• Treatment of duodenal ulcer and gastric ulcer.
• Treatment of reflux esophagitis .
• Prevention of reflux oesophagitis .
• Eradication of Helicobacter pylori (H. pylori) by concomitant administration of appropriate antibiotic therapy for the treatment of ulcers associated with H. pylori .
• Treatment of duodenal ulcer and gastric ulcer Benin , NSAID in patients requiring continuous NSAID treatment .
• Prevention of duodenal ulcer and gastric ulcer induced by NSAIDs in patients at risk ( see section 4.2 ) requiring continued NSAID treatment .
• Gastroesophageal reflux disease symptoms .
• Zollinger -Ellison syndrome.
4.2 . Dosage and administration
For optimal effect , LANZOR must be taken once daily in the morning , except in the case of eradication of H. pylori for which the treatment must be taken twice a day , once in the morning and once in the evening . LANZOR must be taken at least 30 minutes before meals (see section 5.2). The capsules should be swallowed whole with liquid.
For patients with swallowing difficulties , education and clinical practice suggest that the capsules can be opened and mixed with a small amount of water , apple juice or tomato or sprinkled on a small amount of food not microgranules solid (eg yogurt, applesauce ) to facilitate administration. Capsules can be opened and mixed with 40 ml of apple juice for administration via nasogastric tube microgranules (see section 5.2). After preparation of the suspension or mixture , the drug should be administered immediately .

Treatment of duodenal ulcer :
The recommended dose is 30 mg once a day for 2 weeks. Patients whose healing is not complete after this period, treatment can be 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 whose healing is not complete after this period, the treatment can be continued at the same dose for another 4 weeks.
Reflux oesophagitis:
The recommended dose is 30 mg once daily for 4 weeks . Patients whose recovery is not complete after this period, the treatment can be continued at the same dose for another 4 weeks.
Prevention of reflux oesophagitis:
15 mg once per day. The dosage may be increased to 30 mg daily if needed .
Eradication of Helicobacter pylori :
Choosing the right combination therapy should be according to official local guidance regarding bacterial resistance, duration of treatment (usually 7 days but sometimes up to 14 days ) , and the appropriate use of antibacterial agents .
The recommended dosage is 30 mg twice daily LANZOR for 7 days in combination with one of the following combinations :
• 250-500 mg twice daily clarithromycin + 1 g amoxicillin twice daily ,
• 250 mg twice daily clarithromycin + metronidazole 400-500 mg twice daily .
The eradication rate of H. pylori up to 90% are obtained when clarithromycin is associated with LANZOR and amoxicillin or metronidazole.
Six months after successful eradication treatment, the risk of re-infection is low and relapse is therefore unlikely .
The use of a dose comprising 30 mg of lansoprazole twice daily , amoxicillin 1 g twice a day and 400-500 mg of metronidazole twice daily was also studied . Using this combination , there was lower than for the eradication rate regimens involving clarithromycin . They can be adapted for patients unable to take clarithromycin in the eradication therapy , when local resistance rates to metronidazole are low.
Treatment of duodenal ulcer and gastric ulcer Benin , NSAID in patients requiring continued NSAID treatment :
30 mg once a day for four weeks. Patients whose healing is not complete , the treatment can be continued for an additional four weeks. In patients at risk or with ulcers difficult to heal, a longer treatment duration and / or a higher dose may be used.
Prevention of duodenal ulcer and gastric ulcer induced by NSAIDs in patients at risk ( older than 65 years or with a history of gastric or duodenal ulcer) requiring prolonged NSAID treatment :
15 mg once per day. In case of treatment failure , the dose of 30 mg once daily should be used.

Symptomatic gastroesophageal reflux :
The recommended dose is 15 mg or 30 mg per day . Relief of symptoms is obtained rapidly. An individual dose adjustment should be considered. If symptoms are not relieved within 4 weeks with a daily dose of 30 mg , further examinations are recommended.
Zollinger- Ellison :
The recommended starting dose is 60 mg once daily . The dose should be individually adjusted and treatment should be continued for as long as necessary. Daily dosages up to 180 mg have been used . If the required daily dose exceeds 120 mg , it should be divided and administered in two divided doses .
Renal or hepatic impairment :
No dose adjustment is necessary in patients with renal insufficiency.
Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see sections 4.4 and 5.2).
Elderly:
Due to the reduced lansoprazole in the elderly , clearance individual dose adjustment may be necessary. A daily dose of 30 mg should not be exceeded in the elderly unless there are relevant clinical indications.
children:
In the absence of sufficient clinical data using LANZOR is not recommended in children ( see also section 5.2).
Treatment in infants less than 1 year should be avoided , the available clinical data do not demonstrate a beneficial effect of lansoprazole in the treatment of gastro -oesophageal reflux.

