Axagon

Italy
Brand name Axagon
Form tablets, enteric-coated
Active substance / Dosage
ESOMEPRAZOLE
Prescription type Prescription only
ATC code
A02BC05
Registration number 035035
Manufacturer GRUNENTHAL ITALIA S.R.L.

Table of Contents

Patient Information Leaflet

Axagon 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

esomeprazole
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Axagon is and what it is used for

Axagon contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Axagon is used to treat the following conditions:

Adults

  • "Gastro-oesophageal reflux disease" (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
  • Stomach or upper intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Axagon may also be used to prevent the development of stomach ulcers during NSAID treatment.
  • Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
  • Long-term treatment to prevent re-bleeding from ulcers, following initial prevention with intravenous administration of Axagon.

Adolescents aged 12 years and older

  • "Gastro-oesophageal reflux disease" (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
  • Stomach or upper intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Axagon

Do not take Axagon:

  • if you are allergic to esomeprazole or to 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 containing nelfinavir (used to treat HIV infection).
  • if you have ever had a severe skin rash or skin peeling, or skin rash with blisters and/or mouth ulcers after taking Axagon or other related medicines.

Do not take Axagon if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Axagon.

Warnings and precautions

Talk to your doctor or pharmacist before taking Axagon:

  • if you have serious liver problems.
  • if you have serious kidney problems.
  • if you have ever had a skin reaction after treatment with a medicine similar to Axagon that reduces stomach acid.
  • if you are due to have a specific blood test (chromogranin A), as Axagon may mask symptoms of other diseases. Therefore, if any of the following occur before starting or while taking Axagon, inform your doctor immediately:
  • You lose a lot of weight without reason or have difficulty swallowing.
  • You develop stomach pain or indigestion.
  • You start vomiting food or blood.
  • Your stools are black (stools containing blood).

If Axagon has been prescribed for you “as needed”, contact your doctor if symptoms persist or change in nature.

If you take a proton pump inhibitor such as Axagon, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

This medicine may affect how your body absorbs vitamin B12, particularly if taken for a long period. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

  • Extreme tiredness or lack of energy
  • Tingling sensations
  • Red, sore tongue or mouth ulcers
  • Muscle weakness
  • Vision disturbances
  • Memory problems, confusion, depression

Skin rash and skin reactions

If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Axagon may need to be stopped. Remember to also report any other side effects such as joint pain.

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

Children under 12 years of age

Information regarding the dosage recommended for children aged 1 to 11 years is provided in the product information for Axagon sachets. (Consult your doctor or pharmacist if you need further information.)

Other medicines and Axagon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Axagon may affect how some medicines work, and some medicines may affect Axagon.

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

Inform your doctor or pharmacist 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 (used to treat fungal infections).
  • Erlotinib (used to treat cancer).
  • Citalopram, imipramine, or clomipramine (used to treat depression).
  • Diazepam (used to treat anxiety, for muscle relaxation, or in epilepsy).
  • Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Axagon.
  • Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with Axagon.
  • Cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
  • Cisapride (used for indigestion and heartburn).
  • Digoxin (used for heart problems).
  • Methotrexate (a medicine used in high-dose chemotherapy for cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Axagon.
  • Tacrolimus (used in organ transplants).
  • Rifampicin (used to treat tuberculosis).
  • St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed antibiotics such as amoxicillin and clarithromycin together with Axagon to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Axagon with food and drink

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Axagon during this time.

It is not known whether Axagon passes into breast milk, so you should not take Axagon while breastfeeding.

Driving and using machines

It is unlikely that Axagon will affect your ability to drive or use tools or machinery. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If these occur, you should not drive or use machinery.

Axagon contains sucrose

Axagon gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Axagon contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Axagon

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

  • If you have been taking this medicine for a long time, your doctor will monitor you (particularly if you have been taking the medicine for more than one year).
  • If your doctor has told you to take the medicine as needed, inform your doctor if there is any change in your symptoms.

How much medicine to take

  • Your doctor will inform you about the number of tablets to take and for how long. This depends on your physical condition, age, and liver function.
  • The recommended doses are listed below.

Adults from 18 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one gastro-resistant Axagon 40 mg tablet once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if the esophagus has not healed.
  • After healing of the esophagus, the recommended dose is one gastro-resistant Axagon 20 mg tablet once daily.
  • If the esophagus is not damaged, the recommended dose is one gastro-resistant Axagon 20 mg tablet daily. When symptoms are under control, your doctor will inform you that you may take the medicine as needed, up to a maximum of one gastro-resistant Axagon 20 mg tablet per day.
  • In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

  • The recommended dose is one gastro-resistant Axagon 20 mg tablet twice daily for one week.
  • Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

Prevention of gastric ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

Treatment of excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is Axagon 40 mg tablets twice daily.
  • Your doctor will adjust the dose according to your needs and will also decide how long the treatment should continue. The maximum dose is 80 mg twice daily.

