Adverse reactions : תופעות לוואי

4.8 Undesirable effects
As with all cholinergic products, Mestinon dragees 60 mg may have unwanted functional effects on the autonomic nervous system.
Muscarinic-like undesirable effects may include: Nausea, vomiting, diarrhoea, abdominal cramps, gastrointestinal hypermotility as well as increased bronchial secretion, hypersalivation, bradycardia and miosis.
The primary nicotinergic effects are muscle cramps, fasciculations and muscle weakness.

The following categories are used for the frequencies of adverse reactions: -     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)

The following adverse reactions have been observed:

Immune system disorders
Frequency not known:         Drug hypersensitivity
Psychiatric illnesses
In the presence of organic brain changes, psychopathological symptoms through to psychosis may occur during the treatment with pyridostigmine bromide; existing symptoms may intensify.

Nervous system disorders
Frequency not known:         Syncope

Eye disorders
Frequency not known:         Miosis, increased lacrimation, accommodation disorders (e.g.
blurred vision)
Cardiac disorders
Frequency not known:         Arrhythmia (including bradycardia, tachycardia, AV block), Prinzmetal angina

Vascular disorders
Frequency not known:         Flushing, hypotension

Respiratory, thoracic and mediastinal disorders
Frequency not known:        Increased bronchial secretion combined with bronchial obstruction; asthmatics may experience respiratory symptoms

Gastrointestinal disorders
Frequency not known:         Nausea, vomiting, diarrhoea, gastrointestinal hypermotility, hypersalivation, abdominal symptoms (e.g. malaise, pain, cramps)

Skin and subcutaneous tissue disorders
Rare:                      Skin rash (usually subsides after the medication is discontinued.
Medicines containing bromide should not be used).
Frequency not known:       Hyperhidrosis, urticaria

Musculoskeletal and connective tissue disorders
Frequency not known:       Increased muscle weakness, fasciculation (muscle twitching), tremor, muscle cramps or hypotonia

Renal and urinary disorders
Frequency not known:        Increased urge to urinate

Side effects are generally dose-related:
In the course of treatment with Mestinon dragees 60 mg (mostly with oral doses exceeding 150-200 mg pyridostigmine bromide/day) the following side effects in particular may arise: attacks of sweating, salivation, lacrimation, increased bronchial secretion, nausea, vomiting, diarrhoea, abdominal cramps (due to gastrointestinal hypermotility), increased urge to urinate, muscle tremors, muscle cramps, muscle weakness or accommodation disorders (see section 4.9). After taking higher doses (500-600 mg pyridostigmine bromide/day orally), bradycardia as well as adverse cardiovascular reactions and hypotension may occur. Patients with chronic obstructive pulmonary disease (COPD) may also exhibit pulmonary obstruction in addition to increased bronchial secretion. Asthmatics may experience respiratory symptoms.

The side effects listed may also be signs of an overdose or a cholinergic crisis. The cause of the side effects must therefore be clarified (see section 4.9).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il