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OMEPRAZOLE GASTRO-RESISTANT CAPSULES 10MG

Active substance(s): OMEPRAZOLE

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Tell your doctor or pharmacist if you are
OMEPRAZOLE
taking any of the following medicines:
10 mg, 20 mg and 40 mg
• Ketoconazole, itraconazole,
GASTRO-RESISTANT CAPSULES posaconazole or voriconazole (used to
PACKAGE LEAFLET:
INFORMATION FOR THE USER



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. Do not pass it on to others. It may •
harm them, even if their symptoms 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.

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.






treat infections caused by a fungus)
Erlotinib (used for certain types of cancer)
Clarithromycin (antibiotic)
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 infections)
Tacrolimus (in cases of organ
transplantation)
St John’s wort (Hypericum perforatum)
(used to treat mild depression)
Cilostazol (used to treat intermittent
claudication)
Saquinavir (used to treat HIV infection)
Clopidogrel (used to prevent blood
clots (thrombi)).

If your doctor has prescribed the
antibiotics amoxicillin and clarithromycin
as well as omeprazole to treat ulcers
1 WHAT OMEPRAZOLE IS AND
caused by Helicobacter pylori infection, it
WHAT IT IS USED FOR
is very important that you tell your doctor
Omeprazole contains the active substance about any other medicines you are taking.
omeprazole. It belongs to a group of
Taking Omeprazole with food and drink
medicines called ‘proton pump inhibitors’.
You can take your capsules with food or
They work by reducing the amount of
on an empty stomach.
acid that your stomach produces.
Pregnancy and breast-feeding
Omeprazole is used to treat the following
Before taking Omeprazole, tell your doctor
conditions:
if you are pregnant or trying to get
pregnant. Your doctor will decide whether
In adults:
you can take Omeprazole during this time.
• ‘Gastro-oesophageal reflux disease’
(GERD). This is where acid from the
Your doctor will decide whether you can
stomach escapes into the gullet (the
take Omeprazole if you are breast-feeding.
tube which connects your throat to
your stomach) causing pain,
Driving and using machines
inflammation and heartburn
• Ulcers in the upper part of the intestine Omeprazole is not likely to affect your
ability to drive or use any tools or
(duodenal ulcer) or stomach (gastric
machines. Side effects such as dizziness
ulcer)
• Ulcers which are infected with bacteria and visual disturbances may occur (see
called ‘Helicobacter pylori’. If you have section 4). If affected, you should not
drive or operate machinery.
this condition, your doctor may also
prescribe antibiotics to treat the
Important information about some of
infection and allow the ulcer to heal
the ingredients of Omeprazole:
• Ulcers caused by medicines called
This medicine contains the sugar
NSAIDs (Non-Steroidal
sucrose. If you have been told by your
Anti-Inflammatory Drugs). Omeprazole
doctor that you have an intolerance to
can also be used to stop ulcers from
some sugars, contact your doctor before
forming if you are taking NSAIDs
taking this medicinal product.
• Too much acid in the stomach caused
by a growth in the pancreas
3 HOW TO TAKE OMEPRAZOLE
(Zollinger-Ellison syndrome).
Always take Omeprazole exactly as your
In children:
doctor has told you. You should check
Children over 1 year of age and ≥ 10 kg
with your doctor or pharmacist if you are
• ‘Gastro-oesophageal reflux disease’
not sure.
(GERD). This is where acid from the
Your doctor will tell you how many
stomach escapes into the gullet (the
capsules to take and how long to take
tube which connects your throat to
them for. This will depend on your
your stomach) causing pain,
condition and how old you are.
inflammation and heartburn.
The usual doses are given below.
In children, the symptoms of the
condition can include the return of
Adults:
stomach contents into the mouth
To treat symptoms of GERD such as
(regurgitation), being sick (vomiting) and
heartburn and acid regurgitation:
poor weight gain.

