Patient Information Leaflet

Nexium 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

esomeprazole
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nexium is and what it is used for
What you need to know before taking Nexium
How to take Nexium
Possible side effects
How to store Nexium
Contents of the pack and other information

1. What is Nexium and what is it used for?

Nexium contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Nexium is used to treat the following conditions:

Adults

"Gastro-oesophageal reflux disease" (GORD). This occurs when acid from the stomach leaks into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Nexium may also be used to help prevent the development of stomach ulcers during NSAID treatment.
Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment to prevent recurrent bleeding from ulcers, following initial prevention with intravenous administration of Nexium.

Adolescents from 12 years of age

"Gastro-oesophageal reflux disease" (GORD). This occurs when acid from the stomach leaks into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you should know before taking Nexium

Do not take Nexium:

if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
if you are taking a medicine containing nelfinavir (used to treat HIV infection).
if you have previously experienced a severe skin rash or skin peeling, or a rash with blisters and/or mouth ulcers after taking Nexium or other related medicines.

Do not take Nexium if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Nexium.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nexium:

if you have severe liver problems.
if you have severe kidney problems.
if you have previously had a skin reaction after treatment with a medicine similar to Nexium that reduces stomach acidity.
if you are due to have a specific blood test (chromogranin A), as Nexium may mask symptoms of other diseases. Therefore, if any of the following occur before starting or while taking Nexium, inform your doctor immediately:
Unexplained weight loss or difficulty swallowing.
New or worsening stomach pain or indigestion.
Vomiting food or blood.
Black stools (stools containing blood).

If you have been prescribed Nexium “as needed”, contact your doctor if symptoms persist or change in nature.

This medicine may affect how your body absorbs vitamin B12, particularly if taken for a long period. Contact your doctor if you experience any of the following symptoms, which may indicate low levels of vitamin B12:

Extreme tiredness or lack of energy
Tingling sensations
Red, sore tongue or mouth ulcers
Muscle weakness
Vision problems
Memory problems, confusion, depression

Skin rash and skin reactions

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Nexium may need to be stopped. Remember to also report any other side effects such as joint pain.

Serious skin reactions have been reported with Nexium treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking Nexium and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children under 12 years of age

Information on the dosage recommended for children aged 1 to 11 years is provided in the product information for Nexium granules (consult your doctor or pharmacist if you need further information).

Other medicines and Nexium

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Nexium may affect how some medicines work, and some medicines may affect Nexium.

You must not take Nexium tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist 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 fungal infections).
Erlotinib (used to treat cancer).
Citalopram, imipramine, or clomipramine (used to treat depression).
Diazepam (used to treat anxiety, for muscle relaxation, or in epilepsy).
Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Nexium.
Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with Nexium.
Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a medicine used in high-dose chemotherapy for cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Nexium.
Tacrolimus (used in organ transplantation).
Rifampicin (used to treat tuberculosis).
St John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed antibiotics such as amoxicillin and clarithromycin together with Nexium for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Nexium with food and drink

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Nexium during this time.

It is not known whether Nexium passes into breast milk, so you should not take Nexium if you are breastfeeding.

Driving and using machines

It is unlikely that Nexium will affect your ability to drive or use tools or machinery. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If these occur, you should not drive or use machinery.

Nexium contains sucrose

Nexium gastro-resistant tablets contain sucrose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Nexium contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Nexium

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

If you have been taking this medicine for a long time, your doctor will monitor you (especially if you have been taking the medicine for more than one year).
If your doctor has told you to take the medicine as needed, inform your doctor if there is any change in your symptoms.

How much medicine to take

Your doctor will inform you about the number of tablets to take and for how long. This depends on your physical condition, age, and liver function.
The recommended doses are listed below.

Adults from 18 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one gastro-resistant tablet of Nexium 40 mg once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if your oesophagus has not healed.
After healing of the oesophagus, the recommended dose is one gastro-resistant tablet of Nexium 20 mg once daily.
If your oesophagus is not damaged, the recommended dose is one gastro-resistant tablet of Nexium 20 mg daily. When symptoms are under control, your doctor will inform you that you may take the medicine as needed, up to a maximum of one gastro-resistant tablet of Nexium 20 mg per day.
In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their
recurrence:

The recommended dose is one gastro-resistant tablet of Nexium 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one gastro-resistant tablet of Nexium 20 mg once daily for 4 to 8 weeks.