Long-term treatment to prevent rebleeding of ulcers, after initial prevention with intravenous administration of Axagon:
The recommended dose is one Axagon 40 mg tablet once daily for 4 weeks.
Adolescents from 12 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

  • If your doctor has found that your food pipe (esophagus) is slightly damaged, the recommended dose is one gastro-resistant Axagon 40 mg tablet once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if the esophagus has not healed.
  • After healing of the esophagus, the recommended dose is one gastro-resistant Axagon 20 mg tablet once daily.
  • If the esophagus is not damaged, the recommended dose is one gastro-resistant Axagon 20 mg tablet daily.
  • In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

  • The recommended dose is one gastro-resistant Axagon 20 mg tablet twice daily for one week.
  • Your doctor will also instruct you to take antibiotics, 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 or without food.
  • Swallow the tablets whole with a glass of water. Do not chew or crush the tablets, as they contain coated granules that protect the medicine from being degraded by gastric acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

  • If you have difficulty swallowing the tablets:
    • Place the tablets in a glass of still (non-carbonated) water. Do not use any other liquids.
    • Stir until the tablets dissolve (the mixture will not appear clear). Drink immediately or within 30 minutes at the latest. Always stir before drinking.
    • To ensure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. The solid particles contain the medicine and must not be chewed or crushed.
  • If you are completely unable to swallow, the tablet can be mixed with a small amount of water, drawn into a syringe, and administered through a tube directly into the stomach (gastric tube).

Children under 12 years of age
Axagon gastro-resistant tablets are not recommended in children under 12 years of age.
Information on the dosage recommended for children aged 1 to 11 years is provided in the product information for Axagon sachets (consult your doctor or pharmacist if further information is needed).
Elderly
Dose adjustment is not required in the elderly.
If you take more Axagon than you should
If you have taken more Axagon than prescribed by your doctor, inform your doctor or pharmacist immediately.
If you forget to take Axagon

  • If you forget to take a dose of Axagon, take it as soon as you remember. If it is almost time for your next dose, skip 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Axagon and
contact your doctor immediately:

  • Yellowing of the skin, dark urine, and tiredness may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
  • Sudden wheezing, swelling of the lips, tongue, throat or body, rash, feeling faint or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
  • Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may also occur after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also appear. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people):

  • Headache.
  • Stomach or intestinal problems: diarrhoea, stomach ache, constipation, flatulence.
  • Nausea or vomiting.
  • Benign stomach polyps.

Uncommon (may affect up to 1 in 100 people):

  • Swelling of the feet and ankles.
  • Sleep disturbance (insomnia).
  • Dizziness, tingling, drowsiness.
  • Vertigo.
  • Dry mouth.
  • Changes in blood tests monitoring liver function.
  • Rash, urticaria and itching.
  • Fracture of the hip, wrist or spine (if Axagon is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people):

  • Blood disorders, for example reduced numbers of white blood cells and platelets. This may cause weakness, bruising or increased susceptibility to infections.
  • Low sodium levels in the blood. This may cause weakness, vomiting and cramps.
  • Feeling agitated, confused or depressed.
  • Taste disturbances.
  • Vision problems such as blurred vision.
  • Sudden wheezing or shortness of breath (bronchospasm).
  • Inflammation of the inside of the mouth.
  • A fungal infection called “candidiasis” which may affect the intestine.
  • Liver problems, including jaundice which may cause yellow skin, dark urine and tiredness.
  • Hair loss (alopecia).
  • Skin rash after exposure to sunlight.
  • Joint pain (arthralgia) or muscle pain (myalgia).
  • General feeling of illness and lack of energy.
  • Increased sweating.

Very rare (may affect up to 1 in 10,000 people):

  • Changes in blood cell counts, including agranulocytosis (lack of white blood cells in the blood).
  • Aggressiveness.
  • Seeing, feeling or hearing things that are not real (hallucinations).
  • Severe liver problems leading to liver failure and brain inflammation.
  • Sudden onset of severe skin rash, blisters or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
  • Muscle weakness.
  • Severe kidney problems.
  • Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

  • If you take Axagon for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to periodically monitor your blood magnesium levels.
  • Inflammation of the intestine (which may lead to diarrhoea).
  • Erythema, possibly with joint pain.

