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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

esomeprazole

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Nexium is and what it is used for

Nexium contains a medicine called esomeprazole, which belongs to a group of medicines known as 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 for the treatment of a condition called "gastroesophageal reflux disease" (GERD).

• This occurs when acid from the stomach moves up into the esophagus, causing pain, inflammation, and heartburn. Heartburn is a burning sensation that rises from the stomach or lower chest toward the neck.
• In children, symptoms of this condition may include stomach contents returning to the mouth (regurgitation), vomiting, or failure to gain weight.

Children from 4 years of age

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, their doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. 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 in the treatment of HIV infection).

• If you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking Nexium or other related medicines.

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

Warnings and precautions

Talk to 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 medicine similar to Nexium used to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

Nexium may mask symptoms of other conditions. Therefore, if you experience any of the following 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 difficulty swallowing.
• You vomit blood or your stools appear black (blood-stained).

If Nexium has been prescribed “on-demand”, you should contact your doctor if symptoms persist or change. On-demand treatment has not been studied in children and is therefore not recommended for this patient group.

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

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, 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.

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

Taking Nexium with other medicines

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

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

Inform your doctor 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 (for fungal infections).
• Erlotinib (used in cancer treatment).
• Diazepam (used to treat anxiety or as a muscle relaxant).
• Citalopram, imipramine, clomipramine (for the treatment of depression).
• Phenytoin (for epilepsy).
• Warfarin or coumarin (medicines called anticoagulants used to thin the blood).
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in 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 the antibiotics amoxicillin and clarithromycin in addition to Nexium to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.

Taking 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take Nexium during this time.

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

Driving and using machines

Nexium is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or use machines if you experience any of these effects.

Nexium contains sucrose and glucose

Nexium contains sucrose and glucose, which are two types of sugars. Therefore, it is important to maintain careful oral hygiene and to brush your teeth regularly.

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Nexium

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your medicine comes as granules in individual sachets. Each sachet contains 10 mg of esomeprazole. Your doctor will tell you how many sachets to take each day and for how long you should take them.

• Empty the contents of the sachet or sachets into a glass with a small amount of water. Do not use carbonated (sparkling) water. The amount of water needed depends on the number of sachets your doctor has instructed you to take at one time.
• Use 15 millilitres (ml) of water (3 coffee spoons) for each sachet. This means you will need 15 ml for one sachet and 30 ml for two sachets.
• Stir the granules in the water.
• Let the mixture stand for a few minutes until it thickens.
• Stir again and drink the mixture. The granules must not be chewed or crushed. Do not let the mixture stand for more than 30 minutes before drinking.
• If any sediment remains in the glass, add more water, stir, and drink immediately.

You may take Nexium with or without food.

If you are being fed through a gastric tube, your doctor or healthcare professional may administer Nexium through the tube. Additional information for the doctor or healthcare professional 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.

To treat gastroesophageal reflux disease (GERD)

• 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 the doctor will decide the correct dose.

Use in children from 4 years of age

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

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

Use in adults and adolescents

Nexium oral suspension can also be used by patients who have difficulty swallowing the gastro-resistant tablets of Nexium. Dosage information for patients aged 12 years and older is provided in the product information for Nexium MUPS gastro-resistant tablets (consult your doctor or pharmacist if you need further information).

Elderly patients

Dose adjustment is not necessary in elderly 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

• There are no special dose restrictions for patients with kidney problems. However, if you have severe renal impairment, your doctor may decide to perform regular monitoring.

If you take more Nexium than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, indicating the medicine 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 it is almost time for your next dose, do not take the missed dose and wait until your next scheduled dose. Do not take a double dose to make up for the missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems.

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

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

These 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. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), with potentially life-threatening consequences. This could 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, skin itching.
• 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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, depression.
• Disturbance in taste.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the esophagus.
• Liver problems including jaundice, which may cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (decreased number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. 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 problems.
• Enlargement of the breasts in men.

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

• • If you are taking 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, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
  • Inflammation of the intestine (which may lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Nexium may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced white blood cell count (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about the medication you are taking.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 container and sachet after EXP. The expiry date is the last day of the month indicated.

The reconstituted suspension must be used within 30 minutes.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nexium gastro-resistant granules for oral suspension

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

The other components are:

Esomeprazole granules:

Glyceryl monostearate 40-55

Hydroxypropylcellulose

Hypromellose

Magnesium stearate

Methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%

Polysorbate 80

Sugar spheres (sucrose and corn starch)

Talc

Triethyl citrate

Excipient granules:

Anhydrous citric acid (for pH adjustment)

Crospovidone

Glucose

Hydroxypropylcellulose

Iron oxide yellow (E172)

Xanthan gum

Nature of the product and contents of the container

Each Nexium sachet contains fine, light yellow granules. Brown granules may be visible.

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

AstraZeneca AB

152 57 Södertälje

Sweden

Grünenthal GmbH

Zieglerstrasse 6

D- 52078 Aachen

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State	Medicinal product name
Austria, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Romania, Slovenia, Spain, Sweden	Nexium
Belgium, Luxembourg	Nexiam
France	Inexium

Date of the most recent review of this leaflet: May 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Administration instructions for patients with nasogastric or gastric tube:

1. For a 10 mg dose, add the contents of one 10 mg sachet to 15 ml of water.
2. For a 20 mg dose, add the contents of two 10 mg sachets to 30 ml of water.
3. Shake well.
4. Allow to stand for a few minutes to thicken.
5. Shake again.
6. Draw up the suspension into a syringe.
7. Administer through an enteral tube (French size 6 or larger) into the stomach within 30 minutes after reconstitution.
8. Refill the syringe with 15 ml of water for a 10 mg dose or 30 ml for a 20 mg dose.
9. Shake and flush any remaining residue in the enteral tube into the stomach.

Any unused portion of the suspension must be discarded.