Medication info

Genupharm Prucalopride Tablets 1 mg (Prucalopride Succinate)

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 202000368 · 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This product's status changed to Approval withdrawn on 2024.12.19.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 can be taken at any time of the day, irrespective of meals. Adults take 2 mg once daily. Seniors aged 65 and over may start with a dose of 1 mg once daily and may increase to 2 mg once daily if needed. In patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), the dosage is 1 mg once daily, and mild to moderate renal impairment does not require a dosage adjustment.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

This medication is used to treat constipation symptoms in adult patients with chronic constipation when conventional laxatives fail to alleviate symptoms.

How to take

Adult dose

This medication is administered orally and can be taken at any time of the day, irrespective of meals. Adults take 2 mg once daily. Seniors aged 65 and over may start with a dose of 1 mg once daily and may increase to 2 mg once daily if needed. In patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), the dosage is 1 mg once daily, and mild to moderate renal impairment does not require a dosage adjustment.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to the active ingredients or excipients should not take this medication. Additionally, patients with severe renal impairment or structural or functional issues in the intestines, as well as those with certain hereditary lactose intolerance disorders, should avoid using this medication. Patients with severe renal impairment should use this medication with caution and may require a reduced dose. Patients with other serious conditions, such as liver or heart diseases, should also take this medication carefully. Particularly, individuals with a history of heart disease should be especially cautious when using this medication. Patients with severely impaired liver function also require dosage adjustments. Caution is advised when taking this medication with other drugs that may cause certain cardiac arrhythmias. While taking this medication, gastrointestinal symptoms such as headache, abdominal pain, nausea, and diarrhea may occur, and most are mild and transient. However, if symptoms such as palpitations or fatigue arise, it is recommended to consult a healthcare professional. This medication is not recommended during pregnancy due to insufficient confirmed safety, and women of childbearing potential should use effective contraception while taking this medication. Breastfeeding women are also advised to avoid this medication. This drug is not recommended for children or adolescents under 18 years of age. In case of overdose, symptoms such as headache, nausea, and diarrhea may occur, and symptomatic treatment may be required. Severe fluid loss may necessitate electrolyte replenishment. This medication may cause dizziness or fatigue on the first day of administration, necessitating caution when driving or operating machinery. Finally, keep this medication out of reach of children and store it in its original container away from moisture.

Side effects and when to seek care immediately

Serious side effects

Chest discomfort

Mild side effects

  • Headache
  • dizziness
  • tremor
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • indigestion
  • rectal bleeding
Show 24 more
  • bloating
  • abnormal bowel sounds
  • frequent urination
  • fatigue
  • fever
  • lethargy
  • indigestion
  • abdominal distension
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional gastrointestinal disorders
  • loose stools
  • esophagitis
  • duodenal ulcers
  • nasopharyngitis
  • bronchitis
  • herpes zoster
  • athlete's foot
  • bacterial vaginosis
  • bacterial bronchitis
  • facial swelling
  • chest discomfort

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

Storage

This medication should be stored in a container that prevents light and air exposure, avoiding areas with high humidity. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White to off-white round film-coated tablets

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.