Telmisartan/Amlodipine 80/5 mg

Adult dose

The recommended dosage of this medication is one tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). For patients with renal impairment, dosage adjustment is not necessary for mild to moderate cases, but for severe cases, treatment should start at a low dose and be gradually increased. Patients with liver impairment should not exceed a daily dose of 40 mg. In elderly patients, the standard amlodipine regimen is recommended, but caution is needed when increasing the dosage. (Refer to '3. Caution in administering to the following patients') In patients over 75 years old, the clearance of amlodipine is reduced, so treatment should begin at a low dose and be gradually increased.

Child dose

The safety and efficacy of this medication for pediatric patients under 18 years old have not been established, therefore its administration is not recommended.

This medication can cause serious harm to the fetus, especially during the second and third trimesters of pregnancy, so women who are pregnant or may become pregnant should not take it. This drug should not be administered to patients with allergies to the active ingredients or dihydropyridine derivatives, as well as to those with severe liver disease, hypotension, or heart failure. Patients with poor liver function or cholestatic disease should use this medication with caution and may require dose adjustment. Patients with gastrointestinal disorders should be cautious when taking this medication due to the risk of side effects like gastrointestinal bleeding. Patients with impaired renal function or renal artery hypertension may experience worsening renal function or hypotension and need regular blood tests and monitoring of kidney function. Elderly patients may experience a stronger effect from this medication, so it is advisable to start with a low dose and gradually increase it. This medication lowers blood pressure, so symptoms of hypotension may occur, such as dizziness or drowsiness, which necessitates caution when driving or operating machinery. Patients taking this medication are at risk of elevated potassium levels, so caution is needed when using potassium-containing medications or supplements concurrently. In patients with severe heart failure, side effects such as pulmonary edema may occur with the use of this medication, so it should be administered with caution. This drug may interact with other antihypertensive agents or specific medications, so it is essential to inform healthcare professionals about any other medications being taken. In case of overdose, symptoms such as hypotension, dizziness, or cardiac-related abnormal symptoms may appear, thus immediate medical consultation is necessary for appropriate treatment. This medication is not recommended for children as its safety and efficacy have not been sufficiently established for pediatric patients.

Serious side effects

Hives, severe swelling (angioedema), feeling of tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizure, confusion, visual disturbances, paralysis.

Mild side effects

• Dizziness
• peripheral edema
• fainting
• palpitations
• flushing
• hypotension
• orthostatic hypotension
• cough
• abdominal pain
• dyspepsia

This medication is sensitive to light and should be stored in a container that protects it from light. Additionally, when storing the medication, it is important to maintain a cool room temperature, specifically between 1 to 30 degrees Celsius, to help preserve its effectiveness.

Appearance

Biconvex oval double-coated tablet in white and light blue color

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)]