SANDOZ PERINDOPRIL ERBUMINE/ INDAPAMIDE HD

1 Dosing considerations Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD are not for initial therapy and the dose should be determined by titration of the individual components. If during maintenance therapy dosage adjustment is necessary, it is advisable to use individual drugs (see 4 DOSAGE AND ADMINISTRATION).

2 Recommended Dose and Dosage Adjustment Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation and salt restriction. The dosage of other antihypertensive agents being used with Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD may need to be adjusted.

The presence of food in the gastrointestinal tract reduces the bioavailability of perindoprilat. Pediatrics (<18 years) Health Canada has not authorized an indication for pediatric use. Dosage of Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD (perindopril erbumine/ indapamide) must be individualized and adjustment is required in the elderly, and in case of renal impairment.

The elderly Treatment should be initiated after considering blood pressure response and renal function. 73m2) (see 2 CONTRAINDICATIONS). 73m2) (see 2 CONTRAINDICATIONS). 25 mg) should start with the adequate dosage of the combination of the individual components.

Caution should be exercised especially in the elderly patients as greater sensitivity in the elderly cannot be ruled out. 73m2, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium levels.

4 Administration Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD should be taken once daily, preferably in the morning before a meal (see 9 DRUG INTERACTIONS – Drug-Food Interactions).

Sandoz Perindopril Erbumine / Indapamide LD is taken as 1 tablet per day as a single dose. 25 mg). 25 mg) or Sandoz Perindopril Erbumine / Indapamide HD may be substituted if the titrated doses and dosing schedule can be achieved by the fixed combination (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS).

5 Missed Dose If a dose is missed, a double dose should not be taken; the patient should carry on with the next dose at the normal time.

). Treatment of progressive angioedema should be aggressive. Failing a rapid response to medical therapy, mechanical methods to secure an airway should be undertaken before massive oedema complicates oral or nasal intubation. Patients who respond to medical treatment should be observed carefully for a possible rebound phenomenon.

The onset of angioedema associated with the use of ACE inhibitors may be delayed for weeks or months. Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD Page 10 of 76 Patients may have multiple episodes of angioedema with long symptom-free intervals.

Angioedema may occur with or without urticaria. The incidence of angioedema during ACE inhibitor therapy has been reported to be higher in black than in non-black patients. There are reports that switching a patient to another ACE inhibitor could be followed by a recurrence of angioedema.

Because of the potential severity of this rare event, another ACE inhibitor should not be used in patients with a history of angioedema (see 2 CONTRAINDICATIONS). Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see 2 CONTRAINDICATIONS).

g. g. g. swelling of the airways or tongue, with or without respiratory impairment). Caution should be used when initiating ACE inhibitor therapy in patients already taking a mTOR, DPP-IV or NEP inhibitor or vice versa (see

, Special Populations, Breast- feeding). 73m2). - Patients with hypokalemia. - Patients with severe hepatic impairment. - Patients with hepatic encephalopathy. - Combination with anti-arrhythmic agents causing Torsade de pointes (see 9 DRUG INTERACTIONS – Drug-Drug Interactions).

- Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the total lactase deficiency as Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD contain lactose (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/ Resistance).

- Combination with sacubitril/valsartan due to an increased risk of angioedema. Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan.

73m2) (see 7 WARNINGS and PRECAUTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin- System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs).

- Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces (see 9 DRUG INTERACTIONS), - Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney (see 7 WARNINGS AND PRECAUTIONS, Renal).

3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus. Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD Page 6 of 76 • When pregnancy is detected, Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD should be discontinued as soon as possible.

1 Dosing considerations Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD are not for initial therapy and the dose should be determined by titration of the individual components. If during maintenance therapy dosage adjustment is necessary, it is advisable to use individual drugs (see 4 DOSAGE AND ADMINISTRATION).

2 Recommended Dose and Dosage Adjustment Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation and salt restriction. The dosage of other antihypertensive agents being used with Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD may need to be adjusted.

The presence of food in the gastrointestinal tract reduces the bioavailability of perindoprilat. Pediatrics (<18 years) Health Canada has not authorized an indication for pediatric use. Dosage of Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD (perindopril erbumine/ indapamide) must be individualized and adjustment is required in the elderly, and in case of renal impairment.

The elderly Treatment should be initiated after considering blood pressure response and renal function. 73m2) (see 2 CONTRAINDICATIONS). 73m2) (see 2 CONTRAINDICATIONS). 25 mg) should start with the adequate dosage of the combination of the individual components.

Caution should be exercised especially in the elderly patients as greater sensitivity in the elderly cannot be ruled out. 73m2, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium levels.

4 Administration Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD should be taken once daily, preferably in the morning before a meal (see 9 DRUG INTERACTIONS – Drug-Food Interactions).

Sandoz Perindopril Erbumine / Indapamide LD is taken as 1 tablet per day as a single dose. 25 mg). 25 mg) or Sandoz Perindopril Erbumine / Indapamide HD may be substituted if the titrated doses and dosing schedule can be achieved by the fixed combination (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS).

5 Missed Dose If a dose is missed, a double dose should not be taken; the patient should carry on with the next dose at the normal time. 5 OVERDOSAGE The most likely adverse event in case of Sandoz Perindopril Erbumine / Indapamide LD, Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril Erbumine / Indapamide HD […]

05/2023 7 WARNING AND PRECAUTIONS 05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................

2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................

3 1 INDICATIONS ................................................................................................................ 1 Pediatrics (<18 years of age .....................................................................................

2 Geriatrics (>65 years of age) .................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................

4