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APO-TELMISARTAN-AMLODIPINE 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: APO-TELMISARTAN-AMLODIPINE (telmisartan/amlodipine tablets) is indicated for: • treatment of mild to moderate essential hypertension for whom combination therapy with telmisartan and amlodipine is appropriate. APO-TELMISARTAN-AMLODIPINE is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). 1.1…
Verbatim from this product's HC label. Tap a section to expand.
10/2023 7 WARNINGS AND PRECAUTIONS 10/2023 2 CONTRAINDICATIONS 05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 7
1 Adverse Reaction Overview Summary of the safety profile The safety and tolerability of telmisartan and amlodipine has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
No additional adverse reactions were identified in clinical trials with the combination telmisartan plus amlodipine compared to the adverse reactions of the monocomponents. Peripheral edema, a recognized dose dependent adverse reaction of the monocomponent amlodipine, was generally observed at a lower incidence in patients who received the telmisartan/amlodipine combination than in those who received amlodipine alone.
Adverse reactions previously reported with one of the monocomponents (telmisartan or amlodipine) may be potential adverse reactions with telmisartan and amlodipine as well, even if not observed in clinical trials or during the post-marketing period.
Therefore, in addition to the reported adverse reactions during the telmisartan and amlodipine development program all adverse reactions reported in patients who received telmisartan or amlodipine monotherapy, have been listed for telmisartan and amlodipine.
APO-TELMISARTAN-AMLODIPINE (telmisartan / amlodipine tablets) Page 16 of 63 Unclassified / Non classifié Combination therapy showed a favourable safety profile, with lower edema rates than amlodipine monotherapies, especially when comparing amlodipine full-dose monotherapy with amlodipine low-dose combinations, which showed at least comparable or better efficacy.
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.
10/2023 2 CONTRAINDICATIONS 05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Special Populations.............................................................................................
1 Pregnant Women ............................................................................................... 2 Breast-Feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 15 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 ..........................................................................
23 9 DRUG INTERACTIONS .................................................................................................... 1 Serious Drug Interactions....................................................................................
2 Drug Interactions Overview ................................................................................ 3 Drug-Behavioural Interactions ............................................................................ 4 Drug-Drug Interactions .......................................................................................
05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 4
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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Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. , hypotension, orthostatic hypotension, syncope) were rare throughout the double-blind treatment period of a randomized, double- dummy, placebo-controlled 4 x 4 factorial design trial, including the initial 2 weeks of first-line combination therapy.
There were no serious cases. Almost all of the events were of mild or moderate intensity, and the majority of patients continued treatment and recovered without requiring therapy. In a single, randomized double-blind placebo controlled, 8-week factorial design comparing free dose combination telmisartan/amlodipine to monotherapy (telmisartan or amlodipine) and placebo, adverse events (AEs) occurred with similar frequency across the treatment groups, with the highest frequency in the telmisartan 80mg/amlodipine 5 mg (T80/A5) group but the incidence of all AEs, in all groups was within 4% of the placebo group.
Three serious adverse events occurred in the T80/A5 group, none of which were felt to be drug related. The three serious adverse events occurred in 3 different patients and included multiple fractures, deep venous thrombosis, and chest pain (see Table 2).
Table 2:
Summary of adverse events by overall treatment groups in the factorial study. T40/A5 n (%) T40/A10 n (%) T80/A5 n (%) T80/A10 n (%) T40 n (%) T80 n (%) A5 n (%) A10 n (%) Placebo n (%) Incidence over entire study: No. 0) 1 Marked laboratory abnormalities or AEs leading to intervention, other than those considered serious 2 A patient may be counted in more than one seriousness criterion T = Telmisartan 40 or 80 mg; A = amlodipine 5 or 10 mg.
8%). Patient frequencies of some common AEs were higher in some combination groups than in the respective component monotherapy groups, but no consistent patterns were apparent (see Table 3). , peripheral edema, headache and fatigue), all drug-related AEs were reported by <1% of patients in any treatment group.
Additional data on long term safety was based on an open-label, limited study, of 6 month up to 8 months duration and no new safety signals were noted.
Table 3:
Adverse events with […]
5 Drug-Food Interactions ....................................................................................... 6 Drug-Herb Interactions ....................................................................................... 7 Drug-Laboratory Test Interactions .......................................................................
34 10 CLINICAL PHARMACOLOGY ........................................................................................... 1 Mechanism of Action ..........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 37 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
41 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 41 PART II: SCIENTIFIC INFORMATION ........................................................................................
42 13 PHARMACEUTICAL INFORMATION ................................................................................ 42 14 CLINICAL TRIALS ............................................................................................................
1 Clinical Trials By Indication.................................................................................. 43 Study Results .................................................................................................................
2 Comparative Bioavailability Studies..................................................................... 46 15 MICROBIOLOGY […]