Active ingredients: Lansoprazole
Lansox 15 mg hard capsules
Lansox 30 mg hard capsules
Lansox package inserts are available for pack sizes: - Lansox 15 mg hard capsules, Lansox 30 mg hard capsules
- Lansox 15 mg orodispersible tablets, Lansox 30 mg orodispersible tablets
Why is Lansox used? What is it for?
The active ingredient in Lansox is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe Lansox for the following indications:
- Treatment of duodenal and stomach ulcer
- Treatment of inflammation of the esophagus (reflux esophagitis)
- Prevention of reflux esophagitis
- Treatment of heartburn and acid regurgitation
- Treatment of infections caused by the Helycobacter pylori bacterium when given in combination with antibiotic therapy
- Treatment or prevention of duodenal or stomach ulcer in patients requiring continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
- Treatment of Zollinger-Ellison syndrome
Your doctor may have prescribed Lansox for another indication or with a strength other than that stated in this leaflet. Follow your doctor's instructions for taking your medicine.
Contraindications When Lansox should not be used
Do not take Lansox:
- if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansox.
- if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Precautions for use What you need to know before taking Lansox
Take care with Lansox
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dosage.
Your doctor may perform or have done an additional examination called an endoscopy to diagnose your condition and / or rule out a malignant disease.
If diarrhea occurs during treatment with Lansox, contact your doctor immediately, as Lansox has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed Lansox in addition to other medicines for the treatment of Helycobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases: please also carefully read the package leaflet of these medicines.
If you take a proton pump inhibitor such as Lansox, especially for longer than one year, you may have a slightly increased risk of hip, wrist or spine fracture. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis) consult your doctor.
If you are taking Lansox long term (for more than 1 year) your doctor will probably monitor you regularly. He must report any new and exceptional symptoms and circumstances whenever he sees the doctor.
Interactions Which drugs or foods can modify the effect of Lansox
Taking Lansox with other medicines
Tell your doctor if you are taking or have recently taken any other medicines, even those without a prescription.
In particular, tell your doctor if you are taking medicines containing any of the following active ingredients, as Lansox can affect how they work:
- ketoconazole, itraconazole, rifampicin (used to treat infections)
- digoxin (used to treat heart problems)
- 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 to heal ulcers)
- St. John's wort (perforated St. John's wort) (used to treat mild depression)
Taking Lansox with food and drink
For best results you should take Lansox at least 30 minutes before eating.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, breast-feeding or there is a possibility that you may be pregnant, ask your doctor for advice before taking this medicine.
Driving and using machines
Side effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur in patients taking Lansox.
If you experience side effects like these you should be careful as your attention span may decrease.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks that require increased concentration. The use of medicines is one of the factors that can reduce the ability to perform these actions safely, due to their effects or undesirable effects.
Descriptions of these effects can be found in other paragraphs.
Read all the information in this leaflet as a guide.
If you are unsure about something, discuss it with your doctor, nurse or pharmacist.
Important information about some of the ingredients of Lansox
Lansox 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.
Dose, Method and Time of Administration How to use Lansox: Posology
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the hard capsules, your doctor may advise you on an alternative way to take the medicine. Do not crush or chew these hard capsules or the contents of the empty hard capsules, as the medicine will not it would work properly.
If you take Lansox once a day, try to always take it at the same time. You can get better results if you take Lansox first thing in the morning.
If you take Lansox twice a day, you should take the first dose in the morning and the second dose in the evening.
The dose of Lansox depends on your condition. Usual doses of Lansox for adults are given below. Your doctor will sometimes prescribe a different dose and tell you how long the treatment should last.
Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule every day for 4 weeks. If symptoms persist you should tell your doctor. If symptoms are not relieved within 4 weeks, contact your doctor
Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks
Treatment of stomach ulcer: one 30 mg capsule every day for 4 weeks
Treatment of inflammation of the esophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks
Long-term prevention of reflux oesophagitis: one 15 mg capsule every day, the doctor can adjust the dose up to one 30 mg capsule every day
Treatment of Helicobacter pylori infection: The usual dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. Treatment will be every day for 7 days.
