1. Name of the medicinal product

Lansoprazole Delayed-Release Capsules USP 15mg Taj Pharma
Lansoprazole Delayed-Release Capsules USP 30mg Taj Pharma

  1. Qualitative and quantitative composition

a) Lansoprazole Delayed-Release Capsules USP 15mg Taj Pharma
Each Delayed-Release capsule contains:
Lansoprazole USP 15mg
Excipients: Q.S.

b) Lansoprazole Delayed-Release Capsules USP 30mg Taj Pharma
Each Delayed-Release capsule contains:
Lansoprazole USP 30mg
Exc.ipients: Q.S

Excipient(s) with known effect

Also contains sucrose.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Delayed-Release capsules, hard.

Size 1, opaque white hard gelatine capsule.

  1. Clinical particulars

Therapeutic indications

  • Treatment of duodenal and gastric ulcer
  • Treatment of reflux oesophagitis
  • Prophylaxis of reflux oesophagitis
  • Eradication of Helicobacter pylori( pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers
  • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment
  • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy
  • Symptomatic gastroesophageal reflux disease
  • Zollinger-Ellison syndrome.

Posology and method of administration

Posology

Treatment of duodenal ulcer:

The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks.

Treatment of gastric ulcer:

The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.

Reflux oesophagitis:

The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.

Prophylaxis of reflux oesophagitis:

15 mg once daily. The dose may be increased up to 30 mg daily as necessary.

Eradication of Helicobacter pylori:

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

The recommended dose is 30 mg of Lansoprazole Taj Pharma twice daily for 7 days in combination with one of the following:

clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily

clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily

The H. pylori eradication results obtained when clarithromycin is combined with either amoxicillin or metronidazole give rates of up to 90%, when used in combination with Lansoprazole Taj Pharma.

Six months after successful eradication treatment, the risk of re infection is low and relapse is therefore unlikely.

Use of a regimen including Lansoprazole Taj Pharma 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin. It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.

Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment:

30 mg once daily for four weeks. In patients not fully healed the treatment may be continued for another four weeks. For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.

Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age > 65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:

15 mg once daily. If the treatment fails the dose 30 mg once daily should be used.

Symptomatic gastro-oesophageal reflux disease:

The recommended dose is 15 mg or 30 mg daily. Relief of symptoms is obtained rapidly. Individual adjustment of dosage should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.

Zollinger-Ellison syndrome:

The recommended initial dose is 60 mg once daily. The dose should be individually adjusted and the treatment should be continued for as long as necessary. Daily doses of up to 180mg have been used. If the required daily dose exceeds 120mg, it should be given in two divided doses.

Renal impairment:

There is no need for a dose adjustment in patients with impaired renal function.

Hepatic impairment:

Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).

Elderly:

Due to reduced clearance of Lansoprazole Taj Pharma in the elderly an adjustment of dose may be necessary based on individual requirements. A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.

Paediatric population:

The use of Lansoprazole Taj Pharma is not recommended in children as clinical data are limited (see also section 5.2). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.

Method of administration

For optimal effect Lansoprazole Taj Pharma should be taken once daily in the morning, except when used for H. pylori eradication when treatment should be twice a day, once in the morning and once in the evening. Lansoprazole Taj Pharma should be taken at least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with water.

  • Contraindications

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

  • Special warnings and precautions for use

In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with Lansoprazole Taj Pharma because Lansoprazole Taj Pharma can mask the symptoms and delay the diagnosis.

Lansoprazole Taj Pharma, like all proton pump inhibitors (PPIs), might increase the counts of bacteria normally present in the gastrointestinal tract. This may increase the risk of gastrointestinal infections caused by bacteria such as SalmonellaCampylobacter and, especially in hospitalized patients, Clostridium difficile.

Co-administration of Lansoprazole Taj Pharma is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH, such as atazanavir and nelfinavir, due to significant reduction in their bioavailability (see section 4.5). If co-administration of Lansoprazole Taj Pharma with HIV protease inhibitors is unavoidable, close clinical monitoring is recommended.

Hypomagnesaemia

Severe hypomagnesaemia has been reported in patients treated with PPIs like Lansoprazole 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 drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.

Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Lansoprazole Taj Pharma 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.

Daily treatment with any acid-suppressing medications over a prolonged period of time (several years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Cyanocobalamin deficiency should be considered in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, individuals with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy or if relevant clinical symptoms are observed.