In very rare cases, Axagon may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in your general health condition, or fever with local infection symptoms such as neck, throat or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your doctor about all medicines you are taking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axagon

  • 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 which is stated on the carton and on the bottle after "Exp". The expiry date refers to the last day of the month.
  • Store this medicine in the original packaging (blister) or keep the bottle tightly closed in order to protect it from moisture.
  • Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Axagon contains
The active substance is esomeprazole. Axagon gastro-resistant tablets are available in 2 strengths containing 20 mg or 40 mg of esomeprazole (as magnesium trihydrate).
The excipients are: glycerol monostearate 40-55, hypromellose, hydroxypropyl cellulose, iron oxide (20 mg reddish-brown, yellow, 40 mg reddish-brown) (E172), magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, microcrystalline cellulose, synthetic paraffin, macrogols, polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose spheres (sucrose and maize starch), talc, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Axagon and package contents

  • Axagon 20 mg gastro-resistant tablets are light pink, marked with "A/EH" on one side and "20 mg" on the other.
  • Axagon 40 mg gastro-resistant tablets are pink, marked with "A/EI" on one side and "40 mg" on the other.
  • The tablets are supplied in blister packs, wallet packs, and/or cartons containing:
    • 20 mg, 40 mg: bottles of 2-5-7-14-15-28-30-56-60-100-140 (5x28) tablets.
    • 20 mg, 40 mg: blister packs or wallet blister packs of 3-7-7x1-14-15-25x1-28-30-50x1-56-60-90-98-100x1-140 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for Axagon is:
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano, Italy
Axagon is released by AstraZeneca AB, 152-57, Södertälje, Sweden.
GRÜNENTHAL GmbH - Zieglerstraße 6, 52078 Aachen - Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Axagon
Sweden: Axiago

This patient information leaflet was last approved on:
Other sources of information
More detailed information about this medicinal product is available on the AIFA website.
The following 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 some tubes, it is necessary to disperse the tablet in 50 ml of water to prevent the granules from clogging the tube.
  2. Immediately shake the syringe for about 2 minutes to disperse the tablet.
  3. Hold the syringe with the tip upwards and check that the tip is not blocked.
  4. Connect the syringe to the tube, maintaining the above 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 (the syringe must be held with the tip upwards to avoid blocking the tip).
  6. Rotate 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 residue from the syringe. For some tubes, 50 ml of water may be required.

Package leaflet: information for the patient

Axagon 10 mg gastro-resistant granules for oral suspension, in sachet

esomeprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Axagon is and what it is used for

Axagon contains a substance called esomeprazole, which belongs to a group of medicines known as proton pump inhibitors. These medicines work by reducing the amount of acid produced by the stomach.
Axagon is used to treat the following conditions:
Children over 1 year of age
Axagon is used for the treatment of gastro-oesophageal reflux disease (GORD).

  • Gastro-oesophageal reflux occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn. Heartburn is a burning sensation that rises from the stomach or chest towards the neck.
  • In children, symptoms may include regurgitation of stomach contents into the mouth, feeling unwell (vomiting), and poor weight gain.

Children over 4 years of age

  • Ulcers in the upper part of the intestine associated with infection by bacteria called "Helicobacter pylori". In children with this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

3. What you need to know before taking Axagon

Do not take Axagon:

  • if you are allergic to esomeprazole or to other similar proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole), or to any of the other ingredients of this medicine (listed in section 6).
  • if you are taking a medicine containing nelfinavir (used to treat HIV infection).
  • if you have ever had a severe skin rash or skin peeling, or a rash with blisters and/or mouth ulcers after taking Axagon or other related medicines.

Do not take Axagon if any of the above conditions apply to you. If you are unsure, ask your doctor or pharmacist before taking Axagon.
Warnings and precautions
Talk to your doctor or pharmacist before taking Axagon:

  • if you have liver problems – speak to your doctor, as they may wish to prescribe a lower dose
  • if you have kidney problems – discuss this with your doctor
  • if you have ever had a skin reaction after treatment with a medicine similar to Axagon that reduces stomach acid
  • if you are due to have a specific blood test (Chromogranin A)

Axagon may mask the symptoms of other diseases. Therefore, if any of the following occur while you are taking Axagon, inform your doctor immediately:

  • You lose a lot of weight without reason.
  • You have stomach pain or indigestion.
  • You start vomiting repeatedly.
  • You have difficulty swallowing.
  • You vomit blood or have black stools (stools with blood spots). If you have been prescribed Axagon “as needed”, contact your doctor if symptoms persist or change in character. “On-demand” treatment has not been studied in children and is therefore not recommended in this patient group.

