Mikater Plus Tablet 80/12.5 mg

Adult dose

For patients whose blood pressure is not adequately controlled by monotherapy with telmisartan, take this medication once daily with or without food, along with a drink. Before switching to this combination drug with fixed-dose components, it is recommended to adjust the dose of each component individually. Direct switching from monotherapy may be considered when clinically appropriate. - The telmisartan/hydrochlorothiazide combination drug 40/12.5 mg may be given to patients whose blood pressure is not adequately controlled on 40 mg of telmisartan. - The telmisartan/hydrochlorothiazide combination drug 80/12.5 mg may be given to patients whose blood pressure is not adequately controlled on 80 mg of telmisartan. - The telmisartan/hydrochlorothiazide combination drug 80/25 mg may be given to patients whose blood pressure is not adequately controlled by combined treatment of 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide. Improvement in sodium or intravascular volume depletion should be established before starting this medication. Patients with renal impairment In patients with mild to moderate renal impairment, dose adjustment is not required. This medication should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring of kidney function is recommended. Patients with liver impairment In patients with mild to moderate liver impairment, this medication should be administered with caution. Doses exceeding 40/12.5 mg per day should not be given. This medication should not be administered to patients with severe liver impairment (see precautions 2). Thiazide diuretics should be given with caution in patients with liver impairment. Elderly No dose modification is necessary. Pediatric Patients The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age.

Child dose

The safety and efficacy of this medication have not been established for children under 18 years of age, hence no dosing regimen is provided.

This medication should not be used during pregnancy, especially in the second and third trimesters, as it can pose a serious risk to the fetus. Patients with allergies to the components of this medication or those with certain liver or kidney diseases should avoid taking it. Elderly patients, those with issues regarding serum potassium levels, and patients with liver or heart diseases should use this medication with caution. Since this medication lowers blood pressure, there may be occurrences of sudden hypotension, dizziness, or faintness, so caution is necessary. The hydrochlorothiazide component may cause electrolyte imbalances, so potassium and sodium levels should be regularly monitored through blood tests. During the use of this medication, one should avoid excessive sun exposure, and any skin abnormalities should be discussed with a doctor immediately. Interactions may occur if taken with other antihypertensives, diuretics, or potassium supplements, so consultation with a physician or pharmacist is advised. Dizziness or drowsiness may occur when driving or operating machinery, so caution is necessary. In case of overdose, symptoms such as hypotension, electrolyte abnormalities, and dehydration may appear, so one should seek appropriate treatment at a medical facility immediately. Safety has not been established for children, so it is recommended not to use it in pediatric patients. This medication should be kept out of reach of children and stored sealed until use.

Serious side effects

Urticaria, angioedema (including fatal outcomes), respiratory distress, difficulty breathing, pulmonary edema, liver dysfunction/liver disorders, jaundice, severe swelling (edema), increased blood pressure, renal dysfunction, acute renal failure, acute respiratory distress syndrome (ARDS), severe allergic reactions, severe neurological symptoms (fainting, confusion), severe skin reactions (severe rash, blisters, skin peeling, pain in oral/ocular mucosa),

Mild side effects

• Bronchitis
• pharyngitis
• sinusitis
• hypokalemia
• hyperuricemia
• hyponatremia
• anxiety
• depression
• insomnia
• sleep disorders

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help preserve the effectiveness and safety of the medication.

Appearance

White-red biconvex film-coated tablet, which may have red spots on the white layer.

Package unit

30 tablets/box [(10 tablets/Alu-Alu)x3], 30 tablets/bottle