Chemical formula: C₂₀H₂₅NO Molecular mass: 295.426 g/mol
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, 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 |
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