARMA

Do not take Omeprazole and Sodium Bicarbonate Taj Pharma if you:

• are allergic to Omeprazole and Sodium Bicarbonate Taj Pharma or any of the other ingredients of this medicine (listed in Section 6).
• are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esOmeprazole and Sodium Bicarbonate Taj Pharma).
• are taking a medicine containing nelfinavir (used for HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole and Sodium Bicarbonate Taj Pharma.

Warnings and Precautions

Omeprazole and Sodium Bicarbonate Taj Pharma may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole and Sodium Bicarbonate Taj Pharma, or whilst you are taking it, talk to your doctor or pharmacist:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as Omeprazole and Sodium Bicarbonate Taj Pharma has been associated with a small increase in infectious diarrhoea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazole and Sodium Bicarbonate Taj Pharma that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

If you take Omeprazole and Sodium Bicarbonate Taj Pharma 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.

Taking a proton pump inhibitor like Omeprazole and Sodium Bicarbonate Taj Pharma, 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 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 Omeprazole and Sodium Bicarbonate Taj Pharma. Remember to also mention any other ill-effects like pain in your joints.

Other medicines and Omeprazole and Sodium Bicarbonate Taj Pharma

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Omeprazole and Sodium Bicarbonate Taj Pharma can affect the way some medicines work and some medicines can have an effect on Omeprazole and Sodium Bicarbonate Taj Pharma.

Do not take Omeprazole and Sodium Bicarbonate Taj Pharma if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole and Sodium Bicarbonate Taj Pharma.
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.

Your doctor may need to monitor you when you start or stop taking Omeprazole and Sodium Bicarbonate Taj Pharma.

• Rifampacin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infections).
• Tacrolimus (in cases of organ transplantation).
• St John’s Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (to treat HIV infections).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Erlotinib (used to treat different types of cancer).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Omeprazole and Sodium Bicarbonate Taj Pharma treatment.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole and Sodium Bicarbonate Taj Pharma to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Tell your doctor or the medical staff if you undergo a test for tumours.

Omeprazole and Sodium Bicarbonate Taj Pharma with food and drink

You can take your capsules with food or on an empty stomach.

Pregnancy and breast-feeding

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 this medicine.

Your doctor will decide whether you can take Omeprazole and Sodium Bicarbonate Taj Pharma if you are breast-feeding.

Driving and using machines

Omeprazole and Sodium Bicarbonate Taj Pharma is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.

Important information about some of the ingredients of Omeprazole and Sodium Bicarbonate Taj Pharma

Omeprazole and Sodium Bicarbonate Taj Pharma 40mg contains Sunset Yellow (E110) and Allura red (E129). May cause allergic reactions.

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE OMEPRAZOLE AND SODIUM BICARBONATE TAJ PHARMA

Always take Omeprazole and Sodium Bicarbonate Taj Pharma exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition and how old you are.

Adults:

To treat symptoms of GERD such as heartburn and acid regurgitation:

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is 20mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a further 8 weeks if your gullet has not yet healed.
• The recommended dose once your gullet has healed is 10mg once a day.
• If your gullet has not been damaged, the recommended dose is 10mg once a day.
• To treat ulcers in the upper part of the intestine (duodenal ulcer):
• The recommended dose is 20mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
• If the ulcer does not fully heal, the dose can be increased to 40mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

• The recommended dose is 20mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
• If the ulcers do not fully heal, the dose can be increased to 40mg once a day for 8 weeks.

To prevent duodenal and stomach ulcers from coming back:

• The recommended dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (non-steroidal anti inflammatory drugs):

• The recommended dose is 20mg once a day for 4 to 8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

• The recommended dose is 20mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

• The recommended dose is 20mg Omeprazole and Sodium Bicarbonate Taj Pharma twice a day for one week.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison Syndrome):

• The recommended dose is 60mg daily.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Use in children:

To treat symptoms of GERD such as heartburn and acid regurgitation:

• Children over 1 year of age and with a body weight of more than 10kg may take Omeprazole and Sodium Bicarbonate Taj Pharma.

