MYOPRIDIN

5 – 3 mg pridinol 3 times daily The duration of administration is decided by the treating doctor. Administration is independent of meals, with the onset of the effect being faster when the medicinal product is taken before meals. Patients who suffer from hypotension should take the tablets after meals to reduce the risk of fainting.

Children and adolescents No data are available Method of administration For oral use. g. 1 glass of water) and not chewed.

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.

The medicinal product must be used with caution in the elderly, and in patients with severe renal and/or hepatic insufficiency, because higher and/or longer-lasting blood levels must be expected. In patients who suffer from hypotension, the risk of circulatory problems (fainting) may be increased.

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

1 - Glaucoma - Prostate hypertrophy - Syndrome with urinary retention - Gastrointestinal obstructions - Arrhythmia - First trimester of pregnancy