Prevention of gastric ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):

The recommended dose is one gastro-resistant tablet of Nexium 20 mg once daily.

Treatment of excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison
syndrome):

The recommended dose is Nexium 40 mg tablets twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long treatment should continue. The maximum dose is 80 mg twice daily.

Long-term treatment to prevent re-bleeding of ulcers, after initial intravenous Nexium
treatment:
The recommended dose is one tablet of Nexium 40 mg once daily for 4 weeks.
Adolescents from 12 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that the tube connecting your throat to your stomach (oesophagus) is slightly damaged, the recommended dose is one gastro-resistant tablet of Nexium 40 mg once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if the oesophagus has not healed.
After healing of the oesophagus, the recommended dose is one gastro-resistant tablet of Nexium 20 mg once daily.
If the oesophagus is not damaged, the recommended dose is one gastro-resistant tablet of Nexium 20 mg daily.
In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their
recurrence:

The recommended dose is one gastro-resistant tablet of Nexium 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

How to take this medicine

You may take the tablets at any time of the day.
You may take the tablets with or without food.
Swallow the tablets whole with a glass of water. Do not chew or crush the tablets, as they contain coated granules that protect the medicine from being degraded by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

If you have difficulty swallowing the tablets:
- Place the tablets in a glass of non-carbonated water. Do not use any other liquids.
- Stir until the tablets dissolve (the mixture will not appear clear). Drink immediately or within 30 minutes at the latest. Always stir before drinking.
- To ensure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. The solid particles contain the medicine and must not be chewed or crushed.
If you are completely unable to swallow the tablet, it may be mixed with a small amount of water, drawn into a syringe, and administered through a tube directly into the stomach (gastric tube).

Children under 12 years of age
Nexium gastro-resistant tablets are not recommended in children under 12 years of age.
Information on the dosage recommended for children aged 1 to 11 years is provided in the product information for Nexium granules (consult your doctor or pharmacist for further information).
Elderly patients
Dose adjustment is not required in the elderly.
If you take more Nexium than you should
If you have taken more Nexium than prescribed by your doctor, inform your doctor or pharmacist immediately.
If you forget to take Nexium

If you forget to take a dose of Nexium, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

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 Nexium and contact your doctor immediately:

Yellowing of the skin, dark urine, and tiredness may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue, throat or body, rash, feeling faint, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may also occur after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”. These effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people):

Headache.
Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
Nausea or vomiting.
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 sensations, drowsiness.
Vertigo.
Dry mouth.
Changes in blood tests that monitor liver function.
Skin rash, hives, and itching.
Fracture of the hip, wrist, or spine (if Nexium is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people):

Blood problems, such as a reduced number of white blood cells and platelets. This may cause weakness, bruising, or increased susceptibility to infections.
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
Feeling agitated, confused, or depressed.
Changes in taste.
Vision problems, such as blurred vision.
Sudden wheezing or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “candidiasis” that may affect the intestine and is caused by a fungus.
Liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of being unwell and lack of energy.
Increased sweating.

Very rare (may affect up to 1 in 10,000 people):

Changes in the number of blood cells, including agranulocytosis (lack of white blood cells in the blood).
Aggression.
Seeing, feeling, or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take Nexium for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
Inflammation of the intestine (which may lead to diarrhoea).
Erythema, possibly with joint pain.

Nexium, in very rare cases, may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in your general health or fever with signs of localized infection, such as neck, throat, or mouth pain or difficulty urinating, you must consult your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to provide information about any medicines you are taking.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nexium

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp". The expiry date refers to the last day of the month.
Keep this medicine in its original packaging (blister) or keep the bottle tightly closed in order to protect it from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nexium contains
The active substance is esomeprazole. Nexium enteric-coated tablets are available in 2 strengths containing 20 mg or 40 mg of esomeprazole (as magnesium trihydrate).
The excipients are: glycerol monostearate 40-55, hypromellose, hydroxypropylcellulose, iron oxide (20 mg reddish-brown, yellow, 40 mg reddish-brown) (E172), magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, microcrystalline cellulose, synthetic paraffin, macrogols, polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose spheres (sucrose and maize starch), talc, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Nexium and contents of the pack

