Tamsoli Adverse Reactions

Summary of the safety profile: Tamsoli may cause anticholinergic undesirable effects of, in general, mild to moderate severity. The most frequently reported adverse reactions during the clinical studies performed for the development of combination of tamsulosin and solifenacin were dry mouth (9.5%), followed by constipation (3.2%) and dyspepsia (including abdominal pain; 2.4%). Other common undesirable effects are dizziness (including vertigo; 1.4%), vision blurred (1.2%), fatigue (1.2%), and ejaculation disorder (including retrograde ejaculation; 1.5%). Acute urinary retention (0.3%, uncommon) is the most serious adverse drug reaction that has been observed during treatment with combination of tamsulosin and solifenacin in clinical studies.
Tabulated list of adverse reactions: In the table as follows the 'combination of tamsulosin and solifenacin frequency' column reflects adverse drug reactions that have been observed during the double-blind clinical studies performed for the development of combination of tamsulosin and solifenacin (based on reports of treatment-related adverse events, which have been reported by at least two patients and occurred with a frequency higher than for placebo in the double-blind studies).
The columns 'solifenacin frequency' and 'tamsulosin frequency' reflect adverse drug reactions (ADRs) previously reported with one of the individual components (as presented in the Summary of Product Characteristics (SmPCs) of solifenacin 5 and 10 mg and tamsulosin 0.4 mg respectively) that may also occur when receiving combination of tamsulosin and solifenacin (some of these have not been observed during the clinical development program of combination of tamsulosin and solifenacin).
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). (See Tables A and B.)


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Long-term safety of combination of tamsulosin and solifenacin: The profile of undesirable effects seen with treatment up to 1 year was similar to that observed in the 12-week studies. The product is well-tolerated and no specific adverse reactions have been associated with long-term use.
Description of selected adverse reactions: For urinary retention see Precautions.
Older people: The therapeutic indication of Tamsoli, moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with BPH, is a disease affecting elderly men. The clinical development of combination of tamsulosin and solifenacin has been performed in patients 45 to 91 years of age, with an average age of 65 years. Adverse reactions in the elderly population were similar to the younger population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions.