APONORM XL

Posology The recommended daily doses are as follows:

Adults: One capsule daily in adults with severe symptoms of OAB or without sufficient response to 30 mg modified-release capsules. The maximum daily dose is one capsule daily. 2).

Paediatric population:

Due to a lack of data, this product should not be used in children. 1). 2). 2). Use in hepatic impairment In patients with mild impaired hepatic function, there is no need for dose adjustment; however, treatment should proceed with caution.

2). Method of administration Capsules for oral use. Do not crush or chew the capsules. 2). Accordingly, there is no particular recommendation for the intake of Aponorm XL 45 mg in relation to food.

Within each system organ class, the undesirable effects 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).

All undesirable effects are transient and recede after a dose reduction or termination of the therapy after maximum 1-4 days. Immune system disorders Rare: hypersensitivity Psychiatric disorders Very rare: restlessness, confusion Not known: hallucination Nervous system disorders Common: headache Uncommon: tremor, dizziness, dysgeusia Not known: speech disorder Eye disorders Common: accommodation disorder, visual impairment Cardiac disorders Rare: tachycardia Very rare: palpitation Vascular disorders Uncommon: decreased blood pressure with drowsiness, flushing Gastrointestinal disorders Very common: dry mouth Common: constipation, abdominal pain, dyspepsia Uncommon: nausea/vomiting Skin and subcutaneous tissue disorders Uncommon: pruritus Rare: rash Renal and urinary disorders Uncommon: urinary retention, bladder and urethral symptoms General disorders and administration site conditions Common: fatigue During long-term therapy hepatic enzymes should be monitored, because reversible changes of liver enzymes might occur in rare cases.

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 via the national reporting system listed in Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2) Symptoms of the following diseases may be aggravated following administration of the drug: - severe congestive heart failure (NYHA IV) - prostatic enlargement - hiatus hernia with reflux oesophagitis - cardiac arrhythmia - tachycardia Angle-closure glaucoma Propiverine, like other anticholinergics, induces mydriasis.

Therefore, the risk to induce acute angle-closure glaucoma in individuals predisposed with narrow angles of the anterior chamber may be increased. Drugs of this class, including propiverine, have been reported to induce or precipitate acute angle-closure glaucoma.

g. urinary tract infections, malignancy), should be ruled out prior to treatment. Monitoring is recommended especially in first few months after initiating therapy or increasing the dose; consider discontinuing therapy or reducing the dose if serious anticholinergic CNS effects develop.

This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 - obstruction of the bowel - significant degree of bladder outflow obstruction where urinary retention may be anticipated - myasthenia gravis - intestinal atony - severe ulcerative colitis - toxic megacolon - uncontrolled angle closure glaucoma - moderate or severe hepatic impairment - severe renal impairment (creatinine clearance < 30 ml/min) - tachyarrhythmias