Package leaflet: Information for the user

Esomeprazole 20 mg gastro-resistant capsules, hard Esomeprazole 40 mg gastro-resistant capsules, hard

Esomeprazole

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

•    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.

What is in this leaflet

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

1.    What Esomeprazole is and what it is used for

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.

Esomeprazole is used to treat the following conditions:

Adults and young people aged 12 years and above

•    'Gastro-esophageal reflux disease' (GERD): This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

•    Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called 'Helicobacter pylori'. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

•    Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole can also be used to stop stomach ulcers from forming if you are taking NSAIDs.

•    Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

•    Prolonged treatment after prevention of re-bleeding of ulcers with intravenous esomeprazole.

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, lanzoprazole, rabeprazole, omeprazole)

•    if you are taking a medicine containing nelfinavir (used to treat HIV).

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Esomeprazole

•    if you have severe liver problems.

•    if you have severe kidney problems.

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). 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 have been prescribed Esomeprazole "on demand"you should contact your doctor if your symptoms continue or change in character.

Other medicines and Esomeprazole 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 capsules if you are taking a medicine containing nelfinavir (used to treat HIV).

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

•    Atazanavir (used to treat HIV).

•    Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).

•    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.

•    Cisapride (used for indigestion and heartburn).

•    Clopidogrel (used to prevent blood clotting).

•    Digoxin (used for heart problems).

•    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, drink and alcohol See Section 3 for instructions on how to take Esomeprazole.

Pregnancy and breast-feeding

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.

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

Driving and using machines

Esomeprazole is not likely to affect you being able

to drive or use any tools or machines.

3. How to take Esomeprazole

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

•    Esomeprazole capsules are not recommended for children less than 12 years old.

•    If you are taking this medicine for a long time, your doctor will want to monitor you (particularly if you are taking it for more than a year).

•    If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

Taking this medicine

•    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.

What to do if you have trouble swallowing the capsules

•    If you have trouble swallowing the capsules:

° Open the capsule and disperse the content in half a glass of still (non-fizzy) water. Do not use any other liquids.

° Stir, then drink the mixture straight away or within 30 minutes. 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.

How much to take

•    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 usual doses are given below.

To treat heartburn caused by gastro-esophageal reflux disease (GERD):

Adults and children aged 12 years or above:

•    If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual 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 usual 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 usual 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:

•    Adults and young people aged 12 years or above: the usual 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):

•    Adults aged 18 years and above: the usual 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):

•    Adults aged 18 years and above: the usual 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):

•    Adults aged 18 years and above: the usual dose is one Esomeprazole 40 mg gastro-resistant capsule 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.

To be used as prolonged treatment after prevention of re-bleeding of ulcers with intravenous esomeprazole:

•    Adults aged 18 years and above: the usual dose is one Esomeprazole 40 mg gastro-resistant capsule once a day for 4 weeks.

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

If you forget to take Esomeprazole

•    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 u p for a forgotten dose.

If you have any further questions on the use of this medicine, ask 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 Esomeprazole and contact a doctor immediately:

•    Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).

•    Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.This could be'Stevens-Johnson syndrome'or'toxic epidermal necrolysis'

•    Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

These effects are rare, affecting less than 1 in 1,000 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). 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 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).

•    Muscle weakness.

•    Severe kidney problems.

•    Enlarged breasts in men.

Frequency 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, 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.

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 side effects not listed in this leaflet.

5.    How to store Esomeprazole

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25 °C.

•    Keep the bottle tightly closed in order to protect from moisture.

•    Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

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

6.    Contents of the pack and other information What Esomeprazole contains

The active substance is esomeprazole. Esomeprazole gastro-resistant capsules come in two strengths containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate).

The other ingredients are:

Capsule content

Raw pellets: carrageenan; cellulose, microcrystalline; mannitol; sodium hydroxide; sodium hydrogen carbonate

Isolation coat: polyvinylalcohol-PEG copolymer; sodium hydroxide; talc; titanium dioxide (El71); silica, colloidal hydrated

Gastro-resistant coat: methacrylic acid-ethyl acrylate copolymer (1:1); triethyl citrate; talc; titanium dioxide (El71)

Capsule

Esomeprazole20 mg gastro-resistant capsules:

Cap: gelatin; titanium dioxide (El71); iron oxide yellow (E172)

Body: gelatin; titanium dioxide (El 71)

Esomeprazole 40 mg gastro-resistant capsules:

Cap: gelatin; iron oxide red (El 72); titanium dioxide (El 71); iron oxide yellow (E172)

Body: gelatin; titanium dioxide (El 71)

What Esomeprazole looks like and contents of the pack

Esomeprazole20 mg gastro-resistant capsules: Gastro-resistant capsules, hard with a white opaque body and a light yellow opaque cap containing white to off-white gastro-resistant pellets. Esomeprazole 40 mg gastro-resistant capsules: Gastro-resistant capsules, hard with a white opaque body and a light orange opaque cap containing white to off-white gastro-resistant pellets.

Your capsules will come in HDPE plastic bottles with a desiccant capsule contained in the PP caps or in aluminium-aluminium blisters. Do not eat the desiccant capsule.

Pack sizes:

14,15,28,30,50,60,90 and 100 capsules Not all pack sizes may be marketed.

Marketing Authorisation Holder Aristo Pharma GmbH

WallenroderStr.8-10,13435 Berlin, Germany Manufacturer

Medinsa (Laboratories Medicamentos Internacionales S.A.) c/ Solana,26

28850 Torrejon de Ardoz (Madrid)

Spain

Distributed by

Creo Pharma Ltd Felsted Business Centre Felsted, Essex CM6 3LY

This leaflet was last revised in 05/2015

CRE-ES0CRE-PIL-122_05

15/04/2015

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