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Package Leaflet: Information for the patient

Esomeprazole 40 mg powder for solution for injection/infusion

Esomeprazole

What is in this leaflet:

1.    What Esomeprazole is and what it is used for

2.    Whatyou needto know before you are given Esomeprazole

3.    How Esomeprazole is given

4.    Possible side effects

5.    How to store Esomeprazole

6.    Contents of the pack and other information

1. What is Esomeprazole and what it is used for

Esomeprazole 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.

Esomeprazole is used for the short-term treatment of certain conditions, when you are unable to have treatment by mouth. It is used to treat:

-    Gastro-oesophageal reflux disease¹ (GERD) 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 AntiInflammatory Drugs). Esomeprazole 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. What you need to know before you are given Esomeprazole You must not be given Esomeprazole if

-    you are allergic to Esomeprazole or any of the other ingredients of this medicine (listed in section 6)

-    you are allergic to other proton pump inhibitor medicines

-    you are taking a medicine containing nelfinavir (used to treat HIV).

You must not be given Esomeprazole if any of the above apply to you. If you are not sure, talk to your doctor before you are given this medicine.

Take special care with Esomeprazole

Check with your doctor before you are given Esomeprazole if:

-    you have severe liver problems

-    youhaveseverekidneyproblems.

Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you are given Esomeprazole 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 Esomeprazole, especially over a period of more than one year, 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)

Other medicines and Esomeprazole

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 Esomeprazole can affect the way some medicines work and some medicines can have an effect on Esomeprazole.

You must not be given Esomeprazole 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 (usedto treat HIV)

-    ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus)

-    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 needto monitor you when you start or stop having Esomeprazole.

-    medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop having Esomeprazole.

-    cisapride (used for indigestion and heartburn).

Pregnancy and breast-feeding

Before you are given Esomeprazole, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can be given Esomeprazole during this time.

It is not known if Esomeprazole passes into breast milk. Therefore, you should not be given Esomeprazole if you are breastfeeding.

Driving and using machines

Esomeprazole is not likely to affect you being able to drive or use any tools or machines. Esomeprazole contains sodium

This medical product contains less than 1 mmol sodium (17 mg) per dose, i.e. essentially "sodium-free".

3. How Esomeprazole is given

Esomeprazole can be given to children and adolescents aged 1-18 years and adults

including the elderly.

Being given Esomeprazole

Adults

-    Esomeprazole will be given to you by your doctor who will decide how much you need.

-    the usual dose is 20 mg or 40 mg once a day

-    if you have severe liver problems, the maximum dose is 20 mg a day (GERD)

-    the medicine will be given to you as an injection or infusion into one of your veins. This will last for up to 30 minutes

-    the usual dose for prevention of rebleeding gastric or duodenal ulcers, the usual dose is 80 mg administered as intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/hr given over 3 days. If you have severe liver problems for this indication, a continuous infusion of 4 mg/hr given over 3 days may be sufficient.

Children aged    1-18 years

-    Esomeprazole will be given by your doctor who will decide how much you need.

-    For children 1-11 years, the usual dose is10or 20 mg given once a day.

-    For children 12-18 years, the usual dose is 20 or 40 mg given once a day.

-    The medicine will be given as an injection or infusion into a vein. This will last up to 30 minutes.

If you are given too much Esomeprazole

If you think you have been given too much Esomeprazole, talk to your doctor straight

away.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Esomeprazole 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 syndrome¹ or 'toxic epidermal necrolysis'.

-    yellow skin, dark urine and tiredness which can be symptoms of liver problems.

These effects are rare, affecting less than 1 in 1,000 people.

Other side effects include:

Common (affects less than 1 in 10 people)

-    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 1 in 100 people)

-    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.

Rare (affects less than 1 in 1,000 people)

-    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 1 in 10,000 people)

-    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).

-    muscleweakness

-    severe kidney problems

-    enlarged breasts in men

Esomeprazole 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.

Not known (frequency cannot be estimated from the available data)

-    If you are on Esomeprazole 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, increased heart rate. If you 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.

5. HowtostoreEsomeprazole

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) which is stated on the carton or vial. The expiry date refers to the last day of that month.

Store below 30°C. Store in the original package in order to protect from light.

Chemical and physical in-use stability data has been demonstrated for 12 hours at 30°C. From microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and aseptic conditions.

Do not use this medicine if you notice that the visual appearance has changed (only clear solution should be used).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Esomeprazole contains

-    The active substance is Esomeprazole sodium. Each vial contains 42.6 mg of Esomeprazole sodium, equivalent to 40 mg of esomeprazole.

-    The other ingredients are disodium edetate and sodium hydroxide.

What Esomeprazole looks like and contents of the pack

Esomeprazole is a white to off-white powder. It comes ina5ml colourless glass vial with grey rubber stopper and grey flip off aluminum seal containing 40 mg powder for solution for injection/infusion.

Esomeprazole is available in the following pack sizes:

-    pack with 1 vial

-    packwith1x10vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87 2132JHHoofddorp The Netherlands

This medicinal product is authorised in the Member States of the EEA under the

following names:

Denmark:    Esomeprazol SUN 40 mg pulver til injektions- og

infusionsvsske, oplosning

Germany:    Esomeprazol SUN 40 mg Pulver zur Herstellung einer

lnjektions-/lnfusionsldsung

France:    Esomeprazole SUN 40 mg poudre pour solution injectable ou

pour perfusion

Italy:    Esomeprazolo SUN 40 mg polvere per soluzione

iniettabile/infusione

The Netherlands:    Esomeprazol SUN 40 mg poeder voor oplossing voor injectie

en intraveneuze infusie

Spain:    Esomeprazol SUN 40 mg Polvo para solution inyectable y para

perfusion

Sweden:    Esomeprazol SUN 40 mg pulver till injektions-/infusionsvatska,

losning

United Kingdom:    Esomeprazole 40 mg powder for solution for injection/infusion.

This leaflet was last revised in June 2012

Do not be concerned by this list of possible side effects. You maynot get any of them. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.