ESOMEPRAZOLE 20 mg GASTRO-RESISTANT TABLETS ESOMEPRAZOLE 40 mg GASTRO-RESISTANT TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before

you start taking this medicine.

♦    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

♦    If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Esomeprazole is and what it is used for

2.    Before you take Esomeprazole

3.    How to take Esomeprazole

4.    Possible side effects

5.    How to store Esomeprazole

6.    Further information

OWHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR

Esomeprazole 20 mg and 40 mg Gastro-ResistantTablets contains a medicine called esomeprazole.This belongsto a group of medicines called 'proton pump inhibitors'.Theywork by reducing theamountofacid thatyour stomach produces.

Esomeprazole is used to treat the following conditions:

Adults and young people aged 12 years and above ♦ 'Gastroesophagealrefluxdisease' (GERD).This is where acid from the stomach escapes into the gullet (the tube which connects yourthroatto your stomach) causing pain, inflammation and heartburn ♦ Ulcers in the stomach orupper part of the gut (intestine) that are infected with bacteria called ‘Helicobacter pylori'. Ifyou havethis condition,your doctor may also prescribe antibiotics to treat the infection and allowthe 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 treatmentafter prevention of rebleeding of ulcers with intravenous esomeprazole.

BEFORE YOU TAKE ESOMEPRAZOLE Do NOT take Esomeprazole if you are:

♦ allergic(hypersensitive)to esomeprazole or any ofthe other ingredients of this medicine (listed in Section 6: Further information)

♦ allergic to other proton pump inhibitor medicines

♦ takinga medicinecontaining nelfinavir(used to treat HIV).

Do not take Esomeprazole if any of the above apply to you. If you are not sure, talk to yourdoctor or pharmacist before taking Esomeprazole.

Take special care with Esomeprazole Check with your doctor or pharmacist beforetaking Esomeprazole ifyou have: ♦ severe liver problems ♦ severe kidney problems.

Taking a proton pump inhibitor like Esomeprazole, especially over a period of more than one year, may slightly increase your risk offracture inthe hip, wrist or spine.Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Esomeprazole may hide the symptoms of otherdiseases. 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, if you:

♦ lose a lot of weight for no reason and have problems swallowing ♦ get stomach pain or indigestion ♦ begintovomitfoodorblood ♦ pass blackstools(blood-stainedfaeces). Ifyou have been prescribed Esomeprazole "on demand” you should contact your doctor if your symptoms continue or change in character.

Taking other medicines Please tell your doctor or pharmacist if you are taking or have recentlytaken any other medicines, including medicines obtained without a prescription.This is because Esomeprazole can affect the way some medicineswork 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, imipramineor clomipramine (used to treat depression)

♦ Diazepam (used to treat anxiety, relax muscles or in epilepsy)

♦ Phenytoin (used in epilepsy). Ifyou are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole ♦ Medicinesthatareusedtothinyour blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole.

♦    Cisapride(usedforindigestionand heartburn)

♦    Clopidogrel (used to prevent blood clots (thrombi)).

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin aswell as Esomeprazole Gastro-resistant Tablets to treat ulcers caused by Helicobacter pylori infection, it isvery importantthat you tell your doctor about any other medicines you are taking.

Pregnancy and breast-feeding

Before taking Esomeprazole tell your doctor if you are pregnant or trying to get pregnant. Ask yourdoctor or pharmacist for advice before taking any medicine. Your doctor will decide whether you can take Esomeprazole during thistime.

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

Taking Esomeprazole with food and drink

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

Driving and using machines

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

Important information about some of the ingredients of Esomeprazole Gastro-Resistant Tablets

EsomeprazoleGastro-R esistantTablets contain sucrose and lactose, which are types of sugar. If you have been told by your doctor thatyou have an intolerance tosome sugars, talkto your doctor before taking this medicine.

^ HOW TO TAKE ESOMEPRAZOLE

Always take Esomeprazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

♦    Esomeprazoleisnotrecommended for children less than 12 years old.