Nexium 20 mg enteric-coated tablets are light pink with the marking A/EH on one side and 20 mg on the other.
Nexium 40 mg enteric-coated tablets are pink with the marking A/EI on one side and 40 mg on the other.
The tablets are supplied in blister packs, wallet packs, and/or cartons containing:
- 20 mg, 40 mg: bottles of 2-5-7-14-15-28-30-56-60-100-140 (5x28) tablets.
- 20 mg, 40 mg: blister or wallet blister packs of 3-7-7x1-14-15-25x1-28-30-50x1-56-60-90-98-100x1-140 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for Nexium is:
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano
Nexium is released by AstraZeneca AB, 152-57, Södertälje, Sweden, Recipharm Monts, Monts,

France.
GRÜNENTHAL GmbH - Zieglerstraße 6, 52078 Aachen - Germany

This medicinal product is authorised in the European Economic Area member states under the
following names:
Austria, Denmark, Finland, Greece, Iceland, Ireland, Italy, the Netherlands, Norway, Portugal, Sweden:
Nexium
Belgium, Luxembourg: Nexiam
France: Inexium
Germany, Spain: Nexium mups
This leaflet was last approved on:
Other sources of information
More detailed information on this medicinal product is available on the website of AIFA (Italian Medicines Agency).
The following information is intended exclusively for healthcare professionals.

Administration through a gastric tube

Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and about 5 ml of air. For certain tubes, it is necessary to disperse the tablet in 50 ml of water to prevent the granules from blocking the tube.
Shake the syringe immediately for about 2 minutes to disperse the tablet.
Hold the syringe with the tip upwards and check that the tip is not blocked.
Connect the syringe to the tube, maintaining the above position.
Shake the syringe and position it with the tip facing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be held with the tip facing upwards to avoid blockage of the tip).
Rotate the syringe with the tip facing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5, if necessary, to flush any residue from the syringe. For certain tubes, 50 ml of water may be required.

Patient information leaflet

Nexium 10 mg gastro-resistant granules for oral suspension, in sachet

esomeprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nexium is and what it is used for
What you need to know before taking Nexium
How to take Nexium
Possible side effects
How to store Nexium
Contents of the pack and other information

1. What Nexium is and what it is used for

Nexium contains a substance called esomeprazole, which belongs to a group of medicines known as proton pump inhibitors. These medicines work by reducing the amount of acid produced by your stomach.
Nexium is used to treat the following conditions:
Children over 1 year of age
Nexium is used for the treatment of gastro-oesophageal reflux disease (GORD).

Gastro-oesophageal reflux occurs when acid from the stomach leaks into the oesophagus, causing pain, inflammation, and heartburn. Heartburn is a burning sensation that rises from the stomach or chest towards the neck.
In children, symptoms may include regurgitation of stomach contents into the mouth, feeling unwell (vomiting), and poor weight gain.

Children over 4 years of age

Ulcers in the upper part of the intestine associated with infection by bacteria called Helicobacter pylori. In children with this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

3. What you need to know before taking Nexium

Do not take Nexium:

if you are allergic to esomeprazole or to other similar proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole), or to any of the other ingredients of this medicine (listed in section 6).
if you are taking a medicine containing nelfinavir (used to treat HIV infection).
if you have ever had a severe skin rash or skin peeling, or a skin rash with blisters and/or mouth ulcers after taking Nexium or other related medicines.

Do not take Nexium if any of the above conditions apply to you. If you are unsure, ask your doctor or pharmacist before taking Nexium.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nexium:

if you have liver problems, talk to your doctor, as they may wish to prescribe a lower dose.
if you have kidney problems, discuss this with your doctor.
if you have ever had a skin reaction after treatment with a medicine similar to Nexium that reduces stomach acid.
if you need to undergo a specific blood test (Chromogranin A).

Nexium may mask symptoms of other diseases. Therefore, if any of the following occur while you are taking Nexium, inform your doctor immediately:

You lose a lot of weight without reason.
You have stomach pain or indigestion.
You start vomiting repeatedly.
You have difficulty swallowing.
You vomit blood or have black stools (stools with blood spots). If you have been prescribed Nexium “as needed”, contact your doctor if symptoms persist or change in nature. “On-demand” treatment has not been studied in children and is therefore not recommended in this patient group.

