Package Insert: Information for the Patient
Nexium mups 40 mg gastro-resistant tablets
esomeprazole
Read this package insert carefully before starting to take this medication, as it contains important information for you.
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:
Adults
Adolescents 12 years of age and older
If you find yourself 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
Nexium may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking Nexium, contact your doctor immediately:
If your doctor has prescribed Nexium only when you notice some symptoms, you should contact your doctor if the symptoms of your disease persist or change.
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 experience a rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt 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, throat, nose, genital, and conjunctivitis (red and swollen eyes) ulcers. 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.
Children under 12 years
The information on dosing for children aged 1 to 11 years is presented in the Nexium product information in sachets (consult your doctor or pharmacist if you need additional information).
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 purchased 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 tablets if you are taking a medicine that containsnelfinavir(used for the treatment of HIV infection).
Inform your doctor if you are using any of the following medicines:
If your doctor has prescribed antibiotics amoxicillin and clarithromycin in addition to Nexium to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medicine.
Taking Nexium with food and drinks
You can 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 plan to become 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, Nexium should not be taken during pregnancy.
Driving and operating machines
Nexium is unlikely to affect your ability to drive or use tools or machines. However, rare or very 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 side effects.
Nexium contains saccharose
Nexium contains sugar spheres containing saccharose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Nexium contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per Nexium tablet; that is, it is essentially "sodium-free".
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
How much to take
Use in adults aged 18 years and older
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):
For the treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):
Continuation treatment for the prevention of bleeding from peptic ulcer induced with Nexium intravenous:
Use in adolescents aged 12 years and older
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):
How to take this medication
What to do if you have difficulty swallowing
Use in children under 12 years of age
Nexium mups tablets are not recommended for children under 12 years of age.
The information on dosing for children aged 1 to 11 years is presented in the product information for Nexium in sachets (consult your doctor or pharmacist if you need additional information).
Older patients
No adjustment of the dose is necessary in older patients.
If you take more Nexium than you should
If you take more Nexium than your doctor has indicated, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 91 5620420, indicating the medication and the amount ingested
If you forget to take Nexium
If you have any other questions about the use of this medication, 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:
These side effects are rare and may affect up to 1 in 1,000 people.
These side effects are rare and may affect up to 1 in 1,000 people.
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 10people)
Occasional (may affect up to 1 in 100people)
Rare (may affect up to 1 in 1,000people)
Very rare (may affect up to 1 in 10,000people)
Frequency not known (the frequency cannot be estimated from the available data)
In rare cases, Nexium may affect white blood cells, leading to immunodeficiency. If you have an infection with symptoms such as high fever with severe worsening of the general condition or high fever with symptoms of a local infection 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.
Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications 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 medications you no longer need. In this way, you will help protect the environment.
Appearance of the product and contents of the package
2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140 (5x28) tablets.
Packages with blisters in boxes and/or cartonages of 3, 7, 7x1, 14, 15, 25x1, 28, 30, 50x1, 56, 60, 90, 98, 100x1, 140 tablets.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization:
Grünenthal Pharma, S.A.
Doctor Zamenhof, 36 – 28027 Madrid, Spain
Responsible for manufacturing:
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 and in the United Kingdom (Northern Ireland) with the following names:
Member State | Medicine name |
Austria, Denmark, Finland, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Sweden, United Kingdom (Northern Ireland) | Nexium |
Belgium, Luxembourg | Nexiam |
France | Inexium |
Germany, Spain | Nexium mups |
Last review date of this leaflet: December 2021
Other sources of information
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .
This information is intended solely 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 some tubes, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip upwards and check that the tip has not become blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip downwards. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip upwards to prevent the tip from becoming blocked).
6. Repeat the 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 draw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.
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