Telmisartan and Amlodipine Besylate Tablets 40/5 mg

Adult dose

The recommended dosage is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., in the morning). Patients with kidney impairment do not require dosage adjustments for mild or moderate renal impairment, but patients with severe renal impairment should start at a lower dose and increase it gradually. The daily dose for patients with liver impairment must not exceed 40 mg.

Child dose

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

This medication can pose a significant risk to the fetus, especially during the second and third trimesters of pregnancy, therefore pregnant women or women who may become pregnant should not take it. Use is contraindicated in patients with known allergies to the active ingredients or dihydropyridine derivatives, severe liver dysfunction, severe hypotension, severe heart disease, diabetes, or severe kidney disease. Caution should be exercised when administering this drug to patients with compromised liver or kidney function, gastrointestinal disease, or the elderly, and blood pressure, kidney function, and electrolyte status should be monitored regularly. Side effects such as dizziness or edema may occur when taking this medication, and rarer severe side effects can arise, so patients should consult medical professionals immediately if any abnormal symptoms occur. Drug interactions may occur when this medication is taken with other medications, particularly those for heart conditions, diuretics, lithium preparations, and anti-inflammatory drugs. Therefore, it is essential to inform doctors or pharmacists if patients are taking these medications. Women who are pregnant or breastfeeding should not use this medication, and if pregnancy is confirmed, it should be stopped immediately, and alternative treatment should be sought. The safety and efficacy of this medication have not been adequately established in children, and its use is not recommended. Elderly patients should take caution with adjusted dosing, and in cases of overdose, symptoms such as hypotension, dizziness, or cardiac issues may occur, requiring immediate medical attention. This medication should be kept out of reach of children and stored in its original packaging for safety.

Serious side effects

• Hives
• severe swelling (angioedema)
• chest tightness
• difficulty breathing
• cold sweats
• pallor
• severe allergic reactions
• severe rash with high fever
• blisters
• skin peeling

Mild side effects

Dizziness, peripheral edema, upper respiratory infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), anemia, hyperkalemia, hypoglycemia (in diabetic patients), hyponatremia, hyperglycemia, depression, insomnia, anxiety, confusion, drowsiness, migraine, headache, paresthesia, visual disturbances (including diplopia), vertigo, tinnitus, palpitations, bradycardia, tachycardia, flushing, hypotension, orthostatic hypotension, cough, abdominal pain, dyspepsia, nausea, vomiting

This medicine is sensitive to light and should be stored in a container that protects it from light. It is also recommended to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the drug's efficacy and safety.

Appearance

It is a double-layer tablet that is oval-shaped with a convex surface, featuring a white and light gray color.

Package unit

30 tablets/Alu-Alu [30 tablets (10 tablets/Alu-Alu × 3)]