Medication info
Hanwha Rocan Tablet 5/8mg (Rosuvastatin Calcium, Candesartan Cilexetil)

Hanwha Rocan Tablet 5/8mg (Rosuvastatin Calcium, Candesartan Cilexetil)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletCandesartan Cilexetil›8mg / 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 202301659 · Approved 2023.05.24 · Insurance code 651602920

Summary

Main use
(Hypertension, heart failure) improvement and (hypercholesterolemia, cardiovascular disease risk) inhibition effect
Who takes it
Adults · Children
Adult dose
For essential hypertension with candesartan cilexetil, the recommended starting and maintenance dose is 8 to 16 mg once daily. If after 4 weeks at 16 mg once daily blood pressure is still not adequately controlled, the dose can be increased up to 32 mg once daily. For heart failure, the initial dose of 4 mg once daily is recommended, and the dose can be doubled at intervals of more than 2 weeks according to patient tolerability, up to a maximum of once daily.
Child dose
The safety and efficacy for adolescents and children under 18 years old have not been established.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

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

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

This medication is only used for patients who need to take candesartan cilexetil and rosuvastatin simultaneously. Candesartan cilexetil is mainly used for patients with essential hypertension and heart failure who either require additional treatment with ACE inhibitors or have decreased tolerability. Rosuvastatin is used as an adjunct in patients with hypercholesterolemia and combined hyperlipidemia when dietary therapy and exercise are insufficient, and it is also helpful for homozygous familial hypercholesterolemia. Additionally, rosuvastatin lowers cholesterol levels, slows the progression of atherosclerosis, and reduces the risk of cardiovascular disease, thereby decreasing the risk of stroke, myocardial infarction, and vascular revascularization. Therefore, this medication is effectively used in the management of hypertension and cardiovascular disease risks.

How to take

Adult dose

For essential hypertension with candesartan cilexetil, the recommended starting and maintenance dose is 8 to 16 mg once daily. If after 4 weeks at 16 mg once daily blood pressure is still not adequately controlled, the dose can be increased up to 32 mg once daily. For heart failure, the initial dose of 4 mg once daily is recommended, and the dose can be doubled at intervals of more than 2 weeks according to patient tolerability, up to a maximum of once daily.

Child dose

The safety and efficacy for adolescents and children under 18 years old have not been established.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Patients with an allergic reaction to this medication or with liver function issues, pregnant or breastfeeding women, and those with severe kidney or liver impairment should not take this medication. Patients at high risk for muscle disease or muscle damage should also avoid using this medication, especially when taking high doses. Elderly patients or those with hyperkalemia, weakened liver function, and cardiac or kidney diseases require careful monitoring and regular testing when taking this medication. If symptoms such as muscle pain, muscle weakness, or muscle cramps occur during treatment, consult a physician immediately and, if necessary, check the condition through muscle enzyme tests. Liver function tests should also be performed regularly, and if liver enzyme levels significantly increase, the medication should be discontinued. This medication may interact with other blood pressure medications or specific medications, so if you are taking other medications, it is essential to inform your healthcare provider. Women planning to become pregnant should consult their healthcare provider before taking this medication and use appropriate contraception methods. This medication is not recommended for children as safety and efficacy have not been established. Caution is needed while driving or operating machinery, as dizziness or fatigue may occur. In cases of overdose, appropriate treatment is needed based on symptoms, especially if symptoms like hypotension or dizziness occur, medical help should be sought immediately. Keep this medication out of the reach of children, store it in its original container to prevent misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, choking or difficulty breathing, asthma attacks, respiratory symptoms accompanied by cough + fever, jaundice, severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Headache
  • dizziness
  • nasopharyngitis
  • millia
  • local infection
  • periodontitis
  • fatigue
  • inflammation
  • foreign body sensation
  • itching
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  • arthralgia
  • limb pain
  • photophobia
  • dyspepsia
  • nausea
  • increased blood sugar
  • decreased blood sodium
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • tooth extraction
  • cataract
  • musculoskeletal pain
  • neck pain
  • myalgia
  • constipation
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • lethargy
  • joint pain
  • numbness
  • paresthesia
  • chest discomfort
  • syncope
  • generalized pain

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a temperature between 1 and 30 degrees Celsius during storage.

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.