Telmisartan and Hydrochlorothiazide Tablet 80/12.5 mg

Adult dose

For patients whose blood pressure is not adequately controlled with telmisartan alone, to be taken once daily with or without food, alongside water. It is recommended to adjust the doses of each component individually before switching to this fixed-dose combination. In patients with renal impairment, no dose adjustment is necessary for mild to moderate conditions, while patients with severe renal impairment should not be given this medication. In patients with liver impairment, mild to moderate conditions should not exceed a daily dose of 40/12.5 mg.

Child dose

Safety and efficacy have not been established for children under 18 years of age, thus not recommended for use.

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, and should be discontinued immediately upon confirmation of pregnancy. This medication should not be used in patients with allergies to the active ingredient or excipients, hypersensitivity to sulfonamide drugs, pregnant women in the second or third trimester, nursing mothers, patients with bile duct obstruction or cholestasis, and patients with severe liver or kidney impairment. Elderly patients, those with hyperkalemia, liver impairment, valvular heart disease, ischemic heart disease or cerebrovascular disease, gastrointestinal disorders, and renal vascular hypertension should use this medication with caution. While this medication is effective in lowering blood pressure, various side effects may occur, such as dizziness, hypotension, dyspepsia, skin rashes, and muscle pain; if abnormal symptoms arise, consulting a physician immediately is advised. This medication may affect kidney function; therefore, patients with compromised renal function should regularly undergo blood tests and electrolyte assessments, paying particular attention to potassium levels. Interactions may occur when this medication is taken alongside other antihypertensives, diuretics, lithium, and non-steroidal anti-inflammatory drugs, so patients must inform their doctor or pharmacist about all concurrent medications. This medication should not be taken during pregnancy or breastfeeding and it is recommended to switch to another safe antihypertensive if planning for pregnancy. During the use of this medication, dizziness or drowsiness may occur while driving or operating machinery, thus caution is warranted. In cases of overdose, symptoms such as hypotension, electrolyte imbalances, and dehydration may arise; immediate medical attention is required for appropriate treatment. Safety and efficacy have not been established for children, and it is recommended to avoid use in this population, while elderly patients should be closely monitored to prevent excessive blood pressure reduction.

Serious side effects

Urticaria, severe swelling (angioedema), difficulty breathing, chest tightness, angioedema (potentially fatal), dyspnea, respiratory disorders (including pneumonia and pulmonary edema), liver function abnormalities/liver impairment, yellowing of the skin or eyes (jaundice), sudden and severe headache, syncope, sensory disturbances, angioedema, anaphylactic reactions, hypersensitivity, sepsis (potentially fatal), kidney impairment (including acute renal failure), toxic epidermal necrolysis.

Mild side effects

Hypokalemia, hyperuricemia, hyponatremia, anxiety, depression, dizziness, insomnia, sleep disturbances, visual disturbances, temporary blurred vision, vertigo, tachycardia, arrhythmia, hypotension, orthostatic hypotension, diarrhea, dry mouth, abdominal distension, abdominal pain, constipation, dyspepsia, vomiting, gastritis, liver function abnormalities/liver impairment, erythema, pruritus, rash, increased sweating, urticaria, lumbago, muscle cramps, myalgia, arthralgia, erectile dysfunction.

This medication should be stored in a tightly closed container to prevent the ingress of air and moisture. It is best maintained at room temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance

White or off-white, biconvex, round tablets

Package unit

10 tablets/blister x 3