♦    Ifyouaretakingthismedicinefora long time, your doctor willwant 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

♦    Youcantakeyourtabletsatanytime of the day.

♦    You can take yourtablets with food or on an empty stomach.

♦    Swallowyourtabletswholewitha 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 todamagethe pellets.

What to do if you have trouble swallowing the tablets

♦    Ifyou havetroubleswallowingthe tablets:

♦    Putthem intoaglassofstill (non-fizzy) water. Do not use any other liquids

♦    Stiruntilthetabletsbreakup(the mixture will not be clear).Then drink the mixture straight away orwithin 30 minutes. Always stirthe mixture just before drinking it

♦    To make sure that you have drunk all ofthe medicine, rinsethe 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 waterand put into a syringe. It can then be given to you through a tube directly into your stomach ('gastric tube').

How much to take

♦    Yourdoctorwilltellyou howmany 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.

♦    The usual doses are given below.

To treat heartburn caused by gastroesophageal reflux disease (GERD): Adults and children aged 12 and above:

♦    Ifyourdoctorhasfoundthatyour food pipe (gullet) has been slightly damaged, the usual dose is one Esomeprazole 40 mg 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 20 mg gastro-resistant tablet once a day.

♦    Ifyourgullethasnotbeendamaged, the usual dose is one Esomeprazole 20 mg gastro-resistant tablet each day. Oncethe 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 tablet each day.

♦    Ifyou havesevereliverproblems, 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

or above: the usual dose is one Esomeprazole 20 mg gastro-resistant tablettwice a dayforone week

♦    Yourdoctorwillalsotellyoutotake antibiotics for example 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

20 mg gastro-resistant tablet once a day for 4to8 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 20 mg 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 40 mg gastro-resistant tablet twice a day

♦    Yourdoctorwilladjustthedose depending on your needs and will also decide how long you need to take the medicinefor.The maximum dose is 80 mg twice a day.

Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole:

The usual dose is one Esomeprazole 40 mg tablet once a day for 4 weeks.

If you take more Esomeprazole than you should

If you take more Esomeprazole gastro-resistant tablets 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 asyou remember it. However, if it is almosttime for your next dose, skip the missed dose.

Do not take a double dose (two doses at the same time) to make upfor a forgotten dose.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Esomeprazole 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:

♦    Suddenwheezing,swellingofyour lips, tongue and throat or body, rash, fainting ordifficulties 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

♦    If you have an infection with symptomssuch as feverwith a severely reduced general condition or feverwith 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 importantfor you to give information about your medication atthistime.

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

Other side effects include:

Common (affects 1 to 10 users in 100)

♦    Headache

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

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

Uncommon (affects 1 to 10 users in 1,000)

♦    Swellingofthefeetandankles

♦    Disturbedsleep(insomnia)

♦    Dizziness, tingling feelings such as "pins and needles','feeling sleepy

♦    Spinningfeeling(vertigo)

♦    Dry mouth

♦    Changes in blood teststhat check how the liver is working

♦    Skin rash, lumpy rash (hives) and itchy skin

♦    Fracture ofthe hip, wrist or spine (see section 2).

Esomeprazole may in very rare cases affect the white blood cells leading to immune deficiency.

Frequency not known If you are on Esomeprazole for more than three months it is possible thatthe levels of magnesium in your blood may fall. Low levels of magnesium can be seen asfatigue, 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 inthe blood. Your doctor may decide to perform regular blood teststo monitor your levels of magnesium.

Do not be concerned by this list of possible side effects.You may not get any of them.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tellyour doctor or pharmacist.

Reporting of side effects

if you getany side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at:

www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE ESOMEPRAZOLE

Keep out of the reach and sight of children.

Do not use Esomeprazole after the expiry date which is stated on the carton and blister after EXP.The expiry date refers to the last day ofthat month. Store in the original package in orderto protectfrom light and moisture. Esomeprazole should be used no longer than 100 days after firstopening ofthe bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.

