Solif

Solicare is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

The recommended dose for adults and the elderly
: Solifenacin Succinate 5 mg once daily. If needed, the dose may be increased to Solifenacin Succinate 10 mg once daily.
Use in children
: Safety and effectiveness in children have not yet been established. Therefore, Solifenacin Succinate should not be used in children.

Due to the pharmacological effect of Solicare, it may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reactionwith Solicare is dry mouth. It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients treated with 10 mg once daily and in 4% of placebo-treated patients. The severity of dry mouth was generally mild and only occasionally led to discontinuation of treatment. In general,medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with Solicare completed the full study period of 12 weeks treatment.
Gastrointestinal disorders: very common- dry mouth, common-constipation, nausea, dyspepsia, abdominal pain, uncommon- gastroesophageal reflux diseases, dry throat, rare- colonic obstruction, faecal impaction, very rare- vomiting.
Infections and infestations: uncommonurinary tract infection, cystitis.
nervous system disorders: uncommon- somnolence, dysgeusia, very rare-dizziness, headache.
psychiatric disorders: very rare- hallucinations.
eye disorders: common- blurred vision, uncommon- dry eyes.
General disorders and administration site conditions: uncommon- fatigue, peripheral oedema.
Respiratory, thoracic and mediastinal disorders: uncommon nasal dryness.
skin and subcutaneous tissue disorders: uncommon- dry skin, very rare- pruritus, rash, urticaria.
renal and urinary disorders: uncommon- difficulty in micturition, rare- urinary retention.

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solicare. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solicare should be used with caution in patients with: clinically significant bladder outflow obstruction at risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, severe renal impairment (creatinine clearance 30 ml/min), moderate hepatic impairment (Child-Pugh score of 7 to 9) and doses should not exceed 5 mg for these patients. Caution should be taken in concomitant use of a potent CYP3A4 inhibitor e.g. Ketoconazole, hiatus hernia/ gastroesophageal reflux and/or who are concurrently taking medicinal products (such as Bisphosphonates) that can cause or exacerbate oesophagitis, autonomic neuropathy. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. The maximum effect of Solicare can be determined after 4 weeks at the earliest.

Solifenacin is a competitive muscarinic receptor antagonist. It has the highest affinity for M3, M1, and M2 muscarinic receptors. 80% of the muscarinic receptors in the bladder are M2, while 20% are M3. Solifenacin's antagonism of the M3 receptor prevents contraction of the detrusor muscle, while antagonism of the M2 receptor may prevent contraction of smooth muscle in the bladder.