Active ingredients: Lansoprazole
Lansoprazole Mylan 15 mg gastro-resistant capsules
Lansoprazole Mylan 30 mg gastro-resistant capsules
Why is Lansoprazole used - Generic Drug? What is it for?
The active ingredient in your drug is Lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid your stomach produces.
Your doctor may have prescribed Lansoprazole Mylan for the following indications:
- Treatment of duodenal and gastric ulcers.
- Treatment of inflammation of the esophagus (reflux esophagitis).
- Prevention of reflux esophagitis.
- Treatment of heartburn and acid regurgitation.
- Treatment of infections caused by the Helicobacter pylori bacterium when given in combination with antibiotic therapy.
- Treatment or prevention of duodenal or stomach ulcer in patients who require continued treatment with NSAIDs (NSAIDs are used for pain or inflammation).
- Treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Lansoprazole Mylan 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 Lansoprazole - Generic Drug should not be used
Do not take Lansoprazole Mylan
- if you are allergic (hypersensitive) to Lansoprazole Mylan or any of the other ingredients of this medicine (listed in section 6.1).
- if you are taking an antiviral medicine called atazanavir (used to treat HIV).
Precautions for use What you need to know before taking Lansoprazole - Generic Drug
Talk to your doctor or pharmacist before taking Lansoprazole Mylan
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dosage.
Your doctor may perform or have performed a supplementary examination called endoscopy in order to diagnose your disease and / or to rule out a malignant disease.
If diarrhea occurs during treatment with Lansoprazole Mylan, contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed Lansoprazole Mylan in addition to other medicines to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic disease, please read the package leaflet of these medicines carefully.
Taking a proton pump inhibitor such as lansoprazole, especially over a period of more than one year, may slightly increase the risk of wrist, hip or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
If you are taking Lansoprazole Mylan on a long-term basis (for more than a year), your doctor will likely monitor you regularly. You will need to inform him whenever you see him about any symptoms or circumstances that are new and exceptional.
Interactions Which drugs or foods can modify the effect of Lansoprazole - Generic Drug
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription.
In particular, tell your doctor if you are taking medicines containing any of the following active ingredients, as Lansoprazole Mylan can affect the way they work:
- Ketoconazole, itraconazole, rifampicin (medicines to treat infections)
- Digoxin (used to treat heart conditions)
- 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 and acid regurgitation)
- Sucralfate (used to heal ulcers)
- St. John's wort (Hypericum perforatum) (used to treat mild depression)
Lansoprazole Mylan with food and drink
To get the best results from your medicine, you should take Lansoprazole Mylan at least 30 minutes before eating.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you are pregnant or are planning to have a baby, ask your doctor or pharmacist 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 Mylan. If you experience side effects like these, you should be careful as your ability to react may decrease. Do not drive or use machines if these problems concern you.
Only you are able to decide, if you are in a suitable condition to drive a motor vehicle or to cope with tasks that require a high concentration. Due to their mode of action or their undesirable effects one of the factors that can reduce your ability to do these things safely is your use of medicines.
In other paragraphs you can find descriptions of these effects.
Lansoprazole Mylan contains sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this drug.
Dose, Method and Time of Administration How to use Lansoprazole - Generic Drug: Posology
Always take this medicine always exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The dose of Lansoprazole Mylan depends on your state of health. The usual doses of Lansoprazole Mylan for adults are given below. Your doctor may prescribe a different dose and will 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 inform your doctor. If the symptoms do not relieve within 4 weeks, please contact your doctor.
Treatment of duodenal ulcer: One 30 mg capsule every day for 2 weeks
Treatment of gastric 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 each day, your doctor may adjust the dose up to one 30 mg capsule each 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 Lansoprazole Mylan together with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
- 30 mg of Lansoprazole Mylan together with 250 mg of clarithromycin and 400-500 mg of metronidazole
If you are treating your infection because you have an ulcer, the ulcer is unlikely to come back if the infection is treated successfully. To allow your medicine to work at its best, take the medicine at the scheduled times and never forget one dose.
