Olmesafe-AM 5/20 Tablet: Each film coated tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil BP 20 mg.

Olmesafe-AM 5/40 Tablet: Each film coated tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Olmesartan Medoxomil BP 40 mg.

BP

Angiotensin Receptor Blockers &

Calcium channel blocker

Treatment of essential hypertension. Olmesafe-AM is indicated in adult patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil or Amlodipine monotherapy.

Hypersensitivity to the active substances, to dihydropyridine derivatives or to any of the excipients, severe hepatic insufficiency and biliary obstruction.

Adults: The recommended dosage of Olmesartan Medoxomil and Amlodipine is one tablet per day. Olmesafe-AM may be administered in patients whose blood pressure is not adequately controlled by 40 mg Olmesartan Medoxomil or 5 mg Amlodipine alone. Olmesafe-AM can be taken with or without food.

Elderly (age 65 years or over): No adjustment of the recommended dose is generally required for older people but increase of the dosage should take place with care. If up-titration to the maximum dose of 40 mg Olmesartan Medoxomil daily is required, blood pressure should be closely monitored.

The most commonly reported adverse reactions during treatment with Olmesartan Medoxomil and Amlodipine are peripheral oedema, headache and dizziness. Other common side effects are nausea, fatigue, oedema, hypertriglyceridemia, hyperuricemia, somnolence, abdominal pain, influenza-like symptoms.

Symptomatic hypotension may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting, especially after the first dose. Correction of this condition prior to administration of Olmesartan Medoxomil and Amlodipine or close medical supervision at the start of the treatment is recommended.

The blood pressure lowering effect of Olmesartan Medoxomil and Amlodipine can be increased by concomitant use of other antihypertensive medicinal products (e.g. alpha blockers, diuretics). Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin, ACE inhibitors) may lead to increases in serum potassium. Concomitant use of Olmesartan Medoxomil and Amlodipine with lithium is not recommended. When angiotensin-II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, concomitant use of angiotensin-II antagonists and NSAIDs may increase the risk of worsening of renal function and may lead to an increase in serum potassium.

Olmesafe-AM 5/20 Tablet: Each box contains 3x10’s tablets in Alu-Alu blister.

Olmesafe-AM 5/40 Tablet: Each box contains 3x10’s tablets in Alu-Alu blister.

Renal impairment: The maximum dose of Olmesartan Medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 40 mg Olmesartan Medoxomil once daily.

Hepatic impairment: Olmesartan Medoxomil and Amlodipine should be used with caution in patients with mild to moderate hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 40 mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents.

The safety and efficacy of Olmesartan Medoxomil and Amlodipine in children and adolescents below 18 years has not been established. No data are available.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue Olmesartan and Amlodipine combination as soon as possible

There is no experience of overdose with Olmesartan Medoxomil and Amlodipine. The most likely effects of Olmesartan Medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred. Amlodipine overdosage can be expected to lead to excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia.

Store in a cool and dry place, protected from light. Keep all medicine out of the reach of children.