OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES

Active substance: OMEPRAZOLE

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PACKAGE LEAFLET : INFORMATION FOR THE USER
OMEPRAZOLE 20 mg GASTRO-RESISTANT CAPSULES
(Omeprazole)
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.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
• If any of the side effects become serious,
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Omeprazole Gastro-resistant
Capsules are and what they are used for
2. Before you take Omeprazole Gastroresistant Capsules
3. How to take Omeprazole Gastro-resistant
Capsules
4. Possible side effects
5. How to store Omeprazole Gastroresistant Capsules
6. Further information
1. WHAT OMEPRAZOLE GASTRORESISTANT CAPSULES ARE AND
WHAT THEY ARE USED FOR
The active ingredient, omeprazole, belongs
to a group of medicines called “proton pump
inhibitors”. It works by reducing the
production of acid in your stomach.
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.
• Ulcers in the upper part of the intestine
(duodenal ulcer) or stomach (gastric ulcer).
• Ulcers 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.
• Ulcers 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.
• Zollinger-Ellison syndrome, when excess
stomach acids are produced due to a
growth in the pancreas.
In children:
Children over 1 year of age and ≥10kg
• ‘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
• Ulcers 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.

Tell your doctor or pharmacist if you are
taking any of the following medicines:
• Diazepam (used to treat anxiety, to 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 Capsules
• 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 Capsules
• Digoxin (used to treat heart problems)
• Ketoconazole, itraconazole or variconazole
(used to treat infections caused by a
fungus)
• Rifampicin (used to treat tuberculosis)
• Atazanavir or Saquinavir (used to treat HIV
infection)
• Tacrolimus (in cases of organ
transplantation)
• St John’s wort (Hypericum perforatum)
(used to treat mild depression)
• Cilostazol (used to treat intermittent
claudication)
• Clopidogrel (used to prevent blood clots
(thrombi)).
If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well as
Omeprazole 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.
Taking Omeprazole Capsules with food
and drink
You can take your capsules with food or on
an empty stomach.
Pregnancy and Breast-feeding:
Before taking Omeprazole Capsules, tell
your doctor if you are pregnant or trying to
get pregnant. Your doctor will decide
whether you can take Omeprazole Capsules
during this time.
Your doctor will decide whether you can
take Omeprazole Capsules if you are
breast-feeding.
Driving and using machines:
Omeprazole Capsules are not likely to affect
your ability to drive or operate any tools or
machines. However side effects such as
dizziness and visual disturbances may occur
(see section 4). If affected, you should not
drive or operate machinery.
Important information about some of the
ingredients of Omeprazole Capsules:
This medicine 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
GASTRO-RESISTANT CAPSULES
Always take Omeprazole Capsules exactly
as your doctor has told you. You should
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 usual doses are given below.

2. BEFORE YOU TAKE OMEPRAZOLE
GASTRO-RESISTANT CAPSULES
Do not take Omeprazole Capsules:
• if you are allergic (hypersensitive) to
omeprazole or any of the other ingredients
of Omeprazole Capsules
• if you are allergic to medicines containing
other proton pump inhibitors (eg
pantoprazole, lansoprazole, rabeprazole,
esomeprazole)
• if you are taking a medicine containing
nelfinavir (used for HIV infection).
If you are not sure, talk to your doctor or
pharmacist before taking Omeprazole
Capsules.
Take special care with Omeprazole
Capsules:
Omeprazole Capsules may hide the
symptoms of other diseases. Therefore, if
any of the following happen to you before
you start taking Omeprazole 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)
• you experience severe or persistent
diarrhoea, as omeprazole has been
associated with a small increase in
infectious diarrhoea
• you have severe liver problems
• you have an intolerance to sucrose.
If you take Omeprazole Capsules on a longterm 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.
Taking other medicines:
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription. This is because
Omeprazole Capsules can affect the way
some medicines work and some medicines
can have an effect on Omeprazole
Capsules.
Do not take Omeprazole Capsules if you are
taking a medicine containing nelfinavir (used
to treat HIV infection).