If you take a proton pump inhibitor such as Nexium, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

This medicine may affect how your body absorbs vitamin B12, particularly if it needs to be taken for a long time. 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
Tingling sensations
Red, sore tongue or mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression

Skin rash and skin reactions
If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Nexium may need to be stopped. Remember to also report any other side effects such as joint pain.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Nexium treatment. Stop using Nexium and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and Nexium

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because Nexium may affect how some medicines work, and some medicines may affect Nexium.

Do not take Nexium if you are taking nelfinavir (used to treat HIV infection).

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

Atazanavir (used to treat HIV infection).
Clopidogrel (used to prevent blood clots).
Ketoconazole, itraconazolo, or voriconazole (used to treat fungal infections).
Erlotinib (used to treat cancer).
Diazepam (used to treat anxiety or for muscle relaxation).
Citalopram, imipramine, or clomipramine (used to treat depression).
Phenytoin (used in epilepsy).
Warfarin or coumarin (medicines called anticoagulants, used to thin the blood).
Cilostazol (used to treat intermittent claudication — leg pain when walking caused by inadequate blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a medicine used in high-dose chemotherapy for cancer) — if you are taking a high dose of methotrexate, your doctor may temporarily stop your Nexium treatment.
Tacrolimus (used in organ transplants).
Rifampicin (used to treat tuberculosis).
St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed Nexium together with the antibiotics amoxicillin and clarithromycin for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that your doctor is informed about any other ongoing treatments.

Nexium gastro-resistant granules with food and drink

Nexium gastro-resistant granules can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will tell you whether you can take Nexium during this time.

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

Driving and using machines

It is unlikely that Nexium affects the ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If they occur, you should not drive or use machinery.

Nexium contains sucrose and glucose

Nexium contains sucrose and glucose, which are both types of sugars. Therefore, good oral hygiene is important, and you should regularly clean your teeth with a toothbrush.

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking Nexium.

4. How to take Nexium

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your medicine is a granular powder contained in a sachet. Each sachet contains 10 mg of esomeprazole. Your doctor will tell you how many sachets to take each day, as well as how long you should continue treatment.

Empty the contents of the sachet or sachets into a glass of water. Do not use carbonated water. The amount of water required depends on the number of sachets your doctor has instructed you to take at one time.
Use 15 millilitres (ml) of water (3 teaspoons) for each sachet. This means you will need 15 ml for one sachet and 30 ml for two sachets.
Mix the granules in the water.
Allow the mixture to thicken for a few minutes.
Stir again and drink the entire contents. The granules must not be chewed or crushed. Do not leave the mixture for more than 30 minutes before drinking.
If any residue remains in the glass after drinking, add more water, stir, and drink immediately.
Nexium gastro-resistant granules may be taken with or without food.

If you are fed via a tube (gastric feeding), your doctor or nurse will administer Nexium through the tube. Information for doctors or nurses is provided at the end of this leaflet.

Recommended doses are:
Children aged 1 to 11 years

Nexium is not recommended for children under 1 year of age.

Treatment of gastro-oesophageal reflux disease (GORD).

The recommended dose is one sachet (10 mg) or two sachets (20 mg) once daily. The dose for children is based on body weight, and your doctor will determine the correct dose.

Children over 4 years of age
For the treatment of ulcers caused by Helicobacter pylori infection, and to prevent their recurrence

The dose for children is based on body weight, and your doctor will determine the correct dose. Your doctor will also prescribe two antibiotics for the child.

Adults and adolescents aged 12 years and older
For the treatment of gastro-oesophageal reflux disease (GORD)
The recommended dose is two sachets (20 mg) or four sachets (40 mg) once daily.
Nexium oral suspension may also be used in patients who have difficulty swallowing Nexium gastro-resistant dispersible tablets. For patients aged 12 years and older, dosage information is provided in the package leaflet for Nexium gastro-resistant tablets (ask your doctor or pharmacist if you need further information).

Elderly patients
No dose adjustment is necessary for elderly patients.

Patients with liver problems

In patients with severe liver problems, the maximum daily dose of Nexium is two sachets (20 mg). In children aged 1–11 years with severe liver problems, the maximum daily dose must not exceed 10 mg.