Lansoprazole Taj Pharma should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).

Decreased gastric acidity due to Lansoprazole Taj Pharma might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with Lansoprazole Taj Pharma may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

In patients suffering from gastro-duodenal ulcers, the possibility of H.pylori infection as an etiological factor should be considered.

If Lansoprazole Taj Pharma is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.

Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should be regularly performed in these patients.

Very rarely cases of colitis have been reported in patients taking Lansoprazole Taj Pharma. Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.

With the exception of patients treated for the eradication of H. pylori infection, if diarrhoea persists, administration of Lansoprazole Taj Pharma should be discontinued, due to the possibility of microscopic colitis with thickening of the collagen bundle or infiltration of inflammatory cells noted in the large intestine submucosa. In majority of cases, symptoms of microscopic colitis resolve on discontinuation of Lansoprazole Taj Pharma.

The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

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.

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 Lansoprazole Taj Pharma. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors (see section 4.8).

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

  • Interaction with other medicinal products and other forms of interaction

Effects of Lansoprazole Taj Pharma on other medicinal products

Medicinal products with pH dependent absorption.

Lansoprazole Taj Pharma may interfere with the absorption of drugs where gastric pH is critical to bioavailability.

HIV Protease Inhibitors:

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

A study has shown that co-administration of Lansoprazole Taj Pharma (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).

Ketoconazole and itraconazole:

The absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid. Administration of Lansoprazole Taj Pharma may result in sub-therapeutic concentrations of ketoconazole and itraconazole and the combination should be avoided.

Digoxin:

Co-administration of Lansoprazole Taj Pharma and digoxin may lead to increased digoxin plasma levels. The plasma levels of digoxin should therefore be monitored and the dose of digoxin adjusted if necessary when initiating and ending Lansoprazole Taj Pharma treatment.

Medicinal products metabolised by P450 enzymes

Lansoprazole Taj Pharma may increase plasma concentrations of drugs that are metabolised by CYP3A4. Caution is advised when combining Lansoprazole Taj Pharma with drugs which are metabolised by this enzyme and have a narrow therapeutic window.

Warfarin:

There have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with Lansoprazole Taj Pharma and warfarin concomitantly may need to be monitored for increase in INR and prothrombin time.

Theophylline:

Lansoprazole Taj Pharma reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose. Patient monitoring should be taken in co-administration of Lansoprazole Taj Pharma with theophylline.

Tacrolimus:

Co-administration of Lansoprazole Taj Pharma increases the plasma concentrations of tacrolimus (a CYP3A and P-gp substrate). Lansoprazole Taj Pharma exposure increased the mean exposure of tacrolimus by up to 81%. Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lanzoprazole is initiated or ended.

Medicinal products transported by P-glycoprotein

Lansoprazole Taj Pharma has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro. The clinical relevance of this is unknown.

Effects of other drugs on Lansoprazole Taj Pharma

Medicinal products which inhibit CYP2C19

Fluvoxamine:

A dose reduction may be considered when combining Lansoprazole Taj Pharma with the CYP2C19 inhibitor fluvoxamine. A study shows that the plasma concentrations of Lansoprazole Taj Pharma increase up to 4-fold.

Medicinal products which induces CYP2C19 and CYP3A4

Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of Lansoprazole Taj Pharma.

Others

Methotrexate:

Concomitant use with high-dose methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.

Sucralfate/Antacids:

Sucralfate/Antacids may decrease the bioavailability of Lansoprazole Taj Pharma. Therefore Lansoprazole Taj Pharma should be taken at least 1 hour after taking these medicinal products.

NSAIDS

No clinically significant interactions of Lansoprazole Taj Pharma with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.

  • Fertility, pregnancy and lactation

Pregnancy:

For Lansoprazole Taj Pharma no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Therefore, the use of Lansoprazole Taj Pharma during pregnancy is not recommended.

Breast-feeding

It is not known whether Lansoprazole Taj Pharma is excreted in human breast milk. Animal studies have shown excretion of Lansoprazole Taj Pharma in milk.

A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Lansoprazole Taj Pharma should be made taking into account the benefit of breastfeeding to the child and the benefit of Lansoprazole Taj Pharma therapy to the woman.

Fertility:

No human data on the effect of Lansoprazole Taj Pharma on fertility are available. Reproductive studies in pregnant rats and rabbits revealed no Lansoprazole Taj Pharma-related impairment of fertility.