Treatment of duodenal or gastric ulcer in patients requiring continued NSAID treatment: One 30 mg capsule every day for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continued NSAID treatment: One 15 mg capsule each day, your doctor may adjust the dose up to one 30 mg capsule each day.
Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules each day as an initial treatment, then your doctor will work out the best dose for you based on your response to Lansoprazole Mylan.
Method of administration
Swallow the capsule whole with a glass of water before eating. If you find it difficult to swallow the capsules, your doctor may recommend alternative methods of taking your medicine. Do not crush or chew these capsules or the contents of an emptied capsule, as the medication is not working properly.
If you take Lansoprazole Mylan once a day, try to take it at the same time each day. You can get better results if you take Lansoprazole Mylan first thing in the morning.
If you take Lansoprazole Mylan twice a day, you should take the first dose in the morning and the second dose in the evening.
Use in children:
Lansoprazole should not be given to children
Overdose What to do if you have taken an overdose of Lansoprazole - Generic Drug
If you take more Lansoprazole Mylan than you should:
If you take more Lansoprazole Mylan than you have been told to, see your doctor quickly.
If you forget to take Lansoprazole Mylan:
If you forget to take a dose, take the next one as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lansoprazole Mylan:
Do not stop treatment early as your symptoms have improved. Your condition may not be fully cured and may return if you do not complete your course of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Lansoprazole - Generic Drug
Like all medicines, Lansoprazole Mylan can cause side effects, although not everybody gets them.
Stop taking the medicine and tell your doctor immediately or go to the nearest emergency room if you suffer from:
- Diarrhea (common, may affect up to 1 in 10 people). This side effect should be reported to the doctor as this drug has been associated with an increase in infectious diarrhea.
- Pancreatitis (rare, may affect up to 1 in 1,000 people).
- Inflammation of the liver, which can occur with yellow skin and eyes (rare, may affect up to 1 in 1,000 people).
- Angioedema, with symptoms such as: swelling of the face, tongue or pharynx, difficulty swallowing, hives and breathing difficulties (rare, may affect up to 1 in 1,000 people).
- Severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction can include fever, rash, swelling and sometimes a drop in blood pressure (very rare, may affect up to 1 in 10,000 people).
- Very severe skin reactions with redness, blistering, severe inflammation and skin loss (very rare, may affect up to 1 in 10,000 people).
- Very rarely, lansoprazole can cause a reduction in the number of white blood cells (agranulocytosis) and resistance to infections can 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 you should see your doctor immediately. A blood test will be performed to check check for a possible reduction in white blood cells (agranulocytosis) (very rare, may affect up to 1 in 10,000 people).
Other possible side effects:
Common (may affect up to 1 in 10 patients):
- Headache, dizziness
- Diarrhea, constipation, stomach pain, sickness, nausea or vomiting, wind, dry or inflamed mouth or throat
- Skin rash, itching
- Changes in liver function tests
- Tiredness.
Uncommon (may affect up to 1 in 100 patients):
- Depression
- Joint or muscle pain
- Fracture of the wrist, hip or spine
- Water retention or swelling
- Change in blood cell count. If you notice any unusual bruising or bleeding on your skin, please tell your doctor.
Rare (may affect up to 1 in 1000 patients):
- Fever
- Restlessness, sleepiness, confusion, hallucinations, insomnia, visual disturbances, dizziness.
- Change in the sense of taste, loss of appetite, inflammation of the tongue (glossitis)
- Skin reactions such as burning or tingling under the skin, bruising, redness and excessive sweating
- Sensitivity to light
- Hair loss
- Tingling sensation on the skin (paraesthesia), tremor
- Anemia (paleness)
- Kidney problems tell your doctor if you have difficulty urinating.
- Swelling of the chest in men, impotence
- Candidiasis (fungal infection of the skin or mucous membranes)
Very rare (may affect up to 1 in 10,000 patients):
- Inflammation of the mouth (stomatitis)
- Colitis (inflammation of the colon)
- Altered laboratory values such as sodium, cholesterol and triglyceride levels.
Not known (frequency cannot be estimated from the available data): If you have been taking lansoprazole for more than three months it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to have regular blood tests to monitor your magnesium levels.