Patients with kidney problems

In patients with kidney problems, no specific dose reduction is required. However, if you have severe kidney problems, your doctor may decide to perform certain tests.

If you take more Nexium than you should
If you have taken more Nexium than prescribed, contact your doctor for advice.

If you forget to take Nexium
If you forget to take a dose of Nexium, take it as soon as you remember. If it is almost time for your next dose, wait until the usual time and take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use Nexium, consult your doctor or pharmacist.

5. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following serious side effects, stop taking Nexium and contact your doctor immediately:

Yellowing of the skin, dark urine, and tiredness may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue or throat, or swelling of the body, rash, feeling faint, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”. These effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people):

Headache.
Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
Nausea or vomiting.
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 sensations, drowsiness.
Vertigo.
Dry mouth.
Changes in blood tests that monitor liver function.
Rash, hives, and itching.
Fracture of the hip, wrist, or spine (if Nexium is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people):

Blood disorders such as reduced numbers of white blood cells and platelets. This may cause weakness, bruising, or increased susceptibility to infections.
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
Feeling agitated, confused, or depressed.
Taste disturbances.
Vision problems such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
A fungal infection called “candidiasis” that may affect the intestine.
Liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of malaise and lack of strength.
Increased sweating.

Very rare (may affect up to 1 in 10,000 people):

Changes in blood cell counts, including agranulocytosis (absence of white blood cells in the blood).
Aggression.
Seeing, feeling, or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take Nexium for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels.
Inflammation of the intestine (which may lead to diarrhoea).
Erythema, possibly with joint pain.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nexium

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after Exp. The expiry date refers to the last day of that month.
The reconstituted suspension must be taken within 30 minutes.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nexium oral suspension granules contain
The active substance is esomeprazole. Each sachet contains 10 mg of esomeprazole (as trihydrate magnesium).
The excipients are:
Esomeprazole granules:
Glyceryl monostearate 40-55
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
Polysorbate 80
Sucrose spheres (sucrose and maize starch)
Talc
Triethyl citrate
Excipient granules:
Anhydrous citric acid (for pH adjustment)
Crospovidone
Glucose
Hydroxypropyl cellulose
Yellow iron oxide (E 172)
Xanthan gum.

Description of the appearance of Nexium and contents of the pack
Each Nexium sachet contains fine pale yellow granules. Brown granules may be visible.
The oral suspension is a yellow, viscous liquid containing suspended granules.
Each pack contains 28 or 30 sachets. Not all pack sizes may be marketed.

Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano, Italy

Manufacturer
AstraZeneca AB, Gärtunavägen, 152 57 Södertälje, Sweden
GRÜNENTHAL GmbH - Zieglerstraße 6, 52078 Aachen, Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Romania, Slovenia, Spain, Sweden: Nexium
Belgium, Luxembourg: Nexiam
France: Inexium

This leaflet was last approved on:
Other sources of information
More detailed information on this medicinal product is available on the AIFA website.

The following information is intended exclusively for physicians or healthcare professionals

Administration information for patients with nasogastric or gastric tubes:
i. To administer the 10 mg dose, add the contents of one 10 mg sachet to 15 ml of
water.
ii. To administer the 20 mg dose, add the contents of two 10 mg sachets to 30 ml of
water.
iii. Mix.
iv. Allow to thicken for a few minutes.
v. Mix again.
vi. Draw up the suspension into a syringe.
vii. Inject through a tube with a diameter of 6 French or larger into the stomach within 30
minutes after reconstitution.
viii. Refill the syringe with 15 ml of water for the 10 mg dose and with 30 ml of water for the
20 mg dose.
ix. Shake and inject the remaining contents through the nasogastric or gastric tube into the stomach.
Any unused suspension must be discarded.

Package leaflet: information for the user

NEXIUM 40 mg powder for injectable solution/for infusion

esomeprazole
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, nurse or pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

What Nexium is and what it is used for
What you need to know before being administered Nexium
How Nexium is administered
Possible side effects
How to store Nexium
Contents of the pack and other information

1. What Nexium is and what it is used for
Nexium contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Nexium is used for short-term treatment of certain conditions when the patient is unable to take oral therapy. It is used to treat the following conditions:

Adults

"Gastro-oesophageal reflux disease" (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Nexium may also be used to prevent the development of stomach ulcers during NSAID treatment.
Prevention of re-bleeding after endoscopic treatment of acute gastric or duodenal ulcer bleeding.

