Robaduet Tablet 10/5 mg

Adult dose

This medication is taken once daily, regardless of meals. The dosage range is 10/5 mg to 10/20 mg per day. The initial recommended dose is 10/5 mg per day. For patients requiring a greater reduction in LDL cholesterol, the dosage can be adjusted. Lipid levels should be checked 4 weeks or more after initiation of treatment or dosage adjustment to adjust the dosage, with a maximum daily dosage of 10/20 mg.

This medication may rarely cause side effects affecting the muscles, such as muscle pain or weakness, and in severe cases, it could lead to serious muscle damage known as rhabdomyolysis, which might affect kidney function. Therefore, patients with severe muscle symptoms or at high risk of kidney problems should temporarily discontinue or cease the use of this medication. This medication should not be used by individuals allergic to the active ingredient or its components, those with severe liver dysfunction, individuals with muscle diseases, those with very low kidney function, pregnant women or women of childbearing potential, and nursing mothers. Particularly, patients with severe kidney impairment, hypothyroidism, a family history of muscle disease, those who have experienced muscle toxicity from similar medications in the past, individuals with excessive alcohol consumption, Asians, and those taking fibrate medications should be prohibited from taking this medication in high doses. This medication contains lactose and should not be taken by patients with lactose intolerance or certain genetic lactose metabolism disorders. Patients with a history of alcohol abuse or liver disease, those with moderate to severe liver dysfunction, those at high risk of developing myopathy, elderly individuals, those taking fibrate medications, and patients with severe muscle weakness should exercise caution when using this medication and consult a physician immediately if muscle pain or adverse drug effects occur during treatment. While taking this medication, liver function tests and muscle enzyme levels should be monitored regularly, and any symptoms should be reported to healthcare professionals immediately. Pregnant or nursing women should not use this medication due to potential risks to the fetus or baby, and women of childbearing age should employ proper contraception. Safety in children and adolescents has not been adequately established; therefore, it is not recommended. This medication may interact with other drugs, so patients taking anticoagulants, fibrate medications, certain antibiotics, antifungals, or immunosuppressants should inform their physician. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms, along with monitoring liver and muscle function.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever accompanied by severe rash, blisters, peeling skin, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, respiratory issues, yellowing of the skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

• Nasopharyngitis
• dyspepsia
• itching
• headache
• dizziness
• constipation
• nausea
• abdominal pain
• dry mouth
• increased blood sugar

Store this medication in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Pink, rectangular film-coated tablet

Package unit

30 tablets/PTP [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle