Medication info

Prucalopride 1 mg (Prucalopride Succinate)

Prescription medicationTablet경구Expired
Ingredient · strength
Prucalopride Succinate›1.321mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
White round film-coated tablet
Packaging
28 tablets/box [7 tablets/PTP*4]
Approval status
Expired

MFDS item code 201906636 · Approved 2019.09.23

This product's status changed to Expired on 2024.09.23. 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
Administered orally, it can be taken at any time of the day regardless of meals. Adults take 2 mg once daily. For elderly patients aged 65 and older, an initial dose of 1 mg once daily may be prescribed, which can 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 dose is 1 mg once daily.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

This medication is used in adult patients who have failed to relieve symptoms with laxatives for the treatment of chronic constipation. It helps improve chronic constipation, facilitating bowel movements and reducing discomfort associated with constipation. Patients may find it beneficial in alleviating symptoms, so it's advisable to use it consistently and monitor changes in symptoms.

How to take

Adult dose

Administered orally, it can be taken at any time of the day regardless of meals. Adults take 2 mg once daily. For elderly patients aged 65 and older, an initial dose of 1 mg once daily may be prescribed, which can 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 dose is 1 mg once daily.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to the active ingredient or excipients, patients with severely impaired renal function, and patients with serious bowel problems should not take this medication. This medication contains lactose, so patients with genetic disorders that prevent lactose digestion should also avoid it. Patients with severe renal impairment should use this medication cautiously at a reduced dose. Additionally, caution is needed for patients with liver disease, heart disease, lung disease, or neurological disorders. Patients with heart issues or a history of arrhythmias should use this medication with extra care. Patients with severely impaired liver function should also use it at a reduced dose, and caution is required when taken with other medications that can prolong the QTc interval. Gastrointestinal symptoms such as headache, abdominal pain, nausea, and diarrhea may commonly occur during the use of this medication, and these symptoms usually arise at the beginning of treatment and subside over time. Symptoms like dizziness, fatigue, and palpitations may also occur, so if these symptoms worsen, it is recommended to consult a doctor. Severe diarrhea may reduce the effectiveness of oral contraceptives, so it is advisable to use additional contraceptive methods. This medication generally has a low potential for interactions with other medications, but caution is warranted as its concentration in the blood may increase when taken with certain potent drugs. Use of this medication during pregnancy is not recommended, and women of reproductive age should use effective contraceptive methods while taking it. It is also not recommended for breastfeeding women to use this medication. It is better not to administer this medication to children or adolescents under 18 years of age. In cases of overdose, symptoms such as headache, nausea, or diarrhea may occur, and appropriate treatment should be obtained if necessary. This medication may cause dizziness and fatigue on the first day of administration, so caution is needed when driving or operating machinery. Lastly, this medication should be stored out of reach of children and in its original container, avoiding moisture.

Side effects and when to seek care immediately

Mild side effects

  • Headache
  • dizziness
  • tremors
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • indigestion
  • rectal bleeding
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  • bloating
  • abnormal bowel sounds
  • frequent urination
  • fatigue
  • fever
  • malaise

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. Additionally, avoid humid places and store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP*4]

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.