País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hyoscine hydrobromide
Dexcel-Pharma Ltd
N05CM05
Hyoscine hydrobromide
300microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5010605242144
OBJECT 1 KWELLS 300 MICROGRAM TABLETS Summary of Product Characteristics Updated 01-May-2018 | Bayer plc 1. Name of the medicinal product Kwells 300 microgram tablets 2. Qualitative and quantitative composition Hyoscine Hydrobromide 300 microgram For excipients, see section 6.1 3. Pharmaceutical form Tablet Small pink circular, flat faced tablets with bevelled edges. One face is bisected by a score line and the other is plain. 4. Clinical particulars 4.1 Therapeutic indications For the prevention of travel sickness. 4.2 Posology and method of administration 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. 4.3 Contraindications 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. 4.4 Special warnings and precautions for use 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. 4.5 Interaction with other medicinal products and other forms of interaction The ef Leia o documento completo