If you get any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use Lansoprazole Mylan after the expiry date which is stated on the blister, carton and bottle after "EXP". The expiry date refers to the last day of that month.
Blisters: Do not store above 25 ° C. Keep the medicine in the original package to protect it from light.
Bottles: Do not store above 25 ° C. Keep the medicine in the original package to protect it from light.
Use within 30 days of opening. Keep bottle tightly closed after opening.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Lansoprazole Mylan contains
- Each Lansoprazole Mylan 15 mg gastro-resistant capsules contains 15 mg of lansoprazole.
- Each Lansoprazole Mylan 30 mg gastro-resistant capsules contains 30 mg of lansoprazole.
- The other ingredients are sugar spheres, magnesium carbonate, sucrose, maize starch, hydroxypropylcellulose. The capsule shell and shell contain hydroxypropylcellulose, methacrylic acid ethyl acrylate copolymer, talc, macrogol, titanium dioxide (E 171), polysorbate 80 gelatin and colloidal anhydrous silica. The 30 mg capsules also contain Brilliant Blue FCF. 1 (E133) and erythrosine (E127). The printing ink contains shellac, strong ammonia solution, black iron oxide (E172), potassium hydroxide.
What Lansoprazole Mylan looks like and contents of the pack
15 mg: White to cream granules placed in a size 2 hard gelatin capsule with white opaque cap and white opaque body imprinted in black ink 'MYLAN "above' LN 15" on both cap and body.
30 mg: White to cream colored granules placed in a size 0 hard gelatin capsule with opaque pink cap and opaque pink body imprinted in black ink 'MYLAN "above' LN 30" on both cap and body.
Lansoprazole Mylan is available in blister packs and bottles with 7, 14, 28, 30, 56, 60, 84, 98, 100, 500 capsules.
Not all pack sizes may be marketed.
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
LANSOPRAZOLE MYLAN - GASTRORESISTANT CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lansoprazole
Each capsule contains 30 mg of lansoprazole
Excipients with known effect:
Each 15 mg capsule contains 70.5 mg of sucrose
Each 30 mg capsule contains 141.0 mg of sucrose
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Hard gastro-resistant capsules
15 mg: White to cream granules placed in a size 2 hard gelatin capsule with white opaque cap and white opaque body imprinted lengthwise in black ink "MYLAN" above "LN 15" on both cap and on the body.
30 mg: White to cream granules placed in a size 0 hard gelatin capsule with opaque pink cap and opaque pink body imprinted lengthwise with "MYLAN" above "LN 30" on both the cap and body in black ink.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
• Treatment of gastric and duodenal ulcer
• Treatment of reflux esophagitis
• Prophylaxis of reflux esophagitis
• Eradication of Helicobacter pylori (H. pylori) while administering "adequate antibiotic therapy for the treatment of ulcers associated with H. pylori.
• Treatment of benign gastric and duodenal ulcers associated with the use of NSAIDs in patients who require continued NSAID treatment.
• Prophylaxis of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk (see section 4.2) who require continued therapy.
• Symptomatic gastroesophageal reflux disease
• Zollinger-Ellison syndrome.
04.2 Posology and method of administration
Dosage
For optimal effect Lansoprazole Mylan should be taken once daily in the morning, except in the case of eradication of the H. pyloriwhich provides two daily administrations, one in the morning and one in the evening.
Treatment of duodenal ulcer
The recommended dose is 30 mg once a day for 2 weeks. For patients whose ulcers do not heal during this time, continue treatment for another 2 weeks at the same dosage.
Treatment of gastric ulcer
The recommended dose is 30 mg once a day for 4 weeks. Healing of the ulcer usually occurs within 4 weeks, but for those patients whose ulcers do not heal within this time, treatment can be continued for another 4 weeks at the same dosage.
Reflux esophagitis
The recommended dose is 30 mg once a day for 4 weeks. For patients whose ulcers do not heal during this time, continue treatment for another 4 weeks at the same dosage.
Prophylaxis of reflux esophagitis
15 mg once a day. The dose can be increased to 30 mg / day if necessary.
Eradication of Helicobacter pylori
Official guidelines regarding bacterial resistance, duration of treatment (usually 7 days, but sometimes up to 14 days) and appropriate use of antibiotics should be taken into consideration when choosing the appropriate combination therapy.
