Medication info

Simroctie A Tablet

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
White to pale yellow, biconvex, rectangular tablet.
Packaging
30 tablets/PTP[(10 tablets/PTP ×3)]
Approval status
Approval withdrawn

MFDS item code 202002851 · Approved 2020.04.22

This product's status changed to Approval withdrawn on 2025.02.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Lipid improvement for the reduction of risks of hypercholesterolemia (primary, mixed) and atherosclerotic vascular diseases.
Who takes it
Adults
Adult dose
This medication should be administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg daily, with the generally recommended initial dosage being 10/20mg daily. Patients who have a lower need for reducing LDL-cholesterol may start with 10/10mg daily. After dose adjustment, lipid levels should be checked at intervals of more than 4 weeks before adjusting the dosage.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Lipid improvement for the reduction of risks of hypercholesterolemia (primary, mixed) and atherosclerotic vascular diseases.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular diseases due to hypercholesterolemia.
View approved original text

This medication is used to lower total cholesterol, LDL-cholesterol, ApoB protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL-cholesterol levels. It is particularly administered as an adjunct to diet in patients with heterozygous familial and non-familial hypercholesterolemia. In patients with homozygous familial hypercholesterolemia, it may be used as an adjunct or alternative therapy to other lipid-lowering treatments. It should be used in conjunction with appropriate dietary adjustments, particularly in cases where diet alone is insufficient. Before treatment, other causes of dyslipidemia, such as diabetes and hypothyroidism, should be identified and treated if necessary. Thus, this drug is helpful in improving hypercholesterolemia and reducing the risk of atherosclerotic vascular diseases.

How to take

Adult dose

This medication should be administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg daily, with the generally recommended initial dosage being 10/20mg daily. Patients who have a lower need for reducing LDL-cholesterol may start with 10/10mg daily. After dose adjustment, lipid levels should be checked at intervals of more than 4 weeks before adjusting the dosage.

Precautions

This medication carries a risk of muscle-related abnormalities, so if muscle pain or weakness occurs, it should be reported to a doctor immediately. Particularly, the risk of myopathy or rhabdomyolysis may increase when taking high doses or in combination with certain medications, so caution is required. It should not be taken by individuals with an allergy to any component of this medication, severe liver dysfunction, or ongoing unexplained elevations in liver enzyme levels. Pregnant or breastfeeding women should not take this medication, and women of childbearing age must confirm pregnancy before use. The risk of side effects may increase when this medication is taken in combination with certain powerful drugs, so if you are currently taking any medications, you must inform your doctor or pharmacist. Elderly patients or those with reduced kidney function should also exercise special caution when taking this medication. This drug may affect liver function, so it is advisable to conduct liver function tests before and during treatment regularly. Additionally, if unexplained muscle pain or weakness persists during the use of this medication, consult your healthcare provider immediately. This medication may raise blood glucose levels, so patients at risk for diabetes should regularly check their blood glucose. When starting or stopping any new medication while using this drug, always consult with medical personnel, and in case of overdose, visit a hospital immediately for proper treatment. This medicine is not recommended for children and adolescents, especially those under 10 years of age, and must be used under the guidance of a specialist.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthmatic attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • epigastric pain
  • vomiting
  • chest pain
  • chest discomfort
  • numbness
  • cough
  • edema
  • thirst
  • facial swelling
  • fainting
  • insomnia
  • gastritis
  • atrophic gastritis
  • dyspepsia
  • mucus stools
  • irritable bowel syndrome
  • sore throat
  • itching
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract
  • dizziness
  • sensory disturbance
  • depression
  • gallstones
  • cholecystitis

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to pale yellow, biconvex, rectangular tablet.

Package unit

30 tablets/PTP[(10 tablets/PTP ×3)]

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.