Esomeprazole 40 mg powder for solution for injection/infusion.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Esomeprazole is and what it is used for
2. What you need to know before Esomeprazole is given to you
3. How Esomeprazole is given to you
4. Possible side effects
5. How to store Esomeprazole
6. Contents of the pack and other information

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

You must not be given Esomeprazole 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.

Talk to your doctor, or nurse before you are given Esomeprazole if:

• you have severe liver problems.
• you have severe kidney problems.
• you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole that reduces stomach acid.
• you are due to have a specific blood test (Chromogranin A).

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).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazole. Remember to also mention any other ill-effects like pain in your joints.

Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes often come after flu-like symptoms such as fever, headache, body ache. The rash may cover large parts of the body with blistering and peeling of the skin.

If at any time during the treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Tell your doctor or nurse if you are taking, have recently taken, or might take 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 infection).

Tell your doctor or nurse if you are taking any of the following medicines:

• atazanavir (used to treat HIV infection)
• 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 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.
• 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 Esomeprazole treatment.
• tacrolimus (organ transplantation)
• rifampicin (used for treatment of tuberculosis)
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. 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 breast-feeding.

Esomeprazole is not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly occur (see section 4). If affected, you should not drive or use machines.

This medical product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Use in Adults

• Esomeprazole will be given to you by your doctor who will decide how much you need.
• The recommended 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 recommended dose for prevention of re-bleeding gastric or duodenal ulcers, 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, a continuous infusion of 4 mg/hr given over 3 days may be sufficient.

• Esomeprazole will be given by your doctor who will decide how much you need.
• For children 1-11 years, the recommended dose is 10 or 20 mg given once a day.
• For children 12-18 years, the recommended 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 think you have been given too much Esomeprazole, talk to your doctor straight away.

• Yellow skin, dark urine and tiredness which can be symptoms of liver problems. These effects are rare, and may affect up to 1 in 1,000 people.
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction). These effects are rare, and may affect up to 1 in 1,000 people.
• Sudden onset of a severe rash or reddening of the skin with blisters or peeling may occur even after several weeks of treatment. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life threatening consequences. This could be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, ‘toxic epidermal necrolysis’ or ‘drug reaction with eosinophilia and systemic symptoms’. These effects are very rare, and might affect up to 1 in 10,000 people.

Other side effects include:

Common (may affect up to 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
• Benign polyps in the stomach.

Uncommon (may affect up to 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
• Fracture of the hip, wrist or spine (if Esomeprazole is used in higher doses and over long duration).

Rare (may affect up to 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 (may affect up to 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, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness
• Severe kidney problems
• Enlarged breasts in men.

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.
• Inflammation in the gut (leading to diarrhoea).
• Rash, possibly with pain in the joints.

Esomeprazole SUN 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 (for pH adjustment).

Esomeprazole is a white to off-white powder. It comes in a 5 ml colorless 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
• pack with 1x10 vials.

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom( Northern Ireland) under the following names:

Denmark: Esomeprazol SUN 40 mg pulver til injektions- og infusionsvæske, opløsning

Germany: Esomeprazol SUN 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung

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

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

United Kingdom: (Northern Ireland) Esomeprazole 40 mg powder for solution for injection/infusion.

Poland: Esomeprazol SUN 40 mg proszek do sporządzania roztworu do wstrzykiwań i infuzji

Romania: Esomeprazol SUN 40 mg pulbere pentru soluţie injectabilă/perfuzabilă