Medication info
Candelore 10/8 mg (Rosuvastatin, Candesartan)

Candelore 10/8 mg (Rosuvastatin, Candesartan)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletCandesartan Cilexetil›8mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202008719 · Approved 2020.12.11 · Insurance code 657808200

Summary

Main use
(Hypertension, Heart failure) treatment and (Hypercholesterolemia, Cardiovascular disease risk) improvement
Who takes it
Adults · Children
Adult dose
For adults, the initial and maintenance dose of Candesartan Cilexetil for essential hypertension is recommended to be taken orally once daily at 8–16 mg. If blood pressure control is insufficient, the dosage may be increased to a maximum of 32 mg once daily. For adults with heart failure, the initial dose is 4 mg once daily, and it may be doubled every two weeks up to a maximum of 32 mg based on tolerability. For Rosuvastatin, the initial dose is 5 mg once daily, while the maintenance dose is 10 mg. If necessary, the maximum daily dose may be increased.
Child dose
The safety and efficacy in pediatric patients and adolescents below the age of 18 have not been established.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

(Hypertension, Heart failure) treatment and (Hypercholesterolemia, Cardiovascular disease risk) improvement

  • Essential hypertension
  • left ventricular systolic dysfunction
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used for patients who need to take two drugs, Candesartan Cilexetil and Rosuvastatin, simultaneously. Candesartan Cilexetil is used for the treatment of essential hypertension and for patients with left ventricular dysfunction in heart failure, as an add-on therapy to ACE inhibitors or when tolerability is poor. Rosuvastatin helps control hypercholesterolemia and dyslipidemia in conjunction with diet, and delays the progression of atherosclerosis. Additionally, it reduces the risk of cardiovascular events and is used to decrease the risks of stroke, myocardial infarction, and vascular revascularization in high-risk populations with elevated high-sensitivity C-reactive protein levels. Therefore, this medication is effective for the treatment of patients requiring management of hypertension and cholesterol.

How to take

Adult dose

For adults, the initial and maintenance dose of Candesartan Cilexetil for essential hypertension is recommended to be taken orally once daily at 8–16 mg. If blood pressure control is insufficient, the dosage may be increased to a maximum of 32 mg once daily. For adults with heart failure, the initial dose is 4 mg once daily, and it may be doubled every two weeks up to a maximum of 32 mg based on tolerability. For Rosuvastatin, the initial dose is 5 mg once daily, while the maintenance dose is 10 mg. If necessary, the maximum daily dose may be increased.

Child dose

The safety and efficacy in pediatric patients and adolescents below the age of 18 have not been established.

Precautions

This medication can cause severe harm to the fetus if taken during pregnancy, particularly in the second and third trimesters. Therefore, if pregnancy is confirmed, it should be discontinued immediately. Patients who are allergic to any of the components of this medication or have active liver disease should not take it. Pregnant women or nursing mothers, as well as fertile women not using adequate contraception, should not take this medication. Patients with severely impaired liver function and those with muscle disorders should also refrain from taking this medication. Patients with very poor kidney function, those taking certain immunosuppressants, and patients with diabetes or severe renal impairment who are taking certain medications are also contraindicated against this drug. This medication carries a risk of muscle-related side effects, so if symptoms such as myalgia or weakness occur, one should consult a doctor immediately. Elderly patients, those with weak liver function, and those with hyperkalemia should use this medication with caution, and regular blood tests to monitor liver and kidney function and serum potassium levels are important. This medication may interact with other antihypertensives, diuretics, antibiotics, etc., so patients should inform healthcare providers of any other medications they are taking. Side effects such as headaches, dizziness, dyspepsia, and itching may occur during treatment, and if severe skin rash or breathing difficulties occur, the medication should be stopped immediately, and the patient should go to the hospital. This medication may cause dizziness while driving or operating machinery, so caution is advised. Safety and effectiveness in children have not been established, so it is not recommended for them. In case of overdose, symptoms such as hypotension, dizziness, and tachycardia may occur, and immediate treatment at a healthcare facility is required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest discomfort, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the lips or mucous membranes of the eyes, jaundice, liver dysfunction (including hepatitis, elevated ALT and AST), acute kidney failure, worsening kidney function (increased serum creatinine, oliguria), severe edema, severe allergic reactions, severe skin adverse reactions, respiratory problems (dyspnea, cough)

Mild side effects

  • Headache
  • dizziness
  • orthostatic dizziness
  • nasopharyngitis
  • millia
  • localized infection
  • periodontitis
  • fatigue
  • inflammation
  • foreign body sensation
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  • itching
  • generalized itching
  • skin dermatitis
  • musculoskeletal pain
  • joint stiffness
  • neck pain
  • limb pain
  • light sensitivity
  • cataract
  • dyspepsia
  • nausea
  • elevated blood sugar
  • decreased serum sodium
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • dental extraction
  • constipation
  • myalgia
  • asthenia
  • joint pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • thirst
  • sleep disturbance

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 and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will ensure the safety and efficacy of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 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.