Medication info

Procal Tablet 1mg (Prucalopride Succinate)

Prescription medicationTablet경구Expired
Ingredient · strength
Prucalopride Succinate›1.321mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
White round film-coated tablet
Packaging
28 tablets (7 tablets/PTP packaging (Alu-Alu) x 4)
Approval status
Expired

MFDS item code 201900771 · Approved 2019.01.31

This product's status changed to Expired on 2024.01.31. 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 regardless of meals. The adult dosage is 2 mg once daily. For patients aged 65 years and older, the initial dosage is 1 mg once daily, which may be increased to 2 mg if needed. For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), the dosage is 1 mg once daily, while mild to moderate renal impairment does not require dosage adjustment.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Improvement of chronic constipation symptoms

  • Symptoms of chronic constipation
View approved original text

This medication may be an effective treatment option for adult patients with chronic constipation who have not experienced symptom relief after using laxatives. It helps facilitate bowel movements, reducing discomfort caused by constipation and improving bowel function. This drug is used to alleviate chronic constipation symptoms to enhance the quality of life for patients.

How to take

Adult dose

This medication is administered orally and can be taken at any time of the day regardless of meals. The adult dosage is 2 mg once daily. For patients aged 65 years and older, the initial dosage is 1 mg once daily, which may be increased to 2 mg if needed. For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), the dosage is 1 mg once daily, while mild to moderate renal impairment does not require dosage adjustment.

Precautions

This medication should not be used in certain patients. Patients with allergies to the active ingredient or excipients, those with severely impaired kidney function, or those with serious structural abnormalities or inflammation of the gastrointestinal tract should not take this medication. Additionally, this medication contains lactose, so individuals with genetic issues that prevent lactose digestion should avoid it. Patients with severe impairment of kidney function should use this medication cautiously at a reduced dosage. Patients with serious diseases affecting major organs such as the liver, heart, lungs, or nervous system, or those with unstable conditions due to malignancies or HIV should also use caution. Patients with abnormal heart rhythms or a history of ischemic heart disease should be especially careful when using this medication. It is recommended to reduce the dosage for patients with severe liver dysfunction. There is a risk of side effects when this medication is taken with other drugs that can prolong the QT interval. The most common side effects experienced while taking this medication include headaches and gastrointestinal symptoms such as abdominal pain, nausea, and diarrhea. These symptoms typically occur early in treatment and may resolve within a few days. Other reported side effects include dizziness, tremors, palpitations, fatigue, flushing, and malaise, most of which are mild to moderate in severity. If new palpitations occur, consult a physician immediately. Pregnant women are advised not to use this medication, and women of childbearing age must use effective contraception while taking this medication. Breastfeeding women are also advised against taking this medication, as it may be excreted in breast milk. It is preferable not to administer this medication to children or adolescents under the age of 18. In the case of overdose, symptoms such as headache, nausea, and diarrhea may occur, and appropriate treatment should be administered as needed according to the symptoms. Caution is advised when driving or operating machinery during the initial use of this medication, as it may cause dizziness or fatigue. This medication should be stored out of reach of children and kept in its original container away from moisture. There is a low possibility of interaction with other medications; however, caution is needed when using it with certain drugs. Care should be taken when combined with medications that induce QTc prolongation, and the efficacy of this drug may be reduced when used with anticholinergic substances. No significant interactions with food have been reported.

Side effects and when to seek care immediately

Serious side effects

  • Chest discomfort
  • facial swelling
  • peripheral edema
  • edema

Mild side effects

Headache, gastrointestinal symptoms (abdominal pain, nausea, diarrhea), dizziness, tremors, palpitations, vomiting, dyspepsia, rectal bleeding, bloating, abnormal bowel sounds, increased frequency of urination, fatigue, fever, malaise, abdominal distension, discomfort in the abdomen, gastroesophageal reflux disease, rectal pain, hemorrhoids, functional gastrointestinal disorders, soft 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 sealed container that blocks light, and care should be taken to keep it away from moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

28 tablets (7 tablets/PTP packaging (Alu-Alu) x 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.