DARIFENACIN ARISTO

5 mg daily. After 2 weeks of starting therapy, patients should be reassessed. For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response. 5 mg daily. After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety.

2). Paediatric population Darifenacin Aristo is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy. Renal impairment No dose adjustment is required in patients with impaired renal function.

2). Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A). 2). 2). 3). 5 mg dose. The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated.

However, caution should be exercised. 5 mg daily. The dose may be titrated to 15 mg daily to obtain an improved clinical response provided the dose is well tolerated. However, caution should be exercised. Method of administration Darifenacin Aristo is for oral use.

The tablets should be taken once daily with liquid. They can be taken with or without food, and must be swallowed whole and not chewed, divided or crushed.

9% for placebo). Anticholinergic effects, in general, are dose-dependent. 3% for placebo, for dry mouth and constipation, respectively). Tabulated list of adverse reactions The adverse reactions are ranked 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 <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 5 mg and 15 mg, adverse reactions were reported as presented in the table above. Most of the adverse reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.

Treatment with Darifenacin Aristo may possibly mask symptoms associated with gallbladder disease. However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.

5 mg and 15 mg decreased during the treatment period up to 6 months. A similar trend is also seen for the discontinuation rates. Post-marketing experience The following events have been reported in association with darifenacin use in worldwide post-marketing experience: generalised hypersensitivity reactions including angioedema, depressed mood/mood alterations, hallucination.

Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events cannot be estimated from the available data. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Darifenacin Aristo should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or gastrointestinal obstructive disorders, such as pyloric stenosis.

3). Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Darifenacin Aristo. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Darifenacin Aristo should be used with caution in patients with risk of decreased gastrointestinal motility, gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis.

Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor over activity. Caution should be used when prescribing antimuscarinics to patients with pre-existing cardiac diseases. 8).

1. - Urinary retention. - Gastric retention. - Uncontrolled narrow-angle glaucoma. - Myasthenia gravis. - Severe hepatic impairment (Child Pugh C). - Severe ulcerative colitis. - Toxic megacolon. 5).