  • Effects on ability to drive and use machines

Adverse drug reactions such as dizziness, vertigovisual disturbances and somnolence may occur (see section 4.8). Under these conditions the ability to react may be decreased.

  • Undesirable effects

Frequencies are defined as common ( ≥ 1/100, < 1/10); uncommon ( ≥ 1/1,000, < 1/100); rare ( ≥1/10,000, <1/1,000); very rare ( <1/10,000); not known (frequency cannot be estimated from the available data)

CommonUncommonRareVery rareNot Known
Blood and lymphatic system disordersThrombocytopenia, eosinophilia, leucopeniaAnaemiaAgranulocytosis, pancytopenia
Immune system disordersAnaphylactic shock
Metabolism and nutritional disordersHypomagnesaemia (see section 4.4)
Psychiatric disordersDepressionInsomnia, hallucination, confusionVisual hallucinations
Nervous system disordersHeadache, dizzinessRestlessness, vertigo, paraesthesia, somnolence, tremor
Eye disordersVisual disturbances
Gastrointestinal disordersNausea, diarrhoea, stomach ache, constipation, vomiting, flatulence, dry mouth or throat, fundic gland polyps (benign)Glossitis, candidiasis of the oesophagus, pancreatitis, taste disturbancesColitis, stomatitisCollagenous colitis
Hepatobiliary disordersIncrease in liver enzyme levelsHepatitis, jaundice
Skin and subcutaneous tissue disordersUrticaria, itching, rashPetechiae, purpura, hair loss, erythema multiforme, photosensitivitySteven-Johnson syndrome, toxic epidermal necrolysisSubacute cutaneous lupus erythematosus (see section 4.4)
Musculoskeletal and connective tissue disordersArthralgia, myalgia, fracture of the hip, wrist or spine (see section 4.4)
Renal and urinary disordersInterstitial nephritis
Reproductive system and breast disordersGynaecomastia
General disorders and administration site conditionsFatigueOedemaFever, hyperhidrosis, angioedema, anorexia, impotence
InvestigationsIncrease in cholesterol and triglyceride levels, hyponatraemia

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

  • Overdose

The effects of overdose on Lansoprazole Taj Pharma in humans are not known (although the acute toxicity is likely to be low) and, consequently, instruction for treatment cannot be given. However, daily doses of up to 180mg of Lansoprazole Taj Pharma orally and up to 90mg of Lansoprazole Taj Pharma intravenously have been administered in trials without significant undesirable effects.

Please refer to section 4.8 for possible symptoms of Lansoprazole Taj Pharma overdose.

In the case of suspected overdose the patient should be monitored. Lansoprazole Taj Pharma is not significantly eliminated by haemodialysis. If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors,

Lansoprazole Taj Pharma is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach. The inhibition is dose-dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid. Lansoprazole Taj Pharma is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme activity.

Effect on gastric acid secretion:

Lansoprazole Taj Pharma is a specific inhibitor of the parietal cell proton pump. A single oral 30mg dose of Lansoprazole Taj Pharma inhibits pentagastrin-stimulated gastric acid secretion by about 80%. After repeated daily administration for seven days, about 90% inhibition of gastric acid secretion is achieved. It has a corresponding effect on the basal secretion of gastric acid. A single oral dose of 30mg reduces basal secretion by about 70%, and the patients’ symptoms are consequently relieved starting from the very first dose. After eight days of repeated administration the reduction is about 85%. A rapid relief of symptoms is obtained 30mg daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer and reflux oesophagitis within 4 weeks. By reducing gastric acidity, Lansoprazole Taj Pharma creates an environment in which appropriate antibiotics can be effective against H. pylori.

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.

  • Pharmacokinetic properties

Lansoprazole Taj Pharma is a racemate of two active enantiomers that are biotransformed into the active form in the acidic environment of the parietal cells. As Lansoprazole Taj Pharma is rapidly inactivated by gastric acid, it is administered orally in enteric-coated form(s) for systemic absorption.

Absorption and distribution

Lansoprazole Taj Pharma exhibits high (80-90%) bioavailability with a single dose. Peak plasma levels occur within 1.5 to 2.0 hours. Intake of food slows the absorption rate of Lansoprazole Taj Pharma and reduces the bioavailability by about 50%. The plasma protein binding is 97%.

