Axiago 40 mg gastro-resistant tablets

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Axiago 40 mg gastro-resistant tablets

esomeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Axiago is and what it is used for

Axiago 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.

Axiago is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube from 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 for prevention of rebleeding from peptic ulcer after intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube from the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before taking 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 medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking Axiago or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 used to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

Axiago may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking Axiago, contact your doctor immediately:

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

If Axiago has been prescribed only for when you experience symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Axiago, particularly 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 discontinue treatment with Axiago. 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 treatment with Axiago. Stop taking Axiago and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children under 12 years

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

Use of Axiago with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription. This is because Axiago can affect how some medicines work, and some medicines can influence the effect of Axiago.

Do not take Axiago tablets if you are taking a medicine containing nelfinavir (used for the treatment of HIV infection).

Inform your doctor if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for the treatment of 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 when you start or stop taking Axiago.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking Axiago.
• Cilostazol (used for the treatment of intermittent claudication – leg pain when walking caused by insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapeutic agent used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Axiago.
• Tacrolimus (for organ transplant).
• Rifampicin (used for the treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Axiago to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Axiago with food and drink

You may 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 whether you can take Axiago during this period. It is not known whether Axiago passes into breast milk. Therefore, Axiago should not be taken during breastfeeding.

Driving and using machines

Axiago 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.

Axiago contains sucrose

Axiago contains sugar spheres that contain sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Axiago contains sodium

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

3. How to take Axiago

Follow exactly the instructions for administering 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 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 indicated below.

Use in adults aged 18 years and older

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 Axiago 40 mg gastro-resistant tablet once daily for 4 weeks. Your doctor may instruct 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 stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The recommended dose is one Axiago 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 following intravenous esomeprazole:

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

Use in adolescents aged 12 years and older

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 Axiago 40 mg gastro-resistant tablet per day for 4 weeks. Your doctor may instruct 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.

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 still water. Do not use other liquids.
  • Stir until the tablets disintegrate (the solution will not be transparent). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.
  • To ensure you have taken all the medication, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medication – do not chew or crush the granules.
• If you cannot swallow at all, the tablets may 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 provided in the product information for esomeprazole in sachets (consult your doctor or pharmacist if you need additional information).

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Axiago than you should

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

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

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 once) to make up for a forgotten 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 experiences them.

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

• Yellowing of the skin, dark urine, and fatigue, 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 and throat, or 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 blisters or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), with potentially life-threatening 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 enlarged 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.
• Stomach or intestinal effects: stomach pain, constipation, diarrhoea, 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 disturbances (insomnia).
• Dizziness, tingling and numbness, drowsiness.
• Sensation of dizziness.
• Dry mouth.
• Abnormal blood test results indicating liver function problems.
• Skin rash, hives, itching of the skin.
• Hip, wrist, or spinal 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 may cause weakness, bruising, or increase the likelihood of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Altered taste.
• 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 oesophagus.
• Liver problems including jaundice, which may cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• 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 blood cell counts, including agranulocytosis (reduction in the 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 appearance 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.
• Severe kidney disorders.
• Breast enlargement in men.

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

• If you are being treated with Axiago 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 lead to diarrhoea).

• Skin rash, possibly with joint pain.

In very rare cases, Axiago may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduction in white blood cell count (agranulocytosis) via 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 they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 Axiago

• Keep this medicine out of the sight and reach of children.

• Do not store above 30ºC.

• 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) or keep the container 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Axiago

• The active substance is esomeprazole. There are two strengths of Axiago gastro-resistant tablets containing 20 mg or 40 mg of esomeprazole (as magnesium salt trihydrate).

• The other components are glycerol monostearate 40-55, hypromellose, hypromellose, iron oxide (red-brown) (E 172), magnesium stearate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30 percent, microcrystalline cellulose, synthetic paraffin, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and gluten-free corn starch), talc, titanium dioxide (E 171), triethyl citrate.

Appearance of the product and contents of the pack

• Axiago 40 mg gastro-resistant 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 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 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy (IT): Axagon
Spain (ES): Axiago
Sweden (SE): Axiago

Date of the most recent review of this summary: May 2025

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/.

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This information is intended for healthcare professionals only:

Administration via gastric tube

1. Place 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 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 remain with the tip pointing upwards to prevent blockage).
6. Reposition the syringe 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 residue from the syringe. For some tubes, 50 ml of water may be required.