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Package leaflet: information for the user

Esopral 40 mg

Powder for solution for injection/infusion

esomeprazole

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

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

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

• 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.

What is in this leaflet:

1. What Esopral is and what it is used for

2. What you need to know before Esopral is given to you

3. How Esopral is given to you

4. Possible side effects

5. How to store Esopral

6. Contents of the pack and other information

1. What Esopral is and what it is used for

Esopral 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.

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

Adults

• ‘Gastroesophageal reflux disease’ (GERD). 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 caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esopral can also be used to stop stomach ulcers from forming if you are taking NSAIDs.

• Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

Children and adolescents aged 1-18 years

2. What you need to know before Esopral is given to you

You must not be given Esopral:

• If you are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in Section 6: Contents of the pack and further information).

• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lanzoprazole, rabeprazole, omeprazole).

• You are taking a medicine containing nelfinavir (used to treat HIV infection).

You must not be given Esopral 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.

Warnings and precautions

Check with your doctor or nurse before you are given Esopral 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 Esopral that reduces stomach acid.

Esopral may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you are given Esopral 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 Esopral, 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 Esopral. Remember to also mention any other ill effects like pain in your joints.

Other medicines and Esopral

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

You must not be given Esopral 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 Esopral.

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

• 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 Esopral treatment.

• Tacrolimus (organ transplantation).

• Rifampicin (used for treatment of tuberculosis).

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

Pregnancy, breast-feeding and fertility

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 take Esopral during this time.

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

Driving and using machines

Esopral 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.

3. How Esopral is given to you

Esopral can be given to children and adolescents aged 1-18 years and adults, including the elderly.

Being given Esopral

Adults

• Esopral 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 of gastric or duodenal ulcer 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.

Children aged 1-18 years

• Esopral 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 are given too much Esopral

If you think you have been given too much Esopral, 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 Esopral 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 and may affect up to 1 in 1,000 people.

Other side effects include:

Common (may affect up to1 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 (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 Esopral is used in high 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)

• Muscle weakness.

• Severe kidney problems.

• Enlarged breasts in men.

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

• If you are on Esopral 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. 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.

Esopral 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 severelyreduced 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.

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Esopral

• The doctor and hospital pharmacist are responsible for storing, using and disposing of Esopral correctly.

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

• This medicine should be kept in a safe place where children cannot see or reach it.

• Do not store above 30°C.

• 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 24 hours.

6. Contents of the pack and other information

What Esopral contains

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. Each vial contains less than 1 mmol sodium (23 mg) i.e. essentially ‘sodium-free’.

What Esopral looks like and contents of the pack

Esopral is a white to off-white ‘cake’ or powder. This is made into a solution before it is given to you.

Pack sizes: 1 vial, 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Esopral is held by [Tobe completed nationally]

Esopral is released by [Tobe completed nationally]

This medicine is authorised in the Member States of the EEA under the following names:

Member States	Name of the medicinal product
Italy	Esopral
Sweden	Esopral

This leaflet was last approved on 2016-04-01

Other sources of information

Detailed information on this medicine is available on the web site of {MS/Agency}

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The following information is intended for healthcare professionals only:

Esopral IV 40 mg contains 40 mg of esomeprazole, as a sodium salt. Each vial also contains disodium edetate and sodium hydroxide (< 1 mmol sodium).

Vials are for single use only. If the entire reconstituted content of the vial is not required for a single dose, any unused solution should be discarded.

For further information on dose recommendations and storage conditions, see sections 3 and 5, 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 Esopral, 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 12 hours at 30°C. However, from a microbiological point of view, the product should be used immediately.

Esopral injection

To prepare a solution for injection:

Injection 40 mg

For 8 mg/ml esomeprazole reconstituted solution: Prepare the solution by adding 5 ml of 0.9% sodium chloride for intravenous use to the esomeprazole 40 mg vial.

The reconstituted solution for injection should be administered intravenously over a period of at least 3 minutes.

For further information on dose administration, please see SmPC section 4.2.

Esopral Infusion

To prepare a solution for infusion:

Infusion 40 mg

Dissolve the content of one esomeprazole 40 mg vial in up to 100 ml of 0.9% sodium chloride for intravenous use.

Infusion 80 mg

Dissolve the contents of two esomeprazole 40 mg vials in up to 100 ml 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.