FURTHER INFORMATION

What Esomeprazole 20 mg and 40 mg Gastro-Resistant Tablets contain

♦    The active substance is esomeprazole. Esomeprazole gastro-resistant tablets come in two strengths containing

20 mg or 40 mg of esomeprazole (as esomeprazole magnesium).

♦    The other ingredients are:

Seal coated sugar spheres: Sugar spheres (sucrose and maize starch), ethylcellulose, magnesium stearate Drug coat: Povidone K90, magnesium oxide, light (E 530)

Barrier coat: Povidone, magnesium oxide, light (E 530), magnesium stearate

Enteric coat: Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent (contains sodium laurilsulfate and polysorbate 80), diethyl phthalate, talc (E 553b)

Tablet core: Silicified microcrystalline cellulose (microcrystalline cellulose and colloidal anhydrous silica), starlac (lactose monohydrate and maize starch), copovidone K 28, macrogol 8000, crospovidone, silica colloidal, anhydrous, magnesium stearate Film coat: Hypromellose (E 464), macrogol 8000, talc (E 553b), titanium dioxide (E 171), silica colloidal, anhydrous, iron oxide red (E172) Imprint: Opacode S-1-17823 black ink (contains propylene glycol, iron oxide black (E172), shellac glaze).

What Esomeprazole looks like and contents of the pack

Rare (affects 1 to 10 users in 10,000)

♦    Blood problems such as a reduced number ofwhite 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

♦    Eyesightproblemssuchasblurred vision

♦    Suddenlyfeelingwheezyorshortof breath (bronchospasm)

♦    Aninflammationoftheinsideofthe mouth

♦    An infection called "thrush” which can affect the gutand is caused by a fungus

♦    Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness

♦    Hair loss (alopecia)

♦    Skin rashonexposuretosunshine

♦    Joint pains (arthralgia) or muscle pains (myalgia)

♦    Generally feeling unwell and lacking energy

♦    Increased sweating.

Very rare (affects less than 1 user in

10,000)

♦    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 feverand joint pains(Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

♦    Muscleweakness

♦    Severekidneyproblems

♦    Enlarged breasts in men.

Esomeprazole 20 mg gastro-resistant tablets

Brick-red coloured, round shape, biconvex, film-coated tablet, imprinted with "20” on one side and plain on the other side.

Esomeprazole 40 mg gastro-resistant tablets

Brick-red coloured, round shape, bevelled edge, biconvex, film-coated tablet, imprinted with "40” on one side and plain on the other side.

Blister (Aluminium/Aluminium) or HDPE container (HDPE container of neck finish and PP closure with induction sealing wad and a silica gel canister as desiccant).

Pack sizes:

20 mg, blister: 7, 14, 28, 30, 56, 60, 98,

100 gastro-resistanttablets

20 mg, HPDE container: 14, 28, 56, 98,

100 gastro-resistanttablets

40 mg, blister: 14, 28, 30, 56, 60, 98, 100

gastro-resistanttablets

40 mg, HPDE container: 14, 28, 56, 98,

100 gastro-resistanttablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom.

Manufacturer: MerckleGmbH, Ludwig-Merckle-Strasse 3,

D-89143 Blaubeuren, Germany.

This leaflet was last revised in September 2013.

PL 00289/1491 and PL 00289/1492

TEUZD

46002-A 192981.02-GB

ESOMEPRAZOLE 20 mg GASTRO-RESISTANT TABLETS ESOMEPRAZOLE 40 mg GASTRO-RESISTANT TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    Ifyou have any further questions, askyour doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any ofthe side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What Esomeprazole is and what it is used for

2.    Before you take Esomeprazole

3.    How to take Esomeprazole

4.    Possible side effects

5.    How to store Esomeprazole

6.    Further information

OWHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR

Esomeprazole 20 mg and 40 mg Gastro-Resistant Tablets contains a medicine called esomeprazole. This belongs to a group of medicines called 'proton pump inhibitors'.Theywork 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

• 'Gastroesophageal 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 ofthe gut (intestine) that are infected with bacteria called 'Helicobacter pylori'. Ifyou 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 ifyou 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.

