PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE 20MG GASTRO-RESISTANT TABLETS

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 of the 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-oesophageal reflux disease’ (GORD). 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 ‘Helicobacterpylori’. 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 rebleeding of ulcers with intravenous Esomeprazole.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might 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 with food and drink

Esomeprazole may be taken with or without food

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

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.

-    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

Check with 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 them, talk to your doctor straight away:

-    If you lose a lot of weight for no reason and have problems swallowing.

-    If you get stomach pain or indigestion.

-    If you begin to vomit food or blood.

-    If 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).

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).

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).

-    Digoxin (used to treat heart failure)

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.

Always take this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

-    Esomeprazole is 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 tablets at any time of the day.

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

-    Swallow your tablets whole with a drink of water. Do not chew or crush the tablets. This is because the tablets 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

tablets

• If you have trouble swallowing the tablets:

-    Put them into a glass of still (non-fizzy) water. Do not use any other liquids.

-    Stir until the tablets break up (the mixture will not be clear). 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.

• If you cannot swallow at all, the tablet can be mixed with some water and put into syringe. It can then be given to you through a tube directly into your stomach ("gastric tube").

How much to take

Your doctor will tell you how many tablets 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.

To treat heartburn caused by gastro-oesophageal

reflux disease (GORD)

Adults and children aged 12 or above:

•    If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is one Esomeprazole 40mg gastro-resistant tablet 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 20mg gastro-resistant tablet once a day.

•    If your gullet has not been damaged, the usual dose is one Esomeprazole 20mg gastro-resistant tablet 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 20mg gastro-resistant tablet 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 aged 12 or above: the usual dose is one Esomeprazole 20mg gastro-resistant tablet twice a day for one week.

•    Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs

(Non-Steroidal Anti-Inflammatory Drugs)

•    Adults aged 18 and above: the usual dose is one Esomeprazole 20mg gastro-resistant tablet 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 and above: the usual dose is one Esomeprazole 20mg gastro-resistant tablet once a day.

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

•    Adults aged 18 and above: the usual dose is one Esomeprazole 40mg gastro-resistant tablet 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 80mg twice a day.

Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole

•    The usual dose is one Esomeprazole 40mg gastro-resistant tablet 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 up for a forgotten dose.

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

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.

Not known

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.

Do not be concerned by this list of possible side effects. You may not get any of them. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE ESOMEPRAZOLE

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

If you get 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 to swallow (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.

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

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

Do not store above 25 ° C

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

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

Other side effects include:

Common

•    Headache.

•    Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).

•    Feeling sick (nausea) or being sick (vomiting).

Uncommon

•    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

•    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

•    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 extensive brain dysfunction.

•    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.

What Esomeprazole contains

The active substance is esomeprazole.

Each gastro-resistant tablet contains 20mg esomeprazole (as magnesium dihydrate).

The other ingredients are:

Tablet core:

Mannitol (E421)

Cellulose, Microcrystalline Sodium Laurilsulfate,

Hydroxypropylcellulose Talc (E553b)

Methacrylic Acid-Ethyl Acrylate copolymer 1:1, dispersion 30%,

Propylene Glycol

Triethyl Citrate

Polysorbate 80

Glycerol Monostearate 40-55

Silica Colloidal Anhydrous

Hypromellose

Magnesium Stearate

Calcium Hydrogen Phosphate Dihydrate

Crospovidone

Tablet coating:

Hypromellose 15cP (E464)

Titanium Dioxide (E171)

Polydextrose (E1200)

Talc (E553b)

Maltodextrin

Triglycerides, Medium Chain Iron Oxide Yellow (E172)

Iron Oxide Red (E172).

What Esomeprazole looks like and contents of the pack

Esomeprazole 20mg gastro-resistant tablets are light pink, oblong, biconvex, film-coated tablets, with “20” engraved on one side and dimensions of approximately 14.9 x 7.6 mm.

The tablets are available in boxes of 7, 14, 15, 28, 30, 50,    56,    60,    90,    98 and 100 tablets in

OPA/Aluminium/PVC/Aluminium blisters. The blisters are subsequently packed into cardboard boxes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Specifar S.A.

1,28 Octovriou str.,

Ag. Varvara 123 51 Athens, Greece

Distributor

Zentiva,

One Onslow Street,

Guildford,

Surrey,

GU1 4YS, UK

This leaflet was last revised in May 2012.