The recommended dose is 30 mg of Lansoprazole Mylan twice daily 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 up to 90% of H. pylori are obtained when clarithromycin is combined with Lansoprazole Mylan and amoxicillin or metronidazole.
Six months after successful treatment in eradication, the risk of reinfection is low and recurrence is therefore unlikely.
The use of a regimen including Lansoprazole Mylan 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily was also investigated.
Lower eradication rates were noted using this combination compared to 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 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 with incomplete healing, 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 in patients at risk (eg age> 65 years or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment
15 mg once a day. If treatment is unsuccessful, the dose of 30 mg once daily should be used.
Symptomatic treatment of gastroesophageal reflux disease
The recommended dose is 15 mg or 30 mg per day. Symptom relief 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 daily. The dose must be individually adjusted and the treatment 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.
Reduced liver or kidney function
No dosage adjustment is necessary in patients with impaired renal function.
Patients with moderate to severe liver disease should be monitored regularly and a 50% reduction of the daily dose is recommended (see sections 4.4 and 5.2).
Elderly patients
Due to the reduced clearance of lansoprazole in the elderly, dose adjustment may be necessary based on individual needs. The daily dose of 30 mg should not be exceeded in the elderly, unless there are compelling clinical indications.
Pediatric population
The use of Lansoprazole is not recommended in children as clinical data are limited (see also section 5.2).
Method of administration
Lansoprazole should be taken at least 30 minutes before eating (see section 5.2). The capsules should be swallowed whole with liquid.
For patients with swallowing difficulties, studies and clinical practice suggest that the capsules can be opened and the granules mixed with a small amount of water, apple / tomato juice or sprinkled on a small amount of soft food (eg. yogurt, apple puree) to facilitate administration. The capsules can also be opened and the granules mixed with 40 ml of apple juice to be administered through a nasogastric tube (see section 5.2). After preparing the suspension or mixture, the drug should be administered immediately.
04.3 Contraindications
Hypersensitivity to the active substance or to any excipient listed in section 6.1 ..
Lansoprazole must not be administered with atazanavir (see section 4.5).
04.4 Special warnings and appropriate precautions for use
As with other ulcer treatments, the possibility of malignant gastric cancer should be ruled out by initiating anti-ulcer therapy with Lansoprazole Mylan, as Lansoprazole may mask symptoms and delay diagnosis.
Lansoprazole should be used with caution in patients with moderate to 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 such asSalmonella And Campylobacter.
In patients with gastro-duodenal ulcers, the possibility of infection with H. pylori as an etiological factor.
If lansoprazole is used in combination with antibiotics for eradication therapy 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 one 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, discontinuation of treatment should be considered.
Treatment for the prevention of peptic ulcer in patients requiring continued NSAID treatment should be restricted to high-risk patients (e.g., previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of drugs that increase the likelihood of adverse reactions of the upper gastrointestinal tract [eg. corticosteroids or anticoagulants], presence of a serious comorbid factor or prolonged use of NSAIDs at the maximum recommended dose).
Proton pump inhibitors, especially when used in high doses and for long periods (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, especially in the elderly or in the presence of other risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%. Some of these increases may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current guidelines guide clinics and receive adequate intake of vitamin D and calcium.
Hypomagnesemia
Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors (PPIs) such as lansoprazole for at least three months, and in the majority of cases for one year. Severe manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia may occur, but they may begin insidiously and be neglected. In the majority of affected patients, hypomagnesaemia improved after administration of magnesium and discontinuation of PPIs. For patients anticipating prolonged treatment or taking PPIs with digoxin or other medicinal products that can cause hypomagnesaemia (e.g. diuretics ), healthcare professionals should consider measuring magnesium levels prior to initiation of PPI treatment and periodically during treatment.
As Lansoprazole Mylan contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose deficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Effects of Lansoprazole Mylan on 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
The absorption of ketoconazole and itraconazole from the gastrointestinal tract is favored by the presence of gastric acid. Administration of lansoprazole may result in a subtherapeutic concentration of ketoconazole and itraconazole and the combination should be avoided.
