Onduarp

Posology The recommended dose of Onduarp is one tablet per day. The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. Onduarp is indicated for long term treatment. 5). Add on therapy Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.

e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination. Medicinal product no longer authorised 3 Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Onduarp 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.

g. to enhance convenience or compliance Special population Elderly patients No dose adjustment is necessary for elderly patients. Little information is available in the very elderly patients. Patients with renal impairment No posology adjustment is required for patients with mild to moderate renal impairment.

Limited experience is available in patients with severe renal impairment or haemodialysis. 4). 3). Patients with hepatic impairment In patients with mild to moderate hepatic impairment Onduarp should be administered with caution. 4). 3).

Paediatric population The safety and efficacy of Onduarp in children aged below 18 years have not been established. No data are available. Method of administration Onduarp can be taken with or without food. It is recommended to take Onduarp with some liquid.

Summary of the safety profile The most common adverse reactions include dizziness and peripheral oedema. Serious syncope may occur rarely (less than 1 case per 1,000 patients). The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.

Tabulated list of adverse reactions Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System Organ Class Common Uncommon Rare Infections and infestations cystitis Psychiatric disorders depression, anxiety, insomnia Nervous system disorders dizziness somnolence, migraine, headache, paraesthesia syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor Ear and labyrinth disorders vertigo Cardiac disorders bradycardia, palpitations Vascular disorders hypotension, orthostatic hypotension, flushing Respiratory, thoracic and mediastinal disorders cough Gastro-intestinal disorders abdominal pain, diarrhoea, nausea vomiting, gingival hypertrophy, dyspepsia, dry mouth Skin and subcutaneous tissue disorders pruritus eczema, erythema, rash Musculoskeletal and connective tissue disorders arthralgia, muscle spasms (cramps in legs), myalgia back pain, pain in extremity (leg pain) Renal and urinary disorders nocturia Reproductive system, and breast disorders erectile dysfunctionMedicinal product no longer authorised 10 General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise Investigations hepatic enzymes increased blood uric acid increased Additional information on individual components Adverse reactions previously reported with one of the individual components (telmisartan or amlodipine) may be potential adverse reactions with Onduarp as well, even if not observed in clinical trials or during the post-marketing period.

Pregnancy Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy shouldMedicinal product no longer authorised 4 be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.

6). Hepatic impairment Telmisartan is mostly eliminated in the bile. Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Furthermore as with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dose recommendations have not been established.

Onduarp should therefore be used with caution in these patients. Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.

Renal impairment and kidney transplantation When Onduarp is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Onduarp in patients with a recent kidney transplant.

Telmisartan and amlodipine are not dialysable. g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of telmisartan. If hypotension occurs with Onduarp, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.

Treatment can be continued once blood pressure has been stabilised. 3). As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalaemia and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system.

g. 5).