Humetov 10/10 mg Tablets

Adult dosage

This medicine is administered once daily, irrespective of meals. For primary hypercholesterolemia, it is administered in a dosage range of 10/10 mg to 10/80 mg daily, with a recommended initial dose of 10/10 mg or 10/20 mg daily. For patients requiring greater reduction of LDL cholesterol (more than 55%), an initial dose of 10/40 mg daily is recommended. Blood lipid levels should be checked at intervals of more than 2 weeks after administration.

This medicine has been reported to cause a rare side effect called rhabdomyolysis, which involves muscle abnormalities; therefore, if there is severe muscle pain or weakness, the doctor should be notified immediately. Before taking this medicine, liver function tests should be conducted, and patients with poor liver function or liver disease should not take this medicine. Patients with muscle diseases or at high risk for myopathy, such as those with impaired kidney function or hypothyroidism, should take this medicine cautiously. This medicine should not be used by women who are pregnant, may become pregnant, or are breastfeeding, and women of childbearing age should use appropriate contraception during treatment. The risk of side effects from this medicine may increase when taken with certain antibiotics, antifungals, and antivirals, so a discussion with a doctor or pharmacist is necessary when there are additional medications. This medicine can rarely cause symptoms of liver damage, hepatitis, and jaundice; if symptoms such as nausea, vomiting, fatigue, or jaundice of the skin or eyes occur, the use should be stopped, and medical personnel should be contacted immediately. Additionally, this medicine may increase blood glucose levels; therefore, diabetic patients need to manage their blood glucose levels carefully, and it is important to conduct regular checks of liver function and muscle condition during treatment. Symptoms such as dizziness, muscle pain, abdominal pain, and indigestion may occur, and if these symptoms persist or worsen, consultation with medical personnel is necessary. It is not recommended for children as safety and efficacy have not been established, and caution is required for elderly patients as they are at risk for myopathy. In cases of overdose, there is no specific antidote, so immediate medical attention should be sought, and this medicine should be kept out of reach of children.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever, skin or eyes turning yellow (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

• Muscle pain
• abdominal pain
• dizziness
• cough
• nausea
• diarrhea
• joint pain
• muscle weakness
• musculoskeletal pain
• fatigue

This medicine should be stored in a tightly sealed container to prevent air or moisture from entering. The appropriate storage temperature is room temperature between 1°C and 30°C, and it is advisable to avoid excessively hot or cold places.

Appearance

White rectangular film-coated tablet

Package unit

PTP packaging - 30 tablets/box [(10 tablets/PTP packaging (Alu-Alu) × 3)], bottle packaging - 30 tablets/bottle, bottle packaging - 100 tablets/bottle