Olmesartan Medoxomil and Amlodipine Tablets 5/40 mg

Adult dose

The drug should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day if possible (e.g., in the morning). The recommended dosing regimen is as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled with 5 mg amlodipine or 20 mg olmesartan medoxomil monotherapy. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled with 20 mg olmesartan medoxomil monotherapy.

Child dose

Safety and efficacy have not been established in pediatric patients under 18 years of age.

This medication can cause serious harm to the fetus and newborns during the second and third trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the active components or similar substances, those who are pregnant or breastfeeding, individuals with severe liver dysfunction or aortic stenosis, those with biliary obstruction, patients undergoing kidney dialysis, individuals with signs of shock, specific diabetes patients, or those with moderate to severe impairment in kidney function should not take this medication. Due to the risk of hypotension in patients with low body fluid or sodium levels, caution is necessary. Rapid vessel dilation may result in hypotension, so patients with severe heart disease should be especially careful. Patients with heart failure or weakened kidney function may experience changes in kidney function or a deterioration of heart conditions when taking this medication, so careful monitoring by healthcare professionals is advised. Various side effects such as dizziness, headache, low blood pressure, indigestion, and edema may occur; if any abnormal symptoms occur, inform a healthcare professional immediately. Particularly, this medication can increase serum potassium levels, thus regular blood tests are necessary for patients with decreased kidney function or at risk of hyperkalemia. During pregnancy, there may be risks to the fetus, so those who are pregnant or planning to become pregnant should consult their doctor, and breastfeeding individuals should carefully consider whether to take this medication or stop breastfeeding. This medication is not recommended for children under 18 years of age, as safety and efficacy in this population have not been established. Elderly patients may be at risk of reduced kidney and liver function; therefore, treatment should start at a low dose and proceed with caution. In cases of overdose, severe hypotension and side effects due to vasodilation may occur, necessitating immediate medical attention. This medication should be stored in a tightly closed container, away from direct sunlight and moisture, and should not be transferred to another container.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, angioedema, severe allergic reactions, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, severe skin allergic reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, extreme lethargy, liver issues (jaundice), sudden and severe reactions.

Mild side effects

• Dizziness
• headache
• drowsiness
• decreased libido
• palpitations
• hypotension
• orthostatic hypotension
• cough
• nausea
• vomiting

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is advisable to store it at room temperature, between 1°C and 30°C, away from extremes of heat or cold.

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]