Nexium MUPS 20 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nexium mups 20 mg gastro-resistant tablets

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, consult 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Nexium may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcers initially treated with intravenous Nexium.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely 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 any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking Nexium or related medicines.

Do not take Nexium if any of these apply to you. 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 medicine similar to Nexium for reducing 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 events before or while taking Nexium, contact your doctor immediately:

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (indicating blood).

If Nexium has been prescribed only for use when symptoms occur, you should contact your doctor if your symptoms persist or change.

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-related 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 in association with Nexium treatment. Stop taking Nexium and seek immediate medical attention 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 dosing for children aged 1 to 11 years is provided in the product information for Nexium powder for oral suspension (consult your doctor or pharmacist if you need further information).

Taking Nexium with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those 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 tablets if you are taking a medicine containing 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).
• Citalopram, imipramine, clomipramine (for treatment of depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Nexium.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor you when starting or stopping Nexium.
• Cilostazol (used to treat intermittent claudication – leg pain while walking due to 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-dose methotrexate, your doctor may temporarily discontinue your Nexium treatment.
• 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 the antibiotics amoxicillin and clarithromycin in addition to Nexium for treating ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Nexium with food and drink

You may take the tablets with food or on an empty stomach.

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 operate tools or machinery. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

Nexium contains sucrose

Nexium contains sugar spheres that contain sucrose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Nexium contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per gastro-resistant tablet; hence, it is essentially “sodium-free”.

3. How to take Nexium

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

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if your symptoms change.

How much to take

• Your doctor will have told you how many tablets to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are given below:

Use in adults aged 18 years and older

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg Nexium mups gastro-resistant tablet once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.

Once the esophagus has healed, the recommended dose is one 20 mg Nexium mups gastro-resistant tablet once daily.

• If your esophagus is not affected, the recommended dose is one 20 mg Nexium mups gastro-resistant tablet once daily. Once your condition is under control, your doctor may instruct you to take the medicine only when you experience symptoms, up to a maximum of one 20 mg Nexium mups gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg Nexium mups gastro-resistant tablet twice daily for one week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

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

To prevent gastric ulcers in patients taking NSAIDs (non-steroidal anti-inflammatory drugs):

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

For the treatment of excessive stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of Nexium twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment to prevent re-bleeding from peptic ulcer after intravenous Nexium:

• The recommended dose is one 40 mg Nexium mups tablet once daily for 4 weeks.

Use in adolescents aged 12 years and older

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg Nexium mups gastro-resistant tablet daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one 20 mg Nexium mups gastro-resistant tablet once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg Nexium mups gastro-resistant tablet once daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg Nexium mups gastro-resistant tablet twice daily for one week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Place the tablets in a glass of non-carbonated water. Do not use other liquids.

• Stir until the tablets disperse (the solution will not be transparent). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.

• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

• If you are completely unable to swallow, the tablets may be dispersed in water and administered via a syringe directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age

Nexium mups gastro-resistant tablets are not recommended for children under 12 years of age.

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

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Nexium than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, stating 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.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 (serious 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 serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to 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, diarrhoea, 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 disturbances (insomnia).
• Dizziness, tingling and numbness sensations, drowsiness.
• Dizziness or vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• 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, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden feeling of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" that may affect the oesophagus.
• Liver problems including jaundice, which may cause yellowish skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• 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 (reduction in 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 disorders.
• Enlargement of the breasts in men.

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

• If you are being treated with Nexium for more than three months, your blood magnesium levels may decrease. Low magnesium levels may manifest 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 diarrhoea).

• 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 deterioration in general condition, or fever with signs of a local infection such as neck pain, sore throat, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced white blood cell count (agranulocytosis) via a blood test. It is important that, in such cases, you inform your doctor about your medication.

Reporting of adverse effects

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

5. Storage of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.
• Store this medicine in its original packaging (blister) or keep the bottle tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Nexium

• The active substance is esomeprazole. There are two strengths of Nexium MUPS enteric-coated tablets containing 20 mg or 40 mg of esomeprazole (as magnesium trihydrate salt).

• The other components are glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, iron oxide (red-brown, yellow) (E 172), magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent, microcrystalline cellulose, synthetic paraffin, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and gluten-free maize starch), talc, titanium dioxide (E 171), triethyl citrate.

Appearance of the product and contents of the pack

• Nexium MUPS 20 mg enteric-coated tablets are light pink, marked with A/EH on one side and 20 mg on the other.
• The tablets are supplied in:

Bottles containing 2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140 (5x28) tablets.

Blister packs in cartons and/or cardboard boxes containing 3, 7, 7x1, 14, 15, 25x1, 28, 30, 50x1, 56, 60, 90, 98, 100x1, 140 tablets.

• Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.
Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturers:

AstraZeneca AB, 152 57 Södertälje, Sweden
Recipharm Monts, Usine de Monts, 18, rue de Montbazon, F-37260 Monts, France
Grünenthal GmbH, Zieglerstrasse 6 - D-52078 Aachen, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/ .

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This information is intended exclusively for healthcare professionals:

Administration via gastric tube

1. Insert the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For certain tubes, dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe vigorously for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip facing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip facing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe, shake it (the syringe must be kept with the tip facing upwards to prevent blockage of the tip).
6. Reposition 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.
7. Fill the syringe with 25 ml of water and 5 ml of air, and repeat step 5 if necessary to flush any remaining sediment from the syringe. For certain tubes, 50 ml of water may be required.