As with all other anti-ulcer therapies, the possibility of malignant gastric tumor should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay diagnosis .
hypomagnesemia :
Cases of severe hypomagnesemia have been reported in patients treated with inhibitors of the proton pump inhibitors ( PPIs) such as lansoprazole for at least three months and in most cases for a year. The hypomagnesemia may occur with severe clinical signs such as fatigue, tetany , hot delusional , convulsions , dizziness ventricular arrhythmia but may begin insidiously and unnoticed. In most patients, hypomagnesemia improved after magnesium supplementation and off PPI .
In patients requiring prolonged or when combining PPIs with digoxin or drugs that may induce hypomagnesemia (eg, diuretics) , a dosage of blood magnesium therapy should be considered by health professionals before starting PPI therapy and periodically during treatment.
4
Lansoprazole should be used with caution in patients with moderate and severe hepatic impairment ( see sections 4.2 and 5.2).
Decreased gastric acidity due to lansoprazole may increase rates of bacteria normally present in the gastrointestinal tract . Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter .
In patients with peptic ulcers , the possibility of infection with H. pylori as an etiological factor should be considered.
If lansoprazole is used in combination with antibiotics for eradication therapy of H. pylori , then the conditions of use of these antibiotics should also be followed.
Because of limited safety data for use in patients under maintenance treatment for over a year , regular monitoring of the treatment and a thorough evaluation of the benefit / risk should be routinely performed in these patients.
Very rare cases of colitis have been reported in patients taking lansoprazole . Therefore, in the case of severe diarrhea and / or persistent , treatment discontinuation should be considered.
The treatment for the prevention of peptic ulceration of patients requiring continued NSAID treatment should be restricted to high-risk patients ( eg previous gastrointestinal bleeding , perforation or ulcer, advanced age, drug combination known to increase the likelihood occurrence of adverse upper gastrointestinal events [ eg corticosteroids or anticoagulants ] , the presence of a serious co-morbidity factor or prolonged use of NSAID maximum recommended doses)
Inhibitors Proton Pump , especially when used in high doses over a long (> 1 year ) term , may moderately increase the risk of hip fracture , wrist and vertebrae , mainly in patients age or the presence of other risk factors identified . Observational studies suggest that inhibitors Proton pump can increase the risk of fracture overall 10 to 40 %. This increase may be in part due to other risk factors. Patients at risk for osteoporosis should be supported in accordance with current recommendations , and receive appropriate vitamin D and calcium intake.
Due to the presence of sucrose , this drug is not recommended in patients with fructose intolerance, malabsorption of glucose and galactose or sucrase / isomaltase ( rare hereditary metabolic diseases).

Effects of lansoprazole on other drugs
Drugs with pH dependent absorption
Lansoprazole may interfere with the absorption of drugs where gastric pH dependent bioavailability .
• Atazanavir :
A study has shown that concomitant administration of lansoprazole (60 mg once daily ) with atazanavir 400 mg to healthy volunteers significantly reduces exposure to atazanavir ( down about 90% of AUC (area under curve ) and Cmax ( maximum concentration). lansoprazole should not be associated with atazanavir (see section 4.3).
• Ketoconazole and itraconazole :
The absorption of ketoconazole and itraconazole from the gastrointestinal tract is increased in the presence of gastric acid . Administration of lansoprazole may result in lower concentrations of ketoconazole and itraconazole and the combination should be avoided.
• Digoxin:
The combination of lansoprazole and digoxin may lead to increased plasma concentrations of digoxin. Plasma concentrations of digoxin must therefore be
5
monitored and the dose of digoxin adjusted if necessary at the beginning and the end of treatment with lansoprazole.
Drugs metabolized by cytochrome P450 enzymes
Lansoprazole may increase plasma concentrations of drugs metabolized by CYP3A4 . Caution is advised when combining lansoprazole with drugs metabolized by this enzyme and have a narrow therapeutic margin .
• Theophylline:
Lansoprazole reduces the plasma concentration of theophylline , which may decrease the expected clinical effect. Caution is advised when combining the two drugs .
• Tacrolimus:
Coadministration of lansoprazole increases the plasma concentrations of tacrolimus ( a CYP3A substrate and P- gp) . Lansoprazole increases the mean exposure of tacrolimus by up to 81 %. Monitoring plasma concentrations of tacrolimus is recommended at the beginning and end of treatment with lansoprazole.
Medicinal products transported by P-glycoprotein
Inhibition of P-glycoprotein (P -gp) Lansoprazole has been observed in vitro. The clinical relevance is unknown.
Effects of other drugs on lansoprazole
Medicinal products that inhibit CYP2C19
• Fluvoxamine :
A dose reduction may be considered when combining lansoprazole with fluvoxamine , an inhibitor of CYP2C19. Plasma concentrations of lansoprazole increase up to 4 times normal.
Drugs 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.
other
• Sucralfate / Antacids:
Sucralfate, antacids may reduce the bioavailability of lansoprazole. Therefore, lansoprazole should be taken at least 1 hour after taking these drugs.
No significant interaction clinically between lansoprazole and nonsteroidal anti -inflammatory drugs has been demonstrated , although no formal interaction studies have not been performed .

