NEXIUM I.V. 40MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

PS00713

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nexium IV 40mg Powder for solution for injection/infusion
esomeprazole Please read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Nexium is and what it is used for 2. Before Nexium is given to you 3. How Nexium is given to you 4. Possible side effects 5. How to store Nexium 6. Further information 1.What Nexium is and what it is used for Nexium contains a medicine called esomeprazole. This belongs to a group of medicines called proton pump inhibitors. They work by reducing the amount of acid that your stomach produces. Nexium is used for the shortterm treatment of certain conditions, when you are unable to have treatment by mouth. It is used to treat: Gastro-oesophageal reflux disease (GORD) in adults, adolescents and children. This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. Stomach ulcers in adults caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Nexium can also be used to stop stomach ulcers from forming if you are taking NSAIDs. Prevention of rebleeding in adults following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. 2.Before Nexium is given to you You must not be given Nexium if: You are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in Section 6: Further information). You are allergic to other proton pump inhibitor medicines (e.g.pantoprazole, lansoprazole, rabeprazole, omeprazole). You are taking a medicine containing nelfinavir (used to treat HIV). You must not be given Nexium if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine. Take special care with Nexium Check with your doctor or nurse before you are given Nexium if: You have severe liver problems. You have severe kidney problems. Nexium may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you are given Nexium or after you are given it, talk to your doctor straight away: You lose a lot of weight for no reason and have problems swallowing. You get stomach pain or indigestion. You begin to vomit food or blood. You pass black stools (blood-stained faeces). Taking a proton pump inhibitor like Nexium, especially over a period of more than oneyear, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis). Using other medicines Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription. This is because Nexium can affect the way some medicines work and some medicines can have an effect on Nexium. You must not be given Nexium if you are taking a medicine containing nelfinavir (used to treat HIV). Tell your doctor or nurse if you are taking any of the following medicines: Atazanavir (used to treat HIV). Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus). Erlotinib (used to treat cancer). Citalopram, imipramine or clomipramine (used to treat depression). Diazepam (used to treat anxiety, relax muscles or in epilepsy). Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop having Nexium. Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop having Nexium. Cilostazol (used to treat intermittent claudication a pain in your legs when you walk which is caused by an insufficient blood supply). Cisapride (used for indigestion and heartburn). Digoxin (used for heart problems). Methotrexate (a chemotherapy medicine used in high doses to treat cancer) if you are taking a high dose of methotrexate, your doctor may temporarily stop your Nexium treatment. Rifampicin (used for treatment of tuberculosis). St. Johns wort (Hypericum perforatum) (used to treat depression). Pregnancy and breast-feeding Before you are given Nexium, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can be given Nexium during this time. It is not known if Nexium passes into breast milk. Therefore, you should not be given Nexium if you are breastfeeding. Driving and using machines Nexium is not likely to affect you being able to drive or use any tools or machines. 3.How Nexium is given to you Nexium can be given to children and adolescents aged 1-18years and adults, including the elderly. Being given Nexium Adults Nexium will be given to you by your doctor who will decide how much you need. The usual dose is 20mg or 40mg once a day. If you have severe liver problems, the maximum dose for GORD is 20mg a day. The medicine will be given to you as an injection or infusion into one of your veins. This will last for up to 30minutes. For prevention of rebleeding gastric or duodenal ulcers, the usual dose is 80mg administered as intravenous infusion over 30minutes followed by a continuous infusion of 8mg/hr given over 3days. If you have severe liver problems for this indication, a continuous infusion of 4mg/hr given over 3days may be sufficient. Children aged 1-18years Nexium will be given by your doctor who will decide how much you need. For children 1-11years, the usual dose is 10or 20mg given once a day. For children 12-18years, the usual dose is 20or 40mg given once a day. The medicine will be given as an injection or infusion into a vein. This will last for up to 30minutes. If you are given too much Nexium If you think you have been given too much Nexium, talk to your doctor straight away. 4.Possible side effects Like all medicines, Nexium can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop taking Nexium and contact a doctor immediately: Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction). Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. Yellow skin, dark urine and tiredness which can be symptoms of liver problems. These effects are rare, affecting less than 1in 1,000people. Other side effects include: Common (affects less than 1in 10people) Headache. Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence). Feeling sick (nausea) or being sick (vomiting). Injection site reaction. Uncommon (affects less than 1in 100people) Swelling of the feet and ankles. Disturbed sleep (insomnia). Dizziness, tingling feelings such as pins and needles, feeling sleepy. Spinning feeling (vertigo). Eyesight problems such as blurred vision. Dry mouth. Changes in blood tests that check how the liver is working. Skin rash, lumpy rash (hives) and itchy skin. Fracture of the hip, wrist or spine (if Nexium is used in high doses and over long duration).

