• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).
  Do not take Esomeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole.

Talk to your doctor before taking Esomeprazole:

• If you have severe liver problems.
• If you have severe kidney problems.
• If you have a vitamin B12 deficiency or there is a risk of a vitamin B12 deficiency.
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole that reduces stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazole or while you are taking it, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).

If you have been prescribed Esomeprazole “on demand” you should contact your doctor if your symptoms continue or change in character.

Taking a proton pump inhibitor like Esomeprazole, 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 Esomeprazole. Remember to also mention any other ill-effects like pain in your joints.

Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes often come after flu-like symptoms such as fever, headache, body ache. The rash may cover large parts of the body with blistering and peeling of the skin. If at any time during the treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

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 Esomeprazole can affect the way some medicines work and some medicines can have an effect on Esomeprazole.

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

Tell 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 infections caused by a fungus).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole.
• Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Esomeprazole treatment.
• Tacrolimus (organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

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

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

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 Esomeprazole during this time. It is not known if Esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole if you are breastfeeding.

Esomeprazole is not likely to affect you being able to drive or use any 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.

Esomeprazole contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

• Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition, how old you are and how well your liver works.
• The recommended doses are given below.

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esomeprazole 40 mg gastro-resistant capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
• The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastro-resistant capsule once a day.
• If your gullet has not been damaged, the recommended dose is one Esomeprazole 20 mg gastro-resistant capsule each day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazole 20 mg gastro-resistant capsule each day.
• If you have severe liver problems, your doctor may give you a lower dose.

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

• The recommended dose is one Esomeprazole 20 mg gastro-resistant capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one Esomeprazole 20 mg gastro-resistant capsule once a day for 4 to 8 weeks.

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

• The recommended dose is one Esomeprazole 20 mg gastro-resistant capsule once a day.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

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

Prolonged treatment after prevention of re-bleeding of ulcers with intravenous Esomeprazole:

• The recommended dose is one Esomeprazole 40 mg capsule once a day for 4 weeks.

Use in adolescents aged 12 or above_To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is one Esomeprazole 40 mg gastro-resistant capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
• The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastro-resistant capsule once a day.
• If your gullet has not been damaged, the recommended dose is one Esomeprazole 20 mg gastro-resistant capsule each day.
• If you have severe liver problems, your doctor may give you a lower dose.

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

• The recommended dose is one Esomeprazole 20 mg gastro-resistant capsule twice a day for one week.
• Your doctor will also tell you to take antibiotics for example amoxicillin and clarithromycin.

• You can take your capsules at any time of the day.
• You can take your capsules with food or on an empty stomach.
• Swallow your capsules whole with a drink of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

• If you have trouble swallowing the capsules:
  • Put the content into a glass of non-carbonated water. Do not use any other liquids.
  • Stir gently and drink the mixture straight away. Always stir the mixture just before drinking it.
  • To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
• If you cannot swallow at all, the capsule content can be mixed with some water and put into a syringe. It can then be given to you through a tube directly into your stomach (‘gastric tube’).

Esomeprazole gastro-resistant capsules are not recommended for children less than 12 years old.

Information on dosing for children aged 1 to 11 years is provided in Esomeprazole sachet product information (ask your doctor or pharmacist if you require further information).

Dose adjustment is not required in the elderly.

If you take more Esomeprazole than prescribed by your doctor, talk to your doctor or pharmacist straight away.

• If you forget to take a dose, take it as soon as you remember it. However, 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.

• Yellow skin, dark urine and tiredness which can be symptoms of liver problems. These effects are rare, and may affect up to 1 in 1,000 people.
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction). These effects are rare, and may affect up to 1 in 1,000 people.
• Sudden onset of a severe rash or reddening of the skin with blisters or peeling may occur even after several weeks of treatment. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life threatening consequences. This could be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, ‘toxic epidermal necrolysis’ or ‘drug reaction with eosinophilia and systemic symptoms’.

These effects are very rare, and might affect up to 1 in 10,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Fracture of the hip, wrist or spine (if Esomeprazole is used in high doses and over long duration).

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

• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Generally feeling unwell and lacking energy.
• Increased sweating.

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

• Changes in blood count including agranulocytosis (lack of white blood cells)
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men.

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

• If you are on Esomeprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Inflammation in the gut (leading to diarrhoea).
• Rash, possibly with pain in the joints.

Esomeprazole 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 severely reduced 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.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 or 40mg esomeprazole (as magnesium amorphous).
• The other ingredients are:
  Capsule content: sugar spheres, hydroxypropyl cellulose(E 463), hypromellose (E464), magnesium stearate (E 470b), talc (E 553 B), methacrylic acid – ethyl acrylate copolymer (1:1) 30% dispersion, sodium lauryl sulfate (E487), triethyl citrate (E 1505), glyceryl monostearate 40-55, polysorbate 80 (E 433)
  Capsule shell: iron oxide red (E 172), titanium dioxide (E 171), gelatin (E 441), sodium lauryl sulfate (E 487)
  Ink: shellac (E 904), strong ammonia solution (E 527), black iron oxide (E 172), potassium hydroxide(E 525).

Esomeprazole 20 mg gastro-resistant capsules are hard gelatin capsules of about 15mm length with light pink opaque cap and light pink opaque body, cap imprinted with "E7' in black ink containing off-white to brownish coloured pellets.

Esomeprazole 40 mg gastro-resistant capsules are - hard gelatin capsules of about 16mm length with brick red opaque cap and brick red opaque body, cap imprinted with "E8' in black ink containing off-white to brownish coloured pellets.

Pack sizes:

Blister packs

14, 15, 28, 30, 56, 60, 90, 100 gastro-resistant capsules supplied in OPA/Al/PVC/Al blisters and OPA/Al/PE/desiccant/Al/PE blisters.

HDPE bottles

28, 30, 56, 60,90, 100 gastro-resistant capsules supplied in HDPE bottles with screw cap and induction seal liner, containing silica gel.

Not all pack sizes may be marketed.

This medicinal product is authorized in the Member States of the EEA and in the United Kingdom (NI) under the following names:

Germany: ESOMEPRAZOL BASICS 20 mg magensaftresistente Hartkapseln

ESOMEPRAZOL BASICS 40 mg magensaftresistente Hartkapseln

Italy: Raciper

Romania: Esomeprazol Terapia 20 mg capsule gastrorezistente

Esomeprazol Terapia 40 mg capsule gastrorezistente

Sweden: Esomeprazol SUN 20 mg magsaftresistanta kapslar

Esomeprazol SUN 40 mg magsaftresistanta kapslar

United Kingdom (NI): Esomeprazole 20 mg gastro-resistant capsules, hard

Esomeprazole 40 mg gastro-resistant capsules, hard

The Netherlands: Esomeprazol SUN 20 mg maagsapresistente capsules

Esomeprazol SUN 40 mg maagsapresistente capsules