Medication info

Izifru Tablet 1 mg (Prucalopride Succinate)

Prescription medicationTablet경구Expired
Ingredient · strength
Prucalopride Succinate›1.321mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White to off-white round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu*2)
Approval status
Expired

MFDS item code 202001390 · Approved 2020.02.27

This product's status changed to Expired on 2025.02.27. 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 taken orally and can be administered at any time during the day regardless of meals. Adults take 2 mg once daily. For elderly patients aged 65 and over, the initial dose is 1 mg once daily, which may be increased to 2 mg once daily if necessary. For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and severe liver impairment (Child-Pugh class C), the dosage is 1 daily.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

Used for the effective treatment of chronic constipation symptoms in adults where symptoms have not improved with laxative use.

How to take

Adult dose

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

Precautions

This medication should not be administered to certain patients. Specifically, those allergic to the active ingredient or any additives, patients with severely impaired kidney function requiring dialysis, and individuals with serious structural abnormalities or inflammation in the intestines should not use it. Additionally, those with lactose intolerance or certain genetic metabolic disorders should not take this medication. Use with caution and a reduced dosage for patients with poor kidney function. Patients with severe issues relating to the liver, heart, lungs, or nervous system also require caution when using this medication. Individuals with heart rhythm issues or a history of ischemic heart disease should also be careful, and the dosage may need to be lowered for patients with severely diminished liver function. This medication can commonly cause gastrointestinal symptoms such as headaches, abdominal pain, nausea, and diarrhea, which usually resolve within a few days of starting treatment. Dizziness, fatigue, and palpitations may also occur, and if unusual symptoms persist, consultation with a physician is advised. In cases of severe diarrhea, the effectiveness of oral contraceptives may decrease, so it is advisable to use additional contraceptive methods. This medication has a low risk of interactions with other drugs, but caution is needed when taken with certain potent medications. Particularly when combined with medications that can prolong the QTc interval, there may be a risk of side effects, and consultation with a physician is necessary. Use of this medication during pregnancy is not recommended, and women of childbearing potential should employ effective contraception during treatment. It is also not recommended for breastfeeding women. It is advisable not to administer this medication to children or adolescents under 18 years of age. In case of overdose, symptoms such as headaches, nausea, and diarrhea may occur, and appropriate treatment must be provided according to the symptoms. Particularly, dehydration and electrolyte imbalance may occur, so caution is necessary. Dizziness or fatigue may occur while driving or operating machinery, so caution is needed. This medication should be stored out of reach of children and kept in its original container away from moisture.

Side effects and when to seek care immediately

Serious side effects

Ventricular extrasystole, chest discomfort

Mild side effects

  • Headache
  • dizziness
  • tremor
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • dyspepsia
  • rectal bleeding
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  • bloating
  • abnormal bowel sounds
  • frequent urination
  • fatigue
  • fever
  • malaise
  • dyspepsia
  • abdominal distension
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional dyspepsia
  • loose stools
  • esophagitis
  • duodenal ulcer
  • rhinitis
  • bronchitis
  • herpes zoster
  • 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 stored in a sealed container that does not allow light exposure, avoiding humid areas, at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication’s effectiveness and prevents degradation.

Appearance and packaging

Appearance

White to off-white 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.