The recommended antibiotic combinations are:
30 mg of Lansox together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin
30 mg of Lansox together with 250 mg of clarithromycin and 400-500 mg of metronidazole
If you are treating your infection because you have an ulcer, it is likely that the ulcer will not return if the infection is successfully treated. To get the best results from this therapy, take the medicine at the scheduled times and not. never forget a dose.
Treatment of duodenal or stomach ulcer in patients requiring continuous NSAID treatment: one 30 mg capsule every day for 4 weeks.
Prevention of duodenal or stomach ulcer in patients requiring continuous NSAID treatment: one 15 mg capsule each day, the doctor may adjust the dosage to one 30 mg capsule each day.
Zollinger-Ellison syndrome: the usual starting dose is two 30 mg hard capsules each day, then based on your response to Lansox, your doctor will decide which dose is best for you.
Use in children
Lansox must not be given to children.
Take the medicine exactly as your doctor has told you. If you are unsure how to take the medicine you should consult your doctor.
Overdose What to do if you have taken too much Lansox
If you take more Lansox than you should
If you take more Lansox than you have been told, ask your doctor for advice right away.
If you forget to take Lansox
If you forget to take a dose, take it as soon as you remember unless it is too close to your next dose. If this happens, do not take the missed dose and take the rest of the hard capsules as normal. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Lansox
Do not stop taking the treatment early if your symptoms have improved. Your condition may not be fully cured and may return if the treatment period does not end.
If you have any further questions on the use of Lansox, ask your doctor.
Side Effects What are the side effects of Lansox
Like all medicines, Lansox can cause side effects, although not everybody gets them.
The following side effects are common (affects more than 1 in 100 patients)
- headache, dizziness
- diarrhea, constipation, stomach pain, feeling sick, gas (flatulence), dry or inflamed mouth or throat
- skin rash, itching
- changes in liver function tests
- tiredness
The following side effects are uncommon (affects less than 1 in 100 patients)
- depression
- pain in the joints and muscles
- water retention or swelling
- changes in red blood cell counts
The following side effects are rare (affects less than 1 in 1,000 patients)
- fever
- restlessness, sleepiness, confusion, hallucination, insomnia, visual disturbance, dizziness
- change in the sense of taste, loss of appetite, inflammation of the tongue (glossitis)
- skin reactions such as a burning or tingling sensation under the skin, bruising, redness and excessive sweating
- sensitivity to light
- hair loss
- tingling sensation on the skin (paraesthesia), tremor
- anemia (paleness)
- kidney problems
- pancreatitis
- inflammation of the liver (yellow skin or yellow eyes may occur)
- breast swelling in men, impotence
- candidiasis (fungal infection, can affect the skin or mucous membrane)
- angioedema; you should see your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty in swallowing, hives and difficulty in breathing.
The following side effects are very rare (affects less than 1 in 10,000 patients)
- severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions can include fever, rash, swelling and sometimes a drop in blood pressure
- inflammation of the mouth (stomatitis)
- colitis (inflammation of the colon)
- changes in laboratory values such as sodium, cholesterol and triglyceride levels
- very severe skin reactions with redness, blistering, severe inflammation and skin loss
- very rarely Lansox may cause a reduction in the number of white blood cells and resistance to infections may therefore decrease. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local infection symptoms such as sore throat / pharynx / mouth or urinary problems, see your doctor immediately. You will have a blood test to check for a possible reduction in white blood cells (agranulocytosis).
Frequency not known
If you take Lansox for more than three months, your blood levels of magnesium may drop.
Low magnesium levels can manifest themselves with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, please consult your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor should decide whether to check your blood magnesium levels regularly.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Expiry and Retention
Keep Lansox out of the reach and sight of children.
Do not use Lansox after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of the month.