Rare (affects less than 1in 1,000people) Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely. Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps. Feeling agitated, confused or depressed. Taste changes. Suddenly feeling wheezy or short of breath (bronchospasm). An inflammation of the inside of the mouth. An infection called thrush which can affect the gut and is caused by a fungus. Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness. Hair loss (alopecia). Skin rash on exposure to sunshine. Joint pains (arthralgia) or muscle pains (myalgia). Generally feeling unwell and lacking energy. Increased sweating. Very rare (affects less than 1in 10,000people) Changes in blood count including agranulocytosis (lack of white blood cells) Aggression. Seeing, feeling or hearing things that are not there (hallucinations). Severe liver problems leading to liver failure and inflammation of the brain. Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). Muscle weakness. Severe kidney problems. Enlarged breasts in men. Not known (frequency cannot be estimated from the available data) If you are on Nexium for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. Ifyou get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. Inflammation in the gut (leading to diarrhoea). Nexium may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medication at this time. Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5.How to store Nexium The doctor and hospital pharmacist are responsible for storing, using and disposing of Nexium correctly. Do not use this medicine after the expiry date (EXP) shown on the carton or vial. The expiry date refers to the last of that month. This medicine should be kept in a safe place where children cannot reach or see it. Do not store above 30C. Keep the vial in the outer carton in order to protect from light. Vials can, however, be stored exposed to normal indoor light outside the box for up to 24hours. 6.Further information What Nexium contains The active substance is esomeprazole sodium. Each vial of powder for solution for injection/infusion contains 42.5mg of esomeprazole sodium, equivalent to 40mg of esomeprazole. The other ingredients are disodium edetate and sodium hydroxide. Each vial contains less than 1mmol sodium (23mg) i.e. essentially sodium-free. What Nexium looks like and contents of the pack Nexium is a white to off-white cake or powder. This is made into a solution before it is given to you. Pack sizes: 1vial, 10vials. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Nexium is held by AstraZeneca UK Limited, 600Capability Green, Luton LU13LU, United Kingdom. Nexium is released by AstraZeneca AB, S-15185, Sdertlje, Sweden; AstraZeneca UK Ltd, Macclesfield, UK; AstraZeneca GmbH, Wedel, Germany; Corden Pharma GmbH, Plankstadt, Germany; AstraZeneca Reims, Reims, France; Recipharm Monts, Monts, France or NV AstraZeneca SA, Brussels, Belgium.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Reference number Nexium IV 40mg 17901/0221 This is a service provided by the Royal National Institute of Blind People.
This leaflet was prepared in July 2012. AstraZeneca 2012 Nexium is a trade mark of the AstraZeneca group of companies. GI 120145a ----------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only: Nexium IV 40mg contains 40mg of esomeprazole, as a sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1mmol sodium). Vials are for single use only. If the entire reconstituted content of the vial isnot required for a single dose, any unused solution should be discarded. For further information on dose recommendations and storage conditions, see sections 3and5, respectively. Preparation and Administration of Reconstituted Solution: For the reconstitution of solution, withdraw the plastic cap of colour at the top of the vial of Nexium, and pierce the stopper in the centre of the designed circle, by maintaining the needle vertically, in order to be able to cross the stopper correctly. The reconstituted solution for injection or infusion should be clear and colourless to very slightly yellow. It should be inspected visually for particulate matter and discolouration before administration and only clear solution should be used. The shelf life after reconstitution in terms of chemical and physical stability has been demonstrated for 12hours at 30C. However, from a microbiological point of view, the product should be used immediately. Nexium Injection To prepare a solution for injection: Injection 40mg For 8mg/ml esomeprazole reconstituted solution: Prepare the solution by adding 5ml of 0.9% sodium chloride for intravenous use to the esomeprazole 40mg vial. The reconstituted solution for injection should be administered intravenously over a period of at least 3minutes. For further information on dose administration, please see SmPC section 4.2. Nexium Infusion To prepare a solution for infusion: Infusion 40mg Dissolve the content of one esomeprazole 40mg vial in up to 100ml of 0.9% sodium chloride for intravenous use. Infusion 80mg Dissolve the contents of two esomeprazole 40mg vials in up to 100ml of 0.9% sodium chloride for intravenous use. For further information on dose administration, please see SmPC section 4.2. Disposal Any unused product or waste material should be disposed of in accordance with local requirements. Marketing Authorisation Holder AstraZeneca UK Limited, 600Capability Green, Luton, LU13LU, United Kingdom. Leaflet updated: July 2012 AstraZeneca 2012 Nexium is a trademark of the AstraZeneca group of companies. GI 120145a