Medication info

Renolo 2 mg (Prucalopride Succinate)

Prescription medicationApproval withdrawn
Ingredient · strength
Prucalopride Succinate›Strength being verified
Manufacturer / importer
대화제약(주)
Appearance
Pink circular film-coated tablet
Packaging
28 tablets/blister [(14 tablets/Alu-Alu * 2)]
Approval status
Approval withdrawn

MFDS item code 201903036 · Approved 2019.05.10

This product's status changed to Approval withdrawn on 2023.06.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of chronic constipation symptoms
Who uses it
Adults
Adult dosage
This medication is administered orally and can be taken at any time during the day, regardless of meals. Adults take 2 mg once daily. Patients 65 years or older start with 1 mg once daily and may increase to 2 mg once daily if needed. Patients with severe renal impairment and severe hepatic impairment take 1 mg once daily. For patients with mild to moderate renal and hepatic impairment, dosage adjustment is not needed.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

If you are experiencing chronic constipation symptoms and have not found relief with current laxatives, this medication may help. It is primarily used to improve chronic constipation symptoms, alleviating discomfort and assisting in the restoration of normal bowel activities. This medication effectively manages constipation, making daily life more comfortable for patients. It helps to minimize the discomfort associated with constipation when used safely.

Dosage and Administration

Adult dosage

This medication is administered orally and can be taken at any time during the day, regardless of meals. Adults take 2 mg once daily. Patients 65 years or older start with 1 mg once daily and may increase to 2 mg once daily if needed. Patients with severe renal impairment and severe hepatic impairment take 1 mg once daily. For patients with mild to moderate renal and hepatic impairment, dosage adjustment is not needed.

Precautions

This medication should not be used by certain patients. Patients who are allergic to the main ingredient or excipients of this medication should not take it. Patients with severely impaired kidney function, especially those requiring dialysis, should not use this medication. It may be dangerous to administer this medication to patients with structural intestinal abnormalities such as intestinal perforation or obstruction, or severe bowel diseases such as Crohn's disease, ulcerative colitis, or toxic megacolon. This medication contains lactose, so patients with lactose intolerance or related genetic conditions should not take it. For patients with severely reduced kidney function, the dosage should be adjusted and administered cautiously. Patients with serious comorbidities such as liver, heart, lung, neurological, or mental disorders have not been sufficiently studied regarding the safety of this medication, hence caution is advised. Particularly, patients with a history of arrhythmias or ischemic heart disease should be cautious when using this medication. Patients with severe liver dysfunction are also recommended to have the dosage reduced. Caution is required when this medication is taken with other drugs that may prolong the QT interval. The most common side effects of this medication are headaches and gastrointestinal symptoms, including abdominal pain, nausea, and diarrhea. Most side effects are mild to moderate and often appear at the start of treatment but tend to resolve over time. Rarely, symptoms such as dizziness, tremors, palpitations, vomiting, indigestion, rectal bleeding, urinary frequency, and fatigue may occur. If palpitations develop anew, a consultation with a physician is necessary. Use of this medication during pregnancy is not recommended, and women of childbearing potential should use effective contraception while taking this medication. Though it is expected that the therapeutic dose does not significantly impact infants when secreted in breast milk, its use during breastfeeding is not recommended. It is advisable for adolescents and children under 18 years of age not to take this medication. In case of overdose, symptoms may include headache, nausea, and diarrhea, and since there is no specific antidote, appropriate treatment should be administered according to the symptoms. Electrolyte replacement may be necessary due to fluid loss from diarrhea or vomiting. This medication may cause dizziness or fatigue on the first day of treatment; therefore, caution is advised when engaging in activities that require alertness, such as driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Ventricular premature contractions, chest discomfort

Mild side effects

  • Headache
  • dizziness
  • tremors
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • indigestion
  • rectal bleeding
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  • bloating
  • abnormal bowel sounds
  • urinary frequency
  • fatigue
  • fever
  • malaise
  • indigestion
  • abdominal distension
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional dyspepsia
  • loose stools
  • esophagitis
  • duodenal ulcer
  • nasopharyngitis
  • bronchitis
  • shingles
  • 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 is sensitive to light, so it should be stored in a container that does not allow light in. Also, it is best to avoid humid places and store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink circular film-coated tablet

Package unit

28 tablets/blister [(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.