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Nexium 40mg Tablets

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Document: document 6 change

1. What Nexium is and what it is used for


2. Before you take Nexium


3. How to take Nexium


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PACKAGE LEAFLET: INFORMATION FOR THE USER Nexium® 40mg Tablets (esomeprazole magnesium)

This product is available in the above name and strength but will be referred to as Nexium throughout this leaflet.

This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.

Please read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

In this leaflet:

1.    What Nexium is and what it is used for

2.    Before you take Nexium

3.    How to take Nexium

4.    Possible side effects

5.    How to store Nexium

6.    Further information

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 to treat the following conditions:

Adults and young people aged 12 years and above

•    'Gastro-oesophageal reflux disease' (GORD). 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.

•    Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called 'Helicobacterpylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

•    Stomach ulcers caused by medicines called NSAIDs (NonSteroidal Anti-Inflammatory Drugs). Nexium can also be used to stop stomach ulcers from forming if you are taking NSAIDs.

•    Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

•    Prolonged treatment after prevention of rebleeding of ulcers with intravenous Nexium.

Do not take 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).

Do not take Nexium if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Nexium.

Take special care with Nexium

Check with your doctor or pharmacist before taking 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 start taking Nexium or while you are taking 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).

If you have been prescribed Nexium "on demand" you should contact your doctor if your symptoms continue or change in character.

Taking a proton pump inhibitor like Nexium, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine.

T ell 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 pharmacist 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.

Do not take Nexium Tablets if you are taking a medicine containing nelfinavir (used to treat HIV).

T ell your doctor or pharmacist if you are taking any of the following medicines:

•    Atazanavir (used to treat HIV).

•    Clopidogrel (used to prevent blood clots).

•    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 taking Nexium.

•    Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking 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.

•    Tacrolimus (organ transplantation).

•    Rifampicin (used for treatment of tuberculosis).

•    St. John's wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Nexium to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Pregnancy and breast-feeding

Before taking Nexium, tell your doctor if you are pregnant or trying to get pregnant . Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will decide whether you can take Nexium during this time.

It is not known if Nexium passes into breast milk.

Therefore, you should not take 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.

Important information about some of the ingredients of Nexium

Nexium gastro-resistant tablets contain sucrose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Always take Nexium exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

•    Nexium gastro-resistant tablets are not recommended for children less than 12 years old.

•    If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).

•    If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

Taking this medicine

•    You can take your tablets at any time of the day.

•    You can take your tablets with food or on an empty stomach.

•    Swallow your tablets whole with a drink of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have trouble swallowing the tablets

•    If you have trouble swallowing the tablets:

-    Put them into a glass of still (non-fizzy) water. Do not use any other liquids.

-    Stir until the tablets break up (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.

-    To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

•    If you cannot swallow at all, the tablet can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach ('gastric tube').

How much to take

•    Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.

•    The usual doses are given below.

To treat heartburn caused by gastro-oesophageal reflux disease

(GORD):

Adults and children aged 12 or above:

•    If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is one Nexium 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.

•    The usual dose once the gullet has healed is one Nexium 20 mg gastro-resistant tablet once a day

•    If your gullet has not been damaged, the usual dose is one Nexium 20 mg gastro-resistant tablet each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Nexium 20 mg gastro-resistant tablet each day.

•    If you have severe liver problems, your doctor may give you a lower dose.