Medication info
Hanwha Rocan Tablet 10/8 Milligrams (Rosuvastatin Calcium, Candesartan Cilexetil)

Hanwha Rocan Tablet 10/8 Milligrams (Rosuvastatin Calcium, Candesartan Cilexetil)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 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 202301658 · Approved 2023.05.24 · Insurance code 651602910

Summary

Main use
(Hypertension, Heart Failure) Improvement and (Hypercholesterolemia, Cardiovascular Disease Risk) Suppression Effect
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil - Essential Hypertension: The recommended oral dose is 8 to 16 mg once daily. If blood pressure is not adequately controlled after 4 weeks of 16 mg dosing, the dose may be increased up to a maximum of 32 mg once daily. - Heart Failure: The initial dose is 4 mg once daily, and it may be doubled at intervals of more than 2 weeks, with a maximum dose of 32 mg once daily. Rosuvastatin - 5 mg once daily.
Child dose
The safety and efficacy of Candesartan Cilexetil and Rosuvastatin have not been established in pediatric patients (under 18 years of age).

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

(Hypertension, Heart Failure) Improvement and (Hypercholesterolemia, Cardiovascular Disease Risk) Suppression Effect

  • Essential hypertension
  • impaired left ventricular contractile 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 medication is used for patients who need to take both Candesartan Cilexetil and Rosuvastatin simultaneously. Candesartan Cilexetil is applicable in patients with essential hypertension or heart failure, particularly those with impaired left ventricular contractile function, and in cases where ACE inhibitor therapy is insufficient or poorly tolerated. Rosuvastatin is used for hypercholesterolemia, particularly for primary and familial hypercholesterolemia, as well as for mixed dyslipidemia, and serves as an adjunctive treatment when dietary control is difficult. Additionally, Rosuvastatin helps to slow the progression of atherosclerosis and reduce the risk of cardiovascular diseases. This medication is effective in managing both hypertension and dyslipidemia together to improve cardiovascular health.

How to take

Adult dose

Candesartan Cilexetil - Essential Hypertension: The recommended oral dose is 8 to 16 mg once daily. If blood pressure is not adequately controlled after 4 weeks of 16 mg dosing, the dose may be increased up to a maximum of 32 mg once daily. - Heart Failure: The initial dose is 4 mg once daily, and it may be doubled at intervals of more than 2 weeks, with a maximum dose of 32 mg once daily. Rosuvastatin - 5 mg once daily.

Child dose

The safety and efficacy of Candesartan Cilexetil and Rosuvastatin have not been established in pediatric patients (under 18 years of age).

Precautions

This medication may cause serious harm to the fetus when taken during pregnancy, particularly in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients with allergic reactions to this medication, severely impaired liver function, pregnant or nursing women, and those with muscle disorders should not take this medication. Elderly patients or those with mildly impaired liver function, elevated blood potassium levels, or existing cardiovascular disease should take this medication with caution, and regular blood tests and health checks are necessary. This medication may cause muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis; thus, if muscle pain or weakness occurs during use, a doctor should be consulted immediately. Liver function abnormalities may occur, so liver function tests should be conducted regularly before and during treatment, and the medication should be stopped if liver enzyme levels rise significantly. As this medication lowers blood pressure, symptoms of hypotension or dizziness may occur, necessitating caution while driving or operating machinery. Drug interactions may occur, so inform the doctor or pharmacist of any other medications currently being taken. This medication is not recommended for children as its safety and efficacy have not been established. In case of overdose, symptoms may include hypotension or dizziness; seek medical attention immediately for appropriate treatment. Store this medication out of reach of children and avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, facial swelling), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), generalized malaise, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis

Mild side effects

  • Headache
  • nasopharyngitis
  • fatigue
  • dermatitis
  • itching
  • musculoskeletal pain
  • cataract
  • photophobia
  • dyspepsia
  • nausea
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  • increased blood sugar
  • decreased blood sodium
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • tooth extraction
  • orthostatic dizziness
  • dizziness
  • orthostatic vertigo
  • weakness
  • arthralgia
  • paresthesia
  • thirst
  • sleep disturbances
  • decreased libido
  • forgetfulness
  • decreased appetite
  • increased appetite
  • tinnitus
  • dysgeusia
  • erectile dysfunction
  • constipation
  • abdominal pain
  • diarrhea
  • rash
  • generalized itching

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius (room temperature). This way, the effectiveness of the medication is well maintained and can be safely used.

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.