TELMISARTAN AND HYDROCHLOROTHIAZIDE ALEMBIC

Posology Telmisartan and Hydrochlorothiazide Alembic tablets should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.

When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. 5 mg tablets may be administered in patients whose blood pressure is not adequately controlled by Telmisartan 40mg. 5 mg tablets may be administered in patients whose blood pressure is not adequately controlled by Telmisartan 80mg.

4). 5 mg tablets once daily. Telmisartan and Hydrochlorothiazide Alembic tablets are not indicated in patients with severe hepatic impairment. 4).

Older people:

No dosage adjustment is necessary.

Paediatric population:

The safety and efficacy of Telmisartan and Hydrochlorothiazide Alembic tablets in children and adolescents younger than 18 years of age have not been established. No data are available. Method of administration Telmisartan and Hydrochlorothiazide Alembic tablets are for once-daily oral administration and should be taken with liquid, with or without food.

Precautions to be taken before handling or administering the medicinal product Telmisartan and Hydrochlorothiazide Alembic tablets should be kept in the sealed blister due to the hygroscopic property of the tablets. Tablets should be taken out of the blister shortly before administration.

Summary of the safety profile The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely (≥1/10,000 to <1/1,000). The overall incidence of adverse events reported with Telmisartan and Hydrochlorothiazide tablets was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).

Dose-relationship of undesirable effects was not established and they showed no correlation with gender, age or race of the patients. 05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.

Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Telmisartan and Hydrochlorothiazide tablets. 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.

Infections and infestations Rare:

Bronchitis, pharyngitis, sinusitis Immune system disorders Rare: Exacerbation or activation of systemic lupus erythematosus Metabolism and nutrition disorders Uncommon: Hypokalaemia Rare: Hyperuricaemia, hyponatraemia Psychiatric disorders Uncommon: Anxiety Rare: Depression Nervous system disorders Common: Dizziness Uncommon: Syncope, paraesthesia Rare: Insomnia, sleep disorders, Eye disorders Rare: Visual disturbance, vision blurred Ear and labyrinth disorders Uncommon: Vertigo Cardiac disorders Uncommon: Tachycardia, arrhythmias Vascular disorders Uncommon: Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, Rare: Respiratory distress (including pneumonitis and pulmonary oedema) Gastrointestinal disorders Uncommon: Diarrhoea, dry mouth, flatulence Rare: Abdominal pain, constipation, dyspepsia, vomiting, gastritis Hepatobiliary disorders Rare: Abnormal hepatic function/liver disorder Skin and subcutaneous tissue disorders Rare: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria Muscoloskeletal, connective tissue and bone disorders Uncommon: Back pain, muscle spasms, myalgia Rare: Arthralgia, muscle cramps, pain in limb Reproductive system and breast disorders Uncommon: Erectile dysfunction General disorders and administration site conditions Uncommon: Chest pain Rare: Influenza-like illness, pain Investigations Uncommon: Blood uric acid increased Rare: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased Additional information on individual components Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Telmisartan and Hydrochlorothiazide tablets, even if not observed in clinical trials with this product.

Telmisartan:

Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients. 9 %) in placebo controlled trials. The following adverse drug reactions listed below have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.

4). Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: Infections and infestations Not known: Sialadenitis Blood and lymphatic system disorders Not known: Aplastic Anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis, thrombocytopenia Immune system disorders Not known: Anaphylactic reactions, hypersensitivity Endocrine disorders Not known: Diabetes mellitus inadequate control Metabolism and nutrition disorders Not known: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia Psychiatric disorders Not known: Restlessness Nervous system disorders Not known: Light-headedness Eye disorders Not known Xanthopsia, acute angle-closure glaucoma, choroidal effusion Vascular disorders Not known: Vasculitis necrotizing Gastrointestinal disorders Not known: Pancreatitis, stomach discomfort Hepatobiliary disorders Not known: Jaundice hepatocellular, jaundice cholestatic Skin and subcutaneous tissue disorders Not known: Lupus-like syndrome, photosensitivity […]

Pregnancy Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.

6). These patients can be expected to have reduced hepatic clearance for telmisartan. In addition, Telmisartan and Hydrochlorothiazide tablets should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

There is no clinical experience with Telmisartan and Hydrochlorothiazide tablets in patients with hepatic impairment.

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.

3). There is no experience regarding the administration of Telmisartan and Hydrochlorothiazide tablets in patients with recent kidney transplantation. Experience with Telmisartan and Hydrochlorothiazide tablets is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.

Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.

Intravascular hypovolaemia:

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 Telmisartan and Hydrochlorothiazdie tablets.

Dual blockade of the renin-angiotensin-aldosterone system:

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.

by administering telmisartan with other blockers of the renin-angiotensin- aldosterone system) is therefore not recommended. Close monitoring of renal function is advisable if co-administration is considered necessary. g. 8).

Primary aldosteronism:

Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin- angiotensin system. Therefore, the use of Telmisartan and Hydrochlorothiazide tablets are not recommended.

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.

Metabolic and endocrine effects:

Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients under insulin or antidiabetic therapy and telmisartan treatment... Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.

Latent diabetes mellitus may become manifest during thiazide therapy. 5 mg dose contained in Telmisartan and Hydrochlorothiazide tablets, minimal or no effects were reported. 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 hypochloraemic alkalosis).

8). - Hypokalaemia Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia. 5). - Hyperkalaemia Conversely, due […]

1). − Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). 6). − Cholestasis and biliary obstructive disorders. − Severe hepatic impairment. − Severe renal impairment (creatinine clearance < 30 ml/min).

− Refractory hypokalaemia, hypercalcaemia.