Medication info

Genupharm Prucalopride Tablets 2 mg (Prucalopride Succinate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Prucalopride Succinate›2.642mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu×2)
Approval status
Approval withdrawn

MFDS item code 202000367 · Approved 2020.01.22

This product's status changed to Approval withdrawn on 2024.12.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of chronic constipation symptoms
Who takes it
Adults
Adult dose
This medication is administered orally and may be taken at any time of day, regardless of meals. Adults should take 2 mg once daily. For elderly patients aged 65 and older, the initial dose is 1 mg once daily, which can be increased to 2 mg once daily if necessary. For patients with severe kidney impairment (GFR < 30 ml/min/1.73 m2) and severe liver impairment (Child-Pugh class C), the dosage is 1

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement of chronic constipation symptoms

  • Symptoms of chronic constipation
View approved original text

This medication is used as an effective treatment option for adult patients with chronic constipation whose symptoms have not improved with conventional laxative treatment. It facilitates bowel movements and enhances comfort associated with chronic constipation.

How to take

Adult dose

This medication is administered orally and may be taken at any time of day, regardless of meals. Adults should take 2 mg once daily. For elderly patients aged 65 and older, the initial dose is 1 mg once daily, which can be increased to 2 mg once daily if necessary. For patients with severe kidney impairment (GFR < 30 ml/min/1.73 m2) and severe liver impairment (Child-Pugh class C), the dosage is 1

Precautions

This medication should not be used in certain patients. For example, people who are allergic to the active ingredient or excipients, patients with severely impaired kidney function, those with serious intestinal problems, and individuals with genetic issues such as lactose intolerance should not be administered this medication. Additionally, patients with greatly reduced kidney function should use it with caution and at a reduced dose; similar caution applies to patients with other serious conditions such as liver or heart disease. Those with a history of cardiac arrhythmias or ischemic cardiovascular diseases should be especially careful. Common gastrointestinal symptoms such as headache, abdominal pain, nausea, and diarrhea may occur when taking this medication, typically appearing early in treatment and resolving over time. Rarely, symptoms like palpitations, fatigue, or dizziness may arise, and patients should consult a doctor if these symptoms develop. The possibility of drug interactions is relatively low, but caution is needed when taken with certain medications. It is particularly important to be careful when used in conjunction with drugs that can prolong the QTc interval, and the drug concentrations may be altered when combined with some antifungal or heart-related medications. The use of this medication is not recommended during pregnancy, and women of childbearing potential should use effective contraceptive measures while taking it. Nursing mothers should avoid using this medication as it can be excreted in breast milk. It is safest not to administer this medication to children or adolescents under 18 years of age. In case of overdose, symptoms such as headache, nausea, or diarrhea may appear; treatment should be symptomatic. If there is significant fluid loss through diarrhea or vomiting, electrolyte replacement may be necessary. This medication may cause dizziness or fatigue upon initial use, so caution is advised when driving or operating machinery. Finally, this medication should be kept out of reach of children and stored in its original container, protected from moisture.

Side effects and when to seek care immediately

Serious side effects

Chest discomfort, ventricular extrasystole

Mild side effects

  • Headache
  • dizziness
  • tremors
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • dyspepsia
  • rectal bleeding
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  • bloating
  • abnormal bowel sounds
  • increased frequency of urination
  • fatigue
  • fever
  • malaise
  • abdominal distension
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional gastrointestinal disorder
  • loose stools
  • esophagitis
  • duodenal ulcer
  • rhinitis
  • bronchitis
  • shingles
  • athlete's foot
  • bacterial vaginosis
  • bacterial bronchitis
  • facial edema
  • chest discomfort

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

Storage

This medication should be protected from light and moisture and stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu×2)

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.