Children and adolescents aged 1 to 18 years
"Gastro-oesophageal reflux disease" (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.

2. What you should know before Nexium is administered to you

Do not take Nexium:

if you are allergic (hypersensitive) to esomeprazole or to 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).
if you have ever had a severe skin rash or skin peeling, or a rash with blisters and/or mouth ulcers after taking Nexium or other related medicines. Nexium must not be given to you if any of the above apply. If in doubt, consult your doctor or nurse before using this medicine.

Warnings and precautions
Consult your doctor or nurse before using Nexium if:

You have serious liver problems.
You have serious kidney problems.
You have ever had a skin reaction after treatment with a medicine similar to Nexium that reduces stomach acidity.
You need to undergo a specific blood test (Chromogranin A).

Nexium may mask symptoms of other diseases. Therefore, if any of the following occur before or after treatment with Nexium, inform your doctor immediately:

You lose weight significantly without reason and have difficulty swallowing.
You experience stomach pain or indigestion.
You start vomiting food or blood.
Your stools are black (blood-stained stools).

If you take a proton pump inhibitor such as Nexium, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
This medicine may affect how your body absorbs vitamin B12, particularly if it needs to be taken for a long time. 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
Tingling sensations
Red or sore tongue, mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression

Skin rash and skin reactions
If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Nexium. Remember to also report any other side effects such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Nexium treatment. Stop using Nexium and seek immediate medical advice if you notice any symptoms related to these serious skin reactions described in section 4.

Other medicines and Nexium
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Nexium may affect how some medicines work, and some medicines may affect Nexium.
Nexium must not be given to you if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform 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 fungal infections).
Erlotinib (used to treat cancer).
Citalopram, imipramine, or clomipramine (used to treat depression).
Diazepam (used to treat anxiety, for muscle relaxation, or in epilepsy).
Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Nexium.
Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with Nexium.
Cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a medicine used in high-dose chemotherapy to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Nexium.
Tacrolimus (used in organ transplants).
Rifampicin (used to treat tuberculosis).
St. John’s Wort (Hypericum perforatum) (used to treat depression).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using Nexium. Your doctor will decide whether Nexium can be administered during this period.
It is not known whether Nexium passes into breast milk, therefore you must not take Nexium if you are breastfeeding.

Driving and using machines
It is unlikely that Nexium affects your ability to drive or operate machinery. However, side effects such as dizziness and blurred vision may rarely occur (see section 4). If these occur, you must not drive or operate machinery.

3. How Nexium is administered

Nexium can be administered to children and adolescents from 1 to 18 years of age and to adults, including the elderly.
Administration of Nexium
Adults

Nexium will be administered by your doctor, who will decide the required dose.
The recommended dose is 20 mg or 40 mg once daily.
If you have severe liver problems, the maximum dose is 20 mg per day (MRGE).
The medicine will be given to you as an injection or infusion into a vein. The procedure will last no longer than 30 minutes.
The recommended dose for the prevention of re-bleeding from gastric or duodenal ulcers is 80 mg administered as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/h for 3 days. If you have severe liver problems, a continuous infusion of 4 mg/h for 3 days may be sufficient.

Use in children and adolescents

Nexium will be administered by your doctor, who will determine the amount of medicine you need.
In children aged 1 to 11 years, the recommended dose is 10 or 20 mg administered once daily.
In children aged 12 to 18 years, the recommended dose is 20 or 40 mg administered once daily.
The medicine will be administered as an injection or intravenous infusion. The latter will last up to 30 minutes.

