Esomeprazole 20 mg Gastro-resistant Tablets – Patient Information Leaflet (PIL) – (emc)

Esomeprazole 20 mg & 40 mg Gastro-resistant Tablets

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

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

Esomeprazole is used to treat the following conditions:

Esomeprazole contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

1. What Esomeprazole is and what it is used for

2. What you need to know before you take Esomeprazole

Do not take Esomeprazole

• 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 applies to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazole:

• 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 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.

Children under the age of 12 years

Information on dosing for children aged 1 to 11 years is provided in the product information of other dosage forms e.g. sachet (ask your doctor or pharmacist if you require further information).

Other medicines and Esomeprazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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.

Esomeprazole with food and drink

You can take the tablets with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 breast-feeding.

Driving and using machines

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 sucrose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.

Esomeprazole contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.