Lansox should be stored at a temperature not exceeding 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Lansox contains
- The active ingredient is lansoprazole
- The other ingredients are: inert microgranules, sucrose, methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30%, slightly substituted hydroxypropylcellulose, maize starch, magnesium carbonate, talc, macrogol 8000, titanium dioxide, hydroxypropylcellulose, polysorbate 80, colloidal silica anhydrous, gelatin, titanium dioxide (E171), red iron oxide (E172)
What Lansox looks like and contents of the pack
Lansox hard capsules are white and pink. Each hard capsule contains white to pale brownish white gastro-resistant granules
Lansox 15 mg hard capsules: Cartons of 14, 28 and 35 hard capsules
Lansox 30 mg hard capsules: Cartons of 14, 28 and 35 hard capsules
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
LANSOX GOLD DISPERSIBLE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg of lansoprazole
Each orodispersible tablet contains 30 mg of lansoprazole
Excipient (s): Each 15 mg orodispersible tablet contains 15 mg of lactose and 4.5 mg of aspartame
Each 30 mg orodispersible tablet contains 30 mg of lactose and 9.0 mg of aspartame. For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Lansox 15 mg: White to yellowish-white orodispersible tablets with orange to dark brown dots. Each orodispersible tablet contains orange to dark brown gastro-resistant granules.
Lansox 30 mg: White to yellowish-white orodispersible tablets with orange to dark brown dots. Each orodispersible tablet contains orange to dark brown gastro-resistant granules.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
• Treatment of duodenal and gastric ulcer
• Treatment of reflux esophagitis
• Prophylaxis of reflux esophagitis
• Eradication of Helicobacter pylori (H. pylori) administered concurrently with
appropriate antibiotic therapy for the treatment of ulcers associated with H. pylori
• Treatment of benign gatric ulcers and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) in patients requiring continuous NSAID treatment
• Prophylaxis of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk requiring continuous therapy (see section 4.2)
• Symptomatic gastroesophageal reflux disease
• Zollinger-Ellison syndrome
04.2 Posology and method of administration
For optimal effect, Lansox should be taken once daily in the morning, except when used for the eradication of H. pylori when the treatment is to be administered twice a day, once in the morning and once in the evening.
Lansox should be taken at least 30 minutes before food (see section 5.2). Lansox has a strawberry flavor and should be placed on the tongue and sucked slowly.
The tablet disperses rapidly in the mouth, releasing the gastro-protected microgranules which are swallowed with the patient's saliva.
Alternatively, the tablet can be swallowed whole with a drink of water.
The orodispersible tablets can be dispersed in a small amount of water and administered through a nasogastric tube or oral syringe.
Treatment of duodenal ulcer:
The recommended dose is 30 mg once a day for 2 weeks. In patients not completely healed within this period, treatment is continued at the same dose for another two weeks.
Treatment of gastric ulcer:
The recommended dose is 30 mg once a day for 4 weeks. The ulcer usually heals within four weeks, but in patients not completely healed within this period, treatment can be continued at the same dose for another 4 weeks.
Reflux esophagitis:
The recommended dose is 30 mg once a day for 4 weeks. In patients not completely healed within this period, treatment can be continued at the same dose for another 4 weeks.
Prophylaxis of reflux esophagitis:
15 mg once a day. The dose can be increased up to 30 mg per day as needed.
Eradication of Helicobacter pvlori:
When selecting the appropriate combination therapy, local official guidelines regarding bacterial resistance, duration of treatment (most commonly 7 days, but sometimes up to 14 days), and appropriate use of antibacterial agents should be considered.
The recommended dose is 30 mg of Lansox 2 times a day for 7 days in combination with one of the following drugs:
clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily
The eradication rates of "H. pylori up to 90% are obtained when clarithromycin is combined with Lansox and amoxicillin or metronidazole.
Six months after successful eradication treatment, the risk of reinfection is low and recurrence is therefore unlikely.
The use of combination therapy including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily was also examined. Lower eradication rates were noted using this. combination versus regimens using clarithromycin This combination may be suitable for those who cannot take clarithromycin as part of eradication therapy when local metronidazole resistance rates are low.
Treatment of benign gastric ulcers and duodenal ulcers associated with the use of NSAIDs in patients requiring continued NSAID treatment:
30 mg once a day for four weeks. In patients who have not completely healed, treatment can be continued for another four weeks. For patients at risk or with ulcers that are difficult to heal, treatment should probably be extended and / or a higher dose used.
Prophylaxis of gastric and duodenal ulcers associated with NSAID use (age> 65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:
15 mg once a day. If treatment is unsuccessful, the 30 mg once daily dose should be used.
Symptomatic gastroesophageal reflux disease:
The recommended dose is 15 mg or 30 mg per day. Relief of symptoms is achieved quickly. Individual dosage adjustment should be considered. If symptoms do not resolve within 4 weeks with a daily dose of 30 mg, further testing is recommended.