If you use more Nexium than you should
If you think you have been given too much Nexium, inform your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop taking Nexium and
contact your doctor immediately:

Yellowing of the skin, dark urine, and fatigue may be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). These side effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding may also appear in the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (exfoliation of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”. These side effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These side effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people)

Headache.
Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
Nausea or vomiting.
Reactions at the site of administration.
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Sleep disturbance (insomnia).
Dizziness, tingling sensations, drowsiness.
Vertigo.
Vision problems, such as blurred vision.
Dry mouth.
Changes in blood tests that monitor liver function.
Skin rash, hives, and itching.
Fracture of the hip, wrist, or spine (if Nexium is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people)

Blood disorders, for example a reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased susceptibility to infections.
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
Feeling restless, confused, or depressed.
Taste disturbances.
Sudden sensation of breathlessness or shortness of breath (bronchospasm).
Inflammation of the inside of the mouth.
An infection called “candidiasis”, which may affect the intestine and is caused by a fungus.
Liver problems, including jaundice, which may cause yellow skin, dark urine, and fatigue.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of being unwell and lack of strength.
Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

Changes in blood cell counts, including agranulocytosis (lack of white blood cells in the blood).
Aggression.
Seeing, feeling, or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take Nexium for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
Inflammation of the intestine (which may lead to diarrhoea).
Erythema, possibly with joint pain.

Nexium, in very rare cases, may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in general health or fever with local infection symptoms such as neck, throat or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible so that a deficiency in white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to provide information about the medicines you are taking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nexium

Keep this medicine out of the sight and reach of children.
The doctor and hospital pharmacist are responsible for the proper storage, use, and disposal of Nexium.
Do not use this medicine after the expiry date stated on the carton and vial after Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep the vial in the outer packaging to protect the medicine from light.

vials, however, may be stored for up to 24 hours when exposed to normal indoor light
outside their packaging.


6. Contents of the pack and other information

What Nexium contains
The active substance is sodium esomeprazole. Each vial of powder for injectable solution/for
infusion contains 42.5 mg of sodium esomeprazole, equivalent to 40 mg of esomeprazole.
The excipients are edetate disodium and sodium hydroxide. Each vial contains less than 1 mmol of sodium
(23 mg), thus essentially “sodium-free”.

Description of the appearance of Nexium and contents of the pack
Nexium is a "lyophilisate" or white or almost white powder. It is reconstituted into a solution before administration.
Pack sizes: 1 vial, 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Nexium is:
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano, Italy
Nexium is released by AstraZeneca AB, Gärtunavägen, 152-57 Södertälje, Sweden
GRÜNENTHAL GmbH - Zieglerstraße 6, 52078 Aachen, Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Denmark, Finland, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden: Nexium
Belgium, Luxembourg: Nexiam
France: Inexium
Portugal: Nexium I.V.

The following information is intended for healthcare professionals only:

Nexium IV 40 mg contains 40 mg of esomeprazole as the sodium salt. Each vial also contains disodium edetate and sodium hydroxide ( < 1 mmol of sodium).
The vials are for single use only. If the entire reconstituted content of a vial is not required for a single dose, the unused solution must be discarded.
For further information on dosage recommendations and storage conditions, see sections 3 and 5 respectively.
Preparation and administration of the reconstituted solution:
To reconstitute the solution, remove the coloured plastic cap located on top of the Nexium vial and pierce the stopper in the centre of the marked circle, keeping the needle vertical to ensure proper penetration through the stopper.
The reconstituted solution for injection or infusion must be clear and colourless to very pale yellow.
It should be inspected visually for particulate matter and discoloration prior to administration. Only clear solutions should be used.
The chemical and physical in-use stability has been demonstrated to be 12 hours at 30°C. However, from a microbiological standpoint, the product should be used immediately.
Nexium Injection
To prepare a solution for injection:
Injection 40 mg
For a reconstituted solution of 8 mg/ml esomeprazole: Prepare the solution by adding 5 ml of 0.9% sodium chloride solution for intravenous use to the 40 mg esomeprazole vial.
The reconstituted solution for injection must be administered intravenously over at least 3 minutes.
For further information on dose administration, see SmPC section 4.2.
Nexium Infusion
To prepare a solution for infusion:
Infusion 40 mg
Dissolve the contents of one 40 mg esomeprazole vial in up to 100 ml of 0.9% sodium chloride solution for intravenous use.
Infusion 80 mg
Dissolve the contents of two 40 mg esomeprazole vials in up to 100 ml of 0.9% sodium chloride solution for intravenous use.
For further information on dose administration, see SmPC section 4.2.
Disposal
Any unused product or waste material must be disposed of in accordance with local requirements.