Medication info
Hanwha Rokkan Tablets 5/16mg (Rosuvastatin Calcium, Candesartan Cilexetil)

Hanwha Rokkan Tablets 5/16mg (Rosuvastatin Calcium, Candesartan Cilexetil)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletCandesartan Cilexetil›16mg / 1 tablet
Manufacturer / importer
한화제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 202301660 · Approved 2023.05.24 · Insurance code 651602930

Summary

Main use
Treatment of hypertension and heart failure, improvement of hypercholesterolemia, reduction of the risk of cardiovascular disease
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil 1. Essential Hypertension - The initial and maintenance dose is recommended to be 8 to 16 mg orally once a day. - If blood pressure control is insufficient after 4 weeks of 16 mg administration, the dose may be increased up to 32 mg once a day. - Maximum effect occurs within 4 weeks after treatment initiation. 2. Heart Failure - The initial dose is recommended to be 4 mg once a day. - The dose may be doubled at intervals of more than 2 weeks. - Maximum is 32 mg once a day.
Child dose
Candesartan Cilexetil - Safety and efficacy in individuals under 18 years of age have not been established. Rosuvastatin - No specified pediatric dosage.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Treatment of hypertension and heart failure, improvement of hypercholesterolemia, reduction of the risk of cardiovascular disease

  • Essential hypertension
  • heart failure
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hyperlipidemia
  • primary dysbetalipoproteinemia
  • elevated 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 both Candesartan Cilexetil and Rosuvastatin. Candesartan Cilexetil is primarily used for the treatment of essential hypertension, and it helps patients with heart failure with decreased left ventricular function, either in combination with ACE inhibitors or for those who cannot take ACE inhibitors. Rosuvastatin is used as an adjunctive treatment to lower cholesterol levels in patients with hypercholesterolemia and mixed dyslipidemia when dietary measures are insufficient. It also helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in patients at high risk of cardiovascular disease. This medication is used to manage hypertension, hyperlipidemia, and the risk of cardiovascular disease together, improving the patient's overall health status.

How to take

Adult dose

Candesartan Cilexetil 1. Essential Hypertension - The initial and maintenance dose is recommended to be 8 to 16 mg orally once a day. - If blood pressure control is insufficient after 4 weeks of 16 mg administration, the dose may be increased up to 32 mg once a day. - Maximum effect occurs within 4 weeks after treatment initiation. 2. Heart Failure - The initial dose is recommended to be 4 mg once a day. - The dose may be doubled at intervals of more than 2 weeks. - Maximum is 32 mg once a day.

Child dose

Candesartan Cilexetil - Safety and efficacy in individuals under 18 years of age have not been established. Rosuvastatin - No specified pediatric dosage.

Precautions

This medication may cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so discontinuation is necessary as soon as pregnancy is confirmed. It is safe not to administer this medication to patients with poor liver function, severe kidney impairment, or muscular disorders. Elderly patients, patients with hyperkalemia, and those with mild to moderate liver impairment should be carefully monitored during administration, and regular assessments of liver and kidney function are necessary. If symptoms such as muscle pain or muscle weakness occur, inform a doctor immediately, and if necessary, test muscle enzyme levels and discontinue use if abnormalities are found. This medication may interact with other antihypertensive drugs or certain lipid-lowering agents, so inform healthcare providers of any other medications being taken. Women of childbearing potential should use appropriate contraception, and breastfeeding women are advised to avoid this medication; if use is unavoidable, breastfeeding should be stopped. Caution is needed when driving or operating machinery, as dizziness or fatigue may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and faintness

Mild side effects

Headache, dizziness, nasopharyngitis, wheals, local infection, periodontitis, chest discomfort, fatigue, inflammation, foreign body sensation, itching, dermatitis, musculoskeletal pain, neck pain, limb pain, cataract, glare, dyspepsia, nausea, elevated blood glucose, decreased serum sodium, hand fracture, hypoglycemia, nephrolithiasis, cough, tooth extraction, orthostatic dizziness, joint stiffness, generalized pruritus, elevated blood pressure, decreased plasma volume during hemodialysis, ischemic heart disease, and ischemia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1°C and 30°C. This will help maintain the drug's efficacy and safety for a longer time.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.