OLMESARTAN/HYDROCHLOROTHIAZIDE

5 mg or Olmesartan/Hydrochlorothiazide 40 mg/25 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 and 40 mg/25 mg tablets containing the same component doses.

This medicine can be taken with or without food. Elderly (age 65 years or over) In elderly people the same dosage of the combination is recommended as for adults. Blood pressure should be closely monitored. 3). 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). Paediatric population The safety and efficacy of olmesartan/hydrochlorothiazide in children and adolescents below 18 years has not been established.

No data are available. Method of administration Olmesartan/Hydrochlorothiazide is administered once daily, with or without food. 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 and 40 mg/25 mg was investigated in clinical trials in 3,709 patients receiving olmesartan medoxomil in combination with hydrochlorothiazide. 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 Acute cholecystitis Rare Jaundice (intrahepatic cholestatic icterus) Rare Hepatobiliary disorders Autoimmune hepatitis* Not known Allergic dermatitis Uncommon Anaphylactic skin reactions Rare Angioneurotic oedema Rare Rare Cutaneous lupus erythematosus- like reactions Rare Eczema Uncommon Erythema Uncommon Exanthem Uncommon Photosensitivity reactions Uncommon Pruritus Uncommon Uncommon Purpura Uncommon Rash Uncommon Uncommon Uncommon Skin and subcutaneous tissue disorders Reactivation of cutaneous lupus erythematosus Rare FrequencyMedDRA System Organ Class Adverse reactions Olmesartan/ HCTZ Olmesartan HCTZ Toxic epidermal necrolysis Rare Urticaria Rare Uncommon Uncommon Arthralgia Uncommon Arthritis Common Back pain Uncommon Common Muscle spasm Uncommon Rare Muscular weakness Rare Myalgia Uncommon Uncommon Pain in extremity Uncommon Paresis Rare Musculoskeletal 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 Uncommon 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 administration 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 Blood lipids increased Uncommon Blood potassium decreased Uncommon Blood potassium increased Uncommon Blood urea increased […]

Non-melanoma skin cancer An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.

Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.

Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.

8). 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 renin- 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/hydrochlorothiazide in patients with a recent kidney transplantation.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Hepatic impairment There is currently no experience of olmesartan medoxomil in patients with severe hepatic impairment. In patients with moderate hepatic impairment, the maximum dose is 20 mg olmesartan medoxomil. Furthermore, minor alterations of fluid and electrolyte balance during thiazide therapy may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

2). 2). Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Primary aldosteronism Patients with primary aldosteronism generally will not respond to anti-hypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of olmesartan medoxomil/hydrochlorothiazide is not recommended in such patients.

Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance. 5). Latent diabetes mellitus may become manifest during thiazide therapy. Increases in cholesterol and triglyceride levels are undesirable effects known to be associated with thiazide diuretic therapy.

Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy. Electrolyte imbalance As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.

Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and […]

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).