Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
nizatidine, Quantity: 300 mg
Arrow Pharma Pty Ltd
Capsule, hard
Excipient Ingredients: dimeticone 350; purified talc; pregelatinised maize starch; povidone; maize starch; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide yellow; iron oxide red; Gelatin
Oral
30, 7 capsules, 4 capsules, 100
(S4) Prescription Only Medicine
TAZAC is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. TAZAC is also indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied. TAZAC is indicated for up to 8 weeks for the treatment of benign gastric ulcer. TAZAC 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: Size 1 capsule consisting of a brown cap and a pale yellow body, printed with "N300" .; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1994-06-29
TAZAC ® 1 TAZAC ® _nizatidine _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information that is known about Tazac. It does not take the place of talking with your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tazac 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 THIS MEDICINE. You may need to read it again. WHAT TAZAC IS USED FOR Tazac contains an active ingredient called nizatidine. It belongs to a class of medicines called H2-antagonists or H2-blockers. Tazac is used to treat the following conditions: REFLUX OESOPHAGITIS This can be caused by reflux or "washing back" of food and acid from the stomach into the food pipe. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. ULCERS Depending on the position of the ulcer it is either called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. Tazac is also used to stop duodenal ulcers from coming back. Tazac works by reducing the amount of acid in your stomach. This helps reduce the pain and allows the ulcer and reflux disease to heal in most people. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TAZAC IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • nizatidine or other histamine H2- receptor antagonists (e.g. cimetidine, ranitidine, famotidine) • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic r Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – TAZAC (NIZATIDINE) CAPSULES 1 NAME OF THE MEDICINE Nizatidine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TAZAC (nizatidine) is a histamine H2-receptor antagonist. Each capsule contains for oral administration either 150 mg or 300 mg of nizatidine as the active ingredient. 3 PHARMACEUTICAL FORM 150 mg: Size 2 capsule consisting of a dark yellow cap and a pale yellow body, printed with "N150". 300 mg: Size 1 capsule consisting of a brown cap and a pale yellow body, printed with "N300". 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TAZAC is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. TAZAC is also indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied. TAZAC is indicated for up to 8 weeks for the treatment of benign gastric ulcer. TAZAC 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 D OSE 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. 2 Benign Gastric Ulcer--The recommended daily dose is 150 mg twice daily or 300 mg once daily in the evening. 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. Gastroesophageal Reflux Disease--The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily. Dosage Adjustment for Patients with Moderate to Severe Renal Insufficiency--The dose for patients with renal dysfunction should be reduced as follows CREATINE CLEARANCE DO Prečítajte si celý dokument