If you take a proton pump inhibitor such as Axagon, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
This medicine may affect how your body absorbs vitamin B12, particularly if it needs to be taken for a long period. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

  • Extreme tiredness or lack of energy
  • Tingling sensations
  • Red or sore tongue, mouth ulcers
  • Muscle weakness
  • Vision disturbances
  • Memory problems, confusion, depression

Skin rash and skin reactions
If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Axagon may need to be stopped. Remember to also report any other side effects such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Axagon treatment. Stop using Axagon and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Other medicines and Axagon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because Axagon may affect how some medicines work, and some medicines may affect Axagon.
Do not take Axagon if you are taking nelfinavir (used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

  • Atazanavir (used to treat HIV infection).
  • Clopidogrel (used to prevent blood clots).
  • Ketoconazole, itraconazolo, or voriconazole (used to treat fungal infections).
  • Erlotinib (used to treat cancer).
  • Diazepam (used to treat anxiety or for muscle relaxation).
  • Citalopram, imipramine, or clomipramine (used to treat depression).
  • Phenytoin (used in epilepsy).
  • Warfarin or cumarin (medicines called anticoagulants used to thin the blood).
  • Cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
  • Cisapride (used for indigestion and heartburn).
  • Digoxin (used for heart problems).
  • Methotrexate (a medicine used in high-dose chemotherapy for cancer treatment) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Axagon.
  • Tacrolimus (used in organ transplants).
  • Rifampicin (used to treat tuberculosis).
  • St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed Axagon together with the antibiotics amoxicillin and clarithromycin for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that your doctor is informed about any other ongoing treatments.
Axagon gastro-resistant granules with food and drink
Axagon gastro-resistant granules can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will tell you whether you can take Axagon during this time.
It is not known whether Axagon passes into breast milk. Therefore, Axagon should not be taken if you are breastfeeding.
Driving and using machines
It is unlikely that Axagon will affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If these occur, do not drive or operate machinery.
Axagon contains sucrose and glucose
Axagon contains sucrose and glucose, which are both types of sugars. Therefore, good oral hygiene is important, and you should regularly clean your teeth with a toothbrush.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking Axagon.

4. How to take Axagon

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your medicine is a granular preparation contained in a sachet. Each sachet contains 10 mg of esomeprazole. Your doctor will tell you how many sachets to take each day and for how long.

  • Empty the contents of the sachet(s) into a glass containing water. Do not use carbonated water. The amount of water required depends on the number of sachets your doctor has instructed you to take at once.
  • Use 15 millilitres (ml) of water (3 teaspoons) for each sachet. This means you will need 15 ml for one sachet and 30 ml for two sachets.
  • Mix the granules in the water.
  • Allow the mixture to thicken for a few minutes.
  • Stir again and drink the mixture immediately. The granules must not be chewed or crushed. Do not leave the mixture for more than 30 minutes before drinking.
  • If any residue remains in the glass after drinking, add a small amount of water, stir and drink immediately. Gastro-resistant Axagon granules may be taken with or without food.

If you are fed via a feeding tube (gastric tube), your doctor or nurse will administer Axagon through the tube. Information for doctors or nurses is provided at the end of this leaflet.

Recommended doses:

Children aged between 1 and 11 years

  • Axagon is not recommended for children under 1 year of age.

Treatment of gastro-oesophageal reflux disease (GORD).

  • The recommended dose is one sachet (10 mg) or two sachets (20 mg) once daily. The dose for children is based on body weight, and the doctor will determine the correct dose.

Children over 4 years of age
For treatment of ulcers caused by Helicobacter pylori infection, and to prevent their recurrence

  • The dose for children is based on body weight, and the doctor will determine the correct dose. The doctor will also prescribe two antibiotics for the child.

Adults and adolescents aged 12 years and older
For treatment of gastro-oesophageal reflux disease (GORD)
The recommended dose is two sachets (20 mg) or four sachets (40 mg) once daily.
Axagon oral suspension may also be used in patients who have difficulty swallowing gastro-resistant Axagon tablets. For patients aged 12 years and older, dosage information is provided in the package leaflet for Axagon gastro-resistant tablets (ask your doctor or pharmacist if you need further information).

Elderly patients
There is no need to adjust the dose if you are elderly.

Patients with liver problems

  • In patients with severe liver impairment, the maximum daily dose of Axagon is two sachets (20 mg). In children aged 1–11 years with severe liver impairment, the maximum daily dose must not exceed 10 mg.

Patients with kidney problems

  • In patients with kidney problems, no specific dose reduction is required. However, if you have severe kidney problems, your doctor may decide to perform certain tests.

