国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
esomeprazole, Quantity: 20 mg
Alphapharm Pty Ltd
Esomeprazole
Capsule, enteric
Excipient Ingredients: glyceryl monostearate; mannitol; methacrylic acid - ethyl acrylate copolymer (1:1); polysorbate 80; hyprolose; crospovidone; triethyl citrate; purified talc; sodium hydroxide; sucrose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide red; Gelatin; sodium lauryl sulfate; maize starch
Oral
30, 100
(S4) Prescription Only Medicine
NOXICID is indicated for: 1. Gastro-Oesophageal Reflux Disease (GORD) - treatment of erosive reflux oesophagitis - long-term management of patients with healed oesophagitis to prevent relapse - symptomatic treatment of gastro-oesophageal reflux disease (GORD) 2. Patients requiring NSAID therapy - short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. - healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy - prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk. 3. Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion 4. In combination with appropriate antibiotics for: - healing of duodenal ulcer associated with Helicobacter pylori - eradication of Helicobacter pylori in patients with active or healed peptic ulcer.
Visual Identification: White to cream coloured pellets filled in hard gelatin capsule with pink cap and pink body, imprinted with 'MYLAN' over 'EM 20' in black ink on cap and body; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-10-16
NOXICID CAPS _Esomeprazole (as magnesium)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Noxicid. 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 Noxicid 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 NOXICID IS USED FOR _REFLUX OESOPHAGITIS_ Noxicid is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Noxicid is also taken to help stop reflux oesophagitis coming back or relapsing. _UPPER GASTROINTESTINAL_ _SYMPTOMS ASSOCIATED WITH_ _NON-STEROIDAL ANTI-_ _INFLAMMATORY DRUGS_ _(NSAIDS) THERAPY_ Noxicid is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. Noxicid is also taken to help heal and prevent ulcers caused by NSAIDs. _PEPTIC ULCERS ASSOCIATED_ _WITH HELICOBACTER PYLORI_ _INFECTION_ Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach. Depending on the position of the ulcer it is 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 from the stomach. If you have a peptic ulcer, your doctor will prescribe Noxicid with antibiotics. When Noxicid and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics. _ZOLLINGER-ELLISON SYNDROME_ Noxicid is also used to treat a rare condition called Zollinger-Ellison syndrome, wher 阅读完整的文件
AUSTRALIAN PRODUCT INFORMATION NOXICID CAPS _Esomeprazole (as magnesium) capsule _ 1 NAME OF THE MEDICINE Esomeprazole magnesium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in NOXICID is esomeprazole magnesium, a substituted benzimidazole. The NOXICID CAPS 20 mg and 40 mg enteric capsules are comprised of enteric coated pellets containing esomeprazole (as magnesium). List of excipients with known effect: sugars and traces of sulfites. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Noxicid 20 mg enteric capsule are white to cream coloured pellets filled in hard gelatin capsule with pink cap and pink body, imprinted with 'Mylan' over 'EM 20' in black ink on cap and body. Noxicid 40 mg enteric capsule are white to cream coloured pellets filled in hard gelatin capsule with brown cap and brown body, imprinted with 'Mylan' over 'EM 40' in black ink on cap and body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NOXICID CAPS are indicated for: GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) • treatment of erosive reflux oesophagitis • long-term management of patients with healed oesophagitis to prevent relapse • symptomatic treatment of gastro-oesophageal reflux disease (GORD) PATIENTS REQUIRING NSAID THERAPY • short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti- inflammatory drug NSAID (non-selective and COX-2 selective) therapy. • healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy • prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk. PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME AND IDIOPATHIC HYPERSECRETION IN COMBINATION WITH APPROPRIATE ANTIBIOTICS FOR: • healing of duodenal ulcer associated with _Helicobacter pylori_ • eradication of _Helicobacter pylori_ in patients with active o 阅读完整的文件