Package Insert: Information for the User

Nexium 10 mg Gastrorresistente Granules for Oral Suspension in a Blister Pack

esomeprazole

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Nexium contains a medication called esomeprazole that belongs to a group of medications called proton pump inhibitors. These work by reducing the amount of acid produced by the stomach.

Nexium is used to treat the following conditions:

Children from 1 year of age

Nexium is used to treat a condition called “gastroesophageal reflux disease” (GERD).

• It occurs when stomach acid rises up into the esophagus, causing pain, inflammation, andburning. The burning is a sensation of burning that rises from the stomach or lower part of the chest up to the neck.
• In children, symptoms of this condition may include the return of stomach contents to the mouth (regurgitation), vomiting, or failure to gain weight.

Children from 4 years of age

• Infected ulcers caused by a bacteria called “Helicobacter pylori”. If the child has this condition, it is possible that their doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Nexium

• if you are allergic to esomeprazole or other proton pump inhibitors similar (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 that contains nelfinavir (used in the treatment of HIV infection).

If you are in any of these situations, do not take Nexium. If you are unsure, consult your doctor or pharmacist before taking Nexium.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nexium

• if you have severe liver problems.
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a similar medicine to Nexium for reducing stomach acid.
• if you are scheduled to have a specific blood test (Cromogranin A).

Nexium may mask the symptoms of other diseases.Therefore, if you notice any of the following effects while taking Nexium, contact your doctor immediately:

• You lose a lot of weight without reason.
• You have stomach pain or indigestion.
• You start vomiting repeatedly.
• You have trouble swallowing.
• You vomit blood or your stools appear black (blood-stained).

If you have been prescribed Nexium "on demand", you should contact your doctor if the symptoms persist or change. The on-demand treatment has not been investigated in children and is therefore not recommended in this group of patients.

Taking a proton pump inhibitor like Nexium, especially for more than a year, may slightly increase the risk of breaking a hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Rashes and skin symptoms

If you develop a rash, especially on sun-exposed areas of the skin, consult your doctor as soon as possible, as it may be necessary to stop treatment with Nexium. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may include mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after symptoms similar to the flu, such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

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

Use of Nexium with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes medicines bought without a prescription. This is because Nexium may affect the way some medicines work and some medicines may influence the effect of Nexium.

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

Inform your doctor if you are using any of the following medicines:

• Atazanavir (used for HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Diazepam (used to treat anxiety or as a muscle relaxant).
• Citalopram, imipramine, clomipramine (for depression).
• Phenytoin (for epilepsy).
• Warfarin or coumarin (blood-thinning medicines).
• Cilostazol (used to treat intermittent claudication – leg pain caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Nexium.
• Tacrolimus (organ transplant).
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum)(used to treat depression).

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin, in addition to Nexium, to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor if you are taking any other medicine.

Taking Nexium granulated gastro-resistant with food and drinks

The granulated gastro-resistant form of Nexium can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take Nexium during this period.

The safety of Nexium for use during pregnancy has not been established. Therefore, do not take Nexium during pregnancy.

Driving and operating machines

Nexium is unlikely to affect your ability to drive or use tools or machines. However, rare side effects such as dizziness or blurred vision may occur (see section 4). Do not drive or use machines if you notice any of these effects.

Nexium contains saccharose and glucose

Nexium contains saccharose and glucose, which are two types of sugar. Therefore, it is essential to maintain good oral hygiene and brush your teeth regularly.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your medication is presented in the form of granules in individual sachets. Each sachet contains 10 mg of esomeprazole. Your doctor will indicate how many sachets to take each day and for how long.

• Empty the contents of the sachet or sachets into a glass with a little water. Do not use carbonated water. The amount of water depends on the number of sachets your doctor has indicated you should take at once.
• Use 15 milliliters (ml) of water (3 tablespoons of coffee) for each sachet. This means you will need 15 ml for one sachet and 30 ml for two sachets.
• Remove the granules from the water.
• Leave the mixture to stand for a few minutes until it has thickened.
• Remove it again and drink the mixture. The granules should not be chewed or crushed. Do not leave the mixture to stand for more than 30 minutes before drinking it.
• If there is any sediment left in the glass, add more water, stir and drink immediately.

