Medication info
Sitafilo Tablet 100/30mg (Sitagliptin Phosphate Hydrate, Pioglitazone Hydrochloride)

Sitafilo Tablet 100/30mg (Sitagliptin Phosphate Hydrate, Pioglitazone Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tabletPioglitazone Hydrochloride›33.06mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Light orange rectangular film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP x 2]
Approval status
Active

MFDS item code 202302297 · Approved 2023.07.31 · Insurance code 642005070

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medicine can be administered once daily as a single tablet for patients with type 2 diabetes receiving combined treatment with sitagliptin 100mg and pioglitazone 15mg or 30mg, regardless of meals.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medicine is used to help control blood sugar in patients with type 2 diabetes who are suitable for combined administration of sitagliptin and pioglitazone. When taken along with dietary and exercise therapy, it helps effectively manage blood sugar. Therefore, it is used to improve blood sugar control in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

This medicine can be administered once daily as a single tablet for patients with type 2 diabetes receiving combined treatment with sitagliptin 100mg and pioglitazone 15mg or 30mg, regardless of meals.

Precautions

This medicine consists of two components, sitagliptin and pioglitazone, and is used for the treatment of type 2 diabetes. Sitagliptin helps to control blood sugar but may rarely cause serious allergic reactions, skin disorders, or pancreatitis, so symptoms should be carefully monitored during the first three months of administration. Pioglitazone improves the action of insulin in the body but may pose risks for patients with heart failure; patients with symptoms of heart failure or a history of heart failure should not use this medicine. Additionally, it is safe not to administer this medicine to patients with impaired kidney function or severely compromised liver function. Women who are pregnant or may become pregnant, as well as patients with specific genetic lactose intolerance, should also avoid this medicine. During treatment, special attention should be paid to symptoms of hypoglycemia, and the risk of hypoglycemia may increase when used with other diabetes medications. If symptoms of heart failure such as swelling, difficulty breathing, or rapid weight gain occur while taking this medicine, you should immediately consult a healthcare professional. If symptoms indicating liver dysfunction (fatigue, loss of appetite, jaundice, etc.) occur, you should immediately visit a hospital for examination, and discontinuation may be necessary based on liver function test results. This medicine should not be administered to patients with a history of bladder cancer or active bladder cancer; if symptoms of bladder cancer (such as hematuria) occur, you should immediately inform your doctor. It is important to regularly monitor blood sugar, liver function, and kidney function while taking this medicine, and to report any abnormal symptoms to healthcare professionals immediately. Also, this medicine may interact with other medications, so you should inform your doctor or pharmacist about any other medications you are taking.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, Stevens-Johnson syndrome, skin disorders, fatal and non-fatal hemorrhagic or necrotizing pancreatitis, acute pancreatitis, congestive heart failure, symptoms and signs of heart failure (excessive and rapid weight change, shortness of breath, swelling), acute renal failure, severe and disabling arthralgia, bullous pemphigoid, rhabdomyolysis, pneumonia, diabetes complications, metabolic acidosis, falls, heart

Mild side effects

  • Hypoglycemia
  • upper respiratory tract infection
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • thrombocytopenia
  • indigestion
  • dizziness
  • weight gain
  • urinary tract infection
  • lower back pain
  • itching
  • chest pain
  • fatigue
  • weakness
  • cough
  • increased triglycerides in the blood
  • gastritis
  • loss of appetite
  • tremors
  • chills
  • muscle stiffness
  • discomfort in the head
  • increased liver enzymes
  • joint pain
  • knee abnormalities
  • weakness in arms
  • proteinuria
  • increased creatinine in the blood

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

Storage

This medicine should be stored in a container that does not allow light and air to enter and should be kept away from humid places. It is important to maintain a storage temperature between 15 and 30 degrees.

Appearance and packaging

Appearance

Light orange rectangular film-coated tablets

Package unit

28 tablets/box [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.