Lansoprazole Delayed-Release Tablets USP 15mg Taj Pharma

1. Name of the medicinal product

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

2. Qualitative and quantitative composition

a) Lansoprazole Delayed-Release Tablets USP 15mg Taj Pharma
Each Delayed-Release Orally Disintegrating tablet contains:
Lansoprazole USP 15mg
Excipients: Q.S.

b) Lansoprazole Delayed-Release Tablets USP 30mg Taj Pharma
Each Delayed-Release Orally Disintegrating tablet contains:
Lansoprazole USP 30mg
Excipients: Q.S.

Excipients: Each tablet of 15mg and 30mg contains approximately 15mg and 30mg of sucrose respectively.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Orodispersible Delayed-Release Tablet

Lansoprazole Taj Pharma 15mg & 30mg: Flat, round, whitish tablets with greyish specks.

4. Clinical particulars

Therapeutic indications

• Treatment of duodenal and gastric ulcer.
• Treatment of reflux oesophagitis.
• Prophylaxis of reflux oesophagitis
• Eradication of Helicobacter pylori (H. 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.

Lansoprazole Taj Pharma is indicated in adults.

• Posology and method of administration

Posology

Treatment of duodenal ulcer:

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

Treatment of gastric ulcer:

The recommended dose is 30mg 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 30mg 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:

15mg once daily. The dose may be increased up to 30mg once 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 30mg of Lansoprazole Taj Pharma twice daily for 7 days in combination with one of the following:

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

clarithromycin 250mg twice daily + metronidazole 400-500mg 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 30mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500mg 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:

30mg 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:

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

Symptomatic gastro-oesophageal reflux disease:

The recommended dose is 15mg or 30mg 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 30mg, further examinations are recommended.

Zollinger-Ellison syndrome:

The recommended initial dose is 60mg 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.

Impaired renal function:

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

Impaired hepatic function:

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 30mg should not be exceeded in the elderly unless there are compelling clinical indications.

Children:

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 given 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). Lansoprazole Taj Pharma should be placed on the tongue and gently sucked. The tablet rapidly disperses in the mouth, releasing gastroresistant microgranules which are swallowed with the help of a glass of water.

The Orally Disintegrating tablets may be dispersed in a small amount of water and administered via a nasogastric tube or oral syringe.

• 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 should not be co-administered with HIV protease inhibitors, such as atazanavir and nelfinavir, because there is a significant reduction in its bioavailability since the absorption of these depends on the intragastric acid pH (see section 4.5).

Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (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.

Influence on the absorption of vitamin B12:

Lansoprazole Taj Pharma, like all medicines that block acid secretion, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypochlorhydria or achlorhydria. This should be taken into account in long-term treatments in patients with vitamin B12 deficiency or with risk factors of reduced absorption of this vitamin, or in case 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).

Lansoprazol, like all proton pump inhibitors (PPIs), can increase gastric counts of bacteria normally present in the gastrointestinal tract. This can increase the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile.

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 regularly be 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.

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.

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.

As Lansoprazole Taj Pharma contains sucrose, patients with rare hereditary intolerance to fructose, problems with glucose or galactose absorption or sucrose-isomaltase deficiency should not take this medicinal product.

• Interaction with other medicinal products and other forms of interaction

Effects of Lansoprazole Taj Pharma on other drugs

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).

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.

Methotrexate

Concomitant use with high-dose methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. Therefore, in settings with high-dose of methotrexate is used a temporary withdrawal of Lansoprazole Taj Pharma may need to be considered.

Warfarin

Co-administration of Lansoprazole Taj Pharma 60mg and warfarin did not affect the pharmacokinetics of warfarin or INR. 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.

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.

Theophylline:

Lansoprazole Taj Pharma reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose. Patients treated with Lansoprazole Taj Pharma together with theophylline should be under medical supervision

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 Lansoprazole Taj Pharma is initiated or ended.

Medicinal products carried 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

Drugs 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.

Drugs which induce 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

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 drugs.

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

There is limited amount of data from the use of lansoprazol in pregnant women. 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.

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

Lactation

It is not known whether Lansoprazole Taj Pharma is excreted in breast milk. Animal studies have shown excretion of Lansoprazole Taj Pharma in the 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, vertigo, visual 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 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (1/10,000) or not known (cannot be estimated from the available data).

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

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.

5. 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 the secretion of gastric acids:

Lansoprazole Taj Pharma is a specific inhibitor of the parietal cell proton pumps. A single oral dose of 30mg 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 by one oro-dispersible tablet (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%.