Children and adolescents over 4 years of age • If your doctor has found that your food
pipe (gullet) has been slightly
• Ulcers which are infected with bacteria
damaged, the usual dose is 20 mg
called ‘Helicobacter pylori’. If your
once a day for 4-8 weeks. Your doctor
child has this condition, your doctor
may tell you to take a dose of 40 mg
may also prescribe antibiotics to treat
for a further 8 weeks if your gullet has
the infection and allow the ulcer to heal.
not yet healed
• The usual dose once the gullet has
WHAT
YOU
NEED
TO
KNOW
2
healed is 10 mg once a day
BEFORE YOU TAKE OMEPRAZOLE
• If your gullet has not been damaged,
the usual dose is 10 mg once a day.
DO NOT take Omeprazole:
• If you are allergic (hypersensitive) to
To treat ulcers in the upper part of the
omeprazole or to any of the other
intestine (duodenal ulcer):
ingredients of Omeprazole
• The usual dose is 20 mg once a day for
• if you are allergic to medicines
2 weeks. Your doctor may tell you to
containing other proton pump
take the same dose for a further 2
inhibitors (e.g. pantoprazole,
weeks if your ulcer has not yet healed
lansoprazole, rabeprazole,

If
the ulcers do not fully heal, the dose
esomeprazole)
can be increased to 40 mg once a day
• If you are taking a medicine containing
for 4 weeks.
nelfinavir (used for HIV infection)
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 special care with Omeprazole
take the same dose for a further 4 weeks
Omeprazole may hide the symptoms of
if your ulcer has not yet healed
other diseases. Therefore, if any of the
• If the ulcers do not fully heal, the dose
following happen to you before you start
can be increased to 40 mg once a day
taking Omeprazole or while you are taking
for 8 weeks.
it, talk to your doctor straight away:
• You lose a lot of weight for no reason
To prevent the duodenal and stomach
and have problems swallowing
ulcers from coming back:
• You get stomach pain or indigestion
• The usual dose is 10 mg or 20 mg once
• You begin to vomit food or blood
a day. Your doctor may increase the
• You pass black stools (blood-stained
dose to 40 mg once a day.
faeces)
To treat duodenal and stomach ulcers
• You experience severe or persistent
caused by NSAIDs (Non-Steroidal
diarrhoea, as omeprazole has been
Anti-Inflammatory Drugs):
associated with a small increase in
• The usual dose is 20 mg once a day for
infectious diarrhoea
4 to 8 weeks.
• You have severe liver problems
• You have reduced body stores or risk
To prevent duodenal and stomach ulcers
factors for reduced vitamin B¹² and
if you are taking NSAIDs:
receive omeprazole long-term
• The usual dose is 20 mg once a day.
treatment. As with all acid reducing
agents, omeprazole may lead to a
To treat ulcers caused by Helicobacter
reduced absorption of vitamin B¹².
pylori infection and to stop them coming
If you take Omeprazole on a long-term
back:
basis (longer than 1 year) your doctor
• The usual dose is 20 mg omeprazole
will probably keep you under regular
twice a day for one week
surveillance. You should report any new • Your doctor will also tell you to take
and exceptional symptoms and
two antibiotics among amoxicillin,
circumstances whenever you see your
clarithromycin and metronidazole.
doctor.
To treat too much acid in the stomach
Other medicines and Omeprazole
caused by a growth in the pancreas
Please tell your doctor or pharmacist if you (Zollinger-Ellison syndrome):
are taking or have recently taken any other • The usual dose is 60 mg daily
medicines, including medicines obtained • Your doctor will adjust the dose
without a prescription. This is because
depending on your needs and will also
Omeprazole can affect the way some
decide how long you need to take the
medicines work and some medicines can
medicine for.
have an effect on Omeprazole.
Children:
Do not take Omeprazole if you are taking To treat symptoms of GERD such as
a medicine containing nelfinavir (used to heartburn and acid regurgitation:
treat HIV infection).
• Children over 1 year of age and with a
If you are not sure, talk to your doctor or
pharmacist before taking Omeprazole.

