Olmesartan Medoxomil/Amlodipine Besylate/Hydrochlorothiazide 5/40/12.5 mg

Adult dose

This medication is taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20/12.5 mg: administered to patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil combination therapy of 5/20 mg. - 5/40/12.5 mg: administered to patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil combination therapy of 5/40 mg.

Child dose

Safety and efficacy in pediatric patients under 18 years have not been established, and use of this medication is not recommended.

This medication can cause serious harm to the fetus and newborn during the second and third trimesters of pregnancy, so it should be discontinued immediately once pregnancy is confirmed. Patients with allergies to any components of this medication or similar drugs, those who are pregnant or breastfeeding, those with severe hypotension, valvular heart disease, acute heart failure, or serious kidney or liver disorders should not take this medication. Patients with decreased blood volume or electrolyte imbalances may experience hypotension; thus, it is important to assess their condition carefully before administration and to monitor them closely. This drug may affect kidney function, so patients with impaired kidney function should have regular blood tests. It is not recommended for kidney transplant patients or those with severe kidney disorders. Patients with impaired liver function or liver disease require dosage adjustments, and it is advisable not to use this drug in patients with severe liver disease. Patients with valvular heart disease or certain myocardial conditions should exercise caution while taking this medication. The diuretic component of this drug can cause electrolyte imbalances; thus, regular monitoring of sodium, potassium, and other levels in the blood is necessary. Symptoms may include dry mouth, muscle cramps, dizziness, and others. Since this medication has blood-pressure-lowering effects, dizziness or lightheadedness may occur during use, so caution should be exercised when performing hazardous tasks such as operating machinery or driving. Photosensitivity reactions may occur; therefore, excessive exposure to sunlight or ultraviolet light should be avoided. If skin rashes or itching develop, consult a physician. Interactions may occur when this medication is used in conjunction with other antihypertensives or certain medications, so inform your doctor or pharmacist of any drugs you are taking. In cases of overdose, severe hypotension, palpitations, or dizziness may occur, requiring immediate medical attention, and fluid replacement and hypertension treatment may be necessary. Safety and efficacy have not been established for children, so use in this population is not recommended. For elderly patients, starting at a lower dose considering impaired kidney and liver function is advisable.

Serious side effects

• Urticaria, angioedema, Quincke's edema → severe allergic reactions
• Severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa → severe dermatological adverse reactions
• Difficulty breathing, acute respiratory distress syndrome (ARDS), pulmonary edema → respiratory problems
• Jaundice (cholestatic jaundice) → liver abnormalities (jaundice)
• Myocardial infarction, seizures, convulsions, altered consciousness, syncope, pre-syncope, headache → severe neurological symptoms
• Edema (peripheral

Mild side effects

• Peripheral edema
• headache
• dizziness
• upper respiratory tract infection
• nasopharyngitis
• urinary tract infection
• sialadenitis
• leukopenia
• thrombocytopenia
• bone marrow suppression

This medication should be stored in a tightly sealed container to protect it from air and moisture and kept at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy over time.

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/box (10 tablets/Alu-Alu × 3)