Implicor Adverse Reactions




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Full Prescribing Info
Adverse Reactions
The safety profile of Metoprolol tartrate + Ivabradine (Implicor) presented as follows is based on the known safety profile of the individual components.
Summary of the profile: The most common adverse reactions with ivabradine is luminous phenomena (phosphenes) and bradycardia are dose dependent and related to the pharmacological effect of the medicinal product. The most commonly reported adverse reactions with metoprolol are bradycardia, nightmares, headache, somnolence, insomnia, dizziness, palpitations, orthostatic hypotension, peripheral coldness, Raynaud's disease, dyspnea exertional, nausea, constipation, diarrhea, abdominal pain, vomiting, fatigue and libido disorder.
Tabulated list of adverse reactions: The following undesirable effects have been observed during treatment with ivabradine and metoprolol given separately and ranked under the MedRA classification by body system, and under heading of frequency using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See Tables A and B.)

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Description of selected adverse reactions: Luminous phenomena (phosphenes) were reported by 14.5% of patients, described as a transient enhanced brightness in a limited area of the visual field. They are usually triggered by sudden variations in light intensity. Phosphenes may also be described as a halo, image decomposition (stroboscopic or kaleidoscopic effects), colored bright lights, or multiple images (retinal persistency). The onset of phosphenes is generally within the first two months of treatment after which they may occur repeatedly. Phosphenes were generally reported to be of mild to moderate intensity. All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment. Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation. 0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
In the SIGNIFY study, atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group. In a pooled analysis of all the Phase II/III double blind controlled clinical trials with a duration of at least 3 months including more than 40,000 patients, the incidence of atrial fibrillation was 4.86% in ivabradine treated patients compared to 4.08% in controls, corresponding to a hazard ratio of 1.26, 95% CI [1.15-1.39].
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