Metabolism and elimination

Lansoprazole Taj Pharma is extensively metabolised by the liver and the metabolites are excreted by both the renal and biliary route. The metabolism of Lansoprazole Taj Pharma is mainly catalysed by the enzyme CYP2C19. The enzyme CYP3A4 also contributes to the metabolism. The plasma elimination half-life ranges from 1 to 2 hours following single or multiple doses in healthy subjects. There is no evidence of accumulation following multiple doses in healthy subjects. Sulphone, sulphide and 5-hydroxyl derivatives of Lansoprazole Taj Pharma have been identified in plasma. These metabolites have very little or no antisecretory activity.

A study with 14C labelled Lansoprazole Taj Pharma indicated that approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the faeces.

Pharmacokinetics in elderly patients

The clearance of Lansoprazole Taj Pharma is decreased in the elderly, with elimination half-life increased approximately 50% to 100%. Peak plasma levels were not increased in the elderly.

Pharmacokinetics in paediatric patients

The evaluation of the pharmacokinetics in children aged 1 –17 years of age showed a similar exposure as compared to adults with doses of 15 mg for those below 30 kg of weight and 30 mg for those above. The investigation of a dose of 17 mg/m2 body surface or 1 mg/kg body weight also resulted in comparable exposure of Lansoprazole Taj Pharma in children aged 2-3 months up to one year of age compared to adults.

Higher exposure to Lansoprazole Taj Pharma in comparison to adults has been seen in infants below the age of 2-3 months with doses of both 1.0 mg/kg and 0.5 mg/kg body weight given as a single dose.

Pharmacokinetics in hepatic insufficiency

The exposure of Lansoprazole Taj Pharma is doubled in patients with mild hepatic impairment and much more increased in patients with moderate and severe hepatic impairment.

CYP2C19 poor metabolisers

CYP2C19 is subject to genetic polymorphism and 2-6% of the population, called poor metabolisers (PMs), are homozygote for a mutant CYP2C19 allele and therefore lacks a functional CYP2C19 enzyme. The exposure of Lansoprazole Taj Pharma is several-fold higher in PMs than in extensive metabolisers (EMs).

  • Preclinical safety data

Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity.

In two rat carcinogenicity studies, Lansoprazole Taj Pharma produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion. Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and benign Leydig cell tumours. After 18 months of treatment retinal atrophy was observed. This was not seen in monkeys, dogs or mice.

In mouse carcinogenicity studies dose-related gastric ECL cell hyperplasia developed as well as liver tumours and adenoma of rete testis.

The clinical relevance of these findings is unknown.

  1. Pharmaceutical particulars
  • List of excipients

Capsule contents: Hypromellose, Talc, Titanium dioxide, Metacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 %, Triethylcitrate, Sugar spheres (sucrose and maize starch)

Capsule Shells: Titanium dioxide, Purified water, Gelatine.

Printing ink: Shellac and black iron oxide.

  • Incompatibilities

Not applicable.

  • Shelf life

Bottle (HDPE): 24 months. In-use stability has been demonstrated for 28 days

Blister (Al/Al): 24 months

  • Special precautions for storage

Blister pack: Do not store above 30°C. Store in the original package.

Bottle pack: Do not store above 25°C. Keep the bottle tightly closed to protect from moisture.

  • Nature and contents of container

Bottle packs: HDPE container and screw cap with tamper-evident ring containing a desiccant capsule (LDPE)

Bottles of 7, 14, 28 and 56 (28×2) capsules

Blister packs: Al/Al foil. Each blister strip contains 7, 14, 20, 28, 30, 42, 50, 56, 60 and 80 capsules.

Blister packs of 7 (1 blister strip), 14 (2 blister strips), 28 (4 blister strips), 42 (6 blister strips) and 56 (8 blister strips) capsules

Each container contains 14, 28, 42, 56, 60, 80, 100, 240, 360 and 500 capsules.

Not all pack sizes may be marketed

  • Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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

Lansoprazole Delayed-Release Capsules USP 15mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Delayed-Release Capsules USP 15mg 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 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 Lansoprazole Taj Pharma is and what it is used for
  2. What you need to know before you take Lansoprazole Taj Pharma
  3. How to take Lansoprazole Taj Pharma
  4. Possible side effects
  5. How to store Lansoprazole Taj Pharma
  6. Contents of the pack and other information

1. WHAT LANSOPRAZOLE IS AND WHAT IT IS USED FOR

The name of your medicine is Lansoprazole Taj Pharma 15 mg & 30 mg gastro-resistant capsules (called Lansoprazole Taj Pharma throughout this leaflet).

