국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium trihydrate, Quantity: 22.3 mg (Equivalent: esomeprazole, Qty 20 mg)
AstraZeneca Pty Ltd
Tablet, enteric coated
Excipient Ingredients: purified talc; glyceryl monostearate; iron oxide yellow; hypromellose; microcrystalline cellulose; methacrylic acid copolymer; synthetic paraffin; iron oxide red; triethyl citrate; macrogol 6000; polysorbate 80; crospovidone; titanium dioxide; magnesium stearate; hyprolose; sodium stearylfumarate; maize starch; sucrose
Oral
100 tablets, 15 tablets, 7 tablets, 30 tablets
(S4) Prescription Only Medicine
ESOPREZE is 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. Prevention of rebleeding of gastric or duodenal ulcers following treatment with ESOPREZE IV solution by intravenous infusion. 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 or healed peptic ulcer.
Visual Identification: A light pink, oblong, biconvex, film-coated tablet with '20mg' on one side and 'A/EH' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2020-12-01
ESOPREZE E S O P R E Z E CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING ESOPREZE? ESOPREZE contains the active ingredient esomeprazole magnesium trihydrate. ESOPREZE is used to treat reflux conditions and ulcers. ESOPREZE is also taken to help stop reflux coming back or relapsing. For more information, see Section 1. Why am I taking ESOPREZE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE ESOPREZE? Do not take ESOPREZE if you have ever had an allergic reaction to esomeprazole or any of the ingredients listed at the end of the CMI. Do not use if you have allergies to any medicines containing a proton pump inhibitor. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take ESOPREZE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ESOPREZE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE ESOPREZE? • Take one ESOPREZE tablet each day, unless your doctor has told you otherwise. • Swallow ESOPREZE tablets whole with a glass of water. Do not crush or chew the tablets. If the tablets are chewed or crushed they will not work properly. • More instructions can be found in Section 4. How do I take ESOPREZE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING ESOPREZE? THINGS YOU SHOULD DO • Remind any doctor, dentist, or pharmacist you visit that you are taking ESOPREZE. • Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ESOPREZE. THINGS YOU SHOULD NOT DO • Do not take it to treat any other complaints unless your doctor tells you to. • Do not give this medicine to anyone else, even if their symptoms seem similar to yours. 전체 문서 읽기
ESOPREZE Product Information Doc ID-004435580 v 2.0 1(31) AUSTRALIAN PRODUCT INFORMATION ESOPREZE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) MULTIPLE UNIT PELLET SYSTEM 1. NAME OF THE MEDICINE Esomeprazole magnesium trihydrate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in ESOPREZE is esomeprazole magnesium trihydrate, a substituted benzimidazole. The ESOPREZE 20 mg and 40 mg tablets are comprised of enteric coated pellets containing esomeprazole (as magnesium trihydrate). Contains sugars. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM ESOPREZE 20 MG TABLETS are a light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A/EH on the other side. Each tablet contains esomeprazole magnesium trihydrate 22.3 mg as enteric-coated pellets. ESOPREZE 40 MG TABLETS are a pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A/EI on the other side. Each tablet contains esomeprazole magnesium trihydrate 44.5 mg as enteric-coated pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ESOPREZE is 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) ESOPREZE Product Information Doc ID-004435580 v 2.0 2(31) 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. PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING TREATMENT WITH NEXIUM IV SOLUTION BY INTRAVENOUS INFUSION. PATHOLO 전체 문서 읽기