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Package leaflet: information for the patient

Axiago 10 mg gastro-resistant granules for oral suspension, sachet


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

What is in this leaflet:

1. What Axiago is and what it is used for

2. What you need to know before you take Axiago

3. How to take Axiago

4. Possible side effects

How to store Axiago

6. Contents of the pack and other information

What Axiago is and what it is used for

Axiago contains a substance called esomeprazole. This belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid that your stomach produces.

Axiago is used to treat the following conditions:

Children over 1 year of age

Axiago is used to treat a condition called “gastroesophagealreflux disease” (GERD).

Children over 4 years of age

Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

What you need to know before you take Axiago

Do not take Axiago

Do not take Axiago if any of the above apply to you. 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:

Axiago may hide the symptoms of other diseases. Therefore, if any of the following happen to you while you are taking Axiago, you should talk to your doctor immediately:

If you have been prescribed Axiago “on demand” you should contact your doctor if the symptoms are persistent or change character. On demand treatment has not been investigated in children and is therefore not recommended in this patient group.

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).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Axiago. Remember to also mention any other ill effects like pain in your joints.

Other medicines and Axiago

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Axiago can affect the way some medicines work and some medicines can have an effect on Axiago.

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

Tell your doctor or pharmacist if you are taking any of the following medicines:

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Axiago to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Axiago gastro-resistant granules with food and drink

Axiago gastro-resistant granules can be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant, 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 youshould not takeAxiago if you are breast-feeding.

Driving and using machines

Axiago is not likely to affect you being able to drive or use tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). If affected, you should not drive or use machines.

Axiago contains sucrose and glucose

Axiago contains sucrose and glucose which are both types of sugars. Careful oral hygiene and regular tooth brushing are therefore important.

If you have been told by your doctor, that you have an intolerance to some sugars, contact your doctor before taking Axiago.

How to take Axiago

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your medicine comes as granules in individual sachets. Each sachet contains 10 mg of esomeprazole. Your doctor will tell you how many sachets to take each day. He or she will also tell you how long you should take them for.

Axiago gastro-resistant granules can be taken with or without food.

If you are being fed using a feeding (gastric) tube, your doctor or nurse can give you Axiago through your tube. Information for your doctor or nurse is provided at the end of this leaflet.

The recommended dose is:

Children aged 1 to 11 years

Axiago is not recommended for children younger than 1 year.

To treat gastroesophageal reflux disease (GERD)

The recommended dose is one sachet (10 mg) or two sachets (20 mg) once daily. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

Children aged 4 years and older

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back.

The dose for children is based on the child’s weight and your doctor will decide the correct dose. The doctor will also prescribe two antibiotics for your child.

Adults and young people aged 12 and older

To treat gastroesophageal reflux disease (GERD)

The recommended dose is two sachets (2x10 mg) or four sachets (4x10 mg) once daily.

Axiago oral suspension may also be used by patients having difficulty swallowing dispersed Axiago gastro-resistant tablets. Information on dosing for patients from the age of 12 years is in Axiago gastro-resistant tablet product information (ask your doctor or pharmacist if you require further information).


There is no need to alter the dose if you are elderly.

People with liver problems

For people with severe liver problems, the maximum daily dose of Axiago is two sachets (20 mg). For children 1-11 years with severe liver problems, a maximum dose of 10 mg should not be exceeded.

People with kidney problems

There are no special dosage restrictions for people with kidney problems. However, if you have severe kidney problems your doctor may decide to carry out regular tests.

If you take more Axiago than you should

If you have taken more Axiago than prescribed by your doctor, seek medical advice.

If you forget to take Axiago

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for the forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

A severe allergic reaction (anaphylaxis) is a rare side effect, affecting less than 1 in 1,000 people taking Axiago. You may notice sudden wheezing, swelling of your face or body, rash, fainting or difficulties in swallowing. If this happens to you, stop taking Axiago and contact a doctor immediately.

Other side effects include:

Common (may affect up to1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

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

Axiago may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severelyreduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medication at this time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Axiago

This medicinal product does not require any special storage conditions.

Keep out of the sight and reach of children.

Donot use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.

The reconstituted suspension should be used within 30 minutes.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Axiago gastro-resistant granules for oral suspension contains

The active substance is esomeprazole. Each sachet contains 10 mg of esomeprazole (as magnesium


The other ingredients are:

Esomeprazole granules:
Glycerol monostearate 40-55
Hydroxypropyl cellulose
Magnesium Stearate
Methacrylic acid –ethyl acrylate copolymer (1:1) 30% dispersion
Polysorbate 80
Sugar spheres (sucrose and maize starch)
Triethyl citrate

Excipient granules:
Citric acid anhydrous (for pH adjustment)
Hydroxypropyl cellulose
Yellow iron oxide (E172)
Xanthan gum

What Axiago looks like and contents of the pack

Each sachet of Axiago contains pale yellow fine granules. Brownish granules may be visible.

The oral suspension is a thick yellow liquid containing suspended pellets.

Each carton contains 28 sachets.

Marketing Authorisation Holder and Manufacturer

[Tobe completed nationally]

{Name and address}




This medicinal product is authorised in the Member States of the EEA under the following names:

Member State

Name of medicinal product





This leaflet was last revised in


Other sources of information

Detailed information on this medicine is available on the web site of {MS/Agency}


The following information is intended for medical or healthcare professionals only:

Administration information for patients with a nasogastric or gastric tube in place:

1. For a 10 mg dose, add the contents of a 10 mg sachet into 15 ml of water

2. For a 20 mg dose add the contents of two 10 mg sachets into 30 ml of water.

3. Stir

4. Leave for a few minutes to thicken

5. Stir again

6. Draw the suspension into a syringe

7. Inject through the enteric tube, French size 6 or larger, into the stomach within 30 minutes after reconstitution.

8. Refill the syringe with 15 ml water for a 10 mg dose and 30 ml for a 20 mg dose.

9. Shake and flush any remaining contents from the enteric tube into the stomach

Any unused suspension should be discarded.