It belongs to a group of medicines called proton pump inhibitors.

Lansoprazole Taj Pharma works by lowering the amount of acid in your stomach.

It can be used for:

  • Healing ulcers in your stomach or duodenum (gut)
  • Healing and preventing ulcers caused by medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAlDs). This includes medicines like aspirin, ibuprofen, ketoprofen and piroxicam
  • Gastro-Oesophageal Reflux Disease (GORD). This happens when acid from your stomach escapes into your food pipe (oesophagus) causing damage and inflammation

Lansoprazole Taj Pharma can relieve symptoms that can happen with the above conditions and stop them from coming back.

It can also be used to treat:

  • The pain of indigestion or heartburn caused by too much acid (acid-related dyspepsia) in your stomach
  • Illnesses, such as Zollinger-Ellison Syndrome, where the stomach makes large amounts of acid. This can lead to diarrhoea and pain in the stomach
  • Infections caused by the bacteria Helicobacter pyloriwhen given in combination with antibiotic therapy.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE

Do not take Lansoprazole Taj Pharma and tell your doctor if:

  • You are allergic to Lansoprazole Taj Pharma or any of the other ingredients of these capsules (see Section 6: Contents of the pack and other information)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Do not take Lansoprazole Taj Pharma if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Lansoprazole Taj Pharma if:

  • You have liver problems. Your doctor may want to adjust your dose.
  • You have osteoporosis or are taking a type of medicine called corticosteroids (which can increase the risk of osteoporosis). Taking a proton pump inhibitor, like Lansoprazole Taj Pharma, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine.
  • Your doctor may arrange for you to have an endoscopic examination (where a very small camera is inserted down your oesophagus (food pipe) to look into your stomach). This will help find out what is causing your symptoms. It can help to exclude more serious causes of your symptoms such as stomach cancer.
  • Your doctor has given you Lansoprazole Taj Pharma in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic disease please also read the package leaflets of these medicines carefully.
  • You take Lansoprazole Taj Pharma on a long-term basis (longer than 1 year) your doctor will probably ask to see you regularly so he can check how well you are doing. Tell your doctor if you notice any new symptoms or if any of your symptoms are getting worse.
  • You have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Taj Pharma that reduces stomach acid.
  • You are due to have a specific blood test (Chromogranin A).
  • You have low vitamin B12 levels or have risk factors for low vitamin B12 levels and receive long-term treatment with Lansoprazole Taj Pharma. As with all acid reducing agents, Lansoprazole Taj Pharma may lead to a reduced absorption of vitamin B12.

If diarrhoea occurs during the treatment with Lansoprazole Taj Pharma contact your doctor immediately, as Lansoprazole Taj Pharma has been associated with a small increase in infectious diarrhoea.

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 Lansoprazole Taj Pharma. Remember to also mention any other ill-effects like pain in your joints.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Lansoprazole Taj Pharma. Do this even if they applied only in the past.

Other medicines and Lansoprazole Taj Pharma

Please tell your doctor or pharmacist if you are taking or have recently or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Lansoprazole Taj Pharma can affect the way some other medicines work. Also, some medicines can have an affect on the way Lansoprazole Taj Pharma works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
  • Methotrexate (used to treat autoimmune disease and cancer)
  • Ketoconazole, itraconazole, rifampicin (used to treat infections)
  • Digoxin (used to treat heart problems)
  • Warfarin (used to treat blood clots)
  • Theophylline (used to treat asthma)
  • Tacrolimus (used to prevent transplant rejection)
  • Fluvoxamine (used to treat depression and other psychiatric problems)
  • Antacids (used to treat heartburn or acid regurgitation)
  • Sucralfate (used for healing ulcers)
  • St John’s wort, sometimes called Hypericum perforatum(used to treat mild depression)

If you are not sure, talk to your doctor or pharmacist before taking Lansoprazole Taj Pharma.

Taking Lansoprazole Taj Pharma with food and drink

You should take Lansoprazole Taj Pharma at least 30 minutes before food.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist for advice before taking Lansoprazole Taj Pharma if:

  • You are pregnant, think you may be pregnant or are planning to have a baby
  • You are breast-feeding

Driving and using machines

You may feel dizzy, tired, sick, have a headache or problems with your eyesight while taking Lansoprazole Taj Pharma. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients in Lansoprazole Taj Pharma gastro-resistant capsules

Lansoprazole Taj Pharma gastro-resistant capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

  1. HOW TO TAKE LANSOPRAZOLE

Always take Lansoprazole Taj Pharma gastro-resistant capsules exactly as your doctor has told you. The dose will depend on your needs and the illness being treated. Check with your doctor or pharmacist if you are not sure.

