NEXIUM MUPS 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Nexium MUPS 40 mg Gastro-Resistant Tablets

esomeprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Nexium and what is it used for

Nexium contains the medicine esomeprazole, which belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that the stomach produces.

Nexium is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of re-bleeding following treatment of bleeding ulcers with Nexium intravenous.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.

2. What you need to know before you take Nexium

Do not take Nexium

• If you are allergic to esomeprazole or 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 skin reaction after treatment with a medicine similar to Nexium that reduces stomach acid.

If any of these apply to you, do not take Nexium. If you are not sure, talk to 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 ever had a skin reaction after treatment with a medicine similar to Nexium that reduces stomach acid.
• If you are due to have an endoscopy or a test to find out how much acid your stomach is producing.

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

• Unintentional weight loss, difficulty swallowing or food getting stuck.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhoea.

If you have been prescribed Nexium only when your symptoms appear, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like Nexium, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash and other skin reactions

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with Nexium. Also remember to mention any other symptoms that you may have, such as joint pain or fever.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Nexium (see section 4). Stop taking Nexium and contact your doctor immediately if you get any of the symptoms described in section 4.

Children under 12 years

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

Using Nexium with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Nexium can affect how some medicines work and some medicines can affect how Nexium works.

Do not take Nexium tablets if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor if you are taking:

• 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, relax muscles or treat epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Nexium.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Nexium.
• Cilostazol (used to treat intermittent claudication – a condition where the legs do not get enough blood).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Metotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Nexium.
• Tacrolimus (used to prevent organ rejection after a 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 combination with Nexium for treatment of ulcers caused by Helicobacter pylori bacteria, it is very important that you tell your doctor about any other medicines you are taking.

Taking Nexium with food and drink

You can take your tablets at any time of the day, either with food or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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 if Nexium passes into breast milk. Therefore, you should not take Nexium if you are breast-feeding.

Driving and using machines

Nexium is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use machines if you are affected by these side effects.

Nexium contains sucrose

Nexium contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Nexium contains sodium

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

3. How to take Nexium

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

• Your doctor will tell 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 described below.

Adults aged 18 years and over

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Nexium 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your gullet has not healed yet.
• If you have severe liver problems, your doctor may give you a lower dose.

For excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one Nexium 40 mg tablet twice a day.
• Your doctor will adjust the dose depending on your needs and also decide how long you will need to take the medicine for. The maximum dose is two Nexium 40 mg tablets twice a day.

Prevention of re-bleeding following treatment of bleeding ulcers with Nexium intravenous:

• The recommended dose is one Nexium 40 mg tablet once a day for 4 weeks.

Adolescents from 12 years of age

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Nexium 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your gullet has not healed yet.
• If you have severe liver problems, your doctor may give you a lower dose.

Taking this medicine

• You can take your tablets at any time of the day.
• You can take your tablets with food or on an empty stomach.
• Swallow your tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:

• Put the tablet in a glass of water. Do not use other liquids.
• Stir until the tablet breaks up (the mixture will not be clear). You can then drink it straight away or within 30 minutes. Always stir well before drinking.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

• If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (oral syringe).

Children under 12 years of age

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

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

Elderly

No dose adjustment is necessary in patients over 65 years.

If you take more Nexium than you should

If you have taken more Nexium than you should, talk to your doctor or pharmacist straight away.

In case of overdose, contact the national Poison Information Centre on 91 562 04 20, indicating the medicine and the amount taken.

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, skip the missed dose and continue as usual.
• 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 on 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 all people suffer from them.

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

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

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

• A sudden difficulty breathing, swelling of lips, tongue, and throat or body in general, 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. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (exfoliative dermatitis and mucosal erosion) with potentially fatal consequences. This could be a "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 increased lymph node size (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:

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 polyps in the stomach.

Infrequent (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the 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 likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden sensation of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "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 due to sun exposure.
• Pain in the joints (arthralgia) or muscle pain (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.
• Seeing, feeling, or hearing 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 can 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 (frequency cannot be estimated from available data)

• If you are being treated with Nexium for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have 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. Your doctor may decide to perform periodic tests to monitor your magnesium levels.

• Inflammation in the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Nexium can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of the general condition or fever with symptoms of a local infection such as neck, throat, mouth, 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 important that, in this case, you report 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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Nexium

• Keep this medicine out of sight and reach of children.
• Do not store at a temperature above 30°C.
• Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Keep this medicine in its original packaging (blister) or keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Nexium

• The active ingredient is esomeprazole. There are two concentrations of Nexium mups gastro-resistant tablets that contain 20 mg or 40 mg of esomeprazole (as magnesium trihydrate salt).

• The other components are glycerol monostearate 40-55, hypromellose, iron oxide (brown-red) (E 172), magnesium stearate, methacrylic acid copolymer and ethyl acrylate dispersion (1:1) 30 percent, microcrystalline cellulose, synthetic paraffin, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and corn starch without gluten), talc, titanium dioxide (E 171), triethyl citrate.

Appearance of the Product and Package Contents

• Nexium mups 40 mg gastro-resistant tablets are pink and engraved with A/EI on one side and 40 mg on the other.
• The tablets are presented in

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

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

• Only some package 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

Recipharm Monts, Usine de Monts, 18, rue de Montbazon, F-37260 Monts, France

Grünenthal GmbH, Zieglerstrasse 6- D- 52078 Aachen, Germany

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this prospectus: May 2025

Other Sources of Information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

Administration through a 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 some tubes, a dispersion in 50 ml of water is required to prevent the pellets from clogging the tube.
2. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip is not clogged.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip down. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to prevent clogging the tip).
6. Put the syringe back with the tip down and inject immediately 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 sediment remaining in the syringe. For some tubes, 50 ml of water are necessary.