KWELLS

Tablets to be sucked, chewed or swallowed. Adults: 1 tablet every 6 hours if required. Do not take more than 3 tablets in 24 hours.

Elderly:

There is no special dosage regimen for the elderly and as such caution should be exercised Children: Children over 10: ½-1 tablet every 6 hours if required. Do not take more than 1½-3 tablets in 24 hours. Tablets to be taken up to 30 minutes before the start of the journey to prevent travel sickness, or at the onset of nausea.

The listed adverse drug reactions are based on spontaneous reports, thus an organization according to CIOMS II categories of frequency is not pertinent. General: hyperthermia at high temperatures due to decreased sweating. Eye disorders: blurred vision, mydriasis.

Gastrointestinal disorders: dry mouth. 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.

4). Reporting of suspected adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The elderly and patients under medical care (in particular those at risk of acute urinary retention, or with cardiovascular, metabolic, gastrointestinal, liver or renal disease, or suffering from CNS disorders such as seizures) should consult a doctor before taking this product.

In patients with ulcerative colitis its use may lead to ileus or megacolon. Antimuscarinics should be used with caution in persons with Down’s Syndrome. 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.

Prostatic enlargement, paralytic ileus, pyloric stenosis, glaucoma and myasthenia gravis. In addition, Kwells should not be given to patients with a known sensitivity to hyoscine hydrobromide or any other component of the product.