Nexium MUPS 40 mg gastro-resistant tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Nexium mups 40 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, 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 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:

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.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation of treatment to prevent rebleeding from peptic ulcer after initial treatment 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.

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 proton pump inhibitor group (e.g. pantoprazole, lansoprazol, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking Nexium or other related medicines.

Do not take Nexium if any of these situations apply to you. 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 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 taking or while taking Nexium, contact your doctor immediately:

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (stained with blood).

If Nexium has been prescribed for you only when you have symptoms, 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 fractures 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 in association 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.

Children under 12 years

Dosing information for children aged 1 to 11 years is provided in the product information for Nexium sachets (consult your doctor or pharmacist if you need further information).

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 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 when you start or stop taking Nexium.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking Nexium.
• 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 Nexium treatment.
• 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, 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, breast-feeding and fertility

If you are pregnant, breast-feeding, 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 unknown whether Nexium passes into breast milk. Therefore, Nexium should not be taken during breast-feeding.

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 infrequently or rarely (see section 4). You should not drive or use machines 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 told you that you have an intolerance to certain sugars, consult with 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 from 18 years of age

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 Nexium mups 40 mg 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• The recommended dose is one Nexium mups 40 mg tablet 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 for prevention of rebleeding from peptic ulcer with intravenous Nexium:

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

Use in adolescents from 12 years of age

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 gastro-resistant Nexium mups 40 mg tablet per day for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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 disintegrate (the solution will not be clear). 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 cannot swallow at all, the tablets may be dispersed in water and drawn into a syringe. They can then be administered 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 at telephone number 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 missed 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, or throat, or swelling of the whole 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 blistering or peeling, even after several weeks of treatment. Large 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), with potentially fatal 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 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 adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: 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.
• Dizziness sensation.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, 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 sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• 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 yellowing of the 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 (reduced number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (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.
• Serious kidney problems.
• Breast enlargement 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 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 cause 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 deterioration in general condition, or fever with signs of a localized 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 number of white blood cells (agranulocytosis) through a blood test. It is important that, in this case, 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 can 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 pack) 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 in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This 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 (reddish-brown) (E 172), magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) 30% dispersion, 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 40 mg enteric-coated tablets are pink, printed with A/EI on one side and 40 mg on the other.
• The tablets are available in:

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

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

• Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area 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/.

This information is intended exclusively for healthcare professionals:

Administration through a gastric tube

1. Insert the tablet into an appropriate 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. Shake the syringe immediately for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip pointing 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 downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).
6. Turn the syringe back with the tip 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 are required.