The recommended dose for children is based on the child’s weight and the doctor will decide the correct dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

• Children aged over 4 years may take Omeprazole and Sodium Bicarbonate Taj Pharma. The recommended dose for children is based on the child’s weight and the doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine:

It is recommended that you take your capsules in the morning.

You can take your capsules with food or on an empty stomach.

Swallow your capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you or your child have trouble swallowing the capsules:

If you or your child have trouble swallowing the capsules:

• Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
• Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
• To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

If you take more Omeprazole and Sodium Bicarbonate Taj Pharma than you should

If you take more Omeprazole and Sodium Bicarbonate Taj Pharma than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Omeprazole and Sodium Bicarbonate Taj Pharma

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omeprazole and Sodium Bicarbonate Taj Pharma can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking Omeprazole and Sodium Bicarbonate Taj Pharma and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
• Severe liver problems leading to liver failure and inflammation of the brain. Symptoms include jaundice which can cause yellow skin, dark urine and tiredness.
• Omeprazole and Sodium Bicarbonate Taj Pharma may in very rare cases affect the white blood cells leading to immune deficiency (agranulocytosis). If you have an infection with symptoms of fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult a doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.
• Severe kidney problems (interstitial nephritis).
• Rash, possibly with pain in the joints.

Other side-effects include:

Common side effects (may affect up to 1 in 10 people):

• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence), benign polyps in the stomach.
• Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as ‘pins and needles’, feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
• Fracture of the hip, wrist or spine.

Rare side effects (may affect up to 1 in 1000 people):

• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pain (arthralgia) or muscle pains (myalgia).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people):

• Seeing, feeling or hearing things that are not there (hallucinations).
• Sudden onset of severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema mulitforme).
• Muscle weakness.
• Enlarged breasts in men.

Not known side effects (frequency cannot be estimated from the available data):

• Inflammation of the gut (leading to diarrhoea).
• If you are on Omeprazole and Sodium Bicarbonate Taj Pharma 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, 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.

Do not be concerned by this list of possible side-effects. You may not get any of them.

Reporting of side effects

If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OMEPRAZOLE AND SODIUM BICARBONATE TAJ PHARMA

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 carton or label after “EXP”. The expiry date refers to the last day of that month.

Blister pack: Do not store above 25°C. Store in the original package to protect from moisture.

HDPE bottle: Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture.

Do not throw away 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Omeprazole and Sodium Bicarbonate Taj Pharma contains

The active substance is Omeprazole and Sodium Bicarbonate Taj Pharma. Each gastro-resistant capsule contains 20mg or 40mg of Omeprazole and Sodium Bicarbonate Taj Pharma and Sodium Bicarbonate is 1100mg

Components of the Capsule are: Sugar Spheres (sucrose, maize starch), Hypromellose, Sodium hydroxide, Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (methacrylic acid-ethyl acrylate (1:1), sodium lauryl sulphate, polysorbate 80), Talc, Titanium dioxide, Macrogol 6000, Polysorbate 80.

Components of the Capsule shell (see section 2, ‘Important information about some of the ingredients of Omeprazole and Sodium Bicarbonate Taj Pharma’):

20mg – Shell cap – Titanium dioxide, Iron oxide black, Iron oxide red, Gelatin, Sodium lauryl sulphate.

Shell Body – Titanium dioxide, Gelatin, Sodium lauryl sulphate.

40mg – Shell cap – Titanium dioxide, Sunset yellow, Brilliant blue, Allura red, Gelatin, Sodium lauryl sulphate.

Shell Body – Titanium dioxide, Sunset yellow, Brilliant blue, Allura red, Gelatin, Sodium lauryl sulphate.

What Omeprazole and Sodium Bicarbonate Taj Pharma looks like and contents of the pack

The 20mg capsules have a dark pink cap and white body, filled with white to off-white pellets.

The 40mg capsules have a dark pink cap and body, filled with white to off-white pellets.

The capsules are available in plastic bottles or blister packs which contain:

7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 112, 200, 500 in bottles.

7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 98, 100, 112, 200, 500 in blisters.

2 x 50. 250 (dose dispensing in hospitals – bottle only).

Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)Monday through Saturday 9:00 a.m. to 7:00 p.m. EST E-mail: tajgroup@tajpharma.com