Zollinger-Ellison syndrome:
The recommended starting dose is 60 mg once a day. The dose should be individually adjusted and the treatment should be prolonged for the necessary time. Daily doses up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be administered in two divided doses.
Altered liver or kidney function:
It is not necessary to adjust the dose in patients with impaired renal function.
Patients with moderate or severe liver disease should be monitored regularly and a 50% reduction in the daily dose is recommended (see sections 4.4 and 5.2).
Senior citizens:
Due to the reduced clearance of lansoprazole in the elderly, dose adjustment may be necessary based on individual needs. A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.
Children:
The use of Lansox is not recommended in children because clinical data are limited (see also section 5.2).
Treatment of children less than one year of age should be avoided as available data have shown no benefit in the treatment of gastroesophageal reflux disease.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Lansoprazole must not be administered with atazanavir (see section 4.5)
04.4 Special warnings and appropriate precautions for use
As with other anti-ulcer therapies, the possibility of malignant gastric tumors should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole may mask symptoms and delay diagnosis.
Proton pump inhibitors (PPIs) such as lansoprazole have been observed to cause severe hypomagnesaemia in patients treated for at least three months and in many cases for one year.
Serious symptoms of hypomagnesaemia include fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia. They can initially manifest insidiously and be neglected. Hypomagnesaemia improves in most patients after taking magnesium and discontinuing the proton pump inhibitor.
Healthcare professionals should consider measuring magnesium levels before initiating PPI treatment and periodically during treatment in patients on prolonged therapy or on therapy with digoxin or drugs that can cause hypomagnesaemia (eg diuretics).
Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).
The decreased gastric acidity due to lansoprazole can be expected to cause an increase in the gastric amount of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may slightly increase the risk of gastrointestinal infections caused by salmonella and campylobacter.
In patients with gastro-duodenal ulcers, the possibility of infection should be considered H. pylori as an etiological factor.
If lansoprazole is used in combination with antibiotics for H. pylori, then you should also follow the instructions for using these antibiotics.
Due to limited safety data for patients on maintenance treatment for more than 1 year, regular treatment review and full benefit / risk assessment should be performed regularly in these patients.
Cases of colitis have been reported very rarely in patients taking lansoprazole. Therefore, in the event of severe and / or persistent diarrhea, treatment discontinuation should be considered.
Treatment for the prevention of peptic ulcers of patients who need continued NSAID treatment should be limited for high-risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medicinal products that increase the possibility of upper gastrointestinal adverse events [eg corticosteroids or anticoagulants], presence of a severe co-morbid factor or prolonged use of NSAIDs at maximum recommended doses).
Proton pump inhibitors, especially when used in high doses and for prolonged periods (> 1 year), may cause a slightly increased risk of hip, wrist and spine fractures, especially in elderly patients or in the presence of other known risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10% to 40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis should receive treatment according to current clinical practice guidelines and must take an "adequate amount of vitamin D and calcium.
Lansox contains lactose are therefore not suitable for individuals with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.
The tablets contain aspartame, a source of phenylalanine: therefore, they are contraindicated in cases of phenylketonuria.
04.5 Interactions with other medicinal products and other forms of interaction
Effects of lansoprazole with other drugs
Medicinal products whose absorption depends on pH
Lansoprazole can interfere with the absorption of drugs where gastric pH is critical for their bioavailability.
Atazanavir:
One study showed that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers caused a substantial decrease in atazanavir exposure (approximately 90% decrease in AUC and Cmax). . Lansoprazole must not be administered with atazanavir (see section 4.3).
Ketoconazole and itraconazole:
Absorption of ketoconazole and itraconazole from the gastrointestinal tract is enhanced by the presence of gastric acid. Administration of lansoprazole may cause sub-therapeutic concentrations of ketoconazole and itraconazole and the combination should be avoided.
Digoxin:
Co-administration of lansoprazole and digoxin may lead to increased plasma digoxin levels. Therefore, plasma digoxin levels should be monitored and the digoxin dose adjusted, if necessary, when starting or ending treatment with lansoprazole.
Medicinal products metabolised by P450 enzymes
Lansoprazole may increase plasma concentrations of drugs metabolised by CYP3A4. Caution is advised when combining lansoprazole with drugs metabolised by this enzyme and which have a narrow therapeutic window.
