Assessment of adverse effects is based on the following frequencies:
Very common (≥ 1/10) Common (≥ 1/100, < 1/10) Uncommon (≥ 1/1000, < 1/100) Rare (≥ 1/10,000, < 1/1,000) Very rare (≥ 1/10,000) Not known (frequency cannot be estimated from the available data) The frequency of adverse effects was estimated on the basis of a prospective, uncontrolled clinical study with 1,369 patients.
With respect to case reports from the spontaneous reporting system, the frequency cannot be determined due to the lack of a real reference value. It is therefore included in the “not known” category “. See the table below. At the stated doses, adverse effects are rare to uncommon and generally disappear after a dose reduction or after discontinuation of the medicinal product.
The following adverse effects may occur, particularly during concomitant administration with other anticholinergic medicinal products Dry mouth, thirst, transient visual disorder (mydriasis, difficulties with accommodation, photosensitivity, slight increase in intraocular pressure), redness and dryness of the skin, bradycardia followed by tachycardia, micturition disorders, constipation and, very rarely, vomiting, dizziness and unsteady gait.
System organ class Uncommon Rare Not known Immune system disorders Hypersensitivity (such as pruritus allergic, erythema, oedema mucosal, dyspnoea) Psychiatric disorders Restlessness Anxiety, depression Hallucinations Nervous system disorders Dizziness, headache, speech disorder Disturbance in attention, coordination abnormal, taste disorder Tremor, paresthesia Eye disorders Accommodation disorder, visual impairment Glaucomatocycliti c crises in angle closure glaucoma Cardiac disorders Tachycardia Arrhythmia, bradycardia Vascular disorders Circulatory collapse, hypotension Gastrointestinal disorders Nausea, abdominal pain, dry mouth Diarrhea, vomiting Musculoskeletal and connective tissue disorders Muscular weakness Renal and urinary disorders Micturition disorder, acute urinary retention in benign prostate hyperplasia General disorders and administration site conditions Fatigue, asthenia Feeling hot 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.