Section 4.3 (contraindications) prostatic enlargement, paralytic ileus, pyloric stenosis and myasthenia gravis were added.
Section 4.4 (special warnings and precautions) The elderly and patients under medical care (in particular those at risk of acute urinary retention or with metabolic, gastrointestinal, liver or renal disease, or suffering from CNS disorders such as seizures) was added. In patients with ulcerative colitis its use may lead to ileus or megacolon was added. Antimuscarinics should be used with caution in persons with Down’s Syndrome and caution is advisable in patients with diarrhoea. Hyperthermia can occur at high ambient temperatures due to decreased sweating, therefore, Kwells should be used with caution in patients with fever was also added.
May cause drowsiness. As such, children taking Kwells should not be left unattended and avoid alcoholic drink were removed.
Section 4.5 (interactions) interactions with anticholinergics (including amantadine, some antihistamines, phenothiazine antipsychotics and tricyclic antidepressants) were added. Interactions with MAOIs was added. Interaction with alcohol was added. Interaction with domperidone and metoclopromide were added. Interaction with sublingual nitrate tablets was also added.
Section 4.8 (undesirable effects) The following were added: The listed adverse drug reactions are based on spontaneous reports, thus an organization according to CIOMS II categories of frequency is not pertinent.
Hyperthermia, mydriasis, Immune system disorders: allergic reaction and anaphylactic reaction. Hypersensitivity reactions with respective laboratory and clinical manifestations, including asthma syndrome, mild to moderate reactions affecting skin, respiratory tract, gastrointestinal tract, and cardiovascular system, and symptoms such as rash, urticaria, oedema, pruritus, cardio-respiratory distress, have been reported.
Nervous system disorders: drowsiness, dizziness, sedation and somnolence are commonly reported. Central nervous system stimulation including restlessness, hallucinations and confusion, have been less frequently reported following the administration of hyoscine. There have been rare reports of an increase in seizure frequency in epileptic patients (the same caution for this patient population is included in Section 4.4).
Caution in elderly was removed.
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