Digoxin
Co-administration of lansoprazole and digoxin may lead to increased plasma digoxin levels. Plasma digoxin levels should therefore be monitored and the digoxin dose adjusted as needed, at the time of initiation and termination of lansoprazole treatment.
Medicinal products metabolised by P450 enzymes
Lansoprazole may increase the plasma concentrations of drugs which are 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 the two drugs are combined.
Tacrolimus
Co-administration of lansoprazole increases plasma concentrations of tacrolimus (a CYP3A and substrate of P-gp). Exposure to lansoprazole increased the mean exposure of tacrolimus by up to 81%. It is recommended that plasma concentrations of tacrolimus be monitored at the beginning and at the end of concomitant treatment with lansoprazole.
Medicinal products transported by P-glycoprotein
Lansoprazole has been shown to inhibit the transport protein, P-glycoprotein (P-gp) in vitro. The clinical relevance is unknown.
Effects of other drugs on Lansoprazole Mylan
Drugs that inhibit CYP2C19
Fluvoxamine
Dose reduction should be considered when combining lansoprazole with fluvoxamine, which is a CYP2C19 inhibitor.
Plasma concentrations of lansoprazole increase up to 4-fold.
Drugs that induce CYP2C19 and CYP3A4
Enzyme inducers involving CYP2C19 and CYP3A4 such as rifampicin and St. John's wort (Hypericum perforatum) can significantly reduce the plasma concentrations of lansoprazole.
Others
Sucralfate / antacids
Sucralfate / antacids may decrease the bioavailability of lansoprazole. Therefore lansoprazole should be taken at least one hour after taking these drugs.
No clinically significant interactions with non-steroidal anti-inflammatory drugs have 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 are not indicative of direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development.
Therefore the use of Lansoprazole Mylan is not recommended during pregnancy.
Feeding time
It is not known 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 very common (≥1 / 10), common (≥1 / 100 to
04.9 Overdose
There are no known effects of overdose with lansoprazole in humans (although acute toxicity is likely to be low) and, consequently, treatment instructions cannot be given. However, daily doses of up to 180 mg of lansoprazole by mouth and up to 90 mg intravenous lansoprazole have been administered in clinical trials without significant adverse effects.
Refer to section 4.8 for possible symptoms of lansoprazole overdose.
In case of suspected overdose the patient should be monitored. Lansoprazole is not significantly eliminated by hemodialysis. Gastric emptying, charcoal and symptomatic therapy are recommended as needed.
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 activity 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 concentrates in the parietal cells and is activated 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 lansoprazole inhibits pentagastrin-stimulated gastric acid secretion by approximately 80%. After repeated daily administration for seven days, an inhibition of gastric acid secretion of approximately 90% is achieved. This has a corresponding effect on the basal secretion of gastric acid. A single oral dose of 30 mg reduces basal secretion by approximately 70%, and patients' symptoms are consequently relieved from the first dose. After eight days of repeated administration the reduction is approximately 85%. Rapid relief of symptoms is achieved with one capsule (30 mg) per day, and most patients with duodenal ulcer heal within 2 weeks. with gastric ulcer and reflux esophagitis within 4 weeks. By reducing gastric acidity, lansoprazole creates an environment in which appropriate antibiotics can be effective against 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 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 are reached 1.5 to 2 hours after administration. Food intake slows the rate of absorption of lansoprazole and reduces the bioavailability of about 50%. The plasma protein binding is 97%.
Studies have shown that the granules of opened capsules confer an AUC equivalent to those of intact capsules, if the granules are suspended in small quantities of orange juice, apple juice or tomato juice mixed with a spoonful of apple puree. or pear or sprinkled on a kitchen spoon with yoghurt or fresh flaked cheese. An equivalent AUC was also demonstrated for granules suspended in apple juice administered via a nasogastric tube.
Biotransformation and elimination
Lansoprazole is extensively metabolised in the liver and the metabolites are excreted by both the renal and biliary routes. The metabolism of lansoprazole is mainly catalysed by the CYP2C19 enzyme. The CYP3A4 enzyme also contributes to the metabolic process. The plasma elimination half-life ranges from 1 to 2 hours for single or multiple doses in healthy volunteers. There is no evidence of accumulation following multiple doses in healthy volunteers. Sulfonic, sulfur and 5-hydroxyl derivatives of lansoprazole have been identified in plasma. These metabolites have very little or no antisecretory activity.