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 stomach ulcers and duodenal
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 twice a day for a
period of one week.
• Your doctor will also tell you to take two
antibiotics from the following: amoxicillin,
clarithromycin and metronidazole.

To treat too much acid in the stomach
caused by a growth in the pancreas
(Zollinger - Ellison 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.
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 Capsules. 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 over the age of 4 years may take
Omeprazole Capsules. 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 put the contents into a glass of
still (non-fizzy) water, 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 Capsules
than you should:
If you (or someone else) accidentally take
more Omeprazole 20 mg Capsules than
prescribed by your doctor, contact your
doctor or pharmacist straight away.
If you forget to take Omeprazole
Capsules:
If you forget to take a dose, take it as soon
as you remember. However, if it is nearly
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, Omeprazole Capsules
can cause side effects, although not
everybody will experience them.
If you notice any of the following rare but
serious side effects, stop taking
Omeprazole Capsules and contact a
doctor immediately or go to the
emergency department at your nearest
hospital:
• 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 ‘StevensJohnson syndrome’ or ‘toxic epidermal
necrolysis’.
• Yellow skin, dark urine and tiredness which
can be symptoms of liver problems.
Side effects may occur with certain
frequencies, which are defined as follows:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

affects more than 1 user
in 10
affects 1 to 10 users
in 100
affects 1 to 10 users
in 1,000
affects 1 to 10 users in
10,000
affects less than 1 user in
10,000
frequency cannot be estimated from the available
data

Other side effects include:
Common side effects:
• headache
• effects on your stomach or gut: diarrhoea,
constipation, stomach pain, wind
(flatulence)
• feeling sick (nausea) or being sick
(vomiting).
Uncommon side effects:
• swelling of the feet and ankles
• disturbed sleep (insomnia)
• dizziness, tingling feelings such as “pins
and needles”, feeling sleepy
• spinning feeling (vertigo)
• changes in blood tests that check how the
liver is working
• itchy skin, skin rash and lumpy rash (hives)
• generally feeling unwell and lacking
energy.

Rare side effects:
• 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 of confusion, agitation or
depression
• 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 your gut and is caused by a fungus
• liver problems, including jaundice which
can cause yellowing of the 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.
Very rare side effects:
• 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
• enlarged breasts in men
• hypomagnesaemia
Omeprazole 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 medicine at this time.
Do not be concerned by this list of possible
side effects. You may not get any of them. If
any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE OMEPRAZOLE
GASTRO-RESISTANT CAPSULES
• Keep out of the reach and sight of
children.
• Store below 30 °C.
• Do not use Omeprazole after the expiry
date which is stated on the carton after
‘EXP’. The expiry date refers to the last
day of that month
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Omeprazole 20 mg Gastro-resistant
Capsules contain
• The active substance is omeprazole and
each capsule contains 20 mg of
omeprazole as gastro resistant granules.
• The other ingredients are: sugar spheres,
sodium starch glycolate, sodium
laurilsulfate, povidone, potassium oleate,
oleic acid, hypromellose, methacrylic acid ethyl acrylate copolymer (1:1), triethyl
citrate, titanium dioxide and talc. The
capsule coating also contains
carrageenan, titanium dioxide (E171), FDC
blue 1, red 40, hypermellose, potassium
chloride, yellow 6. The printing ink contains
shellac, polyvinylpyrrolidone, propylene
glycol, sodium hydroxide and titanium
dioxide (E171).
What Omeprazole 20 mg Gastro-resistant
Capsules look like and the contents of
the pack
The capsules have an orange body and
blue cap and are marked with O20.
Pack size
Omeprazole 20 mg Capsules are available
in aluminium blisters of 28 capsules.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Laboratorios DAVUR, S.L.U.,
C/Anabel Segura 11,
Edificio Albatros B,
1a planta, Alcobendas,
28108 Madrid, Spain.
Manufacturer:
Teva Pharma, S.L.U.
C/C, nº 4. Polígono Industrial Malpica,
Zaragoza, 50016 Zaragoza
This leaflet was last updated in October
2010
For information in large print, or Braille
please contact the Marketing
Authorisation Holder on
0034 91 659 3220.

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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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