If you take more Axagon than you should
If you have taken more Axagon than prescribed, contact your doctor for advice.

If you forget to take Axagon
If you forget to take a dose of Axagon, take it as soon as you remember. If it is almost time for your next dose, wait until the usual time and take the next dose as normal. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use Axagon, consult your doctor or pharmacist.

5. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects, stop taking Axagon and contact your doctor immediately:

  • Yellowing of the skin, dark urine, and fatigue may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
  • Sudden wheezing, swelling of the lips, tongue, throat or body, rash, feeling faint or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
  • Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may also occur after several weeks of treatment. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people):

  • Headache.
  • Stomach or intestinal problems: diarrhoea, stomach ache, constipation, flatulence.
  • Nausea or vomiting.
  • Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

  • Swelling of the feet and ankles.
  • Sleep disturbance (insomnia).
  • Dizziness, tingling, drowsiness.
  • Vertigo.
  • Dry mouth.
  • Changes in blood tests monitoring liver function.
  • Skin rash, hives, and itching.
  • Fracture of the hip, wrist, or spine (if Axagon is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people):

  • Blood problems such as reduced number of white blood cells and platelets. This may cause weakness, bruising, or increased susceptibility to infections.
  • Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
  • Feeling agitated, confused, or depressed.
  • Altered taste.
  • Vision problems such as blurred vision.
  • Sudden feeling of breathlessness or shortness of breath (bronchospasm).
  • Inflammation inside the mouth.
  • An infection called “candidiasis” which may affect the intestine and is caused by a fungus.
  • Liver problems, including jaundice which may cause yellow skin, dark urine, and fatigue.
  • Hair loss (alopecia).
  • Skin rash upon exposure to sunlight.
  • Joint pain (arthralgia) or muscle pain (myalgia).
  • General feeling of illness and lack of strength.
  • Increased sweating.

Very rare (may affect up to 1 in 10,000 people):

  • Changes in blood cell counts, including agranulocytosis (absence of white blood cells in the blood).
  • Aggressiveness.
  • Seeing, sensing, or hearing things that are not real (hallucinations).
  • Severe liver problems leading to liver failure and brain inflammation.
  • Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
  • Muscle weakness.
  • Severe kidney problems.
  • Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

  • If you take Axagon for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels.
  • Inflammation of the intestine (which may lead to diarrhoea).
  • Erythema, possibly with joint pain.

Axagon, in very rare cases, may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in general health, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to provide information about the medicines you are taking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axagon

This medicine does not require any special storage conditions.

  • Keep out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the carton and sachet after "Exp". The expiry date refers to the last day of that month.
  • The reconstituted suspension must be taken within 30 minutes.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Axagon gastro-resistant granules for oral suspension contains
The active substance is esomeprazole. Each sachet contains 10 mg of esomeprazole (as magnesium trihydrate).
The excipients are:
Esomeprazole granules:
Glyceryl monostearate 40-55
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate
Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion
Polysorbate 80
Sucrose spheres (sucrose and maize starch)
Talc
Triethyl citrate
Excipient granules:
Anhydrous citric acid (for pH adjustment)
Crospovidone
Glucose
Hydroxypropyl cellulose
Yellow iron oxide (E 172)
Xanthan gum.

Description of the appearance of Axagon and the contents of the pack
Each sachet of Axagon contains fine pale yellow granules. Brownish granules may be visible. The oral suspension is a yellow, thick liquid containing suspended granules.
Each pack contains 28 sachets.

Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano, Italy

Manufacturer
AstraZeneca AB, Gärtunavägen, 152 57 Södertälje, Sweden
GRÜNENTHAL GmbH - Zieglerstraße 6, 52078 Aachen, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Axagon
Sweden: Axiago

This leaflet was last approved on:
Other sources of information
More detailed information on this medicinal product is available on the AIFA website.

The following information is intended exclusively for physicians or healthcare professionals

Administration instructions for patients with nasogastric or gastric tube:
i. To administer the 10 mg dose, add the contents of one 10 mg sachet to 15 ml of
water.
ii. To administer the 20 mg dose, add the contents of two 10 mg sachets to 30 ml of
water.
iii. Mix.
iv. Allow to thicken for a few minutes.
v. Mix again.
vi. Draw up the suspension into a syringe.
vii. Inject through a tube with a diameter of 6 French or larger into the stomach within 30
minutes after reconstitution.
viii. Refill the syringe with 15 ml of water for the 10 mg dose and with 30 ml of water for the
20 mg dose.
ix. Shake and inject the remaining contents through the nasogastric or gastric tube into the stomach.
Any unused suspension must be discarded.