Taking your medicine

  • Swallow your capsules whole with a glass of water. Do not crush or chew the capsules.
  • If you are taking Lansoprazole Taj Pharma once a day, take it at the same time every morning before breakfast.
  • If you are taking Lansoprazole Taj Pharma twice a day, take the first dose in the morning before breakfast and the second dose in the evening.

The usual doses for adults are:

Stomach ulcers:

  • One 30 mg capsule every day for 4 weeks

Ulcers of the duodenum:

  • One 30 mg capsule every day for 2 weeks to heal the ulcer
  • Your doctor may then decide you need one 15mg capsule every day to stop it coming back

Ulcers of the stomach and duodenum caused by an NSAID:

  • One 30 mg capsule every day for 4 weeks to heal the ulcer
  • Your doctor may then decide to give you one 15mg or 30mg capsule every day to stop the ulcer or your symptoms coming back
  • Your doctor will tell you when to stop taking Lansoprazole Taj Pharma

Preventing an ulcer and relief of symptoms while taking NSAID:

  • One 15mg or 30mg capsule every day
  • Your doctor will tell you when to stop taking Lansoprazole Taj Pharma

Treatment of infection of Helicobacter pylori:

The usual dose is one 30 mg capsule or two 15 mg capsules in combination with two different antibiotics in the morning and one 30 mg capsule or two 15 mg capsules in combination with two different antibiotics in the evening.

Treatment will usually be every day for 7 days.

The recommended combinations of antibiotics are:

  • 30 mg Lansoprazole Taj Pharma together with 250-500 mg clarithromycin and 1000 mg amoxicillin
  • 30 mg Lansoprazole Taj Pharma together with 250 mg clarithromycin and 400-500 mg metronidazole

If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated. To give your medicine the best chance of working, take it at the right time and do not miss a dose.

Gastro-oesphageal reflux disease (GORD):

  • One 30mg capsule every day for 4 weeks to heal your food pipe (oesophagus) and/or relieve symptoms
  • Your doctor may then decide you need one 15mg or 30mg capsule a day to stop your illness coming back

Indigestion caused by too much acid (acid-related dyspepsia):

  • One 15mg or 30mg capsule every day for 2 to 4 weeks
  • Talk to your doctor once you have completed this course or if your symptoms are not getting better

Zollinger-Ellison syndrome:

  • Two 30mg capsules every day to start with
  • Your doctor will then decide the dose which is best for you depending on how you respond to treatment with Lansoprazole Taj Pharma

Patients with liver problems

If you have severe liver problems your doctor may keep your dose to one capsule a day.

Children

Do not give Lansoprazole Taj Pharma to children.

If you take more Lansoprazole Taj Pharma than you should

Tell your doctor or go to your nearest hospital straight away. Remember to take with you any Lansoprazole Taj Pharma capsules that are left and the pack as well. This is so the doctor knows what you have taken.

If you forget to take Lansoprazole Taj Pharma

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose.

If it is time for your next dose then skip the missed dose and continue with your next dose as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Lansoprazole Taj Pharma

Keep taking the medicine until your doctor tells you to stop. Do not stop taking Lansoprazole Taj Pharma just because you feel better. If you do stop taking Lansoprazole Taj Pharma your illness may get worse again.

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

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Lansoprazole Taj Pharma gastro-resistant capsules can cause side effects, although not everybody gets them.

Stop taking Lansoprazole Taj Pharma and see a doctor or go to a hospital straightaway if:

  • You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reactionto Lansoprazole Taj Pharma gastro-resistant capsules.
  • You have blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of something called Stevens-Johnson syndrome
  • You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. These could be signs of toxic epidermal necrolysis
  • You get symptoms such as yellowing of your skin or whites of your eyes, tiredness and fever. This may be due to inflammation of the liver or changes in the way your liver is working

While these are serious side effects that require urgent medical attention, they are all rare or very rare (affect up to 1 in 1000 people)

Talk to your doctor as soon as possible if:

  • You get long lasting diarrhoea and keep being sick. This can happen because Lansoprazole Taj Pharma lowers the natural acid in your stomach which would normally help to kill bacteria. This can lead to stomach infections.
  • You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.
  • You have difficulty in passing water (urine) or you notice blood in your urine. This may be due to kidney problems or changes in the way your kidneys are working.
  • You bruise more easily than usual or you get more infections than usual. This could be due to a blood problem. Your doctor may want to carry out a blood test.

