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Esomeprazole 40 Mg Gastro-Resistant Tablets

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RANBAXY

LABORATORIES LIMITED PKG. DEV. PAONTA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole 20 mg gastro-resistant tablets Esomeprazole 40 mg gastro-resistant tablets

Esomeprazole

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.

• 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 for heart problems).

• Rifampicin (used for treatment of tuberculosis).

• Clopidogrel (used to prevent blood clots (thrombi))

• 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 your tablets with food or on an empty stomach.

Pregnancy and breast-feeding

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 breastfeeding.

Esomeprazole 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 'Helicobacter pylori'. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcertoheal.

• 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

2. What you need to know before you take Esomeprazole_

Do not take Esomeprazole if:

• You are allergicto Esomeprazole orany of the other ingredients of this medicine (listed in Section 6:).

• 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 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

• You have severe liver problems.

• You have severe kidney problems.

• You have low vitamin B12 level in your body or are at riskof developing it.

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 getstomach pain orindigestion.

• Youbegintovomitfoodorblood.

• 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.

Inform your doctor if you are going to have a laboratory examination for cancer (CgA measurement). Your doctor will advise you to stop taking this medicine for at least five days before going for this test.

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 Tablets 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 afungus).

• 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

Driving and using machines

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

Esomeprazole contains sucrose

Esomeprazole 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.

3. How to Take Esomeprazole_

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 gastro-resistant tablets 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 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.

To treat heartburn caused by gastro-

oesophageal reflux disease (GORD):

Adults and children aged 12or 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 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

• If your 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 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.

• If you have severe liver problems, yourdoctor 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 Esomeprazole 20 mg gastro-resistant tablet twice a day for one week.

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

• 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 get serious, or if you notice any side effects not listed in this leaflet,

• Yourdoctor 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 20 mg gastro-resistant tablet once a day for4 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 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 Esomeprazole 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 Esomeprazole 40 mg tablet onceadayfor4 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 straightaway.

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, askyour doctor or pharmacist.

4. Possible side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

5. How to store Esomeprazole_

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

• Store below 300C

• store in the original package (blister) in order to protect from moisture

• Do not use this medicine after the expiry date which is stated on the blister and the carton after (Exp).The expiry date refers to the last day of that month.

• Do not throw away 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 ofthe pack and other information

What ESOMEPRAZOLE 20 mg/ 40 mg gastro-resitant tablets contain

The active substance is esomeprazole.

20mg: Each tablet contains 20 mg esomeprazole as esomeprazole magnesium (amorphous).

The other ingredients are:

Per tablet core: Hydroxypropyl cellulose (E463), Crospovidone (Type A),

Per tablet coating: Povidone (K30), Macrogol-400, Macrogol-4000, Macrogol 6000, Hypromellose phthalate (HP-55S), Hypromellose phthalate (HP-50), Diethylphthalate, Hydroxypropyl cellulose, Microcrystaline cellulose (PH 101), Microcrystaline cellulose (PH 112), Crosspovidone (TypeB), Sodium stearyl fumarate, Opadry 03B86651 Brown (HMPC 2910/Hypromellose 6cP, Titanium Dioxide(E171), Macrogol/PEG 400, Iron Oxide red (E172)), Sugar spheres (sucrose and maize starch), Talc (E553b)

40mg: Each tablet contains 40 mg esomeprazole as esomeprazole magnesium (amorphous).

The other ingredients are:

Per tablet core: Hydroxypropyl cellulose (E463), Crospovidone (Type A),

What ESOMEPRAZOLE 20 mg/ 40mg gastro-resistant tablets look like and contents of the pack

ESOMEPRAZOLE 20 mg gastro-resistant tablets are light brick red to brown coloured, oval, biconvex, film-coated tablets with 'E5' debossed on one side and plain on other side

ESOMEPRAZOLE 40 mg gastro-resistant tablets are light brick red to brown coloured, oval, biconvex, film-coated tablets with 'E6' debossed on one side and plain on other side

Product is available in following pack sizes 20mg:OPA-AI-PE-dessicant-HDPE/AI blister with 7,14,15,28,30,50,56,60,90,98 and 100 tablets

40 mg: OPA-AI-PE-dessicant-HDPE/AI blisters with 7,14,15,28,30,50,56,60,90,98 and 100 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road W45YE

Manufacturer

Ranbaxy Ireland Ltd., Spafield, Cork Road,

Cashel, Co. Tipperary, Ireland

Basics GmbH, Hemmelrather Weg 201, D-

51377 Leverkusen, Germany

Terapia SA, 124 Fabricii Street, 400 632 Cluj

Napoca, Romania

Marketing authorisation numbers: PL 14894/0630-0631

This medicine is authorised in the Member states ofthe EEAunderthefollowing names:

Belgium: Esomeprazole Ranbaxy 20mg/40mg,

Maagsapresistente Tabletten

France: ESOMEPRAZOLE RANBAXY

20mg/40mg, Comprime Gastro-Resistant

Germany: ESOMEPRAZOL BASICS

20mg/40mg, MagensaftresistenteTabletten

Italy: ESOMEPRAZOLO RANBAXY

20mg/40mg, Compresse Gastro-resistenti

Netherlands: ESOMEPRAZOL 20mg/40mg,

Maagsapresistente Tabletten

Portugal: EZOCLIP 2 0 m g / 4 0 mg

comprimidogastrorresistente

Sweden: Esomeprazole 20mg/40mg,

Enterotabletter

United Kingdom: ESOMEPRAZOLE 20mg/40mg, Gastro-resistant Tablets

This leaflet was last revised March 2012.

LTD

RANBAXY

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Esomeprazole 20/40 mg Tabs (PIL) Size: 140x500 mm Market: UK

Paonta RLL: 05.03.2012 Pharma Code: 94158 5094158

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

Serious side effects

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.

Otherside effects include:

Common (may affect up to 1 in lOpeople)

• 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 tin 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. Rare (may affect up to 1 in 1,000people)

• 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 ordepressed.

• 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 affects 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.

• Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and arrhythmias (heart rhythm disturbances). Severely decreased magnesium level can also lead to decrease in blood calcium level.

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.