Medication info
Telmisartan, Rosuvastatin Calcium, Ezetimibe (Uncoated), Amlodipine Besylate Tablets 40/20/10/5 mg

Telmisartan, Rosuvastatin Calcium, Ezetimibe (Uncoated), Amlodipine Besylate Tablets 40/20/10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Telmisartan›40mg / 1 tabletRosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/box [6 tablets/PTP X 5]
Approval status
Active

MFDS item code 202203052 · Approved 2022.07.21 · Insurance code 645406180

Summary

Main use
Additional treatment for hypertension and dyslipidemia (cholesterol, etc.)
Who takes it
Adults
Adult dose
This medication is for adults only, and the dosage should be individualized based on each patient's needs. The recommended dosage is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning) if possible. The tablets should be swallowed whole and not chewed or divided. The recommended dose for the telmisartan/amlodipine combination is once daily. If blood pressure control is inadequate, further adjustments may be necessary.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Additional treatment for hypertension and dyslipidemia (cholesterol, etc.)

  • Essential hypertension
  • primary hypercholesterolemia
  • familial heterozygous hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication is used for patients who need to take a combination of telmisartan and amlodipine along with a combination of rosuvastatin and ezetimibe. It is primarily prescribed when both hypertension and dyslipidemia need to be treated together. Telmisartan and amlodipine are suitable for patients with essential hypertension who find it difficult to control blood pressure alone, and they help effectively manage blood pressure. Additionally, the combination of rosuvastatin and ezetimibe is used to improve cholesterol levels in patients with primary and mixed dyslipidemia. This medication lowers total cholesterol, LDL cholesterol, Apo B, and triglyceride levels while increasing HDL cholesterol levels, thereby aiding cardiovascular health. Therefore, this medication is used for patients requiring additional control of hypertension and dyslipidemia.

How to take

Adult dose

This medication is for adults only, and the dosage should be individualized based on each patient's needs. The recommended dosage is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning) if possible. The tablets should be swallowed whole and not chewed or divided. The recommended dose for the telmisartan/amlodipine combination is once daily. If blood pressure control is inadequate, further adjustments may be necessary.

Precautions

This medication may cause serious harm to the fetus, especially during the second and third trimesters of pregnancy, so women who are pregnant or may become pregnant should avoid taking it. Patients with muscle-related diseases or severe liver or kidney dysfunction should not use this medication, and it should not be administered to individuals with allergies to any component of the medication. Before taking this medication, liver and kidney function tests should be performed, and if abnormalities are found, a doctor should be consulted. Regular tests should also be conducted during treatment. If symptoms such as muscle pain, weakness, fatigue, or fever occur, a doctor should be notified immediately for examination, and in severe cases, discontinuation of the medication may be necessary. If blood pressure drops too low or symptoms such as dizziness or fainting occur, it is essential to consult a doctor immediately. Hyperkalemia (increased potassium levels in the blood) may occur, so potassium levels should be checked regularly, and caution is needed when using potassium supplements or medications containing potassium. There may be interactions with other medications, so if any other medications are currently being taken, healthcare professionals must be informed, especially with respect to lithium, digoxin, warfarin, and non-steroidal anti-inflammatory drugs. Caution is required during driving or operating machinery as dizziness or drowsiness may occur. This medication contains specific pigments and should not be administered to patients with lactose intolerance or certain genetic diseases. If sudden breathing difficulties or swelling of the face, lips, or tongue occur, the medication should be stopped immediately, and emergency treatment should be sought. Patients with heart failure or cardiovascular diseases should use this medication cautiously, especially if they have very low blood pressure or weak heart function. If any unusual symptoms arise during treatment, immediate consultation with a healthcare professional is essential for appropriate action.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in oral or eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, skin or eye yellowing (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual impairment,

Mild side effects

  • Headache
  • dizziness
  • cough
  • dyspepsia
  • abdominal pain
  • diarrhea
  • nausea
  • fatigue
  • weakness
  • muscle pain
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  • muscle cramps
  • joint pain
  • back pain
  • hair loss
  • rash
  • itching
  • sweating
  • hives
  • angioedema
  • flushing
  • facial swelling
  • urinary difficulty
  • urinary disorders
  • thrombocytopenia
  • anemia
  • insomnia
  • depression
  • paresthesia
  • palpitations
  • nasal congestion
  • ear discomfort
  • taste disturbances
  • erectile dysfunction
  • dry mouth
  • weight changes
  • hyperhidrosis
  • visual disturbances
  • conjunctivitis
  • ear

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/box [6 tablets/PTP X 5]

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.