Medication info

Unicalo Tablets 2 mg (Prucalopride Succinate)

Prescription medicationTablet경구Expired
Ingredient · strength
Prucalopride Succinate›2.642mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets/PTP [(14 tablets/PTP X 2)]
Approval status
Expired

MFDS item code 201901783 · Approved 2019.03.26

This product's status changed to Expired on 2024.03.26. 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 of the day regardless of meals. Adults should take 2 mg once daily. Patients aged 65 and older should take an initial dose of 1 mg once daily, which can be increased to 2 mg once daily if needed. Patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and severe hepatic impairment (Child-Pugh class C) should receive 1.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

This medication is used to treat chronic constipation symptoms in adults for whom laxative use has not improved symptoms.

How to take

Adult dose

This medication is taken orally and can be administered at any time of the day regardless of meals. Adults should take 2 mg once daily. Patients aged 65 and older should take an initial dose of 1 mg once daily, which can be increased to 2 mg once daily if needed. Patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and severe hepatic impairment (Child-Pugh class C) should receive 1.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients who have an allergic reaction to this medication or those with severely impaired kidney function, or serious intestinal problems. Additionally, it should not be used in patients with genetic issues such as lactose intolerance. For patients with severe kidney impairment or other significant conditions affecting the heart, liver, lungs, etc., dosage should be adjusted and patients should be monitored closely. Particular caution is required for patients with a history of heart disease. Taking this medication may frequently cause gastrointestinal symptoms such as headaches, abdominal pain, nausea, and diarrhea, which often occur initially and improve over time. Symptoms such as dizziness, fatigue, and palpitations may also occur, so if they are severe, consultation with a doctor is advised. In cases of severe diarrhea, the effectiveness of oral contraceptives may be reduced, so it is advisable to use additional contraceptive methods. The likelihood of drug interactions is low with this medicine, but caution is needed when used with specific medications. Especially when used with drugs that prolong the QTc interval, there is a risk of cardiac side effects, thus caution is advised. The use of this medication is not recommended during pregnancy, and women of childbearing age should utilize effective contraception while taking it. The use of this medication 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 cases of overdose, symptoms such as headaches, nausea, and diarrhea may appear, and treatment suitable for the symptoms should be received. Particularly, if there is significant fluid loss due to diarrhea or vomiting, electrolyte replenishment may be necessary. This medication can cause dizziness and fatigue on the first day of use, thus caution is needed when driving or operating machinery. When storing, keep it out of the reach of children and protect it from moisture by storing it in the original container.

Side effects and when to seek care immediately

Serious side effects

  • Chest discomfort
  • facial swelling
  • peripheral edema
  • swelling

Mild side effects

Headache, gastrointestinal symptoms (abdominal pain, nausea, diarrhea), dizziness, tremors, palpitations, vomiting, indigestion, rectal bleeding, bloating, abnormal bowel sounds, frequent urination, fatigue, fever, malaise, 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 symptoms.

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

Storage

This medication should be protected from light and moisture and stored at a cool room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/PTP [(14 tablets/PTP X 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.