Medication info
Hanwha Rocan Tablet 20/32 mg (Rosuvastatin Calcium, Candesartan Cilexetil)

Hanwha Rocan Tablet 20/32 mg (Rosuvastatin Calcium, Candesartan Cilexetil)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletCandesartan Cilexetil›32mg / 1 tablet
Manufacturer / importer
한화제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 202301656 · Approved 2023.05.24 · Insurance code 651602890

Summary

Main use
(Hypertension, heart failure) improvement and (hypercholesterolemia, cardiovascular disease risk) suppression
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil 1. Essential Hypertension - It is recommended to administer 8-16 mg orally once daily as both initial and maintenance doses. - If blood pressure control is insufficient after 4 weeks of treatment at 16 mg once daily, it can be increased to a maximum of 32 mg once daily. 2. Heart Failure - An initial dose of 4 mg once daily is recommended. - Dosage may be doubled at intervals of more than 2 weeks, with a maximum of 32 mg once daily.
Child dose
Candesartan Cilexetil - The safety and efficacy regarding adolescents and children under 18 years have not been established. Rosuvastatin - There are no specific dosing guidelines for children.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

(Hypertension, heart failure) improvement and (hypercholesterolemia, cardiovascular disease risk) suppression

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

This drug is used when two medications are needed simultaneously. Candesartan Cilexetil is used for the treatment of essential hypertension and in heart failure patients with impaired left ventricular systolic function who require additional therapy to ACE inhibitors or are intolerant to them. Rosuvastatin is used as an adjunct to dietary therapy in patients with hypercholesterolemia and mixed dyslipidemia, particularly reducing LDL cholesterol levels in patients with hypercholesterolemia, thus delaying the progression of atherosclerosis. It also helps reduce the risks of stroke, myocardial infarction, and arterial revascularization procedures in patients at high risk of cardiovascular disease. Therefore, this medication is used to manage hypertension, heart failure, and hyperlipidemia simultaneously to improve cardiovascular health.

How to take

Adult dose

Candesartan Cilexetil 1. Essential Hypertension - It is recommended to administer 8-16 mg orally once daily as both initial and maintenance doses. - If blood pressure control is insufficient after 4 weeks of treatment at 16 mg once daily, it can be increased to a maximum of 32 mg once daily. 2. Heart Failure - An initial dose of 4 mg once daily is recommended. - Dosage may be doubled at intervals of more than 2 weeks, with a maximum of 32 mg once daily.

Child dose

Candesartan Cilexetil - The safety and efficacy regarding adolescents and children under 18 years have not been established. Rosuvastatin - There are no specific dosing guidelines for children.

Precautions

This drug can cause serious harm to the fetus when taken during pregnancy, especially in the second and third trimesters, so it should be stopped immediately if pregnancy is confirmed. It should not be used in patients with hypersensitivity to the drug, severely impaired liver function, pregnant or nursing women, and patients with muscle disorders. Use of this drug is prohibited or requires caution in patients with severe kidney disease or those taking certain other medications. Close monitoring is necessary for the elderly, patients with weakened liver function, and patients with hyperkalemia when taking this medication, and regular liver function tests and muscle-related tests should be performed. This drug may cause muscle-related side effects such as muscle pain or weakness; if these symptoms occur, consult a healthcare professional immediately. Moreover, since this drug can affect liver function, it should be discontinued if liver enzyme test results exceed three times the normal upper limit. Interactions may occur when taken with other antihypertensive or cholesterol-lowering medications, so it is essential to inform healthcare providers about other medications being taken. This drug is not recommended for children, as its safety and efficacy in this population have not been established. Caution is advised as dizziness may occur while driving or operating machinery, and it should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction
  • Severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever
  • Yellowing of skin or eyes (jaundice), extreme lethargy, liver anomalies (jaundice)
  • Sudden and severe headache

Mild side effects

  • Headache
  • dizziness
  • rhinitis
  • sebaceous cyst
  • localized infection
  • periodontitis
  • fatigue
  • inflammation
  • foreign body sensation
  • dermatitis
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  • musculoskeletal pain
  • neck pain
  • limb pain
  • cataract
  • photophobia
  • dyspepsia
  • nausea
  • increased blood sugar
  • decreased serum sodium
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • tooth extraction
  • itching
  • generalized pruritus
  • arthralgia
  • asthenia
  • orthostatic dizziness
  • constipation
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps

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

Storage

This drug should be stored in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (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.