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Gastrointestinal System

Lansoprazol STADA® 30 mg

 

Pack size:

Box of 3 blisters x 10 capsules.

 

Composition:

Each capsule contains lansoprazol (as lansoprazole pellets) 30 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30ºC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

The drug should be taken orally before eating, and do not crush or chew capsule.

  • Active gastric ulcer.
    One capsule once daily, for 4 weeks, therapy can be continued for another 2 to 4 weeks if necessary.
  • Esophagitis due to gastroesophageal reflux disease.
    One capsule once daily, for 4 weeks, and therapy can be continued for another 4 weeks if necessary.
  • Zollinger-Ellison syndrome.
    1 – 2 capsules once daily. Treatment duration depends on responses of the disease.ctive gastric ulcer.

Or as prescribed by physicians.
 

  • Patients with known hypersensitivity to any ingredient of the drug.
  • Pregnancy.
  • Lactation.
  • Children.


 


Most common:

  • The most common symptoms of adverse reactions with lansoprazole are gastrointestinal, such as diarrhoea, abdominal pain and, some patients experience headache and vertigo.

Common:

  • Headache, vertigo.
  • Diarrhoea, abdominal pain, nausea, vomiting, constipation, dyspepsia.
  • Skin eruptions.

Less common:

  • Fatigue.

Laboratory values:

  • Increases in serum gastrin levels, liver enzymes, hematocrit, hemoglobin, urinary protein excretion and uric acid levels have been served.

     

  • Proton pump inhibitors (PPIs), especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10 – 40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
  • Severe hypomagnesaemia has been reported in patients treated with PPIs for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPIs.
  • For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPIs treatment and periodically during treatment.
  • Hepatic insufficiency: Dose reduction in patients with severe hepatic disease should be considered.
  • Pediatric: The effectiveness and tolerance of lansoprazole in children has not been established. Therefore, lansoprazole should not be indicated in children.
  • Geriatric: Since the gastric acid secretion and other physiological functions are decreased in elderly patients, lansoprazole should be administered with caution.
  • Pregnancy: There are no adequate or well-controlled studies in pregnant woman, this drug should be used during pregnancy only if clearly needed.
  • Lactation: It is not known whether lansoprazole is excreted in human milk.
  • Effects on ability to drive and use machines: Adverse drug reactions such as dizziness, vertigo, visual disturbances and somnolence may occur. Under these conditions the ability to react may be decreased.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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