body weight of more than 10 kg may
nephritis)
take omeprazole. The dose for children • Increased sweating.
is based on the child’s weight and the
Very rare side effects
doctor will decide the correct dose.
• Changes in blood count including
To treat ulcers caused by Helicobacter
agranulocytosis (lack of white blood
pylori infection and to stop them coming
cells)
back:
• Aggression
• Children aged over 4 years may take
• Seeing, feeling or hearing things that
omeprazole. The dose for children is
are not there (hallucinations)
based on the child’s weight and the
• Severe liver problems leading to liver
doctor will decide the correct dose
failure and inflammation of the brain
• Your doctor will also prescribe two
• Sudden onset of a severe rash or
antibiotics called amoxicillin and
blistering or peeling skin. This may be
clarithromycin for your child.
associated with a high fever and joint
pains (Erythema multiforme,
Taking this medicine
Stevens-Johnson syndrome, toxic
• It is recommended that you take your
epidermal necrolysis)
capsules in the morning
• Muscle weakness
• You can take your capsules with food • Enlarged breasts in men
or on an empty stomach
• Hypomagnesaemia.
• Swallow your capsules whole with half
a glass of water. Do not chew or crush Omeprazole may in very rare cases affect
the capsules. This is because the
the white blood cells leading to immune
capsules contain coated granules which deficiency. If you have an infection with
stop the medicine from being broken
symptoms such as fever with a severely
down by the acid in your stomach. It is reduced general condition or fever with
important not to damage the granules. symptoms of a local infection such as
pain in the neck, throat or mouth or
What to do if you or your child have
difficulties in urinating, you must consult
trouble swallowing the capsules
your doctor as soon as possible so that a
• If you or your child have trouble
lack of white blood cells (agranulocytosis)
swallowing the capsules:
can be ruled out by a blood test. It is
• Open the capsules and swallow the important for you to give information
contents directly with half a glass of about your medicine at this time.
water or put the contents into a glass
of any acidic fruit juice (e.g. apple,
Frequency not known
orange or pineapple) or apple sauce If you are on omeprazole for more than
• Then drink the mixture straight away three months it is possible that the levels
or within 30 minutes.
of magnesium in your blood may fall.
Low levels of magnesium can be seen as
If you take more Omeprazole than you
fatigue, involuntary muscle contractions,
should
disorientation, convulsions, dizziness,
If you take more Omeprazole than
increased heart rate. If you get any of
prescribed by your doctor, talk to your
these symptoms, please tell your doctor
doctor or pharmacist straight away.
promptly. Low levels of magnesium can
also lead to a reduction in potassium or
If you forget to take Omeprazole
calcium levels in the blood. Your doctor
If you forget to take a dose, take it as
may decide to perform regular blood
soon as you remember it. However, if it tests to monitor your levels of
is almost time for your next dose, skip
magnesium.
the missed dose. Do not take a double
dose to make up for a forgotten dose.
Taking a proton pump inhibitor like
omeprazole, especially over a period of
more than one year, may slightly increase
4 POSSIBLE SIDE EFFECTS
your risk of fracture in the hip, wrist or
Like all medicines, Omeprazole can cause spine. Tell your doctor if you have
side effects, although not everybody gets osteoporosis or if you are taking
them.
corticosteroids (which can increase the
risk of osteoporosis).
If you notice any of the following rare but
serious side effects, stop taking
Do not be concerned by this list of
Omeprazole and contact a doctor
possible side effects. You may not get any
immediately:
of them. If any of the side effects get
• Sudden wheezing, swelling of your
serious, or if you notice any side effects
lips, tongue and throat or body, rash,
not listed in this leaflet, please tell your
fainting or difficulties in swallowing
doctor or pharmacist.
(severe allergic reaction)
• Reddening of the skin with blisters or
5 HOW TO STORE OMEPRAZOLE
peeling. There may also be severe
blisters and bleeding in the lips, eyes, Keep out of the reach and sight of children.
mouth, nose and genitals. This could
Do not store above 25°C.
be ‘Stevens-Johnson syndrome’ or
Do not use Omeprazole after the expiry
‘toxic epidermal necrolysis’
date that is stated on the carton after ‘EXP’.
• Yellow skin, dark urine and tiredness
The expiry date refers to the last day of
which can be symptoms of liver
that month.
problems.
Blister pack: Store in the original package
to protect from moisture.
Side effects may occur with certain
HDPE bottle: Keep the bottle tightly closed
frequencies, which are defined as follows: to protect from moisture.
Very common: affects more than
1 user in 10
Common:
affects 1 to
10 users in 100
Uncommon:
affects 1 to
10 users in 1,000
Rare:
affects 1 to
10 users in 10,000
Very rare:
affects less than
1 user in 10,000
Not known:
frequency cannot be
estimated from the
available data