pregnancy
No clinical data on exposed pregnancies are available to lansoprazole . The animal studies do not indicate direct or indirect harmful effects with respect to pregnancy , embryonal / fetal development, parturition or postnatal development .
Therefore, for safety reasons , the use of lansoprazole is not recommended during pregnancy.
nursing
Excretion in breast milk of lansoprazole is not known . Studies in animals have shown excretion of lansoprazole in milk.
The decision to continue / discontinue breast-feeding or to continue / discontinue therapy with lansoprazole should take into account the benefit of breast-feeding to the child and the benefit of lansoprazole therapy to the mother.

Side effects, such as dizziness, vertigo, visual disturbances and somnolence may occur (see section 4.8). Under these conditions , the ability to react may be decreased.

Frequencies are defined as common (> 1/100 , < 1/10) , uncommon ( > 1:1000 , < 1/100) , rare ( > 1:10,000 ; < 1/1.000) , very rare (<1 / 10,000) .
Frequencies are defined as common (> 1/100, <1/10), uncommon (> 1:1000, <1/100), rare (> 1:10,000; <1/1.000), very rare (<1 / 10,000).

Reporting of suspected adverse reactions :

إذا كان لديك سؤال عن هذا المستحضر او ترغب في كتابة تقرير حول عرض جانبي نرجو الاتصال على:
If you have questions about this product or if you wish to report an adverse event
Saudi Vagilance Center المركز الوطني للتيقظ والسلامة الدوائية
فاكس: 5660502110 Fax:0112057662
npc.drug@sfda.gov.sa

Report adverse reactions allows continuous monitoring of risk / benefit ratio of the drug after its placing on the market. As healthcare professionals you must report all suspected adverse reactions to your Regional Pharmacovigilance Centre using the form ( Cerfa No. 10011 * 02) available on the website of the National Security Agency of Medicines and Products health ( MSNA ) www.ansm.sante.fr .
You can also report any adverse event by contacting us by phone at 0800394000 (toll Sanofi France ) .

The effects of overdose on lansoprazole in humans are not known (although the acute toxicity is likely to be small ) , and therefore no action to be taken for treatment can not be given. However, daily doses up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in clinical trials without significant undesirable effects .
Please refer to section 4.8 for possible symptoms of lansoprazole overdose .
In the case of suspected overdose , the patient should be monitored. Lansoprazole is not significantly removed by hemodialysis. If necessary , gastric emptying, charcoal and symptomatic therapy is recommended .

Pharmacotherapeutic group: inhibitors of the proton pump , ATC code: A02BC03
Lansoprazole is an inhibitor of gastric proton pump . It inhibits the final stage of gastric acid formation by inhibiting the activity of proton pump H + / K + ATPase in the parietal cells of the stomach. The inhibition is dose -dependent. Exert its effects on both basal and stimulated secretion of gastric acid. Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment and reacts with sulfohydrique group of proton pump H + / K + ATPase causing inhibition of the enzyme activity .
Effect on gastric acid secretion :
Lansoprazole is a specific inhibitor of the proton pump of the parietal cells . A single oral dose of lansoprazole inhibits about 80% of gastric acid secretion stimulated by pentagastrin . After repeated daily administration for a period of seven days, about 90% of gastric secretion is inhibited. It has a similar effect on the basal secretion of gastric acid. A single oral dose of 30 mg reduces basal secretion by about 70%, the patients' symptoms are consequently relieved after the first dose . After 8 days of repeated administration the reduction is about 85 %. Rapid relief of symptoms is obtained by one capsule ( 30 mg ) per day in most patients with duodenal ulcer heal within 2 weeks, patients with gastric ulcer and gastroesophageal reflux in 4 weeks. By reducing gastric acidity, lansoprazole creates an environment in which appropriate antibiotics can be effective against H. pylori .

