Telmisartan/Amlodipine Tablet 80/5mg

Adult dose

The recommended dose for adults is 1 tablet once daily, to be taken with water, regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). The 40/5 mg dosage is administered to patients whose blood pressure is not adequately controlled with 5 mg Amlodipine or 40 mg Telmisartan. The 80/5 mg dosage is administered to patients whose blood pressure is not adequately controlled with 5 mg Amlodipine or this drug at 40/5 mg. ### Dosage for the drug: The recommended dose of this drug is 1 tablet once daily, to be taken with water, regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). Before administering this drug, it is suggested to adjust the dose with each individual component (Amlodipine or Telmisartan); however, if the blood pressure is not controlled with each individual component, a direct switch to this medication should be considered: - 40/5 mg: For patients whose blood pressure is not adequately controlled with 5 mg Amlodipine or 40 mg Telmisartan. - 80/5 mg: For patients whose blood pressure is not adequately controlled with 5 mg Amlodipine or this medication 40/5 mg. - 40/10 mg: For patients whose blood pressure is not adequately controlled with 10 mg Amlodipine. ### For patients with kidney impairment: Mild to moderate kidney impairment does not typically require dosage adjustment; however, for patients with severe kidney impairment, it is recommended to start treatment at a lower dose and gradually increase it. Periodic monitoring of serum potassium and creatinine levels is also suggested. Telmisartan is not removed by hemodialysis. ### For patients with liver impairment: The daily dose of Telmisartan for patients with mild or moderate liver impairment should not exceed 40 mg. ### For the elderly: Standard Amlodipine dosing is recommended for elderly patients, but caution should be exercised when increasing the dose. (Refer to section ‘3. Precautions in specific patient groups’.) For those aged 75 and above, due to decreased clearance of Amlodipine, treatment should start at a lower dose and should be gradually increased. ### For pediatric patients: The safety and efficacy in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Child dose

The safety and efficacy in pediatric patients under 18 years of age have not been established, so its use is not recommended.

This medication may severely affect the fetus when administered during pregnancy, especially in the second and third trimesters; therefore, it should not be taken by pregnant women or those who may become pregnant. Caution is required when administering this drug to patients with specific conditions, such as those with severely impaired liver function, severe hypotension, or cardiac issues. When administering this drug, close observation and dosage adjustment are necessary for patients with impaired liver or kidney function, gastrointestinal disorders, or in the elderly. During treatment, side effects such as dizziness or swelling may occur, and serious adverse reactions may rarely happen, so if any abnormal symptoms arise, immediate consultation with a healthcare professional is necessary. Interactions may occur when taken with other medications; therefore, if any other medications are being taken, it is essential to inform the doctor or pharmacist. It is advisable for pregnant or nursing women to avoid taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately and the healthcare provider consulted. The safety and efficacy of this drug have not been established for children under 18 years old, so its use is not recommended. In the case of overdose, hypotension or heart problems may occur, requiring immediate emergency treatment and appropriate care as instructed by a healthcare professional.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe dermatological reactions, shortness of breath, asthma attacks, pulmonary edema, liver dysfunction (jaundice), hepatitis, jaundice, acute renal failure, severe neurological symptoms (severe headaches, seizures, altered consciousness, visual disturbances, paralysis), severe swelling or abdominal pain

Mild side effects

• Dizziness
• peripheral edema
• upper respiratory infection
• urinary tract infection
• anemia
• hyperkalemia
• hypoglycemia
• hyponatremia
• hyperglycemia
• depression

This medication is sensitive to light and should be stored in a container that is lightproof. Additionally, it is essential to store the medication at a cool room temperature, between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

Appearance

White or slightly off-white, oval, biconvex tablets

Package unit

10 tablets/Alu-Alu x 3, 30 tablets/bottle