Medication info

Flucal Tablet 2 mg (Prucalopride Succinate)

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

MFDS item code 201902362 · Approved 2019.04.17

This product's status changed to Expired on 2024.04.17. 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 during the day, regardless of meals. Adults should take 2 mg once daily. Elderly patients aged 65 years and older should be prescribed an initial dose of 1 mg once daily, which can be increased to 2 mg once daily if necessary. Patients with severe renal impairment and severe hepatic impairment should take 1 mg once daily, while patients with mild to moderate renal impairment do not require dosage adjustment. 1 day 2m

Ingredients

Manufacturer
성원애드콕제약(주)

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

Used for the treatment of chronic constipation symptoms in adult patients for whom laxatives have not improved symptoms.

How to take

Adult dose

This medication is taken orally and can be administered at any time during the day, regardless of meals. Adults should take 2 mg once daily. Elderly patients aged 65 years and older should be prescribed an initial dose of 1 mg once daily, which can be increased to 2 mg once daily if necessary. Patients with severe renal impairment and severe hepatic impairment should take 1 mg once daily, while patients with mild to moderate renal impairment do not require dosage adjustment. 1 day 2m

Precautions

This medication should not be used in certain patients. Those allergic to the main ingredient or additives should not take this medication. Patients with severely impaired kidney function requiring dialysis should also avoid using this medication. Its use is contraindicated in cases of structural or functional problems in the intestines or severe inflammatory bowel disease. Additionally, this medication contains lactose, and is not to be used in patients with lactose intolerance or certain genetic metabolic disorders. Patients with severe renal impairment may find excretion of this medication difficult, which could lead to increased blood concentration; therefore, dosage should be reduced and used cautiously. Caution is also necessary in patients with severe coexisting conditions such as liver, cardiovascular, pulmonary, or neurological diseases, as the safety of this medication has not been thoroughly established. Particularly, patients with a history of arrhythmia or ischemic heart disease should use this medication carefully. In cases of severe liver dysfunction, dosage should be reduced and taken with care. This medication should be used cautiously in conjunction with other drugs that may prolong the QT interval. The most common side effects experienced during treatment with this medication include headache and gastrointestinal symptoms such as nausea, diarrhea, abdominal pain, etc. Most side effects are mild to moderate and typically appear early in treatment but often resolve over time. Rarely, manifestations like heart palpitations, dizziness, and fatigue may occur, and if severe symptoms arise, consultation with a physician is advised. This medication may cause severe diarrhea, which can reduce the effectiveness of oral contraceptives, thus it is recommended to use additional contraceptive methods. Interactions with other medications are generally not significant, but caution should be exercised when combined with certain potent drugs as blood levels may change. This is especially important for medications that also carry a risk of QT prolongation. Experience with the use of this medication during pregnancy is limited, and its use during pregnancy is not recommended. Women of childbearing age should utilize effective contraception methods while taking this medication. During breastfeeding, although some of this medication may be excreted into breast milk, the effects on the infant are undetermined, hence use is not recommended. It is advisable not to use this medication in children or adolescents under 18 years of age. In case of overdose, symptoms such as headache, nausea, and diarrhea may occur; there is no specific antidote, but appropriate treatment according to symptoms is necessary. If there is severe fluid loss due to overdose, electrolyte replenishment may be necessary. This medication can cause dizziness or fatigue on the first day of intake, so caution is advised when engaging in activities that require alertness such as driving or operating machinery. Store this medication out of reach of children and keep it in its original container away from moisture.

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, vomiting, indigestion, rectal bleeding, bloating, abnormal bowel sounds), dizziness, tremors, palpitations, increased urination, fatigue, fever, malaise, abdominal distension, 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 away from humid areas. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

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

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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.