Document: document 3 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8
• document 9
• document 10
• document 11
• document 12
• document 13
• document 14
• document 15
• document 16
• document 17
• document 18
• document 19

---

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 fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

•    Muscle weakness.

•    Severe kidney problems.

•    Enlarged breasts in men

•    Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and arrhythmias (heart rhythm disturbances).

Esomep 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.

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 tell your doctor or pharmacist.

5. HOW TO STORE ESOMEP

•    Keep out of the reach and sight of children.

•    Do not store above 30°C.

•    Keep this medicine in the original container (blister) or keep the container tightly closed (bottle) in order to protect from moisture.

•    Do not take your tablets after the expiry date (EXP) shown on the carton, wallet pack or blister foil. The expiry date refers to the last day of

that month.

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

L

6. FURTHER INFORMATION

What Esomep contains

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

The other ingredients are glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, iron oxide (20 mg and 40 mg: reddish-brown; 20 mg tablets: yellow) (E172), magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 per cent, microcrystalline cellulose, synthetic paraffin, macrogol (polyethyleneglycol 6000), polysorbate 80, crospovidone (type A), sodium stearyl fumarate, sugar spheres (sucrose and corn starch), talc, titanium dioxide (E171), triethyl citrate.

What Esomep looks like and contents of the pack

•    Esomep 20 mg gastro-resistant tablets are light pink, oblong, biconvex, film-coated and engraved with an _r^A1 on one side and 20 mg on the other side.

•    Esomep 40 mg gastro-resistant tablets are pink,

oblong, biconvex, film-coated and engraved with

an ^A on one side and 40 mg on the other side.

EI    ^a

•    Your tablets will come in a blister pack in wallets

and/or cartons containing

20 mg, 40 mg: Bottles of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140(5x28) tablets.

20 mg, 40 mg: Blister packs in wallet and/or carton of 3, 7, 7x1, 14, 15, 25x1,28, 30, 50x1,56, 60, 90, 98, 100x1, 140 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for Esomep are held by AstraZeneca UK Ltd, 600 Capability Green, Luton,

LU1 3LU, United Kingdom.

Esomep is released by AstraZeneca AB, S-151 85, Sodertalje, Sweden; AstraZeneca AB, Umea, Sweden; AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom; AstraZeneca GmbH, Wedel, Germany; Biofabri S.L, Pontevedra, Spain; Corden Pharma GmbH, Plankstadt, Germany; Recipharm Monts, Monts, France or AstraZeneca Reims, Reims, France.

Leaflet prepared: October 2011 © AstraZeneca 2011

Esomep is a trade mark of the AstraZeneca group of companies.

GI 11 0108

AstraZeneca*^

I___I

Please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Esomep is and what it is used for

2.    Before you take Esomep

3.    How to take Esomep

4.    Possible side effects

5.    How to store Esomep

6.    Further information

1. WHAT ESOMEP IS AND WHAT IT IS USED FOR

Esomep 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.

Esomep is used to treat the following conditions:

•    ‘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.

L _ _ _ _ _ _ _ _ _ _ .

2. BEFORE YOU TAKE ESOMEP

Do not take Esomep if:

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

•    You are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lanzoprazole, rabeprazole, omeprazole).

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

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

Take special care with Esomep

Check with your doctor or pharmacist before taking Esomep if:

•    You have severe liver problems.

•    You have severe kidney problems.

Esomep may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomep 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 Esomep “on demand” you should contact your doctor if your symptoms continue or change in character.

Using other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription. This is because Esomep can affect the way some medicines work and some medicines can have an effect on Esomep.

f)o not take Esomep Tablets if you |are taking a medicine containing nelfinavir (used to treat HIV).

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

_    _ _T 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 I in epilepsy).

I* Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you | when you start or stop taking Esomep.

•    Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomep.

I* Cilostazol (used to treat intermittent claudication -, a pain in your legs when you walk which is caused I by an insufficient blood supply).

I* Cisapride (used for indigestion and heartburn).

•    Digoxin (used for heart problems).

|* Rifampicin (used for treatment of tuberculosis).

•    St John’s Wort (Hypericum perforatum) (used to treat depression).

ilf your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomep 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 Esomep, tell your doctor if you 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 Esomep during this time.

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

[Taking Esomep with food and drink

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

[Driving and using machines

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

.Important information about some of the ingredients of Esomep

[Esomep gastro-resistant tablets contain sucrose, which is 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.

(For 20 mg tablet: sucrose 28 mg, for 40 mg tablet: sucrose 30 mg

3. HOW TO TAKE ESOMEP

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

•    Esomep gastro-resistant tablets are not recommended for children less than 12 years old.

•    If you are taking this medicine for a long time, your

_r —    -| doctor will want to monitor you

(particularly if you are taking it I for more than a year). i    i* 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 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 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.

•    The usual doses are given below.

j

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 Esomep 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 Esomep 20 mg gastro-resistant tablet once a day

•    If your gullet has not been damaged, the usual dose is one Esomep 20 mg 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 Esomep 20 mg 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 18 or above: the usual dose is one Esomep 20 mg 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 Esomep 20 mg 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 Esomep 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 Esomep 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 rebleeding of ulcers with intravenous esomeprazole:

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

If you take more Esomep than you should

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

If you forget to take Esomep

•    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 _L time) tojnake up_for aJorgotten dose^

4. POSSIBLE SIDE EFFECTS

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

If you notice any of the following serious side effects, stop taking Esomep 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 1 to 10 users in 10,000. 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)

•    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.

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 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.

. _ _ _ _ _ _ _ _ _ _ j

3