£ BEFORE YOU TAKE ESOMEPRAZOLE

Do NOT take Esomeprazole if you are:

• allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in Section 6: Further information)

• allergic to other proton pump inhibitor medicines • taking a medicine containing nelfinavir (used to treat HIV).

Do not take Esomeprazole if any of the above apply to you. Ifyou are not sure, talk to your doctor or pharmacist before taking Esomeprazole.

Take special care with Esomeprazole

Check with your doctor or pharmacist before taking Esomeprazole ifyou have:

• severeliverproblems • severe kidney problems.

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 ifyou have osteoporosis or ifyou are taking corticosteroids (which can increase the risk of osteoporosis). 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, if you:

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

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

Taking other medicines

Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained 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 ifyou are taking a medicine containing nelfinavir (used to treat HIV). Tell your doctor or pharmacist ifyou are taking any ofthe following medicines:

• Atazanavir (used to treat HIV)

• Ketoconazole, itraconazole orvoriconazole (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). Ifyou 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 clots (thrombi)). Ifyour doctor has prescribed you the antibiotics amoxicillin and clarithromycin as well as Esomeprazole Gastro-resistantTablets to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Pregnancy and breast-feeding Before taking Esomeprazole tell your doctor ifyou are pregnant or trying to get pregnant. Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will decide whether you can take Esomeprazole during this time.

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

Taking Esomeprazole with food and drink

You can take your tablets with food or on an empty

stomach.

Driving and using machines

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

Important information about some of the ingredients of Esomeprazole Gastro-Resistant Tablets

Esomeprazole Gastro-ResistantTablets contain sucrose and lactose, which are types of sugar. Ifyou have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Q

HOW TO TAKE ESOMEPRAZOLE

Always take Esomeprazole exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.

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

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

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

Taking this medicine

•    You can take your tablets at any time ofthe day.

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

•    Swallow your tablets whole with a drink ofwater. 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

•    Ifyou 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 drinkthe mixture straight away or within 30 minutes. Always stir the mixture just before drinking it

•    To make sure that you have drunk all ofthe medicine, rinse the glass very well with half a glass ofwater and drink it.The solid pieces contain the medicine - do not chew or crush them.

•    Ifyou cannot swallow at all, the tablet 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').

How much to take

•    Your doctor will tell you how manytablets 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 gastroesophageal reflux disease (GERD):

Adults and children aged 12 and above:

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

•    Ifyour gullet has not been damaged, the usual dose is one Esomeprazole 20 mg gastro-resistant tablet each day. Once the condition has been controlled, your doctor maytell you to take your medicine as and when you need it, up to a maximum of one Esomeprazole 20 mg gastro-resistant tablet each day.

•    Ifyou 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 and above: the usual dose is one Esomeprazole 20 mg gastro-resistant tablet 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 and above: the usual dose is one Esomeprazole 20 mg gastro-resistant tablet once a day for 4to8 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 20 mg gastro-resistant tablet once a day.

Placement for Pharmacode no.

Approved

180 x 450 mm Front/Back

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 40 mg 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 80 mg twice a day.

Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole:

The usual dose is one Esomeprazole 40 mg tablet once a day for 4 weeks.

If you take more Esomeprazole than you should

Ifyou take more Esomeprazole gastro-resistant tablets than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Esomeprazole

Ifyou forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skipthe missed dose.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Esomeprazole 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 ofyour lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction)

•    Reddening ofthe 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

•    Ifyou have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms ofa 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 ofwhite 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.

