AURO-TELMISARTAN HCTZ

). 1 Pediatrics • Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of telmisartan and hydrochlorothiazide tablets in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics • Geriatrics (> 65 years of age): No dosage adjustment is necessary. It should be recognized, however, that greater sensitivity in some older individuals cannot be ruled out. 4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin System (RAS) with ARBs, ACEIs or aliskiren-containing drugs).

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the

5 mg). A dose-relationship of undesirable effects was not established, and they showed no correlation with gender, age, or race of the patients. The combination of telmisartan and hydrochlorothiazide has been evaluated for safety in 1725 patients including 716 treated for over six months and 420 for over one year.

In clinical trials with the individual components used in combination, no unexpected adverse events have been observed. Adverse experiences have been limited to those that have been previously reported with telmisartan and hydrochlorothiazide monotherapy.

In general, treatment with the combination was well tolerated; most adverse experiences were mild and transient in nature and did not require discontinuation of therapy. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

5 mg telmisartan/hydrochlorothiazide combination, irrespective of their causal relationship, are presented in the following table. This table includes the results of two pivotal studies. One study, a factorial design, compared the use of various doses of telmisartan tablets and hydrochlorothiazide tablets in combination to telmisartan alone, hydrochlorothiazide alone and placebo.

8 Pharyngitis Upper Respiratory Tract infection HCTZ = hydrochlorothiazide Note: Telmisartan 80 mg open label treatment is not included in the Telmisartan 80 mg column Additional adverse reactions reported in clinical trials with telmisartan plus hydrochlorothiazide are listed below according to system organ class: Body as a Whole: Allergy, leg pain.

4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin System (RAS) with ARBs, ACEIs or aliskiren-containing drugs). • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, Auro-Telmisartan HCTZ Product Monograph Page 5 of 66 COMPOSITION AND PACKAGING section of the product monograph. 1 Pregnant Women). 2 Breast-feeding women). • Patients with anuria due to the presence of hydrochlorothiazide.

• Patients with the rare hereditary condition of fructose intolerance (HFI). 18 mg of mannitol per maximum recommended daily dose. , galactosaemia, the Lapp Lactase deficiency or glucose-galactose malabsorption. 5 mg and 80 mg/25 mg. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, angiotensin II receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus.

1 Special Populations). 5 mg components as described below. 2 Recommended Dose and Dosage Adjustment • Auro-Telmisartan HCTZ (telmisartan/hydrochlorothiazide) is not for initial therapy. 5 mg) once daily. 5 mg), may be switched to Auro-Telmisartan HCTZ (telmisartan 80 mg/hydrochlorothiazide 25 mg) once daily.

Telmisartan Monotherapy The recommended dose of telmisartan is 80 mg once daily. The antihypertensive effect is Auro-Telmisartan HCTZ Product Monograph Page 6 of 66 present within 2 weeks and maximal reduction is generally attained after four weeks.

If additional blood pressure reduction is required, a thiazide diuretic may be added. No initial dosing adjustment is necessary for elderly patients or for patients with renal impairment but greater sensitivity in some older individuals cannot be ruled out.

Markedly reduced telmisartan plasma levels were observed in patients on hemodialysis. Diuretic Treated Patients In patients receiving diuretics, telmisartan therapy should be initiated with caution, since these patients may be volume depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.

4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin System (RAS) with ARBs, ACEIs or aliskiren-containing drugs). • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, Auro-Telmisartan HCTZ Product Monograph Page 5 of 66 COMPOSITION AND PACKAGING section of the product monograph. 1 Pregnant Women). 2 Breast-feeding women). • Patients with anuria due to the presence of hydrochlorothiazide.

• Patients with the rare hereditary condition of fructose intolerance (HFI). 18 mg of mannitol per maximum recommended daily dose. , galactosaemia, the Lapp Lactase deficiency or glucose-galactose malabsorption. 5 mg and 80 mg/25 mg.