OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE

Posology Adults Olmesartan Medoxomil/Hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil alone. 5mg is administered once daily, with or without food.

1). 5 mg hydrochlorothiazide may be administered in patients whose blood pressure is not adequately controlled by the optimal monotherapy olmesartan medoxomil 20 mg alone. 5 mg hydrochlorothiazide. Older people (age 65 years or over) In older people the same dosage of the combination is recommended as for adults.

4). 3). 2). 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 20 mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically- impaired patients who are receiving diuretics and/or other antihypertensive agents.

There is no experience of olmesartan medoxomil in patients with severe hepatic impairment. 3). Paediatric population The safety and efficacy of Olmesartan Medoxomil/Hydrochlorothiazide in children and adolescents below 18 years has not been established.

No data are available. g. one glass of water). The tablet should not be chewed and should be taken at the same time each day.

0%). 4). 5 mg or 20/25 mg and 466 patients treated with placebo for periods of up to 21 months, the overall frequency of adverse reactions on olmesartan medoxomil / hydrochlorothiazide combination therapy was similar to that on placebo.

5 mg - 20/25 mg (2%) and placebo (3%). The frequency of adverse reactions on olmesartan Medoxomil / hydrochlorothiazide overall relative to placebo appeared to be unrelated to age (< 65 years versus ≥65 years), gender or race although the frequency of dizziness was somewhat increased in patients aged ≥75 years.

5 mg and 40 mg/25 mg. Adverse reactions from Olmesartan Medoxomil/Hydrochlorothiazide in clinical trials, post-authorisation safety studies and spontaneous reporting are summarised in the below table as well as adverse reactions from the individual components olmesartan medoxomil and hydrochlorothiazide based on the known safety profile of these substances.

The following terminologies have been used in order to classify the occurrence of adverse reactions: 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).

4) Very rare Intestinal angioedema Rare Acute cholecystitis Rare Jaundice (intrahepatic cholestasic icterus) Rare Hepato-biliary disorders Autoimmune hepatitis* Not known Allergic dermatitis Uncommo n Anaphylactic skin reactions Rare Angioneurotic oedema Rare Rare Cutaneous lupus erythematodes-like reactions Rare Eczema Uncommon Erythema Uncommo n Exanthem Uncommo n Photosensitivity reactions Uncommo n Pruritus Uncommo n Uncommo n Purpura Uncommo n Rash Uncommon Uncommo n Uncommo n Reactivation of cutaneous lupus erythematodes Rare Toxic epidermal necrolysis Rare Skin and subcutaneous tissue disorders Urticaria Rare Uncommo n Uncommo n Musculoskelet Arthralgia Uncommon Arthritis Common Back pain Uncommon Common Muscle spasm Uncommon Rare Muscular weakness Rare Myalgia Uncommon Uncommo n Pain in extremity Uncommon Paresis Rare al and connective tissue disorders Skeletal pain Common Acute renal failure Rare Rare Haematuria Uncommon Common Interstitial nephritis Rare Renal insufficiency Rare Renal dysfunction Rare Renal and urinary disorders Urinary tract infection Common Reproductive system and breast disorders Erectile dysfunction Uncommon Uncommo n Asthenia Common Uncommo n Chest pain Common Common Face oedema Uncommo n Fatigue Common Common Fever Rare Influenza-like symptoms Common Lethargy Rare Malaise Rare Uncommo n Pain Common Peripheral oedema Common Common General disorders and administration site […]

Intravascular volume depletion:

Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Olmesartan Medoxomil/Hydrochlorothiazide.

g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.

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 rennin-angiotensin- aldosterone system.

3). No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance is ≥ 30 mL/min, < 60 mL/min). However, in such patients Olmesartan Medoxomil/Hydrochlorothiazide should be administered with caution and periodic monitoring of serum potassium, creatinine and uric acid levels is recommended.

Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function. If progressive renal impairment becomes evident, careful reappraisal of therapy is necessary, with consideration given to discontinuing diuretic therapy.

There is no experience of the administration of Olmesartan Medoxomil/Hydrochlorothiazide in patients with a recent kidney transplantation.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS):

1 or to other sulfonamide-derived substances (since hydrochlorothiazide is a sulfonamide-derived medicinal product). Severe renal impairment (creatinine clearance < 30 mL/min). Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia.

Severe hepatic impairment, cholestasis and biliary obstructive disorders. 6). 1).