Medication info

Simlot T F Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
White to off-white, biconvex, rectangular tablet
Packaging
30 tablets/PTP[(10 tablets/PTP ×3)]
Approval status
Approval withdrawn

MFDS item code 202002852 · 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This product's status changed to Approval withdrawn on 2025.02.27.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
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, with a generally recommended starting dose of 10/20mg. For patients in whom the need for LDL cholesterol reduction is low, treatment can begin with 10/10mg daily. After initiation or dosage adjustment, blood lipid levels should be verified at intervals of more than 4 weeks.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

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

This medication is used to lower elevated total cholesterol, LDL cholesterol, Apo B protein, and triglycerides, while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. In patients with homozygous familial hypercholesterolemia, it may be used as an adjunct to other lipid-lowering treatments or alone when alternative therapies are not feasible. This medication is particularly recommended when diet or non-drug treatments do not adequately respond, and its effectiveness is maximized when used together with appropriate dietary regimens. It is important to identify and manage underlying secondary causes, such as diabetes or hypothyroidism, before treatment. Accurate measurement of lipid levels helps in formulating a treatment plan tailored to the patient's condition. In conclusion, this medication is effectively used to reduce the risk of hypercholesterolemia and associated cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, with a generally recommended starting dose of 10/20mg. For patients in whom the need for LDL cholesterol reduction is low, treatment can begin with 10/10mg daily. After initiation or dosage adjustment, blood lipid levels should be verified at intervals of more than 4 weeks.

Precautions

This medication can cause serious muscle-related side effects, such as myopathy and rhabdomyolysis. If you experience muscle pain or weakness, you should immediately inform your doctor, who can check for muscle damage through blood tests. The risk of muscle side effects increases, especially at high doses, so caution is needed. This medication should not be used in patients with severe liver disease, pregnant women, or nursing mothers. It should also not be taken by individuals with known hypersensitivity to this medication. The risk of muscle side effects may increase when used in combination with other specific medications, so you must inform your doctor or pharmacist of any other drugs you are taking. Elderly patients or those with muscle weakness should use this medication with extra caution and regular health check-ups are necessary. Due to potential impacts on liver function, it is recommended to undergo regular liver function tests. Women of childbearing potential should confirm their pregnancy status before taking this medication, and it should be discontinued during pregnancy. Nursing mothers should also stop breastfeeding if taking this medication, as it may affect the infant. While taking this medication, unexplained muscle pain, weakness, fatigue, or gastrointestinal symptoms may occur, so consult a healthcare professional immediately if any such symptoms arise. Lastly, it is important to regularly monitor liver function and muscle condition through blood tests during treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema, facial swelling), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, painful mucous membranes of the mouth/eyes, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS), shortness of breath or difficulty breathing, asthma attacks, respiratory issues such as cough and fever, yellowing of the skin or eyes (jaundice)

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • myalgia
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • dyspepsia
  • flatulence
  • paresthesia
  • dizziness
  • depression
  • cholelithiasis
  • cholecystitis
  • thrombocytopenia
  • vomiting
  • pancreatitis
  • rash
  • urticaria
  • pruritus
  • weakness
  • fever
  • chills
  • flushing
  • asthenia
  • respiratory issues (cough, sore throat)
  • alopecia
  • decreased libido
  • erectile dysfunction
  • cataract
  • anemia
  • elevated creatine phosphokinase

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It should be kept at room temperature between 1°C and 30°C, away from excessively hot or cold places.

Appearance and packaging

Appearance

White to off-white, 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.