Medication info

Newbis Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Ranitidine Hydrochloride›84mg / 1 tabletTripotassium Bismuth Dicitrate›100mg / 1 tabletSucralfate Hydrate›300mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
This medication is a round, white film-coated tablet. (This medication consists of a core layer and an outer layer, both of which are white film-coated tablets.)
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201405078 · Approved 2014.10.31

This product's status changed to Expired on 2024.10.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal diseases such as gastric and duodenal ulcers and gastritis
Who takes it
Adults
Adult dose
Typically, without regard to meals, 2 tablets should be taken orally twice a day, in the morning and before bedtime. 1) Gastric and duodenal ulcers: Administer 2 tablets twice a day, or 4 tablets once a day before bedtime. Especially for patients with duodenal ulcers, taking 4 tablets twice a day in the morning and before bedtime results in a higher treatment rate. 2) Reflux esophagitis: Take 2 tablets twice a day for 8 weeks, or 4 tablets once a day before bedtime.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of gastrointestinal diseases such as gastric and duodenal ulcers and gastritis

  • Gastric and duodenal ulcers
  • gastritis
  • Zollinger-Ellison syndrome
  • reflux esophagitis
  • Mendelson's syndrome
  • postoperative ulcers
  • gastric and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs
View approved original text

This medication is used for ulcers of the stomach and duodenum, gastritis, and disorders associated with excessive gastric acid secretion such as Zollinger-Ellison syndrome. It is also effective in treating reflux esophagitis and preventing ulcers that may occur after surgery. When administered before anesthesia, it helps prevent Mendelson's syndrome. It can be used to treat gastric and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). This medication protects the gastric mucosa and regulates gastric acid secretion, improving symptoms. Thus, it is widely used in treating various gastrointestinal diseases.

How to take

Adult dose

Typically, without regard to meals, 2 tablets should be taken orally twice a day, in the morning and before bedtime. 1) Gastric and duodenal ulcers: Administer 2 tablets twice a day, or 4 tablets once a day before bedtime. Especially for patients with duodenal ulcers, taking 4 tablets twice a day in the morning and before bedtime results in a higher treatment rate. 2) Reflux esophagitis: Take 2 tablets twice a day for 8 weeks, or 4 tablets once a day before bedtime.

Precautions

This medication should not be used in patients undergoing dialysis. Patients who have had allergic reactions to this medication or its components should not be administered. It should not be used in patients with a history of acute porphyria as it may trigger seizures. Patients with kidney function problems or those who have undergone upper gastrointestinal surgery should not be given this medication. It is safer not to use this medication in pregnant women or women who may become pregnant, as well as in premature and newborn infants. Patients on a diet restricting potassium intake should also avoid taking this medication. Care should be exercised when administering to patients with liver dysfunction, a history of drug allergies, the elderly, or those with a history of kidney disorders. Particular caution is needed when taken with nonsteroidal anti-inflammatory drugs, and regular examinations are required for patients with a history of gastric ulcers. This medication may conceal the symptoms of gastric cancer, therefore, patients with gastric ulcers or recently developed dyspeptic symptoms in middle-aged individuals should confirm malignancy before use. Patients with gastric or duodenal ulcers infected with Helicobacter pylori should receive eradication therapy in conjunction. Special caution is needed for severely ill patients, patients with hypophosphatemia, or those with swallowing difficulties. Severe allergic reactions such as anaphylactic shock may occur very rarely during the use of this medication, and if symptoms arise, administration should be stopped immediately, and appropriate treatment should be sought. If hypersensitive reactions such as skin rash, angioedema, fever, or bronchospasm occur, discontinue the medication. A decrease in blood cell counts has been reported rarely, so if symptoms like fatigue, bleeding, or fever occur, a blood test should be conducted, and discontinuation should follow if abnormalities are confirmed. Symptoms of liver dysfunction may appear, so if jaundice or hepatitis symptoms occur, immediate discontinuation is necessary. Cardiac arrhythmias or vasculitis have been reported rarely, requiring caution. Gastrointestinal symptoms such as nausea, vomiting, constipation, diarrhea, or abdominal pain may occur, and stool may turn dark, but this will not require special treatment. Neurological symptoms such as dizziness, drowsiness, confusion, or seizures may occur rarely, so if abnormal symptoms appear, administration should be discontinued or appropriate measures taken. Endocrine abnormalities such as gynecomastia or erectile dysfunction have also been reported rarely. Myalgia or arthralgia may occur, and in severe cases, rhabdomyolysis may appear, so if symptoms are present, administration should be stopped. Skin reactions such as rash or alopecia may appear rarely. Avoid long-term use and carefully monitor treatment progress, administering only the minimum required dose. The elderly, patients with chronic lung diseases, diabetes, or those with weakened immunity may have an increased risk of pneumonia, so caution should be exercised. If dizziness or drowsiness occurs during the use of this medication, driving or operating dangerous machinery should be avoided. This medication may interact with other drugs, so especially when taking anticoagulants, blood tests should be conducted to monitor the condition closely. When taking specific antibiotics or other medications, it is advisable to space the administration apart. Pregnant or breastfeeding women should not take this medication for safety. Safety and efficacy in children have not been adequately confirmed; thus, use is not recommended. This medication may affect the results of certain clinical tests, so this should be disclosed during testing. In case of overdose, appropriate measures such as inducing vomiting or gastric lavage should be taken, and if necessary, blood dialysis may also be performed. This medication reduces gastric acid secretion, which may promote bacterial proliferation in the stomach; therefore, ophthalmic examinations may be needed during prolonged use.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylactic shock
  • vasculitis
  • hepatitis
  • jaundice
  • dizziness
  • seizures
  • confusion
  • altered consciousness
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  • convulsions
  • liver dysfunction
  • pancytopenia
  • agranulocytosis
  • aplastic anemia
  • acute interstitial nephritis

Mild side effects

  • Skin rash
  • angioedema
  • fever
  • hypotension
  • chest pain
  • serum enzyme elevation
  • nausea
  • vomiting
  • constipation
  • diarrhea
Show 25 more
  • abdominal distension
  • abdominal pain
  • loss of appetite
  • dizziness
  • drowsiness
  • confusion
  • agitation
  • insomnia
  • headache
  • heaviness of the head
  • malaise
  • anxiety
  • depression
  • hallucinations
  • blurred vision
  • involuntary movement disorders
  • gynecomastia
  • galactorrhea
  • erectile dysfunction
  • decreased libido
  • arthralgia
  • myalgia
  • skin itching
  • glossitis
  • blackening of the tongue

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container that is well-ventilated, at a temperature between 1 and 30 degrees Celsius. This way, the effectiveness of the medication will be well maintained and deterioration will be prevented.

Appearance and packaging

Appearance

This medication is a round, white film-coated tablet. (This medication consists of a core layer and an outer layer, both of which are white film-coated tablets.)

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.