Telmisartan STELLA 40 mg

Rx

Indications

• Treatment of essential hypertension.
• Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage.

Dosage

Adult

• Hypertension:
  40 mg once daily (may be 20 mg once daily, use of suitable dosage forms),
  Increase to a maximum of 80 mg once daily if the target blood pressure is not achieved, may be used in combination with thiazide.
• Cardiovascular prevention:
  80 mg once daily, close monitoring of blood pressure and if appropriate adjustment of medications that lower blood pressure may be necessary.

Severe renal impairment/ haemodialysis

• An initial dose of 20 mg once daily.

Mild to moderate hepatic impairment

• A daily maximum dose 40 mg once daily.

Adolescents aged < 18 years

• The safety and efficacy have not been established.

Usage

• Telmisartan STELLA 40 mg is administered orally, taken without regard to meals.

• Known hypersensitive to any of the active substance or excipients of the product.
• Second and third trimesters of pregnancy and lactation.
• Biliary obstructive disorders.
• Severe hepatic impairment.
• The concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).

Uncommon:

• Upper respiratory tract infection, urinary tract infection.
• Anaemia.
• Hyperkalemia.
• Depression, insomnia.
• Syncope.
• Vertigo.
• Bradycardia.
• Hypotension, orthostatic hypotension.
• Dyspnoea, cough.
• Abdominal pain, diarrhea, dyspepsia, flatulence, vomiting.
• Hyperhidrosis, pruritus, rash.
• Myalgia, back pain, muscle spasms.
• Renal impairment.
• Chest pain, asthenia.
• Blood creatinine increased.

• When pregnancy is detected, telmisartan should be discontinued as soon as possible.
• Use with caution in patients: mild to moderate hepatic impairment; bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney; vascular tone and renal function depend predominantly on the activity of the RAAS; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; diabetic patients; severe hypertension; ischaemic cardiovascular disease; > 70 years old.
• Telmisartan is not to be given to patients with cholestasis; fructose intolerance.
• When using in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
• Not recommended for patients with primary aldosteronism.
• Intravascular hypovolaemia and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting should be corrected before the administration of telmisartan.
• Risk of porphyria and hyperkalaemia.
• The dose of 80 mg contains 3.864 mg sodium. This is equivalent to approximately 0.2% of the recommended maximum daily intake of sodium for an adult.
• Gastroduodenal ulcer can work or other stomach problems (increased risk of gastrointestinal bleeding).
• It should be taken into account when driving vehicles or operating machinery.