Belmetec Tablet 20 mg (Olmesartan Medoxomil)

Adult dose

The recommended initial dose is 10 mg once daily, taken regardless of meals. If blood pressure is not adequately controlled at this dose, it may be increased to 20 mg once daily. If additional blood pressure reduction is needed, the maximum dose of 40 mg once daily can be administered. The blood pressure-lowering effect appears within 2 weeks of starting treatment, and the maximum effect occurs in about 8 weeks. If blood pressure is not adequately controlled when this medication is used alone, it may be combined with thiazide diuretics such as hydrochlorothiazide. To improve adherence, it is recommended to take it at the same time each day (e.g., morning). For patients at risk of intravascular volume depletion (e.g., those receiving diuretics, particularly patients with renal impairment), it is recommended to start treatment at a low dose while monitoring their condition closely. <Elderly> No dosage adjustment is necessary when administering this medication to elderly patients aged 65 years and older. Although no overall differences in efficacy and safety between elderly and younger patients have been observed, it cannot be ruled out that some elderly patients may exhibit more sensitive responses. <Renal Impairment Patients> In patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min), the maximum dose is 20 mg once daily. <Liver Impairment Patients> No dose adjustment is necessary in patients with mild liver impairment. The recommended initial dose in patients with moderate liver impairment is 10 mg once daily, and it can be increased up to a maximum of 20 mg per day. There is no experience in using this medication in patients with severe liver impairment, so it is not recommended for this patient group. <Children> Safety and efficacy in children have not been established.

Child dose

Safety and efficacy in pediatric patients have not been established.

This medication can cause serious harm or death to the fetus and newborn if administered to pregnant women in the second and third trimesters; thus, it should be discontinued immediately upon confirmation of pregnancy. It should not be used in individuals allergic to any components of this medication, during pregnancy or breastfeeding, in patients undergoing kidney dialysis, those with severe liver dysfunction, biliary obstruction, and specific genetic lactose intolerance. Patients with low blood volume or sodium may experience low blood pressure upon initiating this medication, necessitating careful monitoring of their condition and taking appropriate actions as needed. Patients with severe heart failure or impaired kidney function may see a worsening of kidney function while taking this medication, hence regular blood tests to monitor kidney status are crucial. This medication may induce hyperkalemia; therefore, especially in patients with heart failure or kidney dysfunction, routine monitoring of serum potassium levels is recommended. Patients with aortic stenosis, mitral valve stenosis, or obstructive heart disease should take special precautions when using this medication. Dizziness may occur when taking this medication, so it is advisable to avoid hazardous activities such as working at heights or driving machinery. The safety of this medication has been verified in clinical trials involving over 3,800 patients, with dizziness being a common side effect. Other symptoms may include abdominal pain, headache, muscle pain, rash, but most are mild and temporary. If any adverse reactions are severe or persist, consult a physician immediately. This medication may interact with diuretics, potassium-sparing diuretics, potassium supplements, lithium, and non-steroidal anti-inflammatory drugs, so it is important to inform healthcare providers of any other medications being taken. Particular caution is required for diabetes patients or those with moderate to severe impairment of kidney function to avoid interactions with certain medications. During pregnancy, it should be avoided to prevent severe fetal damage, and in breastfeeding, care should be taken as adverse effects may appear in infants, thereby a careful decision must be made. Safety in children has not been established, hence it is generally not used in pediatric patients. Elderly patients may require dosage adjustments; hence caution is advised during use. In cases of overdose, low blood pressure and palpitations may occur, and appropriate treatment should be obtained as necessary. Although no carcinogenic risks have been reported with long-term use of this medication, immediate consultation with healthcare professionals is necessary if any abnormal symptoms appear during administration.

Serious side effects

Urticaria, angioedema, anaphylactic reaction, intestinal angioedema, rhabdomyolysis, hyperkalemia, acute renal failure, elevated serum creatinine, urticaria, hepatic dysfunction (elevated liver enzymes, increased bilirubin levels), autoimmune hepatitis

Mild side effects

Dizziness, headache, palpitations, nausea, diarrhea, abdominal pain, low back pain, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, sinusitis, cough, itching, hair loss, hypercholesterolemia, hyperlipidemia, hyperuricemia, arthralgia, arthritis, myalgia, weakness, vomiting, chronic malabsorption-like bowel disorders, blood pressure increase, epistaxis, upper respiratory infection

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. Additionally, it is advisable to store it at room temperature, ideally between 1 to 25 degrees Celsius, avoiding extremes of heat or cold.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle