Skip to Content

UK Edition. Click here for US version.

ESOMEPRAZOLE 20MG GASTRO-RESISTANT CAPSULES HARD

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Esomeprazole 20mg and 40mg Gastro-resistant Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- 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 side effects not listed
in this leaflet. See section 4.
- The full name of this medicine is Esomeprazole 20mg and 40mg Gastro-resistant Capsules but
within the leaflet it will be referred to as Esomeprazole capsules.

What is 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 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 adolescents 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 Anti-Inflammatory 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)
 are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole,
omeprazole)
 are taking a medicine containing nelfinavir (used to treat HIV infection).
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.
Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazole capsules if you:
 have severe liver problems
 have severe kidney problems
 have ever had a skin reaction after treatment with a medicine similar to Esomeprazole capsules that
reduces stomach acid
 you are due to have a specific blood test (Chromogranin A).
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 capsules. Remember to also mention any other illeffects like pain in your joints.

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 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 capsules “on demand” you should contact your doctor if your
symptoms continue or change in character.
Talk to your doctor if you experience severe or persistent diarrhoea; esomeprazole has been associated with a
small increased risk of infectious diarrhoea.
Taking a proton pump inhibitor like Esomperazole Capsules, 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).
Children under the age of 12 years
Esomperazole Capsules should not be used in children younger than 12 years. More appropriate
pharmaceutical forms of this medicine may be available.
Other medicines and Esomeprazole capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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
infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
 atazanavir or saquinavir (used to treat HIV infection).
 clopidogrel (used to prevent blood clots)
 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).

digoxin (used for heart problems).



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 capsules treatment.

tacrolimus (organ transplantation)

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, breast-feeding and fertility

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 capsules during this time.
It is not known if Esomeprazole capsules 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 your ability to drive or use any tools or machines. However,
side effects such as dizziness and blurred vision may uncommonly or rarely occur (see section 4). If affected,
you should not drive or use machines.
Esomeprazole capsules contain sucrose and parahydroxybenzoates (E216 and E218)
Esomeprazole capsules contain sugar spheres which contain sucrose, a type of sugar, propyl-phydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218):
 If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor
before taking this medicine
 Parahydroxybenzoates may cause allergic reactions (possibly delayed).

3. How to take Esomeprazole capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
 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.
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 recommended doses are given below.
To treat heartburn caused by gastro-oesophageal reflux disease (GORD):
Adults and adolescents aged 12 years or above:
 If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is
one capsule of Esomeprazole 40mg 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 capsule of Esomeprazole 20mg once a day
 If your gullet has not been damaged, the recommended dose is one capsule Esomeprazole 20mg 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 capsule of Esomeprazole 20mg 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 recommended dose is one capsule of Esomeprazole 20mg 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 recommended dose is one capsule of Esomeprazole 20mg 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 capsule of Esomeprazole 20mg 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 capsule of Esomeprazole 40mg 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 80mg twice a day.
To be used as prolonged treatment after prevention of rebleeding of ulcers with intravenous
Esomeprazole:
Adults aged 18 years and above:
 The recommended dose is one capsule of Esomeprazole 40mg once a day for 4 weeks.
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 glass of water. Do not chew or crush the capsules or their
contents. This is because the capsules contain coated granules which stop the medicine from being broken
down by the acid in your stomach. It is important not to damage the granules.
What to do if you have trouble swallowing the capsules

If you have trouble swallowing the capsules:
Open the capsule carefully above half a glass of still (non-fizzy) water and empty the content of
the capsule (granules) into the glass. Do not use any other liquids.
Stir. 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 content of 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’).
Children under the age of 12 years
Esomeprazole capsules should not be used in children younger than 12 years. More appropriate
pharmaceutical forms of this medicine may be available.
Older people
Dose adjustment is not required in the elderly.
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 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 capsules 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, seen rarely)
 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 ‘erythema multiforme’, ‘Stevens-Johnson syndrome’ or
‘toxic epidermal necrolysis’, seen very rarely.
 yellow skin, dark urine and tiredness which can be symptoms of liver problems, seen rarely.
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)
 benign polyps in the stomach.
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 (if Esomeprazole capsules are used in high doses and over long duration)
Rare (may affect up to 1 in 1,000 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
 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) (see *below)
 aggression
 seeing, feeling or hearing things that are not there (hallucinations)
 severe liver problems leading to liver failure and inflammation of the brain
 muscle weakness
 severe kidney problems
 enlarged breasts in men
Not known (frequency cannot be estimated from the available data)

 inflammation in the gut (leading to diarrhoea)
 If you are on Esomeprazole capsules 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 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.
 rash, possible with pain in the joints
*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.
Reporting of side effects
If you 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 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 store above 25°C.
Keep this medicine in the original container (blister) or keep the container tightly closed (bottle) in order
to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton, bottle or blister foil after
‘EXP’. The expiry date refers to the last day of that month.
After opening the bottle, the capsules should be used within 3 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Esomeprazole capsules contain
 The active substance is esomeprazole.
Esomeprazole capsules come in two strengths containing 20mg or 40mg of esomeprazole (as magnesium
dihydrate).
 The other ingredients are:
Capsule content: sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35%
(containing dimethicone, propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid,
sodium benzoate, polyethylene glycol sorbitan monolaureate, octylphenoxy polyethoxy ethanol and propylene
glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate
copolymer (1:1) dispersion 30 % (containing copolymer of methacrylic acid and ethyl acrylate, sodium lauryl
sulfate and polysorbate 80, triethyl citrate and stearoyl macrogolglycerides.
Capsule shell: black iron oxide (E 172), shellac, gelatin, yellow iron oxide (E 172) and titanium dioxide (E
171).
What Esomeprazole capsules look like and contents of the pack
 Esomeprazole 20mg capsules have an opaque yellow cap and an opaque white body. “20mg” is printed
in black both on the cap and on the body.
 Esomeprazole 40mg capsules have an opaque yellow cap and an opaque yellow body. “40mg” is printed
in black both on the cap and on the body.
Your capsules will come in packs of 28 capsules

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturers
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This leaflet was last revised in June 2017

If you would like a leaflet with larger text, please contact 01271 385257.

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK
The following information is intended for healthcare professionals only:
Administration through gastric tube
1.

Add the contents of a capsule into approximately 25 ml or 50 ml of water. (For some tubes, dispersion
in 50 ml water is needed to prevent the granules from clogging the tube).
Stir.

2.

Draw the suspension into a syringe and add approximately 5 ml of air.

3.

Immediately shake the syringe for approximately 2 minutes to disperse the granules.

4.

Hold the syringe with the tip up and check that the tip has not clogged.

5.

Attach the syringe to the tube whilst maintaining the above position.

6.

Shake the syringe and position it with the tip pointing down. Immediately inject 5-10 ml into the tube.
Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid
clogging of the tip).

7.

Turn the syringe with the tip down and immediately inject another 5-10 ml into the tube.
Repeat this procedure until the syringe is empty.

8.

Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to wash down any
sediment left in the syringe. For some tubes, 50 ml water is needed.

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.

Hide