Telmisartan and Amlodipine Besilate Tablets 80/10 mg

Adult dose

The recommended dose of this medication is 1 tablet once a day, 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). In patients with severe renal impairment, initiate treatment with a lower dose and gradually increase it. For patients with liver impairment, the daily dosage should not exceed 40 mg. In the elderly (75 years and over), start treatment with a lower dose and adjust as necessary.

Child dose

Administration to pediatric patients under 18 years of age is not recommended.

This medication can pose serious risks to the fetus and newborn during pregnancy, especially in the second and third trimesters, so it should not be taken by pregnant women or women who may become pregnant. It should not be administered to patients with allergies to the ingredients or similar drugs, or those with specific liver dysfunction, heart valve disease, or severe hypotension. Patients with impaired liver or kidney function, particularly those with severe liver or kidney disorders, require closer monitoring and potential dose adjustments when using this medication. As this medication lowers blood pressure, it can cause hypotension in patients with depletion of fluids or salt, so assessing and monitoring the condition before administration is important. There is a risk of elevated potassium levels in the blood; thus, patients at risk for hyperkalemia should have their potassium levels checked regularly through blood tests. This medication may interact with certain drugs, so if taking other medications, it is important to consult with a doctor or pharmacist, especially when taken with digoxin, lithium, warfarin, or non-steroidal anti-inflammatory drugs. The safety and efficacy of this medication have not been established in children, so it is not recommended for pediatric use. When administered to elderly patients, careful monitoring is required as they may respond more sensitively, and dosage adjustments may be needed. In case of overdose, symptoms such as low blood pressure, dizziness, and changes in heart rate may occur, requiring immediate medical attention and appropriate emergency treatment if necessary. Patients may experience drowsiness or dizziness during treatment, so caution is needed when driving or operating hazardous machinery. Keep out of reach of children, and it is best to take the product out of its packaging just before administration.

Serious side effects

Urticaria, angioedema (with fatal outcomes), Stevens-Johnson syndrome, photosensitivity reactions, exfoliative dermatitis, toxic epidermal necrolysis, anaphylactic reactions, sepsis (including fatal outcomes), hepatitis, jaundice, liver function abnormalities, liver impairment, myocardial infarction, ventricular tachycardia, arrhythmias, atrial fibrillation, vasculitis, respiratory distress, interstitial lung disease, renal function impairment (including acute renal failure), syncope, cerebral infarction, congestive heart failure, intestinal vascular edema

Mild side effects

• Dizziness
• peripheral edema
• syncope
• drowsiness
• headache
• paresthesia
• dysgeusia
• tremors
• visual disturbances
• vertigo

This medication is sensitive to light and should be stored in a tightly closed container that protects from light. It is recommended to maintain room temperature between 1 and 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance

White oval biconvex film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3), 30 tablets/bottle