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 or 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

• ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach enters the oesophagus (the passage between the throat and stomach) causing pain, inflammation and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole can also be used to prevent stomach ulcers from developing if you are taking NSAIDs.
• Prevention of rebleeding following therapeutic endoscopy for acute bleeding from gastric or duodenal ulcers.

• ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach enters the oesophagus (the passage between the throat and stomach) causing pain, inflammation and heartburn.

• 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 inhibitors (e.g. pantoprazole, lanzoprazole, 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 talk to your doctor immediately, if any of the following applies to you before or after you are given Esomeprazole:

• you are losing a lot of weight for no obvious reason and have difficulty swallowing.
• you get stomach pain or digestive disorders.
• You vomit food or blood.
• you pass black stools (bloody faeces).

Using a proton pump inhibitor like esomeprazole may slightly increase your risk of fractures in the hip, wrist or spine, especially if used over a period of more than one year. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may 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.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may cause ulcers in the mouth, throat, nose, genitals, and include conjunctivitis (red and swollen eyes). These severe skin rashes often appear after flu-like symptoms such as fever, head and limb pain. The rash may affect large parts of the body and are accompanied by blistering and peeling of the skin.

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

This medicine may affect the way that your body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B12:

• Extreme tiredness or lack of energy
• Pins and needles
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Problems with memory, confusion, depression

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained 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 for epilepsy)
• phenytoin (used in epilepsy). If you are taking phenytoin, you doctor will need to monitor you when you start or stop using esomeprazole.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop using esomeprazole.
• Cilostazol (used to treat intermittent claudication - a pain in your legs when you walk caused by an insufficient blood circulation).
• 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 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 or breast-feeding, 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.

Pregnancy

Your doctor will decide whether you can use esomeprazole during this time.

Breast-feeding

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

Esomeprazole is not likely to affect you being able to drive or use 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.

Each vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’.

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 takes up to 30 minutes.
• The recommended dose for prevention of re-bleeding of gastric or duodenal ulcer is 80 mg administered as intravenous infusion over a period of 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.

Children and adolescents aged 1 to 18 years

• Esomeprazole will be given by the doctor who will decide how much is needed.
• For children 1-11 years of age, the recommended dose is 10 or 20 mg given once a day.
• For children 12-18 years of age, 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 takes up to 30 minutes.

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 of powder for solution for injection/infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.

The other ingredients are: disodium edetate and sodium hydroxide (for pH-adjustment).

Esomeprazole 40 mg powder for solution for injection/infusion is white to off white porous cake or powder. This is made into a solution before it is given to you.

Esomeprazole is filled in 5 ml type-I, clear glass vial stoppered with dark grey bromobutyl rubber stopper and sealed with purple aluminium flip off seal.

Esomeprazole is available in packs of 1, 10 and 50 vials.

Not all pack sizes may be marketed.

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