You can take Nexium with food or on an empty stomach.

If you are being fed through a gastric tube, your doctor or healthcare staff may administer Nexium through the tube. Additional information for the doctor or healthcare staff is provided at the end of this leaflet.

The recommended dose is described below:

Use in children aged 1 to 11 years

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

Para treat gastroesophageal reflux disease (GERD)

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

Use in children from 4years of age

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence.

Use in adults and adolescents

Nexium oral suspension can also be used by patients who have difficulty swallowing the Nexium gastro-resistant tablets. Information on dosing for patients aged 12 years and over is presented in the Nexium mups gastro-resistant tablets product information (consult your doctor or pharmacist if you need additional information).

Older patients

No dose adjustment is necessary for older patients.

Patients with liver problems

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

Patients with kidney problems

• No special dose restrictions are necessary for patients with kidney problems. However, if you have severe kidney problems, your doctor may decide to monitor you regularly.

If you take more Nexium than you should

If you take more Nexium than your doctor has prescribed, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, indicating the medication and the amount ingested.

If you forget to take Nexium

If you forget to take a dose, take it as soon as you remember. However, if there is not much time left before your next dose, do not take the missed dose and wait until the next dose. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Nexium and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that may be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

These side effects are rare and may affect up to 1 in 1,000 people.

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals. Skin rashes can turn into severe skin damage and generalised peeling (epidermal and superficial mucous membrane damage) with potentially fatal consequences. It could be a "multiforme erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

These side effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign stomach polyps.

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, numbness, somnolence.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if Nexium is used at high doses and for a long period).

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

• Blood disorders such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden sensation of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A known infection called "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthralgia) or muscles (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

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

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Liver disorders that can lead to liver failure or brain inflammation.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms may be accompanied by high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Increased breast size in men.

Frequency not known (the frequency cannot be estimated from the available data)

• • If you are being treated with Nexium for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood.
  • Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In rare cases, Nexium may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as severe worsening of the general condition or fever with local infection symptoms such as neck pain, throat pain, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) through a blood test. It is essential to inform your doctor about your medication in this case.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the carton after CAD. The expiration date is the last day of the month indicated.

The reconstituted suspension must be used within 30 minutes.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nexium gastro-resistant granules for oral suspension

The active ingredient is esomeprazole. Each sachet contains 10 mg of esomeprazole (as magnesium trihydrate).

The other components are:

Esomeprazole granules:

Mono- and diglycerides 40-55

Hydroxypropyl cellulose

Hydroxypropyl methylcellulose

Magnesium stearate

Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%

Polysorbate 80

Sugar spheres (sucrose and maize starch)

Talc

Triethyl citrate

Excipient granules:

Anhydrous citric acid (for pH adjustment)

Crospovidone

Glucose

Hydroxypropyl cellulose

Yellow iron oxide (E172)

Xanthan gum

Appearance of the product and contents of the pack

Each sachet of Nexium contains fine yellowish granules. There may be visible brown granules.

The oral suspension is a thick, yellow liquid containing suspended granules.

Each pack contains 28 or 30 sachets. Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer responsible:

AstraZeneca AB

152 57 Södertälje

Sweden

Grünenthal GmbH

Zieglerstrasse 6

D- 52078 Aachen

Germany

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:

Last revision date of this leaflet: December 2021

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Instructions for administration in patients with nasogastric or gastric tubes:

1. For a dose of 10 mg, add the contents of one 10 mg sachet to 15 ml of water.
2. For a dose of 20 mg, add the contents of two 10 mg sachets to 30 ml of water.
3. Shake.
4. Leave for a few minutes to thicken.
5. Shake again.
6. Fill a syringe with the suspension.
7. Inject through the enteral tube, (French size 6 or larger), into the stomach within 30 minutes of reconstitution.
8. Fill the syringe with 15 ml of water for a dose of 10 mg and 30 ml for a dose of 20 mg.
9. Shake and draw up any sediment remaining in the enteral tube into the stomach.

Any remaining suspension not used should be discarded.