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SOLIFENACIN SUCCINATE/TAMSULOSIN HYDROCHLORIDE TORRENT is a brand name for Tamsulosin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy.
Verbatim from this product's MHRA label. Tap a section to expand.
4 mg) once daily taken orally with or without food. 4 mg). The tablet must be swallowed whole, intact without biting or chewing. Do not crush the tablet. Patients with renal impairment The effect of renal impairment on the pharmacokinetics of solifenacin succinate/tamsulosin hydrochloride has not been studied.
2). solifenacin succinate/tamsulosin hydrochloride, can be used in patients with mild to moderate renal impairment (creatinine clearance >30 mL/min). 4). Patients with hepatic impairment The effect of hepatic impairment on the pharmacokinetics of solifenacin succinate/tamsulosin hydrochloride has not been studied.
2). solifenacin succinate/tamsulosin hydrochloride, can be used in patients with mild hepatic impairment (Child-Pugh score ≤7). 4 mg). 3). 4 mg). g. 5). Paediatric population There is no relevant indication for use of solifenacin succinate/tamsulosin hydrochloride in children and adolescents.
Other brands of Tamsulosin in United Kingdom.
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Summary of the safety profile Solifenacin succinate/tamsulosin hydrochloride may cause anticholinergic undesirable effects of, in general, mild to moderate severity. 4%). 5%). 3%, uncommon) is the most serious adverse drug reaction that has been observed during treatment with solifenacin succinate/tamsulosin hydrochloride in clinical studies.
Tabulated list of adverse reactions In the table below the 'solifenacin succinate/tamsulosin hydrochloride frequency' column reflects adverse drug reactions that have been observed during the double-blind clinical studies performed for the development of solifenacin succinate/tamsulosin hydrochloride (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 that may also occur when receiving solifenacin succinate/tamsulosin hydrochloride (some of these have not been observed during the clinical development program of solifenacin succinate/ tamsulosin hydrochloride).
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).
4 mg# Stevens-Johnson syndrome Very rare Erythema multiforme Very rare* Not known* Exfoliative dermatitis Not known* Not known* Musculoskeletal and connective tissue disorders Muscular weakness Not known* Renal and urinary disorders Urinary retention*** Uncommon Rare Difficulty in micturition Uncommon Renal impairment Not known* Reproductive system and breast disorders Ejaculation disorders including retrograde ejaculation and ejaculation failure Common Common Priapism Very rare General disorders and administration site conditions Fatigue Common Uncommon Peripheral oedema Uncommon Asthenia Uncommon #: The ADRs from solifenacin and tamsulosin included in this table are the ADRs listed in the summary of product characteristics of both products.
*: from post-marketing reporting. Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of solifenacin or tamsulosin and their causation cannot be reliably determined.
**: from post-marketing reporting, observed during cataract and glaucoma surgery. 4. Long–term safety of solifenacin succinate/tamsulosin hydrochloride The profile of undesirable effects seen with treatment up to 1 year was similar to that observed in the 12-week studies.
The combination of solifenacin succinate and tamsulosin hydrochloride is well- tolerated and no specific adverse reactions have been associated with long-term use. 4. Older people The therapeutic indication of solifenacin succinate/tamsulosin hydrochloride,, moderate to severe storage symptoms (urgency, […]
solifenacin succinate/tamsulosin hydrochloride, should be used with caution in patients with: - severe renal impairment, - risk of urinary retention, - gastrointestinal obstructive disorders, - risk of decreased gastrointestinal motility, - hiatus hernia/gastroesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis, - autonomic neuropathy.
The patient should be examined in order to exclude the presence of other conditions, which can cause similar symptoms to benign prostatic hyperplasia. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with solifenacin succinate/tamsulosin hydrochloride, is initiated.
If a urinary tract infection is present, appropriate antibacterial therapy should be started. QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre- existing long QT syndrome and hypokalaemia, who are treated with solifenacin succinate.
Angioedema with airway obstruction has been reported in some patients on solifenacin succinate and tamsulosin. If angioedema occurs, solifenacin succinate/tamsulosin hydrochloride, should be discontinued and not restarted. Appropriate therapy and/or measures should be taken.
Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate/tamsulosin hydrochloride, should be discontinued and appropriate therapy and/or measures should be taken.
As with other alpha1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Patients starting treatment with solifenacin succinate/tamsulosin hydrochloride, should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have disappeared.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after the operation.
Therefore, the initiation of therapy with solifenacin succinate/tamsulosin hydrochloride, in patients for whom cataract or glaucoma surgery is scheduled is not recommended. Discontinuing treatment with solifenacin succinate/tamsulosin hydrochloride 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not been established.
During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with solifenacin succinate/tamsulosin hydrochloride in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
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5), - Patients with severe gastrointestinal conditions (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and patients at risk for these conditions, - Patients with a history of orthostatic hypotension.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.