Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
nizatidine, Quantity: 150 mg
Alphapharm Pty Ltd
Capsule
Excipient Ingredients: magnesium stearate; croscarmellose sodium; Gelatin; allura red AC; pregelatinised maize starch; colloidal anhydrous silica; quinoline yellow; titanium dioxide; sodium lauryl sulfate; iron oxide yellow; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
60 capsules, 30 capsules
(S4) Prescription Only Medicine
TACIDINE is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. TACIDINE is also indicated for the maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150mg at bedtime, after healing of the active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied. TACIDINE is indicated for up to 8 weeks for the treatment of benign gastric ulcer. TACIDINE is indicated for up to 12 weeks for the treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux.
Visual Identification: Capsule with a pale yellow body and a dark yellow cap. The body is printed with "NZ 150" and the cap with G" in black ink.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2003-04-29
TACIDINE ® _nizatidine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TACIDINE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking TACIDINE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TACIDINE IS USED FOR TACIDINE contains the active ingredient nizatidine. Nizatidine belongs to a group of medicines called histamine (H2) antagonist or histamine (H2) blockers. These medicines work by reducing the amount of stomach acid produced which in turn reduces the pain and allows the ulcers and/or reflux disease to heal in most people. ULCERS TACIDINE is used to treat both gastric ulcers and duodenal ulcers. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum (which is part of your small intestine). The ulcers can be caused in part by too much acid being made in the stomach. TACIDINE is also used to help stop duodenal ulcers from coming back. REFLUX DISEASE TACIDINE is also used to treat reflux oesophagitis or reflux disease. This is caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (also known as the oesophagus). Reflux causes burning sensation in the chest rising up to the throat (heartburn) and most often occurs after eating or at night. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. TACIDINE is not recommended for use in children, as the safety and effectiveness have not been established. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE TACIDINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE TACIDINE IF YOU HAVE AN ALLERGY TO: • Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION TACIDINE ® _nizatidine capsule _ 1 NAME OF THE MEDICINE Nizatidine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TACIDINE capsules contain 150 mg or 300 mg of nizatidine as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TACIDINE 150 capsules – hard gelatin capsule with a pale yellow body and dark yellow cap. The body has “NZ 150” and the cap has “G” printed in black. TACIDINE 300 capsules – hard gelatin capsule with a light brown body and cap. The body has “NZ 300” and the cap has “G” printed in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TACIDINE is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. TACIDINE is also indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg at bedtime, after healing of the active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied. TACIDINE is indicated for up to 8 weeks for the treatment of benign gastric ulcer. TACIDINE is indicated for up to 12 weeks for the treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux. 4.2 DOSE AND METHOD OF ADMINISTRATION ACTIVE DUODENAL ULCER The recommended oral dosage for adults is 150 mg twice daily or 300 mg once daily in the evening (for up to 8 weeks). In most cases, the ulcer will heal within 4 weeks. BENIGN GASTRIC ULCER The recommended daily dose is 150 mg twice daily or 300 mg once daily in the evening (for up to 8 weeks). Prior to treatment with nizatidine, care should be taken to exclude the possibility of gastric cancer. MAINTENANCE THERAPY The recommended oral dosage for adults with duodenal ulcer is 150 mg once daily in the evening for a period not exceeding 12 months. Continuous therapy with nizatidine for longer than 12 months has not been studied. GASTRO-OESOPHAGEAL REFLUX DISEASE The recommended Perskaitykite visą dokumentą