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

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Omeprazole Gastro-Resistant
Capsules contain:
• The active ingredient is omeprazole
(10 mg, 20 mg or 40 mg)
• The other ingredients are:
• Capsule content: sugar spheres
(consisting of corn starch and
Other side effects include:
sucrose), sodium laurilsulfate,
Common side effects
anhydrous disodium phosphate,
• Headache
mannitol (E421), hypromellose,
• Effects on your stomach or gut:
macrogol 6000, talc, polysorbate 80,
diarrhoea, stomach pain, constipation,
titanium dioxide (E171), methacrylic
wind (flatulence)
acid-ethyl acrylate copolymer (1:1)
• Feeling sick (nausea) or being sick
• Capsule shells consist of gelatine.
(vomiting).
The 10 and 20 mg capsules also
contain the colouring agents,
Uncommon side effects
quinoline yellow aluminium lake
• Swelling of the feet and ankles
(E104) and titanium dioxide (E171).
• Disturbed sleep (insomnia)
The 40 mg capsules contain indigo
• Dizziness, tingling feelings such as
carmine aluminium lake (E132) and
“pins and needles”, feeling sleepy
titanium dioxide (E171).
• Spinning feeling (vertigo)
• Changes in blood tests that check how
What Omeprazole Gastro-Resistant
the liver is working
• Skin rash, lumpy rash (hives) and itchy Capsules look like and contents of the pack:
Gastro-resistant capsule, hard.
skin
Omeprazole 10 mg: Opaque yellow
• Generally feeling unwell and lacking
capsule containing off-white to
energy.
cream-white spherical microgranules
Omeprazole 20 mg: Opaque yellow
Rare side effects
capsule containing off-white to
• Blood problems such as a reduced
number of white cells or platelets. This cream-white spherical microgranules
can cause weakness, bruising or make Omeprazole 40 mg: Opaque blue and
opaque white capsule containing
infections more likely
off-white to cream white spherical
• Allergic reactions, sometimes very
microgranules.
severe, including swelling of the lips,
The capsules are supplied in blisters of 7,
tongue and throat, fever, wheezing
• Low levels of sodium in the blood. This 14, 15, 28, 30, 50, 56, 60, 90, 100, 140, 280,
and 500 capsules and in HDPE bottles of
may cause weakness, being sick
7, 14, 28, 30, 56, 60, 90, 98 and 100
(vomiting) and cramps
capsules.
• Feeling agitated, confused or
depressed
Not all pack sizes may be marketed.
• Taste changes
• Eyesight problems such as blurred
Marketing Authorisation Holder and
vision
Manufacturer
• Suddenly feeling wheezy or short of
The Marketing Authorisation Holder is
breath (bronchospasm)
TEVA UK Limited.
• Dry mouth
• An inflammation of the inside of the
Company responsible for manufacture is
mouth
LICONSA, Avda. Miralcampo No 7, Pol.
• An infection called “thrush” which can Industrial Miralcampo, 19200 Azuqueca
affect the gut and is caused by a
de Henares (Guadalajara) – Spain.
fungus
This leaflet was last revised: May 2012.
• Liver problems, including jaundice
which can cause yellow skin, dark
PL 00289/1230-2
urine, and tiredness
• Hair loss (alopecia)
• Skin rash on exposure to sunshine
• Joint pains (arthralgia) or muscle pains
(myalgia)
• Severe kidney problems (interstitial
86184-Z

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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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