A study with C14-radiolabelled lansoprazole indicated that approximately one third of the administered radioactivity was excreted in the urine and two thirds was recovered in the faeces.
Pharmacokinetics in elderly patients:
The clearance of lansoprazole is reduced in the elderly, with an elimination half-life increased from approximately 50% to 100%. The peak plasma levels in the elderly are not increased.
Pharmacokinetics in pediatric patients
Estimates of pharmacokinetics in children aged 1 to 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. a dose of 17 mg / m2 body surface area or 1 mg / kg body weight in children from 2-3 months up to 1 year of age resulted in "exposure to lansoprazole comparable to that in adults."
"Longer exposure to lansoprazole vis-à-vis 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 dose. single.
Pharmacokinetics in hepatic insufficiency
Exposure to lansoprazole doubled in patients with mild hepatic impairment and much greater in patients with moderate to severe hepatic impairment.
CYP2C19 poor metabolisers
CYP2C19 is subject to a genetic polymorphism and 2-6% of the population, called poor metabolisers (PMs), are homozygous for the mutant CYP2C19 allele and therefore lack 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 from conventional safety pharmacology, repeated dose, reproductive toxicity or genotoxicity studies reveal no special hazard for humans.
In two carcenogenicity 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 was also observed, as well as Leydig cell hyperplasia and tumors. benign Leydig cells Retinal atrophy was observed after 18 months of treatment This was not observed in monkeys, dogs or mice.
In mouse carcenogenicity studies, dose-related hyperplasia of gastric ECL cells as well as liver tumors and adenoma of the testicular network developed.
The clinical significance of these findings is unknown.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Gastro-resistant granules:
Sugar balls
Heavy magnesium carbonate
Sucrose
Cornstarch
Low-substituted hydroxypropylcellulose
Coating:
Hydroxypropylcellulose
Ethyl acrylate copolymer of methacrylic acid (1: 1) dispersion 30% per cent
Talc (E553b)
Macrogol
Titanium dioxide (E171)
Polysorbate 80 (E433)
Inside of the capsule:
Talc
Anhydrous colloidal silica
Capsule shell:
Jelly
Titanium dioxide (E171)
Brilliant Blue FCF (E133) (30 mg only)
Erythrosine (E133) (30 mg only)
Printing ink:
Shellac
Strong ammonia solution
Black iron oxide (E 172)
Potassium hydroxide
06.2 Incompatibility
Not applicable.
06.3 Period of validity
3 years.
Bottles: Use within 30 days of opening. Keep bottle tightly closed after opening.
06.4 Special precautions for storage
Blisters: Do not store above 25 ° C. Keep the medicine in the original package to protect it from light.
Bottles: Do not store above 25 ° C. Keep the medicine in the original package to protect it from light. Use within 30 days of opening. Keep bottle tightly closed after opening.
06.5 Nature of the immediate packaging and contents of the package
The HDPE bottle packaging consists of an opaque white HDPE bottle with an opaque white cap.
The blister packs consist of opaque white PVC film coated with PVdC and coated with aluminum film tempered with heat-sealing lacquer.
Blister packs: packs of 7, 14, 28, 30, 56, 60, 84, 98, 100, 500 capsules.
