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ALEMBIC-TELMISARTAN/HCTZ is a brand name for Telmisartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Alembic-Telmisartan / HCTZ (80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated for: • treatment of mild to moderate essential hypertension in patients in whom combination therapy with telmisartan and hydrochlorothiazide is considered appropriate. Alembic-Telmisartan / HCTZ (80 mg telmisartan/25 mg…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 02/2025 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery 02/2025 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 02/2025 7 WARNINGS AND PRECAUTIONS, Renal 02/2025 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 02/2025 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 ....................................................................... 4 1 INDICATIONS ........................................................................................................................
1 Pediatrics ..................................................................................................................... 2 Geriatrics .....................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................................
5 4 DOSAGE AND ADMINISTRATION........................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE ....................................................................................................................... 7
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 Alembic-Telmisartan / HCTZ Product Monograph Page 18 of 75 Protected B / Protégé B 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.
5 mg of telmisartan/hydrochlorothiazide to telmisartan 80 mg alone. 8 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.
, Driving and Operating Machinery 02/2025 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 02/2025 7 WARNINGS AND PRECAUTIONS, Renal 02/2025 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 02/2025 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 ....................................................................... 4 1 INDICATIONS ........................................................................................................................
1 Pediatrics ..................................................................................................................... 2 Geriatrics .....................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................................
5 4 DOSAGE AND ADMINISTRATION........................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
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, Alembic-Telmisartan / HCTZ Product Monograph Page 5 of 75 Protected B / Protégé B STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. 1Pregnant Women). 2 Breast-feeding women).
• Patients with anuria due to the presence of hydrochlorothiazide. • Patients with the rare hereditary condition of fructose intolerance (HFI). 88 mg of mannitol per maximum recommended daily dose. o Meglumine: Alembic-Telmisartan / HCTZ contains 24 mg meglumine per maximum recommended daily dose.
, galactosaemia, the Lapp Lactase deficiency or glucose-galactose malabsorption. 4 mg of lactose monohydrate in the dose strength of 80/25 mg.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Telmisartan in Canada.
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Alembic-Telmisartan / HCTZ Product Monograph Page 20 of 75 Protected B / Protégé B Central and Peripheral Nervous System: Vertigo.
Gastro-intestinal System:
Dyspepsia, gastritis, gastro-intestinal disorder.
Metabolic and Nutritional System:
Hypokalaemia, loss of diabetic control, hyperuricaemia.
Musculo-Skeletal System:
Myalgia, arthralgia.
Nervous System Disorders:
Sleep disorder.
Psychiatric System:
Anxiety.
Respiratory System:
Bronchitis, sinusitis, respiratory distress, pneumonitis. Reproductive system and breast disorders: erectile dysfunction.
Skin and Appendages System:
Eczema, skin disorder.
Urinary System:
Urinary tract infection. 5 mg) used in combination discontinued due to hypotension. Adverse events occurred at approximately the same rates in men and women, older and younger patients and black and non-black patients. Abnormal Hematologic and Clinical Chemistry Findings In controlled trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of telmisartan and hydrochlorothiazide in combination.
8% No patient discontinued treatment due to an increase in BUN. 4% No patient discontinued treatment due to an increase in creatinine. 2% Changes in hemoglobin were not considered clinically significant and there were no discontinuations due to anemia.
6% Changes in hematocrit were not considered clinically significant and there were no discontinuations due to anemia.
Liver function Tests:
Occasional elevations of liver enzymes and/or serum bilirubin have occurred. No telmisartan/hydrochlorothiazide treated patients discontinued therapy due to abnormal liver function. Serum Electrolytes: see 7 WARNINGS AND PRECAUTIONS.
Telmisartan Additional side effects were reported in clinical trials with telmisartan in the indication hypertension or in patients 50 years or older at high risk of cardiovascular events. Telmisartan has been evaluated for safety in 27 clinical trials involving 7968 patients.
Of these 7968 patients, 5788 patients were treated with telmisartan […]
7 5 OVERDOSAGE ....................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..........................................
8 7 WARNINGS AND PRECAUTIONS ............................................................................................ 1 Special Populations ...................................................................................................
1 Pregnant Women ................................................................................................... 2 Breast-feeding ........................................................................................................
3 Pediatrics ................................................................................................................ 4 Geriatrics ................................................................................................................
17 Alembic-Telmisartan / HCTZ Product Monograph Page 3 of 75 Protected B / Protégé B 8 ADVERSE REACTIONS .......................................................................................................... 1 Adverse Reaction Overview.......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................. 3 Less Common Clinical Trial Adverse Reactions .......................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ................................................................................ 30 9 DRUG INTERACTIONS..........................................................................................................
1 Serious Drug Interactions .......................................................................................... 2 Drug Interactions Overview .......................................................................................
3 Drug-Behavioural Interactions................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions ............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 41 10 CLINICAL PHARMACOLOGY ...............................................................................................
1 Mechanism of Action............................................................................................... 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 44 11 STORAGE, STABILITY AND DISPOSAL .................................................................................
47 12 SPECIAL HANDLING INSTRUCTIONS................................................................................... 47 13 PHARMACEUTICAL INFORMATION....................................................................................
48 14 CLINICAL TRIALS ................................................................................................................ 1 Clinical Trials by Indication ......................................................................................
2 Comparative Bioavailability Studies […]