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OMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): OMEPRAZOLE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Omeprazole 40 mg
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.

WHAT IS IN THIS LEAFLET
1 What Omeprazole is and what it is
used for
2 What you need to know before
you take Omeprazole
3 How to take Omeprazole
4 Possible side effects
5 How to store Omeprazole
6 Contents of the pack and other
information
1 WHAT OMEPRAZOLE IS AND

WHAT IT IS USED FOR

Omeprazole contains the active substance
omeprazole. It belongs to a group of
medicines called ‘proton pump inhibitors’.
They work by reducing the amount of acid
that your stomach produces.
Omeprazole is used to treat the following
conditions:
In adults:
• ‘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.
•U
 lcers in the upper part of the intestine
(duodenal ulcer) or stomach (gastric ulcer).
•U
 lcers which 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.
•U
 lcers caused by medicines called NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs).
Omeprazole can also be used to stop ulcers
from forming if you are taking NSAIDs.
• T oo much acid in the stomach caused by
a growth in the pancreas (Zollinger-Ellison
syndrome).
In children:
Children over 1 year of age and ≥ 10 kg
• ‘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.
In children, the symptoms of the condition
can include the return of stomach contents
into the mouth (regurgitation), being sick
(vomiting) and poor weight gain.
Children and adolescents over 4 years of age
•U
 lcers which are infected with bacteria
called ‘Helicobacter pylori’. If your child
has this condition, your doctor may also
prescribe antibiotics to treat the infection
and allow the ulcer to heal.

2 WHAT YOU NEED TO KNOW

BEFORE YOU TAKE OMEPRAZOLE
Do not take Omeprazole

• If you are allergic to omeprazole or any of
the other ingredients of this medicine (listed
in section 6).
• If you are allergic to medicines containing
other proton pump inhibitors (e.g.
pantoprazole, lansoprazole, rabeprazole,
esomeprazole).
• If you are taking a medicine containing
nelfinavir (used for HIV infection).

Warnings and precautions

Talk to your doctor or pharmacist before
taking Omeprazole.
Omeprazole may hide the symptoms of other
diseases. Therefore, if any of the following
happen to you before you start taking
Omeprazole 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).
• You experience severe or persistent
diarrhoea, as omeprazole has been
associated with a small increase in infectious
diarrhoea.
• You have severe liver problems.
Taking a proton pump inhibitor like
Omeprazole, 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).
If you take Omeprazole on a long-term basis
(longer than 1 year) your doctor will probably
keep you under regular surveillance. You
should report any new and exceptional
symptoms and circumstances whenever you
see your doctor.
Omeprazole may interfere with some test
(chromogranin A). To avoid this interference
the omeprazole should be temporarily
stopped five days before testing.

Other medicines and Omeprazole

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. This is because Omeprazole
can affect the way some medicines work
and some medicines can have an effect on
Omeprazole.

Do not take Omeprazole 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:
• Ketoconazole, itraconazole, posaconazole
or voriconazole (used to treat infections
caused by a fungus)
• Digoxin (used to treat heart problems)
• 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
Omeprazole
• Medicines that are used to thin your blood,
such as warfarin or other vitamin K blockers.
Your doctor may need to monitor you when
you start or stop taking Omeprazole
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ
transplantation)
• Erlotinib (used to treat cancer)
• Methotrexate (used to treat rheumatoid
arthritis and some cancers)
• St John’s wort (Hypericum perforatum)
(used to treat mild depression)
• Cilostazol (used to treat cramp-like pain in
your legs when you walk and is caused by
insufficient blood supply in your legs)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots )
If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well
as Omeprazole to treat ulcers caused
by Helicobacter pylori infection, it is very
important that you tell your doctor about any
other medicines you are taking.

Omeprazole with food and drink

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

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 for advice before
taking this medicine. Your doctor will decide
whether you can take Omeprazole during
this time.
Your doctor will decide whether you can take
Omeprazole if you are breastfeeding.

Driving and using machines

Omeprazole is not likely to affect your
ability to drive or use any tools or machines.
Side effects such as dizziness and visual
disturbances may occur (see section 4). If
affected, you should not drive or operate
machinery.

Omeprazole contains sucrose

If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

3 HOW TO TAKE OMEPRAZOLE
Always take Omeprazole exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor will tell you how many capsules
to take and how long to take them for. This
will depend on your condition and how old
you are.
The recommended doses are given below.
Adults:
To treat symptoms of GERD such as
heartburn and acid regurgitation:
• If your doctor has found that your food
pipe (gullet) has been slightly damaged,
the usual dose is 20 mg once a day for 4-8
weeks. Your doctor may tell you to take a
dose of 40 mg for a further 8 weeks if your
gullet has not yet healed.
• The usual dose once the gullet has healed is
10 mg once a day.
• If your gullet has not been damaged, the
usual dose is 10 mg once a day.
To treat ulcers in the upper part of the
intestine (duodenal ulcer):
• The usual dose is 20 mg once a day for 2
weeks. Your doctor may tell you to take the
same dose for a further 2 weeks if your ulcer
has not yet healed.
• If the ulcer does not fully heal, the dose
can be increased to 40 mg once a day for 4
weeks.
To treat ulcers in the stomach (gastric ulcer):
• The usual dose is 20 mg once a day for 4
weeks. Your doctor may tell you to take the
same dose for a further 4 weeks if your ulcer
has not yet healed.
• If the ulcer does not fully heal, the dose
can be increased to 40 mg once a day for 8
weeks.
To prevent the duodenal and stomach
ulcers from coming back:
• The usual dose is 10 mg or 20 mg once a
day. Your doctor may increase the dose to
40 mg once a day.
To treat duodenal and stomach ulcers
caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):
• The usual dose is 20 mg once a day for 4–8
weeks.
To prevent duodenal and stomach ulcers if
you are taking NSAIDs:
• The usual dose is 20 mg once a day.
To treat ulcers caused by Helicobacter
pylori infection and to stop them coming
back:
• The usual dose is 20 mg Omeprazole twice a
day for one week.
• Your doctor will also tell you to take
two antibiotics among amoxicillin,
clarithromycin and metronidazole.
To treat too much acid in the stomach caused
by a growth in the pancreas (ZollingerEllison syndrome):
• The usual dose is 60 mg daily.
• Your doctor will adjust the dose depending
on your needs and will also decide how long
you need to take the medicine for.

