Medication info

Renolo Tablet 1mg (Prucalopride Succinate)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201903035 · 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This product's status changed to Approval withdrawn on 2023.06.08.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
Treatment of chronic constipation symptoms
Who uses it
Adults
Adult dosage
This medication is taken orally and can be taken at any time of the day regardless of meals. Adults take 2mg once daily. For elderly patients over 65 years old, the initial dose is 1mg once daily, which may be increased to 2mg once daily if necessary. For patients with renal impairment, severe cases should use 1mg once daily, while mild to moderate cases do not require dose adjustment. For patients with liver impairment, severe cases (Child-Pugh class C) should take 1mg once daily.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Treatment of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

This medication is used to effectively treat chronic constipation symptoms in adult patients for whom symptom relief is difficult with laxative therapy.

Dosage and Administration

Adult dosage

This medication is taken orally and can be taken at any time of the day regardless of meals. Adults take 2mg once daily. For elderly patients over 65 years old, the initial dose is 1mg once daily, which may be increased to 2mg once daily if necessary. For patients with renal impairment, severe cases should use 1mg once daily, while mild to moderate cases do not require dose adjustment. For patients with liver impairment, severe cases (Child-Pugh class C) should take 1mg once daily.

Precautions

This medicine should not be used in certain patients. For example, those who are allergic to any ingredients or excipients in this medicine should not take it. Also, patients with severely impaired kidney function or gastrointestinal issues should not use this medicine. Individuals with genetic issues such as lactose intolerance may also be at risk when taking this medication. Patients with severe renal impairment should take this medicine cautiously with a reduced dosage. Patients with serious conditions affecting the heart, liver, lungs, or nervous system should also be careful when using this medicine. Those with a history of arrhythmias or cardiovascular disease should exercise particular caution. This medicine may cause gastrointestinal symptoms such as headache, abdominal pain, nausea, and diarrhea, which typically appear shortly after starting the medication and improve over time. Dizziness, fatigue, and palpitations may also occur, and should be discussed with a doctor if they arise. Severe diarrhea may reduce the effectiveness of oral contraceptives, so it is advisable to use additional contraceptive methods. This medicine has a low potential for interactions with other medications. However, caution is required when used concurrently with specific antifungal agents or cardiac medications. Additionally, the effectiveness of this medicine may be diminished if taken with medications like atropine. Use of this medicine during pregnancy is not recommended, and women of childbearing age should employ effective contraception while taking it. Nursing mothers are also advised to avoid this medication. It is recommended not to use this medicine in children or adolescents under 18 years of age. In case of overdose, symptoms may include headache, nausea, and diarrhea; in such cases, symptom-specific treatment should be provided. Proper replenishment may be necessary if dehydration or electrolyte imbalances occur due to overdose. This medicine 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 in a dry place.

Side effects and when to seek care immediately

Serious side effects

  • Chest discomfort
  • facial swelling
  • peripheral edema
  • edema
  • ventricular extrasystoles

Mild side effects

  • Headache
  • dizziness
  • tremors
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • dyspepsia
  • rectal bleeding
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  • flatulence
  • abnormal bowel sounds
  • increased urination
  • fatigue
  • fever
  • malaise
  • indigestion
  • abdominal bloating
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional dyspepsia
  • 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 protects it from light and air, and kept in a cool, dry place at room temperature between 1°C and 30°C. This helps maintain its efficacy and prevent deterioration.

Appearance and packaging

Appearance

White to off-white round 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.