Axiago 20 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Axiago 20 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, ask 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 may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Axiago 20 mg is and what it is used for
2. What you need to know before taking Axiago 20 mg
3. How to take Axiago 20 mg
4. Possible side effects
5. How to store Axiago 20 mg
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 for the treatment of the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers associated with infection by a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Axiago may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcer after initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers associated with infection by a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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 proton pump inhibitor group (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, skin peeling, blistering, or mouth ulcers after taking Axiago or other related medicines.

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

Warnings and precautions

Talk to 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 conditions. 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 use when symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Axiago, especially 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 on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop 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 obtained without a prescription. This is because Axiago may affect how some medicines work, and some medicines may influence the effect of Axiago.

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

Inform your doctor if you are taking 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 treatment of depression).
• Diazepam (used to treat 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 to treat intermittent claudication – leg pain when walking due to poor blood flow).
• 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 discontinue your Axiago treatment.
• 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 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 drinks

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take Axiago during this time. 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 rarely or very rarely (see section 4). You should not drive or operate machinery 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 informed you that you have 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; this 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.

• 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 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 older

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

• If your doctor has determined that your esophagus is slightly 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.
• Once the esophagus has healed, the recommended dose is one Axiago 20 mg gastro-resistant tablet once daily.
• If your esophagus is not affected, the recommended dose is one Axiago 20 mg gastro-resistant tablet once daily. Once your condition has been controlled, your doctor may instruct you to take the medicine only when you notice symptoms, up to a maximum of one Axiago 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one Axiago 20 mg gastro-resistant tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one Axiago 20 mg gastro-resistant tablet once daily for 4 to 8 weeks.

To prevent gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one Axiago 20 mg gastro-resistant tablet once daily.

For the treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of Axiago 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 induced with 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 slightly affected, the recommended dose is one Axiago 40 mg gastro-resistant tablet 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.
• Once the esophagus has healed, the recommended dose is one Axiago 20 mg gastro-resistant tablet once daily.
• If your esophagus is not affected, the recommended dose is one Axiago 20 mg gastro-resistant tablet once daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one Axiago 20 mg gastro-resistant tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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 (non-carbonated) water. Do not use other liquids.

• Stir until the tablets disintegrate (the solution will not be clear). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.

• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

• If you cannot swallow at all, the tablets may be dispersed in water and administered via a syringe. They can then be delivered 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 granules for oral suspension (consult your doctor or pharmacist if you need further 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, stating 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 the same time) 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, throat, or entire 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 blistering 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 serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to 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 disturbance (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, skin itching.
• Fracture of the hip, wrist, or spine (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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increase the likelihood of infections.
• Low sodium levels in blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• 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 malaise 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 are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset 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.
• Enlargement of the breasts 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 carry out periodic blood tests to monitor your magnesium levels.
• Inflammation in 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 deterioration in 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 reduced white blood cell count (agranulocytosis) through a blood test. It is important that, in such cases, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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 30°C.

• 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 pack) or keep the container tightly closed to protect it from moisture.

• Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines 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 trihydrate salt).

• The other components are glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, iron oxide (reddish-brown, yellow) (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.

Nature of the product and contents of the container

• Axiago 20 mg gastro-resistant tablets are light pink in colour, marked with "A/EH" on one side and "20 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 European Economic Area member states 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 about 5 ml of air. For certain tubes, a dispersion in 50 ml of water may be required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe 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 gastric tube while maintaining the previous position.
5. Shake the syringe and position it with the tip downward. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip upward to prevent blockage).
6. Reposition the syringe with the tip downward 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 certain tubes, 50 ml of water may be required.