Continued over page

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AAAG6627

Omeprazole Gastro-resistant 40mg Capsules PIL - UK
item no: AAAG6627

dimensions: 140 x 540

print proof no: 1

pharmacode:

origination date: 14.03.14

min pt size: 8pt

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originated by: S.Anson
approved for print/date

colours/plates:

revision date:

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revised by:

date sent: 14.03.14

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Use in children:
To treat symptoms of GERD such as
heartburn and acid regurgitation:
• Children over 1 year of age and with a
body weight of more than 10 kg may take
Omeprazole. The dose for children is based
on the child’s weight and the doctor will
decide the correct dose.
To treat ulcers caused by Helicobacter
pylori infection and to stop them coming
back:
• Children aged over 4 years may take
Omeprazole. The dose for children is based
on the child’s weight and the doctor will
decide the correct dose.
• Your doctor will also prescribe two
antibiotics called amoxicillin and
clarithromycin for your child.

Taking this medicine

• It is recommended that you take your
capsules in the morning.
• You can take your capsules with food or on
an empty stomach.
• Swallow your capsules whole with half a
glass 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 or your child have
trouble swallowing the capsules

• If you or your child have trouble swallowing
the capsules:
- Open the capsules and swallow the
contents directly with half a glass of water,
or mix the contents with a small amount
of yoghurt, any acidic fruit juice (e.g. apple,
orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking
it (the mixture will not be clear). Then drink
the mixture straight away or within 30
minutes.
- 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 take more Omeprazole than
you should

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

If you forget to take Omeprazole

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 to make up for a
forgotten dose.

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 rare
but serious side effects, stop taking
Omeprazole 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.
Other side effects include:
Common side effects (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 side effects (may affect up to 1
in 100 people)
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
•D
 izziness, tingling feelings such as “pins and
needles”, feeling sleepy.
• Spinning feeling (vertigo).
•C
 hanges in blood tests that check how the
liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
• Fracture of the hip, wrist or spine.
Rare side effects (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.
• Allergic reactions, sometimes very severe,
including swelling of the lips, tongue and
throat, fever, wheezing.
• 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).
• Dry mouth.
• 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).
• Severe kidney problems (interstitial
nephritis).
• Increased sweating.

Omeprazole 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 medicine at this time.
Not known (frequency cannot be
estimated from the available data)
• Inflamation in the gut (leading to
diarrhoea).
• If you are on Omeprazole 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.
Do not be concerned by this list of possible
side effects. You may not get any of them.

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 Yellow Card
Scheme: 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 OMEPRAZOLE
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date which is stated on the pack after “EXP:”.
The expiry date refers to the last day of that
month. HDPE bottle: Use within 3 months
of opening.
• Store below 25°C.
• Store this blister in the original package or
keep the bottle tightly closed in order to
protect from moisture. Replace cap firmly
after use.
• 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 Omeprazole 40mg gastroresistant capsules contains:

• The active substance is omeprazole.
Omeprazole 40mg capsules contain 40 mg
of omeprazole.
• The other ingredients are:
•C
 apsule content: sugar spheres (consisting
of corn starch and sucrose), sodium
laurilsulfate, Disodium phosphate,
anhydrous, mannitol, hypromellose 6
cP, macrogol 6000, talc, polysorbate 80,
titanium dioxide (E 171), and methacrylic
acid-ethylacrylate copolymer (1:1) .
•C
 apsule shell: gelatine, the colouring agent
indigo carmine (E 132) and titanium dioxide
(E 171).

What Omeprazole 40mg gastroresistant capsules looks like and
contents of the pack
Opaque blue and opaque white capsule
containing off-white to cream white spherical
microgranules.
Pack sizes:
Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98,
100, 140 or 280 capsules; hospital pack of 500
capsules.
HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60,
90 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder:
CHEMO IBÉRICA, S.A.
Gran Vía Carlos III, 98, 7th,
08028 Barcelona
SPAIN
Manufacturer
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial
Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN

This leaflet was last revised in 03/2014.

If you would like a
leaflet with larger
text, please contact
01271 311257.

Very rare side effects (may affect up to 1 in
10,000 people)
•C
 hanges in blood count including
agranulocytosis (lack of white blood cells).
• Aggression.
• S eeing, feeling or hearing things that are
not there (hallucinations).
• S evere liver problems leading to liver failure
and inflammation of the brain.
• S udden 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.
• Enlarged breasts in men.
Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAG6627

Omeprazole Gastro-resistant 40mg Capsules PIL - UK
item no: AAAG6627

dimensions: 140 x 540

print proof no: 1

pharmacode:

origination date: 14.03.14

min pt size: 8pt

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date:

Technical Approval

revised by:

date sent: 14.03.14

supplier: Liconsa

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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