The above side effects are all rare or very rare (affect up to 1 in 1000 people).

If any of the following side effects gets serious or lasts longer than a few days, tell your doctor or pharmacist.

Common (affects up to 1 in 10 people)

  • headaches, feeling dizzy or tired, or a general feeling of being unwell
  • diarrhoea, constipation, stomach pains, feeling sick (nausea) or being sick (vomiting), wind
  • dry or sore mouth or throat, benign polyps in the stomach
  • skin rash, itching
  • changes in the way your liver is working (shown by a blood test)

Uncommon (affects up to 1 in 100 people)

  • low mood (depression)
  • joint or muscle pain
  • water retention which may cause swollen arms or legs
  • fracture of the hip, wrist or spine (if Lansoprazole Taj Pharma is used in high doses and over a long period of time)
  • changes in blood cell counts

Rare (affects up to 1 in 1000 people)

  • fever
  • feeling restless, drowsy or confused
  • seeing or hearing things which are not there (hallucinations)
  • numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
  • difficulty sleeping (insomnia)
  • problems with your vision
  • feeling dizzy, possibly with a “spinning” feeling (vertigo)
  • a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
  • skin reactions such as burning or pricking feeling under the skin, bruising, red or purple spots which may be itchy or blister.
  • excessive sweating
  • being more sensitive to the sun than usual
  • hair loss (alopecia)
  • trembling
  • feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia.
  • kidney problems
  • pancreatitis
  • inflammation of the liver (may be seen as yellow skin or eyes)
  • swelling of the breasts in men, being unable to get or keep an erection (impotence)
  • candidiasis fungal infection, such as thrush, which may affect your esophagus (food pipe)
  • angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe.

Very rare (affects up to 1 in 10,000 people)

  • severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
  • inflammation of your mouth (stomatitis)
  • colitis (bowel inflammation)
  • changes in test values such as sodium, cholesterol and triglyceride levels
  • very severe skin reactions with reddening, blistering, severe inflammation and skin loss
  • very rarely Lansoprazole Taj Pharma may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately.

A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).

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

  • rash, possibly with pain in the joints
  • skin-related forms of lupus or a lupus rash
  • If you are on Lansoprazole 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.
  • Visual hallucinations

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.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. HOW TO STORE LANSOPRAZOLE

Blister packs

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which you will find on the pack.
  • Store in the original package.
  • Do not store above 30°C.
  • 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 protect the environment.

Bottles

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which you will find on the pack.
  • Any capsules remaining 28 days after first opening should either be discarded safely or returned to your pharmacist
  • Keep the bottle tightly closed to protect from moisture
  • Do not store above 25°C.
  • 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 protect the environment.
  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lansoprazole Taj Pharma gastro-resistant capsules contain

The active substance is Lansoprazole Taj Pharma.

Each 15 mg capsule contains 15 mg Lansoprazole Taj Pharma.

Each 30 mg capsule contains 30 mg Lansoprazole Taj Pharma.

The other ingredients are hypromellose, talc, titanium dioxide, metacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 %, triethylcitrate, sugar spheres (sucrose and maize starch), gelatine and black ink (Shellac and Black Iron Oxide.

What Lansoprazole Taj Pharma gastro-resistant capsules look like and contents of the pack

Lansoprazole Taj Pharma 15mg gastro-resistant capsules are white and imprinted with LAN 15.

Lansoprazole Taj Pharma 30mg gastro-resistant capsules are white and imprinted with LAN 30.

Bottle packs: HDPE container and screw cap with tamper-evident ring containing a desiccant capsule (LDPE)

Bottles of 7, 14, 28 and 56 (28×2) capsules

Blister packs: Al/Al foil. Each blister strip contains 7, 14, 20, 28, 30, 42, 50, 56, 60 and 80 capsules.

Blister packs of 7 (1 blister strip), 14 (2 blister strips), 28 (4 blister strips), 42 (6 blister strips) and 56 (8 blister strips) capsules

Each container contains 14, 28, 42, 56, 60, 80, 100, 240, 360 and 500 capsules.

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