TELMISARTAN/HYDROCHLOROTHIAZIDE GLENMARK

Posology Telmisartan/Hydrochlorothiazide 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. 4). 5 mg once daily. Telmisartan/Hydrochlorothiazide is not indicated in patients with severe hepatic impairment. 4). Elderly No dosage adjustment is necessary.

Paediatric population The safety and efficacy of Telmisartan/Hydrochlorothiazide in children and adolescents aged below 18 have not been established. No data are available. Method of administration Telmisartan/Hydrochlorothiazide 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/Hydrochlorothiazide should be kept in the sealed blister due to the hygroscopic property of the tablets. 6).

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 reactions reported with Telmisartan/Hydrochlorothiazide 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 adverse reactions 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/Hydrochlorothiazide. 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 erythematosus1 Metabolism and nutrition disorders 13 Uncommon: Rare: Psychiatric disorders Uncommon: Rare: Nervous system disorders Common: Uncommon: Rare: Eye disorders Hypokalaemia Hyperuricaemia, hyponatraemia Anxiety Depression Dizziness Syncope, paraesthesia Insomnia, sleep disorders Rare: Visual disturbance, vision blurred Ear and labyrinth disorders Uncommon: Vertigo Cardiac disorders 14 Uncommon: Tachycardia, arrhythmias Vascular disorders Uncommon: Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon: Rare: Gastrointestinal disorders Uncommon: Rare: Hepatobiliary disorders Dyspnoea Respiratory distress (including pneumonitis and pulmonary oedema) Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting, gastritis Rare: Abnormal hepatic function/liver disorder2 Skin and subcutaneous tissue disorders Rare: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria Muscoloskeletal, connective tissue and bone disorders Uncommon: Rare: Back pain, muscle spasms, myalgia Arthralgia, muscle cramps, pain in limb Reproductive system and breast disorders Uncommon: Erectile dysfunction General disorders and administration site conditions Uncommon: Rare: Investigations Uncommon: Rare: Chest pain Influenza-like illness, pain Blood uric acid increased Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions” Additional information on individual components Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Telmisartan/Hydrochlorothiazide, even if not observed in clinical trials with this product.

4. Special warnings and special precautions for use 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). 3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. In addition, Telmisartan/Hydrochlorothiazide 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/Hydrochlorothiazide 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/Hydrochlorothiazide in patients with recent kidney transplantation. Experience with Telmisartan/Hydrochlorothiazide is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric 4 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/Hydrochlorothiazide. 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. 3 • 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. 1).