Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Hyoscine hydrobromide
Bayer Limited
A04AD; A04AD01
Hyoscine hydrobromide
300 microgram(s)
Tablet
Product not subject to medical prescription
Other antiemetics; scopolamine
Marketed
1979-04-01
Patient Information Leaflet Kwells 300 microgram tablets Hyoscine Hydrobromide Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Kwells 300 microgram tablets carefully to get the best results from them. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If you have any unusual effects after taking this medicine, tell your doctor or pharmacist. IN THIS LEAFLET: 1. What are Kwells tablets and what are they used for? 2. Before you take Kwells tablets 3. How to take Kwells tablets 4. Possible side effects 5. How to store Kwells tablets 6. Further information 1. WHAT ARE KWELLS® TABLETS AND WHAT ARE THEY USED FOR? Kwells 300 microgram tablets are used for the fast and effective prevention and control of travel sickness. Travel sickness happens when the brain receives mixed messages. Visual messages from the eyes inform the brain that the immediate surroundings are stationary, but a delicate balancing organ in the ear tells the brain that you are moving. This conflicting information triggers the nausea we associate with travel sickness. The active substance in Kwells tablets is hyoscine hydrobromide. Hyoscine hydrobromide temporarily reduces the effect of movement on the balance organs of the inner ear and the nerves responsible for nausea. Because Kwells tablets melt in the mouth, absorption into the bloodstream is very rapid and they can be taken up to 30 minutes before travelling or at the onset of sickness. BCH19044 2. BEFORE YOU TAKE KWELLS® TABLETS DO NOT take Kwells tablets if you: • Are allergic (hypersensitive) to hyoscine hydrobromide or any of the other ingredients in the tablets ( see Section 6. Further Information ). • Have glaucoma. • Blockage of intestines (Paralytic ileus). • Narrowing of the stomach outlet (Pyloric stenosis). • Myasthe Lue koko asiakirja
Health Products Regulatory Authority 18 June 2020 CRN009P73 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kwells 300 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hyoscine Hydrobromide 300 microgram Excipient(s) with know effect This product contains sodium (as saccharin sodium), please see section 4.4 for further information. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Small, circular, pink, flat tablet with bevelled edges and a single scoreline on the surface. The scoreline is to allow breaking of the tablet into 2 for dosage purposes and ease of swallowing only. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of motion sickness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tablets to be sucked, chewed or swallowed Tablets to be taken up to 30 minutes before the start of the journey to prevent travel sickness, or at the onset of nausea. 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. Children under 10: not to be given. 4.3 CONTRAINDICATIONS Prostatic enlargement, paralytic ileus, pyloric stenosis, glaucoma, myasthenia gravis and hepatic impairment. Known hypersensitivity to hyoscine hydrobromide or any other ingredient in 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. Health Products Regulatory Authority 18 June 2020 CRN009P73 Lue koko asiakirja