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ESOMEPRAZOLE 20 MG GASTRO-RESISTANT HARD CAPSULES

Active substance(s): ESOMEPRAZOLE

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2494
24.05.13[2]

Esomeprazole 20 mg gastro-resistant
hard capsules
(esomeprazole magnesium)
PATIENT INFORMATION LEAFLET
Your medicine will be referred to as Esomeprazole Capsules throughout
the following leaflet.
Esomeprazole Capsules are also available in other strengths.
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 or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
- If any of the side effects gets serious, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Esomeprazole Capsules are and what they are used for.
2. What you need to know before you take Esomeprazole Capsules.
3. How to take Esomeprazole Capsules.
4. Possible side effects.
5. How to store Esomeprazole Capsules.
6. Contents of the pack and other information.
1. WHAT ESOMEPRAZOLE CAPSULES ARE ANDWHAT THEY ARE
USED FOR
Esomeprazole Capsules contain 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 Capsules are 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 AntiInflammatory Drugs). Esomeprazole Capsules 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 YOUTAKE ESOMEPRAZOLE
CAPSULES
Do not take Esomeprazole Capsules:
- If you are allergic (hypersensitive) to esomeprazole or any of the other
ingredients of this medicine (listed in section 6: Further information).
- If you are allergic to other proton pump inhibitor medicines.
(pantoprazole, lansoprazole, rabeprazole, omeprazole).
- If you are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole Capsules if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking Esomeprazole
Capsules.
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.
Esomeprazole may also reduce the absorption of vitamin B12, especially
on long-term therapy.
Warnings and Precautions
Check with your doctor, pharmacist or nurse before taking Esomeprazole
Capsules:
- If you have severe liver problems.
- If you have severe kidney problems.
Esomeprazole Capsules may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you start taking
Esomeprazole Capsules or while you are taking them, 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 Esomeprazole 'on demand' you should contact
your doctor if your symptoms continue or change in character.
Other medicines and esomeprazole
Please tell your doctor or pharmacist if you are taking, or have recently
taken, or might take any other medicines.
This includes medicines that you buy without a prescription.
This is because Esomeprazole Capsules can affect the way some
medicines work and some medicines can have an effect on Esomeprazole
Capsules.
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
Capsules.
- 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
Capsules.
- Cisapride (used for indigestion and heartburn).
- Clopidogrel (used to prevent blood clots (thrombi)).
- 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 Capsules 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 capsules with food or on an empty stomach.
Pregnancy and breast-feeding
Before taking Esomeprazole Capsules, 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
Esomeprazole Capsules during this time.
It is not known if Esomeprazole passes into breast milk. Therefore, you
should not take Esomeprazole Capsules if you are breast-feeding.
Driving and using machines
Esomeprazole Capsules are not likely to affect you being able to drive or
use any tools or machines.
Important information about some of the ingredients of Esomeprazole
Capsules
Esomeprazole Capsules 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 CAPSULES
Always take Esomeprazole Capsules exactly as your doctor has told you.
You should 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 empty the pellets into half a glass of still (nonfizzy) water. Do not use any other liquid.
- 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 capsule 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 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 or above:
- If your doctor has found that your food pipe (gullet) has been slightly
damaged, the usual dose is one Esomeprazole 40 mg 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
Capsule once a day.
- If your gullet has not been damaged, the usual dose is one
Esomeprazole 20 mg 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 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 or above: the usual dose is one
Esomeprazole 20 mg Capsule 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 AntiInflammatory Drugs):
- Adults aged 18 and above: the usual dose is one Esomeprazole 20 mg
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 and above: the usual dose is one Esomeprazole 20 mg
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 and above: the usual dose is one Esomeprazole 40 mg
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 rebleeding of
ulcers with intravenous esomeprazole:
- Adults aged 18 and above: the usual dose is one Esomeprazole 40 mg
Capsule once daily for 4 weeks.
If you take more Esomeprazole Capsules than you should
If you take more Esomeprazole Capsules than prescribed by your doctor,
talk to your doctor or pharmacist straight away.
If you forget to take Esomeprazole Capsules:
- 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 product, ask your doctor
or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Esomeprazole Capsules 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 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.
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 1000 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.
Not known (frequency cannot be estimated from available data):
- If you are on esomeprazole for more than three months if it 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 Capsules 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 you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
5. HOWTO STORE ESOMEPRAZOLE CAPSULES
Keep this medicine out of the sight and reach of children.
Do not use Esomeprazole Capsules after the expiry date which is stated on
the carton or blister foil after 'EXP'. The expiry date refers to the last day of
that month.
Do not store above 25º C. Store in the original package in order to protect
from moisture.
If your capsules become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Esomeprazole Capsules contains
The active substance is esomeprazole.
Each gastro-resistant capsule contains 20 mg esomeprazole as
esomeprazole magnesium.
The other ingredients of the capsule content are:
- Core: sugar spheres (sucrose and maize starch), crospovidone,
hydroxypropylcellulose.
- Sub-coating: mannitol.
- Enteric coating: methacrylic acid - ethyl acrylate polymer (1:1) dispersion
30%, triethyl citrate, glycerol monostearate, polysorbate 80.
- Lubricant: talc.
The other ingredients of the capsule shell are red iron oxide E172, titanium
dioxide E171, gelatin, purified water, sodium lauryl sulphate.
The other ingredients of the printing ink are shellac, propylene glycol,
strong ammonia solution, black iron oxide E172, potassium hydroxide,
ethanol, isopropyl alcohol, butyl alcohol and purified water.

What Esomeprazole Capsules looks like and contents of the pack
Esomeprazole Capsules are hard gelatin capsules with pink cap and pink
body, imprinted with 'Mylan' over 'EM 20' in black ink on cap and body filled
with white to cream coloured pellets.
Your capsules will come in blister packs containing 30 capsules.
Manufacturer and Product Licence Holder
Manufactured by
Gerard Laboratories., 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland.
Generics [UK] Limited., Station Close, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Procured from within the EU by Product Licence Holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/2494

Leaflet revision and issue date (Ref) 24.05.13[2]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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