ALEMBIC-TELMISARTAN

1 Dosing Considerations The antihypertensive effect is 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. 2 Recommended Dose and Dosage Adjustment Treatment of Essential Hypertension: The recommended dose of Alembic-Telmisartan (telmisartan) is 80 mg once daily.

Patients with renal Impairment No initial dosing adjustment is necessary 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.

Patients with hepatic Impairment For patients with hepatic impairment a starting dose of 40 mg is recommended and should be administered with caution (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).

Risk Reduction of Cardiovascular Morbidity:

The recommended dose is 80 mg once daily in patients 55 years or older at high risk for a cardiovascular event. It is not known whether doses lower than 80 mg of telmisartan are effective in preventing cardiovascular morbidity. It can be administered with other antihypertensive agents except an ACEI.

______________________________________________________________________________ Alembic-Telmisartan Product Monograph Page 6 of 39 Unclassified / Non classifié When initiating telmisartan therapy at this dose, monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.

Drug discontinuation If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, Alembic-Telmisartan should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears.

When pregnancy is detected, Alembic-Telmisartan should be discontinued as soon as possible. 4 Administration Alembic-Telmisartan tablets are for once-daily oral administration and should be swallowed whole with liquid. Alembic-Telmisartan can be taken with or without food.

5 Missed Dose Alembic-Telmisartan should be taken at the same time each day, preferably in the morning. However, if a dose is missed during the day, the next dose should be continued at the usual time. Do not double dose.

9%) in controlled clinical trials. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of telmisartan in patients treated for prevention of cardiovascular morbidity and mortality was consistent with that obtained in hypertensive patients.

2 Clinical Trial Adverse Drug 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. Telmisartan has been evaluated for safety in 27 clinical trials involving 7968 patients treated for hypertension.

Of these 7968 patients, 5788 patients were treated with telmisartan monotherapy including 1058 patients treated for ≥1 year and 1395 patients treated in placebo- controlled trials. The following potentially serious adverse events have been reported rarely with telmisartan in controlled clinical trials: syncope and hypotension.

1% in telmisartan-treated patients. ______________________________________________________________________________ Alembic-Telmisartan Product Monograph Page 12 of 39 Unclassified / Non classifié The safety profile of telmisartan in patients treated for risk reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.

In this program, 11% of patients treated with telmisartan discontinued study medication due to adverse events. The most common adverse events that led to discontinuation were dizziness, hypotension and headache. The adverse drug reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports.

07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ....................................................................................................................

4 2 CONTRAINDICATIONS ........................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................

5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 6 5 OVERDOSAGE .....................................................................................................................

6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING......................................... 6 7 WARNINGS AND PRECAUTIONS........................................................................................... 1 Special Populations................................................................................................

1 Pregnant Women............................................................................................... 2 Breast-feeding .................................................................................................. 3 Pediatrics ..........................................................................................................

4 Geriatrics .......................................................................................................... 1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Drug Reactions ....................................................................

07/2023 7 WARNINGS AND PRECAUTIONS 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS .................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................

4