OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE

5 mg is 1 tablet per day. 5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan medoxomil 40 mg alone. 5 mg fixed dose combination. 5 mg tablets containing the same component doses. 5 mg can be taken with or without food.

Older people (age 65 years or over) In older people the same dosage of the combination is recommended as for adults. Blood pressure should be closely monitored. Renal impairment Olmesartan Medoxomil/Hydrochlorothiazide is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min).

The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 30 – 60 mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group, and periodic monitoring is advised.

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

There is no experience of olmesartan medoxomil in patients with severe hepatic impairment. 3). 5 mg 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 was investigated in clinical trials in 3709 patients receiving olmesartan medoxomil in combination with hydrochlorothiazide. 5 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 Uncommon Anaphylactic skin reactions Rare Angioneurotic oedema Rare Rare Cutaneous lupus erythematodes-like reactions Rare Eczema Uncommon Erythema Uncomm on Exanthem Uncommon Photosensitivity reactions Uncomm on Pruritus Uncommon Uncomm on Purpura Uncomm on Rash Uncommon Uncommon Uncomm on Reactivation of cutaneous lupus erythematodes Rare Toxic epidermal necrolysis Rare Skin and subcutaneo us tissue disorders Urticaria Rare Uncommon Uncomm on Arthralgia Uncommon Arthritis Common Musculosk eletal and connective Back pain Uncommon Common Muscle spasm Uncommon Rare Muscular weakness Rare Myalgia Uncommon Uncommon Pain in extremity Uncommon Paresis Rare 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 Reproducti ve system and breast disorders Erectile dysfunction Uncommon Uncomm on Asthenia Common Uncommon Chest pain Common Common Face oedema Uncommon Fatigue Common Common Fever Rare Influenza-like symptoms Common Lethargy Rare Malaise Rare Uncommon Pain Common Peripheral oedema Common Common General disorders and administrat ion site conditions Weakness Uncommon Alanine aminotransferase increased Uncommon Aspartate aminotransferase increased Uncommon Blood calcium increased Uncommon Blood creatinine increased Uncommon Rare Common Blood creatine phosphokinase increased Common Blood glucose increased Uncommon Blood haematocrit decreased Rare Blood haemoglobin decreased Rare Investigati ons Blood lipids Uncommon increased Blood potassium decreased Uncommon Blood potassium increased Uncommon Blood urea increased Uncommon Common Common Blood urea nitrogen increased Rare Blood uric acid increased Rare Gamma glutamyl transferase increased Uncommon […]

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.

Renal impairment and kidney transplantation:

Olmesartan Medoxomil/Hydrochlorothiazide should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min). The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 30 – 60 mL/min) is 20 mg olmesartan medoxomil once daily.

5 mg and 20 mg/25 mg 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. 3). There is no experience of the administration of Olmesartan Medoxomil/Hydrochlorothiazide in patients with a recent kidney transplantation.

1 or to other sulfonamide-derived substances (since hydrochlorothiazide is a sulfonamide-derived medicinal product). 2). Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia. 2). 6). 1).