Theophylline:
Lansoprazole reduces plasma concentrations of theophylline, which may decrease the expected clinical effect for that dose. Caution is advised when combining the two drugs.
Tacrolimus:
Co-administration of lansoprazole increases plasma concentrations of tacrolimus (a CYP3A and P-gp substrate). Lansoprazole exposure increased the mean tacrolimus exposure by up to 81%.
It is recommended that tacrolimus plasma concentrations be monitored at the beginning and at the end of concomitant treatment with lasoprazole.
Medicinal products transported by P-glycoprotein
Lansoprazole has been observed to inhibit the transport of the P-glycoprotein protein, (P-gp) in vitro. The clinical relevance is unknown.
Effects of other drugs on lansoprazole
Drugs that inhibit CYP2C19
Fluvoxamine:
A dose reduction should be considered when combining lansoprazole with fluvoxamine,
CYP2C19 inhibitor. Plasma concentrations of lansoprazole increase up to 4-fold.
Drugs that induce CYP2C19 and CYP3A4
Inducer enzymes that affect CYP2C19 and CYP3A4 such as rifampicin and St. John's wort (Hypericum perforated) can markedly reduce plasma concentrations of lansoprazole.
Others:
Sucralfate / antacids:
Sucralfate / antacids may decrease the bioavailability of lansoprazole. Therefore lansoprazole should be taken at least one hour before taking these drugs.
No clinically significant interaction of lansoprazole with non-steroidal anti-inflammatory drugs has been demonstrated, although no formal interaction studies have been conducted.
04.6 Pregnancy and lactation
Pregnancy:
No clinical data on exposed pregnancies are available for lansoprazole. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development.
Therefore the use of lansoprazole is not recommended during pregnancy.
Feeding time:
It is unknown whether lansoprazole is excreted in human breast milk. Animal studies have shown that lansoprazole is excreted in milk.
A decision on whether to continue / discontinue breast-feeding or to continue / discontinue lansoprazole therapy must be made taking into account the benefit of breast-feeding for the child and the benefit of lansoprazole therapy for the woman.
04.7 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.
04.8 Undesirable effects
Frequencies are defined as common (> 1/100, 1 / 1,000, 1 / 10,000,
04.9 Overdose
There are no known effects of overdose with lansoprazole in humans (although low acute toxicity is possible) and, consequently, treatment instructions cannot be given. However, daily doses of up to 180 mg lansoprazole by mouth and up to 90 mg intravenous lansoprazole was administered in clinical trials without significant undesirable effects Refer to section 4.8 for possible symptoms of lansoprazole overdose.
If overdose is suspected, the patient should be monitored. Lansoprazole is not significantly eliminated by hemodialysis. If necessary, gastric emptying, charcoal and symptomatic therapy are recommended.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC03
Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the H + / K + ATPase of the parietal cells of the stomach. The inhibition is dose-dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid. Lansoprazole concentrates. in parietal cells and becomes active in their acidic environment, where it reacts with the sulfhydryl group of H + / K + ATPase causing inhibition of enzymatic activity.
Effect on gastric acid secretion
Lansoprazole is a specific inhibitor of the parietal cell of the proton pump. A single oral dose of 30 mg lansoprazole inhibits pentagastrin-stimulated gastric acid secretion by approximately 1 "80%. After repeated daily administration for 7 days, an inhibition of gastric acid secretion of 90% is achieved. This has a corresponding effect on secretion. gastric acid. A single oral dose of 30 mg reduces basal secretion by approximately 70%, and patient symptoms are consequently relieved from the first dose. After 8 days of repeated administration the reduction is approximately 1 "85%. Rapid relief of symptoms is achieved with one orodispersible tablet (30 mg) per day, and most patients with duodenal ulcer heal within 2 weeks, patients with gastric ulcer and reflux oesophagitis within 4 weeks. By reducing gastric acidity, lansoprazole creates an environment in which appropriate antibiotics can be effective against l "H pylori.
05.2 Pharmacokinetic properties
Lansoprazole is a racemate of two active enantiomers which are biotransformed into active form in the acidic environment of the parietal cells. Since lansoprazole is rapidly inactivated by gastric acid, it is administered orally in gastroprotected forms for systemic absorption.
