CombiRoze Tablets 10/10 Milligrams

Adult dose

This medication is taken once daily without regard to meals. The dosage range is from 10/5 mg to 10/20 mg per day. The initial recommended dose is 10/5 mg once daily. For patients requiring greater reduction of LDL-cholesterol, the dose may be adjusted accordingly. After starting treatment or adjusting the dose, check blood lipid levels at intervals of more than 4 weeks and then adjust the dosage as needed, with a maximum of 10/20 mg per day.

This medication may affect the muscles, posing a risk of muscle pain or weakness, and in severe cases, rhabdomyolysis, which is the destruction of muscle tissue. It should be used with caution in patients with conditions that can cause muscle damage, such as serious infections, hypotension, major surgery, trauma, hypothyroidism, or decreased kidney function, and may need to be temporarily discontinued if necessary. Patients allergic to any of the ingredients, those with severely reduced liver function, muscle diseases, severe renal impairment, pregnant women, or breastfeeding women should not use this medication. Additionally, the risk of muscle damage may increase when combined with certain medications, so it is essential to consult a doctor or pharmacist if taking other medications. If symptoms such as muscle pain, cramps, weakness, fatigue, feverishness, etc., occur during treatment, notify healthcare personnel immediately, and if necessary, blood tests should be conducted to check for muscle damage. Since this medication can affect liver function, liver function tests should be performed before starting treatment, and if any abnormal symptoms occur during treatment, the tests should be repeated. This medication should not be taken during pregnancy or while breastfeeding as it may be harmful to the fetus or newborn, and women of childbearing age should use appropriate contraception during treatment. Elderly patients or those with decreased kidney function also require caution when using this medication, and dosage adjustments may be necessary based on symptoms or test results. Dizziness or headaches may occur during treatment, so care should be taken when driving or operating machinery. There is no specific antidote for overdose, so treatment based on symptoms and appropriate supportive therapy is necessary, and regular monitoring of liver function and muscle-related tests should be carried out. The safety and efficacy of this medication have not been established in children, so it is not recommended. This medication should be kept out of reach of children, and it is advisable not to transfer it to other containers.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, coma

Mild side effects

• Nasopharyngitis
• dyspepsia
• headache
• dizziness
• rash
• itching
• muscle pain
• fatigue
• weakness
• diarrhea

This medication should be stored in a tightly sealed container to protect it from air and moisture exposure. Additionally, it should be stored at room temperature between 1°C and 30°C, away from extreme heat or cold.

Appearance

Yellow rectangular film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP×3]