Studies have shown that oro-dispersible tablets dispersed in a small amount of water and given via syringe directly into the mouth or administered via naso-gastric tube result in equivalent AUC compared to the usual mode of administration.

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 15mg for those below 30 kg of weight and 30mg for those above. The investigation of a dose of 17mg/m2 body surface or 1mg/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 1.0mg/kg and 0.5mg/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

Preclinical 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.

6. Pharmaceutical particulars

• List of excipients

Sugar spheres (sucrose and maize starch);

Magnesium Carbonate;

Hypromellose;

Polysorbate 80;

Macrogol 6000;

Triethyl Citrate;

Talc;

Copolymer of Methacrylic Acid and Ethyl Acrylate;

Copolymer of Methyl Acrylate, Methyl Methacrylate and Methacrylic Acid;

Microcrystalline Cellulose;

Hydroxypropyl Cellulose;

Sodium Saccharin;

Mannitol;

Tropical Flavouring;

Malic Acid;

Magnesium Stearate.

• Incompatibilities

Not applicable.

• Shelf life

3 years.

• Special precautions for storage

Do not store above 30°C

• Nature and contents of container

Lansoprazole Taj Pharma 15mg & 30mg Orally Disintegrating tablets is presented in aluminium/aluminium blisters.

Each container of Lansoprazole Taj Pharma 15mg & 30mg contains 14, 28, 56, 98, 100, 240, 250, 360 and 500 or 1000 Orally Disintegrating tablets.

Not all pack sizes may be marketed.

• Special precautions for disposal and other handling

No special 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 Tablets USP 15mg/30mg Taj Pharma

Package leaflet: Information for the patient

Lansoprazole Orodispersible Tablets USP 15mg Taj Pharma

Lansoprazole 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 Taj Pharma is and what it is used for

The active ingredient in Lansoprazole Taj Pharma is Lansoprazole Taj Pharma, which is a proton pump inhibitor.

Proton pump inhibitors reduce the amount of acid that your stomach makes.

Your doctor may prescribe Lansoprazole Taj Pharma for the following indications:

• Treatment of duodenal and stomach ulcer
• Treatment of inflammation in your oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacteria Helicobacter pyloriwhen given in combination with antibiotic therapy
• Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation)
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazole Taj Pharma for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor’s instructions for taking your medicine.

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

2. What you need to know before you take Lansoprazole Taj Pharma

Do not take Lansoprazole Taj Pharma:

• if you are allergic to Lansoprazole Taj Pharma or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Please tell your doctor if you have serious liver disease. The doctor may have to adjust your dosage.

Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.

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 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 your pain or rheumatic disease: please also read the package leaflets of these medicines carefully.

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. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you take Lansoprazole 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.

Talk to your doctor before taking Lansoprazole Taj Pharma:

• if 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 you are due to have a specific blood test (Chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Taj Pharma that reduces stomach acid.
• 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.

Other medicines and Lansoprazole Taj Pharma

Tell your doctor if you are taking, have recently taken or might take any other medicineseven those acquired without a prescription.

In particular tell your doctor if you are taking medicines containing any of the following active substances as Lansoprazole Taj Pharma may affect the way these drugs work:

• 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 diseases)
• antacids (used to treat heartburn or acid regurgitation)
• sucralfate (used for healing ulcers)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)

Lansoprazole Taj Pharma with food and drink

For the best results from your medicines you should take Lansoprazole Taj Pharma at least 30 minutes before food.

Pregnancy, breast-feeding and fertility

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

Driving and using machines

Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Lansoprazole Taj Pharma. If you experience side effects like these you should take caution as your ability to react may be decreased.

You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines.

Descriptions of these effects can be found in other sections.

Read all the information in this leaflet for guidance.

Discuss with your doctor, nurse or pharmacist if you are unsure about anything.

Lansoprazole Taj Pharma contains sucrose.

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

3. How to take Lansoprazole Taj Pharma

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

Place the tablet on your tongue and suck gently. The tablet rapidly dissolves in the mouth, releasing microgranules which you should swallow without chewing with the help of a glass of water.

Your doctor might instruct you to take the tablet with a syringe, in case you have serious difficulties with swallowing.

The following instructions should be followed if administered via an oral syringe:

It is important that the appropriateness of the selected oral syringe is carefully tested.

• Remove the plunger of the syringe (at least 5 ml syringe for the 15mg tablet and 10 ml syringe for the 30mg tablet).
• Put the tablet into the barrel.
• Put the plunger back onto the syringe.
• For the 15mg tablet: Draw 4 ml tap water into the syringe.
• For the 30mg tablet: Draw 10 ml tap water into the syringe.
• Invert the syringe and draw an additional 1 ml of air into it.
• Shake the syringe gently for 10-20 seconds until the tablet is dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2-5 ml of tap water to flush the remnants out of the syringe into the mouth
• Repeat the precedent step if necessary

If you are taking Lansoprazole Taj Pharma once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole Taj Pharma first thing in the morning.

If you are taking Lansoprazole Taj Pharma twice a day, you should have the first dose in the morning and the second dose in the evening.

The dose of Lansoprazole Taj Pharma depends on your condition. The usual doses of Lansoprazole Taj Pharma for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.

Treatment of heartburn and acid regurgitation: one 15mg or 30mg orodispersible tablet every day for 4 weeks. If symptoms persist you should report to your doctor. If your symptoms are not relieved within 4 weeks, please contact your doctor.

Treatment of duodenal ulcer: one 30mg orodispersible tablet every day for 2 weeks

Treatment of stomach ulcer: one 30mg orodispersible tablet every day for 4 weeks

Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30mg orodispersible tablet every day for 4 weeks

Long-term prevention of reflux oesophagitis: one 15mg orodispersible tablet every day, your doctor may adjust your dose to one 30mg orodispersible tablet every day.

Treatment of infection of Helicobacter pylori: The usual dose is one 30mg orodispersible tablet in combination with two different antibiotics in the morning and one 30mg orodispersible tablet in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days.

The recommended combinations of antibiotics are:

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

Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 30mg orodispersible tablet every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15mg orodispersible tablet every day, your doctor may adjust your dose to one 30mg orodispersible tablet every day.

Zollinger-Ellison syndrome: The usual dose is two 30mg orodispersible tablets every day to start with, then depending on how you respond to Lansoprazole Taj Pharma the dose that your doctor decides is best for you.

Use in children:

Lansoprazole Taj Pharma should not be given to children.

If you take more Lansoprazole Taj Pharma than you should

If you take more Lansoprazole Taj Pharma than you have been told to, seek medical advice quickly.

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 nearly time for your next dose. If this happens skip the missed dose and take the remaining orodispersible tablets as normal. Do not take a double dose to make up for a forgotten orodispersible tablet.

If you stop taking Lansoprazole Taj Pharma

Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment.

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

4. Possible side effects

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

The following side effects are common (occur in more than 1 in 100 patients):

• headache, dizziness
• diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
• skin rash, itching
• changes in liver function test values
• tiredness
• benign polyps in the stomach.

The following side effects are uncommon (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts.
• risks of fracture in the hip, wrist or spine.

The following side effects are rare (occur in less than 1 in 1000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, 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, reddening and excessive sweating
• sensitivity to light
• hair loss
• feelings of ants creeping over the skin (paresthesiae), trembling
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the mucosa)
• 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.

The following side effects are very rare (occur in less than 1 in 10000 patients):

• 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).

The following side effect occurs with frequency not known:

• 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.
• rash, possibly with pain in the joints
• visual hallucinations

Reporting of side effects

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

5. How to store Lansoprazole 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 blister and carton after ‘EXP’. The expiry date refers to the last day of that month.

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.

6. Contents of the pack and other information

What Lansoprazole Taj Pharma contains

• The active substance is Lansoprazole Taj Pharma
• The other ingredients are Sugar Spheres (Sucrose and Maize Starch), Magnesium Carbonate, Hypromellose, Polysorbate 80, Macrogol 6000, Triethyl Citrate, Talc, Copolymer of Methacrylic Acid and Ethyl Acrylate, Copolymer of Methyl Acrylate, Methyl Methacrylate and Methacrylic Acid, Microcrystalline Cellulose, Hydroxypropyl Cellulose, Sodium Saccharin, Mannitol, Tropical flavoring, Malic Acid and Magnesium Stearate.

What Lansoprazole Taj Pharma looks like and contents of the pack

Lansoprazole Taj Pharma 15mg & 30mg are flat, round, whitish orodispersible tablets speckled with microgranules.

Lansoprazole Taj Pharma 15mg & 30mg Orally Disintegrating tablets is presented in aluminium/aluminium blisters.

Each container of Lansoprazole Taj Pharma 15mg & 30mg contains 14, 28, 56, 98, 100, 240, 250, 360 and 500 or 1000 Orally Disintegrating tablets.

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