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ESOMEPRAZOLE 40 MG GASTRO-RESISTANT HARD CAPSULES

Active substance(s): ESOMEPRAZOLE / ESOMEPRAZOLE MAGNESIUM / ESOMEPRAZOLE / ESOMEPRAZOLE MAGNESIUM / ESOMEPRAZOLE / ESOMEPRAZOLE MAGNESIUM

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2509
19.05.17[6]

Esomeprazole 40mg gastro-resistant
hard capsules
(esomeprazole magnesium)
PATIENT INFORMATION LEAFLET
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.
Your medicine will be referred to as Esomeprazole Capsules throughout the
following leaflet. Also available as the 20mg gastro-resistant capsules.
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 AND WHAT THEY ARE
USED FOR
Esomeprazole Capsules 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 Capsules are 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 '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 YOU TAKE ESOMEPRAZOLE
CAPSULES
Do not take Esomeprazole Capsules:
- If you are allergic to esomeprazole or any of the other ingredients of this
medicine (listed in section 6).
- If you are allergic to the group of medicines called ‘benzimidazoles’, which
includes other proton pump inhibitor medicines (e.g. pantoprazole,
lansoprazole, rabeprazole, omeprazole) as well as other different types of
medicine.
- If you are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole Capsules if any of the above applies to you. If
you are not sure, talk to your doctor or pharmacist before taking
Esomeprazole Capsules.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Esomeprazole
Capsules:
- If you have severe liver problems.
- If you have severe kidney problems.
- If you have ever had a skin reaction after treatment with a medicine
similar to esomeprazole that reduces stomach acid.
If you get a rash on your skin, especially in areas exposed to the sun tell
your doctor as soon as you can, as you may need to stop your treatment
with esomeprazole. Remember to also mention any other ill-effects like pain
in your joints.
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.
Esomeprazole Capsules may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you start taking
this medicine 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 Esomeprazole “on demand” you should contact
your doctor if your symptoms continue or change in character.
Other medicines and Esomeprazole Capsules
Tell your doctor or pharmacist if you are taking, 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).
- Erlotinib (used to treat cancer).
- 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.

- Cilostazol (used to treat intermittent claudication – a pain in your legs
when you walk which is caused by an insufficient blood supply).
- Cisapride (used for indigestion and heartburn).
- Clopidogrel (used to prevent blood clots (thrombi)).
- Digoxin (used for heart problems).
- Tacrolimus (used to reduce the immune response, helping to prevent
rejection of organ transplant or to treat skin reactions such as eczema)
- Methotrexate (a chemotherapy medicine used in high doses to treat
cancer) – if you are taking a high dose of methotrexate, your doctor may
temporarily stop your Esomeprazole treatment.
- 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.
Pregnancy and breast-feeding
If you are pregnant, 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 Capsules if you are breast-feeding.
Driving and using machines
Esomeprazole can cause side effects such as dizziness and blurred vision.
If you are affected by these you should not drive, use tools or operate
machinery.
Esomeprazole Capsules contains sucrose
If you have been told by your doctor that you have an intolerance to some
sugars, such as sucrose, talk to your doctor before taking this medicine.
3. HOW TO TAKE ESOMEPRAZOLE CAPSULES
Always take this medicine 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 (non-fizzy)
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. If you have severe liver problems, your doctor may give
you a lower dose.
The recommended doses are given below.
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 recommended 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 recommended dose once the gullet has healed is one Esomeprazole
20 mg Capsule once a day.
- If your gullet has not been damaged, the recommended 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.
To treat ulcers caused by Helicobacter pylori infection and to stop
them coming back:
- Adults and young people aged 12 or above: the recommended 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 recommended 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 recommended 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 recommended 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 recommended 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 your doctor has told you to,
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 medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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:
Uncommon (may affect up to 1 in 100 people):
- Fracture of the hip, wrist or spine (if Esomeprazole is used in high doses
and over long duration)
Rare (may affect up to 1 in 1,000 people):
- Sudden wheezing, swelling of your lips, tongue and throat or body, rash,
fainting or difficulty swallowing or breathing (severe allergic reaction).
- Yellow skin, dark urine, pale stools with fever, feeling or being sick and
tiredness, which can be signs of liver problems.
Low numbers of white blood cells, which may lead to a severely reduced
general condition or fever with signs of a local infection such as pain in the
neck, throat or mouth or difficulty urinating.
Very rare (may affect up to 1 in 10,000 people):
- Reddening of the skin with blisters or peeling. There may also be severe
blisters and bleeding in the lips, eyes, mouth, nose and genitals, with joint
pain and high fever. This could be ‘erythema multiforme’, ‘StevensJohnson syndrome’ or ‘toxic epidermal necrolysis’.
- Changes to the number of certain cells in your blood causing tiredness,
weakness or pale skin (low red blood cells), bruising or bleeding more
frequently or for longer than normal (low platelets).
- Passing less urine than usual or being unable to pass urine, blood or
mucous in the urine, pain in the lower back possibly with rash, fever,
feeling or being sick. These may be signs of kidney problems.
- For patients who have liver problems, these may get worse and lead to
swelling of the brain, which can cause changes in concentration,
personality or behaviour, problems concentrating or thinking or feeling
sleepy or drowsy.
Not known (cannot be estimated from the available data):
- Inflammation in the gut causing pain and diarrhea, possibly containing
blood.
- Rash, possibly with pain in the joints
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.
Rare (may affect up to 1 in 1000 people)
- 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.
- 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)
- Aggression.
- Seeing, feeling or hearing things that are not there (hallucinations).
- Muscle weakness.
- 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.
Reporting of 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. 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 on the
safety of this medicine.
5. HOW TO 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 40 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 oxideE172, yellow
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 are hard gelatin capsules with brown cap and brown body,
imprinted with 'Mylan' over 'EM 40' 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 20636/2509

Leaflet revision and issue date (Ref) 19.05.17[6]

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Expand Transcript

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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