Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mibe pharma UK Ltd, 4 Coleman Street, 6th Floor, London, EC2R 5AR, United Kingdom
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.
Myopridin potentiates the effect of anticholinergics such as atropine (see section 4.8).
This medicinal product is contraindicated in the first trimester of pregnancy.
During the further course of pregnancy, the medicinal product may only be used after a careful medical consideration, under medical supervision and only if absolutely necessary.
There are no data on the passage of pridinol intohuman milk.
Use during breastfeeding should be avoided.
No data are available on the influence of pridinol on human fertility.
Due to potential anticholinergic effects on eyesight (see section 4.8), greater caution is advised when driving vehicles and operating machines.
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 | Glaucomatocyclitic 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 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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