AXIAGO 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Axiago 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 Package Leaflet

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

1. What is Axiago and what is it used for

Axiago contains a medicine called esomeprazole which belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid that the stomach produces.

Axiago is used for the treatment of the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). 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 tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of bleeding from a peptic ulcer with esomeprazole intravenous.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). 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 Axiago

Do not take Axiago:

• 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 inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to Axiago to reduce stomach acid.

If you are in any of these situations, do not take Axiago. If you are not sure, consult your doctor or pharmacist before taking Axiago.

Warnings and precautions

Consult your doctor or pharmacist before taking Axiago:

• 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 Axiago to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Axiago may hide the symptoms of other diseases. Therefore, if you notice any of the following events before or while taking Axiago, 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 (blood-stained).

If you have been prescribed Axiago only when you notice symptoms, you should contact your doctor if the symptoms of your disease persist or change.

Taking a proton pump inhibitor like Axiago, especially over a period of 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).

Rashes and skin symptoms

If you get a rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as you may need to stop treatment with Axiago. Remember to mention any other symptoms that you may notice, such as joint pain.

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

Children under 12 years of age

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

Using Axiago with other medicines

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

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

Tell your doctor if you are using 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 depression).
• Diazepam (used for anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Axiago.
• Medicines used to make the blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking Axiago.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood pumping).
• 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 Axiago.
• 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 along with Axiago to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

Taking Axiago 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 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 Axiago during this time. It is not known if Axiago passes into breast milk. Therefore, you should not take Axiago during breastfeeding.

Driving and using machines

Axiago is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you experience any of these effects.

Axiago contains sucrose

Axiago contains sugar spheres that contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Axiago contains sodium

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

3. How to take Axiago

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

• If you take this medicine for a long time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has told you to take this medicine only when you notice symptoms, inform your doctor if the 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 over

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

• If your doctor has found that your esophagus is slightly affected, the recommended dose is one 40 mg gastro-resistant tablet of Axiago once a day for 4 weeks. Your doctor may tell you to take 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 acid production in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg tablet of Axiago twice a day.
• 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 a day.

Continuation of prevention of bleeding from a peptic ulcer with esomeprazole intravenous:

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

Use in adolescents aged 12 years and over

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

• If your doctor has found that your esophagus is slightly affected, the recommended dose is one 40 mg gastro-resistant tablet of Axiago once a day for 4 weeks. Your doctor may tell you to take 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.

Taking this medicine

• You can take the tablets at any time of the day.
• You can 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 which prevent the medicine from being destroyed by the acid in the stomach. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:
• • Put the tablets in a glass of water without gas. Do not use other liquids.
  • Stir until the tablets disintegrate (the solution will not be clear). You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.
  • To make sure you have taken all the medicine, rinse the glass well with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush the granules.
• If you cannot swallow at all, the tablets can be dispersed in water and introduced 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

Axiago 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 esomeprazole sachet product information (consult your doctor or pharmacist if you need additional information).

Elderly patients

No dose adjustment is necessary in elderly patients.

If you take more Axiago than you should

If you take more Axiago than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420, indicating the medicine and the amount taken.

If you forget to take Axiago

• 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 the missed dose.

If you have any other 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 all people suffer from them.

If you observe any of the following serious adverse effects, stop taking Axiago 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. Blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) 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 size of 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:

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 sensation, and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Hip, wrist, or spine fracture (if Axiago 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 feeling 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).
• Aggressiveness.
• 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 size of the breasts in men.

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

• If you are treated with Axiago for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary 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 of the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Axiago 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 pain, 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 is not listed 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. Storage of Axiago

• Keep this medicine out of the 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 at the SIGRE point in 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 Axiago

• The active ingredient is esomeprazole. There are two concentrations of Axiago 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, 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

• Axiago 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.

• It is possible that only some package sizes are 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Italy (IT) Axagon

Spain (ES) Axiago

Sweden (SE) Axiago

Date of the Last Revision of this Prospectus: May 2025

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/.

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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, 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 upwards 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 downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip upwards to avoid clogging the tip).
6. Put the syringe back with the tip downwards 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 drag any sediment that remains in the syringe. For some tubes, 50 ml of water are necessary.