Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium trihydrate, Quantity: 44.528 mg (Equivalent: esomeprazole, Qty 40 mg)
Sandoz Pty Ltd
Tablet, enteric coated
Excipient Ingredients: crospovidone; purified talc; light magnesium oxide; purified water; pregelatinised maize starch; microcrystalline cellulose; silicon dioxide; glyceryl monostearate; polysorbate 80; methacrylic acid - ethyl acrylate copolymer (1:1); povidone; iron oxide red; macrogol 6000; hyprolose; hypromellose phthalate; macrogol 400; maize starch; sucrose; titanium dioxide; hypromellose
Oral
Al/Al blister pack (PVC/OPA/Al/PVC/Al foil) of 7, 14, 30, 100s, 14, Al/Al blister pack (PVC/OPA/Al/PVC/Peelable child resistance
(S4) Prescription Only Medicine
Esomeprazole enteric-coated tablet 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] Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypers
Visual Identification: Pink coloured, oblong, biconvex, coated tablets debossed with '40' on one side and 'CE' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2018-11-02
ESOMEPRAZOLE SZ 1 ESOMEPRAZOLE SZ _esomeprazole (as magnesium trihydrate) enteric-coated tablet _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Esomeprazole SZ. It does not contain all the information that is known about Esomeprazole SZ. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Esomeprazole SZ 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 ESOMEPRAZOLE SZ IS USED FOR _REFLUX OESOPHAGITIS _ Esomeprazole SZ 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. Esomeprazole SZ is also taken to help stop reflux oesophagitis coming back or relapsing. _UPPER GASTROINTESTINAL _ _SYMPTOMS ASSOCIATED WITH _ _NON-STEROIDAL ANTI-_ _INFLAMMATORY DRUGS _ _(NSAIDS) THERAPY _ Esomeprazole SZ is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. Esomeprazole SZ 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 Esomeprazole SZ with antibiotics. When Esomeprazole SZ and antibiotics are taken together, they work to kill the bacterium and let you Read the complete document
210610-Esomeprazole SZ-pi Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION ESOMEPRAZOLE SZ ® (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) ENTERIC COATED TABLETS 1. NAME OF THE MEDICINE Esomeprazole magnesium trihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Esomeprazole SZ 20 mg: Each tablet contains 20 mg of esomeprazole. Esomeprazole SZ 40 mg: Each tablet contains 40 mg of esomeprazole. Esomeprazole SZ (esomeprazole enteric-coated 20 mg and 40 mg tablets) is comprised of enteric-coated pellets containing esomeprazole (as magnesium trihydrate). _List of excipients with known effect:_ sugars For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Esomeprazole SZ 20 mg: Light pink coloured, oblong, biconvex, coated tablets debossed with '20' on one side and ‘CE’ on the other. Esomeprazole SZ 40 mg: Pink coloured, oblong, biconvex, coated tablets debossed with '40' on one side and ‘CE’ on the other side. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Esomeprazole SZ (esomeprazole enteric-coated 20 mg and 40 mg tablet) is indicated for: • _GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): _ o treatment of erosive reflux oesophagitis. o long-term management of patients with healed oesophagitis to prevent relapse. o symptomatic treatment of gastro-oesophageal reflux disease (GORD). • _PATIENTS REQUIRING NSAID THERAPY: _ o short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. o healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. o 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 _ _ESOMEPRAZOLE SOLUTION ADMINISTERED BY INTRAVENOUS INFUSION. _ 210610-Esomeprazole SZ-pi Page 2 of 27 • _PATHOLOGICAL HYP Read the complete document