Medication info

Silophil Tablet (Polycarbophil Calcium)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Calcium Polycarbophil›625mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001663 · Approved 2020.03.11

This product's status changed to Approval withdrawn on 2024.12.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms of chronic constipation and nonspecific diarrhea (including irritable bowel syndrome)
Who takes it
Adults · Children
Adult dose
This medication should be taken orally with at least 250 mL of water or liquid. Adults should take 1,250 mg of polycarbophil calcium once, orally 1 to 4 times a day. The recommended initial adult dosage is 1,250 to 2,500 mg per day, and it can be increased up to 5,000 mg per day. It should not be taken right before sleep and at least 1 hour should be allowed for digestion before going to bed.
Child dose
For children (6 to 12 years old), take 625 mg of polycarbophil calcium once, 1 to 3 times a day orally. Consult a doctor for children under 6 years old.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Relief of symptoms of chronic constipation and nonspecific diarrhea (including irritable bowel syndrome)

  • Chronic constipation
  • nonspecific diarrhea
  • constipation and diarrhea in irritable bowel syndrome
View approved original text

This medication is used to treat symptoms of constipation and diarrhea arising from chronic constipation, nonspecific diarrhea, and irritable bowel syndrome as an adjunctive treatment.

How to take

Adult dose

This medication should be taken orally with at least 250 mL of water or liquid. Adults should take 1,250 mg of polycarbophil calcium once, orally 1 to 4 times a day. The recommended initial adult dosage is 1,250 to 2,500 mg per day, and it can be increased up to 5,000 mg per day. It should not be taken right before sleep and at least 1 hour should be allowed for digestion before going to bed.

Child dose

For children (6 to 12 years old), take 625 mg of polycarbophil calcium once, 1 to 3 times a day orally. Consult a doctor for children under 6 years old.

Precautions

This drug should not be used in certain patients. Firstly, it should not be administered to patients who have an allergy to this drug or its ingredients. Patients with unexplained rectal bleeding may also be at risk if taking this drug. It is not suitable for patients with severe dehydration. Patients who have difficulty swallowing food due to conditions such as hernias or diaphragm issues should not take this drug. This medication may be hazardous to patients who need to lie down or are at risk of reflux. Patients with issues related to bowel or defecation functions should also avoid this medication. Patients with acute abdominal conditions such as appendicitis or gastrointestinal bleeding should be cautious as symptoms may worsen. Patients with bowel obstruction or bowel strictures may also experience worsening symptoms while taking this drug. For patients with hypercalcemia, this medication may worsen their condition. Patients with kidney stones may find this drug exacerbates their stones. It is advisable to avoid use in patients with severe renal failure. Patients experiencing severe abdominal pain, nausea, or vomiting should also refrain from using this medication. Additionally, it should be administered with caution to certain patients. Patients who need to limit calcium intake should be careful due to the risk of hypercalcemia. Those taking active vitamin D preparations should be monitored as they may develop hypercalcemia. Patients taking cardiac glycosides may experience enhanced effects of the drug, leading to side effects. Patients with low gastric acidity or a history of gastrectomy may experience reduced effects of this drug. For renal failure patients undergoing dialysis or mild cases, there may be risks of calcium deposition in tissues, hence caution is required. While taking this drug, allergic reactions such as skin rash or itching may occur, and if such symptoms arise, administration should be stopped immediately. Blood cell counts may decrease and gastrointestinal symptoms such as nausea, vomiting, dry mouth, abdominal bloating, diarrhea, constipation, and abdominal pain may occur. Liver function tests may also show elevated levels. Symptoms of hypercalcemia, edema, headache, and blood or protein in urine have also been reported. This drug should be taken with ample water, as taking it without water can lead to obstruction or swelling of the throat or esophagus, which is dangerous. If chest pain, vomiting, difficulty swallowing, or breathing difficulties occur after taking this drug, consult a physician or pharmacist immediately. This medication is for symptomatic relief; if symptoms do not improve after more than 7 days, discontinue use and consult a professional. If taken for more than 3 months, regular monitoring of status is advised, and if any abnormalities occur, discontinue use. This drug may interfere with the absorption of other medications, so it is recommended to take other medications at least 2 hours apart. In particular, when taken with tetracycline antibiotics or quinolone antimicrobials, the calcium in this medication may reduce drug absorption. Caution should be exercised when using it with active vitamin D preparations due to increased risk of hypercalcemia. Taking it with calcium supplements may lead to excessive calcium and possible hypercalcemia, which may diminish the drug’s effectiveness. There is a heightened risk of side effects such as arrhythmias when used in conjunction with cardiac glycosides. Using it with acid secretion inhibitors or antacids may reduce its effectiveness. Pregnant women or those who may become pregnant should only use this drug when the benefits outweigh the risks, as safety is still not fully established. Safety in pediatric patients has not been sufficiently confirmed. Elderly individuals should adjust dosages carefully due to increased risk of renal impairment and hypercalcemia.

Side effects and when to seek care immediately

Serious side effects

  • Chest pain
  • difficulty breathing
  • severe abdominal pain
  • severe nausea
  • severe vomiting

Mild side effects

  • Rash
  • itching
  • leukopenia
  • nausea
  • vomiting
  • dry mouth
  • abdominal bloating
  • diarrhea
  • constipation
  • abdominal pain
Show 14 more
  • abdominal distension
  • AST elevation
  • ALT elevation
  • LDH elevation
  • γ-GTP elevation
  • ALP elevation
  • elevated total bilirubin
  • bowel obstruction
  • fecal impaction
  • hypercalcemia
  • edema
  • headache
  • hematuria
  • proteinuria

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

Storage

This drug should be stored in a tightly sealed container to prevent air from entering, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle

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.