Absorption and distribution:
Lansoprazole exhibits high bioavailability (80-90%) with a single dose. Peak plasma levels occur within 1.5-2.0 hours. Food intake slows the absorption rate of lansoprazole and reduces bioavailability by approximately 50%. Plasma protein binding is 97%.
Studies have shown that orodispersible tablets dispersed in a small amount of water and administered with a syringe directly into the mouth or through a nasogastric tube give an AUC equivalent to that obtained with the usual method of administration.
Metabolism and elimination:
Lansoprazole is extensively metabolised in the liver and the metabolites are excreted via the kidney and biliary. The metabolism of lansoprazole is mainly catalysed by the CYP2C19 enzyme. The CYP3A4 enzyme also contributes to the metabolism. The plasma elimination half-life ranges from 1 to 2 hours following single or multiple doses in healthy volunteers. There is no evidence of accumulation following multiple doses in healthy volunteers. Sulfone, sulphide and 5-hydroxyl derivatives of lansoprazole have been identified in plasma. These metabolites have very little or no anti-secretory activity.
A study with 14C-labeled lansoprazole 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 is decreased in the elderly, with an elimination half-life increased from approximately 50% to 100%. Peak plasma levels are not increased in the elderly.
Pharmacokinetics in pediatric patients:
Evaluation of pharmacokinetics in children aged 1-17 years showed similar exposure to adults with doses of 15 mg for those weighing less than 30 kg, and 30 mg for those weighing more. dose of 17 mg / m2 body surface area or 1 mg / kg body weight in infants from 2-3 months to 1 year of age resulted in lansoprazole exposure comparable to that in adults.
Higher lansoprazole exposure towards adults was noted in infants below 2-3 months of age at 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 doubled in patients with mild hepatic insufficiency and much more in patients with moderate and severe hepatic insufficiency.
Poor metabolisers CYP2C19
CYP2C19 is subject to genetic polyformism and 2-6% of subjects, called poor metabolisers (PMs), are homozygous for the mutant CYP2C19 allele and therefore lose the functional CYP2C19 enzyme. Exposure to lansoprazole is several times higher in PMs than in extensive metabolisers (EMs).
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity or genotoxicity.
In two carcinogenicity studies in rats, lansoprazole caused dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion.
Intestinal metaplasia has also been observed, as well as Leydig cell hyperplasia and benign Leydig cell tumors. Retinal atrophy was observed after 18 months of treatment. This was not observed in monkeys, dogs or mice.
In mouse carcinogenicity studies, dose-related hyperplasia of gastric ECL cells as well as liver tumors and adenoma of the testicular network developed.
The clinical relevance of these findings is unknown.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate, microcrystalline cellulose, magnesium carbonate, poorly substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose, titanium dioxide, talc, mannitol, methacrylic acid-ethylacrylate copolymer (1: 1) dispersion 30%, polyacrylate dispersion 30%, Macrogol 8000, polyacrylate dispersion 80, triethyl citrate, anhydrous citric acid, yellow iron oxide (E172) and red iron oxide (E172), crospovidone, strawberry flavor, aspartame, magnesium stearate.
06.2 Incompatibility
Not relevant
06.3 Period of validity
3 years unopened and properly stored.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C. Store in the original packaging.
06.5 Nature of the immediate packaging and contents of the package
Lansox 15 mg orodispersible tablets: Cartons of 14 and 28 orodispersible tablets
Lansox 30 mg orodispersible tablets: Cartons of 14 and 28 orodispersible tablets
Not all pack sizes may be marketed
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Takeda Italia SpA - Via Elio Vittorini 129 - 00144 Rome
08.0 MARKETING AUTHORIZATION NUMBER
Lansox 15 mg orodispersible tablets - 14 orodispersible tablets A.I.C. N ° 028600070
Lansox 30 mg orodispersible tablets - 14 orodispersible tablets A.I.C. N ° 028600094
Lansox 15 mg orodispersible tablets - 28 orodispersible tablets A.I.C. N ° 028600082
Lansox 30 mg orodispersible tablets - 28 orodispersible tablets A.I.C. N ° 028600106
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
12 July 2002/31 October 2004
10.0 DATE OF REVISION OF THE TEXT
January 2013
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