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

Other side effects include:

Common (affects 1 to 10 users in 100)

•    Headache

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

•    Feeling sick (nausea) or being sick (vomiting). Uncommon (affects 1 to 10 users in 1,000)

•    Swellingofthefeetandankles

•    Disturbed sleep (insomnia)

•    Dizziness, tingling feelings such as "pins and needles" feeling sleepy

•    Spinningfeeling(vertigo)

•    Dry mouth

•    Changes in blood tests that check how the liver is working

•    Skin rash, lumpy rash (hives) and itchy skin

•    Fracture ofthe hip, wrist or spine (see section 2). Rare (affects 1 to 10 users in 10,000)

•    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 ofthe inside ofthe 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)

•    Skinrashonexposuretosunshine

•    Joint pains (arthralgia) or muscle pains (myalgia)

•    Generally feeling unwell and lacking energy

•    Increased sweating.

Very rare (affects less than 1 user in 10,000)

•    Changes in blood count including agranulocytosis (lack ofwhite blood cells)

•    Aggression

•    Seeing, feeling or hearing things that are not there (hallucinations)

•    Severe liver problems leading to liver failure and inflammation ofthe 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.

Esomeprazole may in very rare cases affect the white blood cells leading to immune deficiency. Frequency not known

Ifyou 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 ofthese 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 ofpossible side effects. You may not get any ofthem.

If any ofthe side effects get serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

Ifyou get any side effects, talk to your doctor,

pharmacist or nurse.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.

By reporting side effects you can help provide more information onthe safety of this medicine.

Q HOW TO STORE ESOMEPRAZOLE

Keep out of the reach and sight of children.

Do not use Esomeprazole after the expiry date which is stated on the carton and blister after EXP The expiry date refers to the last day ofthat month. Store in the original package in order to protect from light and moisture.

Esomeprazole should be used no longer than 100 days after first opening ofthe bottle.

Medicines should not be disposed ofvia wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will helpto protect the environment.

Q FURTHER INFORMATION

What Esomeprazole 20 mg and 40 mg Gastro-Resistant Tablets contain

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

•    The other ingredients are:

Seal coated sugar spheres: Sugar spheres (sucrose and maize starch), ethylcellulose, magnesium stearate

Drug coat: Povidone K. 90, magnesium oxide, light (E530)

Barrier coat: Povidone, magnesium oxide, light (E530), magnesium stearate Enteric coat: Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent (contains sodium laurilsulfate and polysorbate 80), diethyl phthalate, talc (E553b)

Tablet core: Silicified microcrystalline cellulose (microcrystalline cellulose and colloidal anhydrous silica), starlac (lactose monohydrate and maize starch), copovidone K. 28, macrogol 8000, crospovidone, silica colloidal, anhydrous, magnesium stearate

Film coat: Hypromellose (E464), macrogol 8000, talc (E553b), titanium dioxide (E171), silica colloidal, anhydrous, iron oxide red (E172)

Imprint: Opacode S-1-17823 black ink (contains propylene glycol, iron oxide black (E172), shellac glaze).

What Esomeprazole looks like and contents of the pack

Esomeprazole 20 mg gastro-resistant tablets

Brick-red coloured, round shape, biconvex, film-coated tablet, imprinted with "20" on one side and plain on the other side.

Esomeprazole 40 mg gastro-resistant tablets

Brick-red coloured, round shape, bevelled edge, biconvex, film-coated tablet, imprinted with "40" on one side and plain on the other side.

Blister (Aluminium/Aluminium) or HDPE container (HDPE container of neck finish and PP closure with induction sealing wad and a silica gel canister as desiccant).

Pack sizes:

20 mg, blister: 7, 14, 28, 30, 56, 60, 98,100

gastro-resistant tablets

20 mg, HPDE container: 14, 28, 56, 98,100

gastro-resistant tablets

40 mg, blister: 14, 28, 30, 56, 60, 98,100

gastro-resistant tablets

40 mg, HPDE container: 14, 28, 56, 98,100

gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom. Manufacturer: Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.

This leaflet was last revised in September 2013.

PL 00289/1491 and PL 00289/1492

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