Medication info
Rotacan Tablets 5/8 Milligrams

Rotacan Tablets 5/8 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletCandesartan Cilexetil›8mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201702407 · Approved 2017.05.16 · Insurance code 643605430

Summary

Main use
(Hypertension, heart failure) improvement and (hyperlipidemia, cardiovascular disease risk) suppression
Who takes it
Adults · Children
Adult dose
Candesartan Cilexetil for essential hypertension: The recommended dose is 8 to 16 mg orally once daily. If blood pressure is not adequately controlled after 4 weeks of treatment at 16 mg once daily, the dose may be increased to a maximum of 32 mg once daily. Heart failure: The initial dose of 4 mg once daily is recommended, and the dose may be doubled at intervals of more than 2 weeks, with a maximum of 32 mg once daily possible. Rosuvastatin primary hyperlipidemia
Child dose
Candesartan Cilexetil for children (adolescents and children under 18 years): Safety and efficacy have not been established.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

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

  • Essential hypertension
  • heart failure
  • hyperlipidemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used for patients who need to take both Candesartan Cilexetil and Rosuvastatin simultaneously. Candesartan Cilexetil is mainly used for patients with essential hypertension and heart failure with reduced left ventricular function, and is administered as an add-on therapy when ACE inhibitors are not sufficient or not well tolerated. Rosuvastatin is used as an adjunct when dietary and exercise regimens are not sufficient for controlling hyperlipidemia, particularly in patients at high risk for cardiovascular disease, by lowering cholesterol levels and delaying atherosclerosis progression. It also helps to reduce risks associated with stroke, myocardial infarction, and vascular reconstruction. Therefore, this medication is used to treat patients with hypertension, heart failure, hyperlipidemia, and cardiovascular risk.

How to take

Adult dose

Candesartan Cilexetil for essential hypertension: The recommended dose is 8 to 16 mg orally once daily. If blood pressure is not adequately controlled after 4 weeks of treatment at 16 mg once daily, the dose may be increased to a maximum of 32 mg once daily. Heart failure: The initial dose of 4 mg once daily is recommended, and the dose may be doubled at intervals of more than 2 weeks, with a maximum of 32 mg once daily possible. Rosuvastatin primary hyperlipidemia

Child dose

Candesartan Cilexetil for children (adolescents and children under 18 years): Safety and efficacy have not been established.

Precautions

This medication may cause serious harm to the fetus or newborn if taken during pregnancy, so it should be stopped immediately if pregnancy is confirmed. It should not be used in individuals allergic to this medication or its components, those with severe liver dysfunction or active liver disease, pregnant or nursing women, and those with severe kidney impairment. Additionally, individuals with genetic conditions that prevent them from digesting lactose should not take this medication. Elderly individuals, those with high serum potassium levels, liver dysfunction, or cardiovascular diseases should exercise special caution when taking this medication. Patients who experience symptoms such as muscle pain or weakness should consult a doctor immediately, and it is advisable to have regular muscle-related examinations. This medication may affect liver function, so liver enzyme levels should be regularly monitored, and the medication should be discontinued if abnormalities are found. There may be interactions if this medication is taken with other drugs; therefore, it is essential to inform the doctor or pharmacist of any other medications being taken. Pregnant or nursing women should not take this medication, and women of childbearing potential should use appropriate contraceptive methods. Safety and efficacy for children have not been established, and it is not recommended for use in this population. Elderly patients are at risk of side effects from blood pressure reduction and should take caution when using this medication. In case of overdose, symptoms such as hypotension and dizziness may occur, and immediate consultation with healthcare professionals is necessary. During treatment with this medication, caution should be exercised while driving or operating machinery due to potential dizziness. Lastly, this medication should be stored out of the reach of children and kept in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema (swelling of the face, lips, tongue, throat, etc.), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in the oral/conjunctival mucosa, difficulty or shortness of breath, asthma attack, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, loss of consciousness

Mild side effects

  • Headache
  • dizziness
  • orthostatic dizziness
  • nasopharyngitis
  • miliary rash
  • local infection
  • periodontitis
  • fatigue
  • foreign body sensation
  • dermatitis
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  • itching
  • joint stiffness
  • limb pain
  • cataract
  • photophobia
  • dyspepsia
  • nausea
  • elevated blood glucose
  • reduced sodium in the blood
  • hand fractures
  • hypoglycemia
  • nephrolithiasis
  • cough
  • tooth extraction
  • constipation
  • abdominal pain
  • diarrhea
  • loss of appetite
  • abdominal distension
  • asthenia
  • arthralgia
  • muscle cramps
  • gout
  • erectile dysfunction
  • sensory disturbances
  • chest discomfort
  • syncope

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

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.