Bottles: packs of 7, 14, 28, 30, 56, 60, 84, 98, 100, 500 capsules.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions for disposal.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations
07.0 MARKETING AUTHORIZATION HOLDER
Mylan S.p.A., Via Vittor Pisani, 20 - 20124 Milan Italy
08.0 MARKETING AUTHORIZATION NUMBER
AIC: 040843017 / M "15 mg hard gastro-resistant capsules" 7 capsules in blister PVV / PVDC / AL
AIC: 040843029 / M "15 mg hard gastro-resistant capsules" 14 capsules in blister PVV / PVDC / AL
AIC: 040843031 / M "15 mg hard gastro-resistant capsules" 28 capsules in blister PVV / PVDC / AL
AIC: 040843043 / M "15 mg hard gastro-resistant capsules" 30 capsules in blister PVV / PVDC / AL
AIC: 040843056 / M "15 mg hard gastro-resistant capsules" 56 capsules in blister PVV / PVDC / AL
AIC: 040843068 / M "15 mg hard gastro-resistant capsules" 60 capsules in blister PVV / PVDC / AL
AIC: 040843070 / M "15 mg hard gastro-resistant capsules" 84 capsules in blister PVV / PVDC / AL
AIC: 040843082 / M "15 mg hard gastro-resistant capsules" 98 capsules in blister PVV / PVDC / AL
AIC: 040843094 / M "15 mg hard gastro-resistant capsules" 100 capsules in blister PVV / PVDC / AL
AIC: 040843106 / M "15 mg hard gastro-resistant capsules" 500 capsules in blister PVV / PVDC / AL
AIC: 040843118 / M "15 mg hard gastro-resistant capsules" 7 capsules in HPDE container
AIC: 040843120 / M "15 mg hard gastro-resistant capsules" 14 capsules in HPDE container
AIC: 040843132 / M "15 mg hard gastro-resistant capsules" 28 capsules in HPDE container
AIC: 040843144 / M "15 mg hard gastro-resistant capsules" 30 capsules in HPDE container
AIC: 040843157 / M "15 mg hard gastro-resistant capsules" 56 capsules in HPDE container
AIC: 040843169 / M "15 mg hard gastro-resistant capsules" 60 capsules in HPDE container
AIC: 040843171 / M "15 mg hard gastro-resistant capsules" 84 capsules in HPDE container
AIC: 040843183 / M "15 mg hard gastro-resistant capsules" 98 capsules in HPDE container
AIC: 040843195 / M "15 mg hard gastro-resistant capsules" 100 capsules in HPDE container
AIC: 040843207 / M "30 mg hard gastro-resistant capsules" 7 capsules in blister PVV / PVDC / AL
AIC: 040843219 / M "30 mg hard gastro-resistant capsules" 14 capsules in blister PVV / PVDC / AL
AIC: 040843221 / M "30 mg hard gastro-resistant capsules" 28 capsules in blister PVV / PVDC / AL
AIC: 040843233 / M "30 mg hard gastro-resistant capsules" 30 capsules in blister PVV / PVDC / AL
AIC: 040843245 / M "30 mg hard gastro-resistant capsules" 56 capsules in blister PVV / PVDC / AL
AIC: 040843258 / M "30 mg hard gastro-resistant capsules" 60 capsules in blister PVV / PVDC / AL
AIC: 040843260 / M "30 mg hard gastro-resistant capsules" 84 capsules in blister PVV / PVDC / AL
AIC: 040843272 / M "30 mg hard gastro-resistant capsules" 98 capsules in blister PVV / PVDC / AL
AIC: 040843284 / M "30 mg hard gastro-resistant capsules" 100 capsules in blister PVV / PVDC / AL
AIC: 040843296 / M "30 mg hard gastro-resistant capsules" 500 capsules in blister PVV / PVDC / AL
AIC: 040843308 / M "30 mg hard gastro-resistant capsules" 7 capsules in HPDE container
AIC: 040843310 / M "30 mg hard gastro-resistant capsules" 14 capsules in HPDE container
AIC: 040843322 / M "30 mg hard gastro-resistant capsules" 28 capsules in HPDE container
AIC: 040843334 / M "30 mg hard gastro-resistant capsules" 30 capsules in HPDE container
AIC: 040843346 / M "30 mg hard gastro-resistant capsules" 56 capsules in HPDE container
AIC: 040843359 / M "30 mg hard gastro-resistant capsules" 60 capsules in HPDE container
AIC: 040843361 / M "30 mg hard gastro-resistant capsules" 84 capsules in HPDE container
AIC: 040843373 / M "30 mg hard gastro-resistant capsules" 98 capsules in HPDE container
AIC: 040843385 / M "30 mg hard gastro-resistant capsules" 100 capsules in HPDE container
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
10.0 DATE OF REVISION OF THE TEXT
March 2013
