AXIAGO 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Axiago 20 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 experience 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 20 mg and what is it used for
2. What you need to know before you take Axiago 20 mg
3. How to take Axiago 20 mg
4. Possible side effects
5. Storage of Axiago 20 mg
6. Contents of the pack and other information

1. What is Axiago and what is it used for

Axiago contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Axiago is used for the treatment of 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.
• Ulcers in the stomach or duodenum (the tube leading out of the stomach) that are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers in the stomach or duodenum caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Axiago can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Treatment of NSAID-induced peptic ulcers after intravenous esomeprazole.

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.
• Ulcers in the stomach or duodenum (the tube leading out of the stomach) that are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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 inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV).
• If you have ever had a skin reaction such as a rash, possibly with blisters, after taking Axiago or other medicines of the same class.

If any of the above apply to you, do not take Axiago. If you are not sure, talk to your doctor or pharmacist before taking Axiago.

Warnings and precautions

Talk to 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 that reduces stomach acid.
• If you are due to have an endoscopy or a test to find out why you are losing blood from your stomach or duodenum.

Axiago may hide the symptoms of other diseases. Therefore, if you are prescribed Axiago on an ‘on-demand’ basis, you should contact your doctor if your symptoms change or get worse.

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If you have been prescribed Axiago only when you notice symptoms, you should see your doctor if these symptoms persist or change.

Taking a proton pump inhibitor like Axiago, 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 reactions

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with Axiago. Also 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 rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported in association with the use of esomeprazole (see section 4). If you get any of the symptoms of these severe skin reactions, stop taking Axiago and contact your doctor or go to the hospital immediately.

Children under 12 years

Information on the use of esomeprazole in patients of 1 to 11 years of age is available in the esomeprazole granules for oral suspension package leaflet (ask your doctor or pharmacist if you need more 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 that you can buy without a prescription. This is because Axiago can affect the way some medicines work and some medicines may affect the way Axiago works.

Do not take Axiago if you are taking a medicine containing nelfinavir (used to treat HIV).

Tell your doctor if you are taking:

• Atazanavir (used to treat HIV).
• 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 in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Axiago.
• Medicines that are used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Axiago.
• Cilostazol (used to treat intermittent claudication – a condition where the leg does not get enough blood when walking, leading to pain).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with Axiago.
• Tacrolimus (used after organ transplants).
• 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 with Axiago to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Taking Axiago with food and drink

You can take your tablets with food or on an empty stomach.

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 Axiago during this time. It is not known if Axiago passes into breast milk. Therefore, you should not take Axiago if you are breast-feeding.

Driving and using machines

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

Axiago contains sugar

Axiago 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.

Axiago contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per gastro-resistant tablet, that is to say essentially ‘sodium-free’.

3. How to take Axiago

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 take it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, you should contact 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.

Use in adults aged 18 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, 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 oesophagus has not healed yet.
• Once your oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet of Axiago once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg gastro-resistant tablet of Axiago once a day. After your symptoms have been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20 mg gastro-resistant tablet of Axiago per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to stop them coming back:

• The recommended dose is one 20 mg gastro-resistant tablet of Axiago twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take at the same time as Axiago.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant tablet of Axiago once a day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant tablet of Axiago once a day.

For the treatment of too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of Axiago twice a day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg of Axiago twice a day.

For the prevention of bleeding from stress ulceration in seriously ill patients:

• The recommended dose is one 40 mg vial of esomeprazole intravenously every 24 hours.

Use in adolescents aged 12 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, 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 oesophagus has not healed yet.
• Once your oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet of Axiago once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg gastro-resistant tablet of Axiago once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to stop them coming back:

• The recommended dose is one 20 mg gastro-resistant tablet of Axiago twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take at the same time as Axiago.

Taking this medicine

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

• If you have difficulty swallowing the tablets:

• Put the tablets in a glass of water. Do not use other liquids.
• Stir until the tablets break up (the mixture will not be clear). You can take the mixture immediately or within 30 minutes. Always stir well before taking.
• To make sure you get the full dose of the medicine, rinse the glass with half a glass of water and drink it. The solid particles 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 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 the use of esomeprazole in patients of 1 to 11 years of age is available in the esomeprazole granules for oral suspension package leaflet (ask your doctor or pharmacist if you need more 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, talk to your doctor or pharmacist straight away.

In case of overdose, contact the national Poison Information Centre on 91 5620420, stating the name of 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, 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 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.

• 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 skin redness with blisters or peeling, even after several weeks of treatment. Important 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.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, skin itching.
• 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.
• Taste alteration.
• 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.
• Joint pain (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 skin peeling. 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 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 in 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, 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 Axiago

• 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 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 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, iron oxide (brown-red, yellow) (E 172), magnesium stearate, methacrylic acid copolymer and ethyl acrylate dispersion 30 percent, microcrystalline cellulose, synthetic paraffin, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and cornstarch without gluten), talc, titanium dioxide (E 171), triethyl citrate.

Appearance of the Product and Package Contents

• Axiago 20 mg gastro-resistant tablets are light pink in color, engraved with A/EH on one side and 20 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/.

_____________________________________________________________________________

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 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 avoid 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 drag any sediment that remains in the syringe. For some tubes, 50 ml of water are necessary.