Lansoprazole is a racemate of two active enantiomers are metabolized into the active form in the acidic environment of the parietal cells . Since lansoprazole is rapidly inactivated by gastric acid , it is administered orally in gastro - resistant form for systemic absorption .
Absorption and Distribution :
The bioavailability of lansoprazole in a single dose is high ( 80-90%) . Peak plasma concentrations are reached within 1.5 to 2.0 hours. Intake of food slows the rate of absorption of lansoprazole and reduced bioavailability by approximately 50 % . The plasma protein binding is 97 %.
Studies have shown that the microgranules from the opening of a capsule provide an area under the curve (AUC ) equivalent to the intact capsule if the microgranules are mixed in a small amount of orange juice , apple juice or tomato juice or mixed with a tablespoon of applesauce or pear , or sprinkled on a tablespoon of yoghurt, custard or cream cheese . Equivalent AUC has also been found for mixed with apple juice administered by nasogastric tube microgranules .
Metabolism and Elimination
Lansoprazole is extensively metabolized by the liver and the metabolites are excreted by the kidney and biliary tract. The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19. The enzyme CYP3A4 also contributes to the metabolism . The half - life in plasma of lansoprazole is between 1.0 and 2.0 hours following single or multiple doses in healthy subjects . There is no evidence of accumulation after multiple doses in healthy subjects . The sulfone derivatives , sulfite and 5 - hydroxy lansoprazole have been identified in plasma. These metabolites have very little or no antisecretory activity.
A study with 14C labeled lansoprazole indicated that approximately one third of the administered radiation was excreted in the urine and two-thirds in the faeces.
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Pharmacokinetics in elderly patients
The clearance of lansoprazole is reduced in the elderly, with an elimination half-life increased by approximately 50 % to 100 % . Peak plasma concentrations are not increased in the elderly .
Pharmacokinetics in children
The evaluation of the pharmacokinetics in children aged 1-17 years showed a similar exposure to adults with doses of 15 mg for those weighing less than 30 kg and 30 mg for those above . The study of a dose of 17 mg/m2 body surface or 1 mg / kg body weight showed comparable exposure of lansoprazole in children aged 2-3 months to a year compared to adults.
Higher exposure to lansoprazole in comparison to adults has been reported in children under 2-3 months with doses of 1.0 mg / kg and 0.5 mg / kg of body weight given as a single dose.
Pharmacokinetics in patients with hepatic impairment
The exposure of lansoprazole is doubled in patients with mild hepatic impairment and even higher in patients with moderate to 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 has a functional CYP2C19 enzyme functional . The exposure of lansoprazole is several-fold higher in PMs than in extensive metabolisers (EMs ) .

Preclinical data from conventional studies of safety pharmacology, repeated dose toxicity , toxicity to reproduction or genotoxicity revealed no special hazard for humans.
Two carcinogenicity studies in rats, lansoprazole produced gastric enterochromaffin cell hyperplasia (ECL ) related to dose and ECL cell carcinoids associated with hypergastrinemia in relation to inhibition of acid secretion. Intestinal metaplasia was also observed , as well as Leydig cell hyperplasia and benign Leydig cell tumors . After 18 months of treatment retinal atrophy was observed . This was not seen in monkeys , dogs and mice.
Mice during the carcinogenicity studies appeared gastric ECL cell hyperplasia (ECL ) related to the dose , liver tumors and adenoma of rete testis . The clinical relevance of this finding is not known .

Heavy magnesium carbonate , neutral microgranules ( sucrose , corn starch) , sucrose , corn starch, hydroxypropyl cellulose of low substitution degree hydroxypropylcellulose , copolymer of methacrylic acid and ethyl acrylate ( 1 : 1 ) ( dispersion 30 percent ) ( Eudragit L30 D -55 ) , talc , macrogol 6000 , titanium dioxide , polysorbate 80 , anhydrous colloidal silica .
Capsule shell :
- Head ( orange): gelatin, titanium dioxide, erythrosine , iron oxide yellow .
- Body (blue): gelatin, titanium dioxide.

Not applicable

Store at a temperature not exceeding 25 ° C
Keep the bottle tightly closed in order to protect from moisture
Keep the blisters in the outer carton to protect from moisture.

7, 14 , 28 and 60 capsules in blister packs (PVC / PVDC / Aluminium) .
14 and vial 15 capsules (PE ) .
All presentations may be marketed.

No special requirements .