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OMEPRAZOLE 20MG GASTRO-RESISTANT TABLETS

Active substance(s): OMEPRAZOLE

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Omeprazole
(Referred to as Omeprazole tablets throughout this 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.
• 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 tablets are and what they are used for
2. What you need to know before you take Omeprazole tablets
3. How to take Omeprazole tablets
4. Possible side effects
5. How to store Omeprazole tablets
6. Contents of the pack and other information

1.

WHAT OMEPRAZOLE TABLETS
ARE AND WHAT THEY ARE USED FOR

Omeprazole tablets 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 tablets
are used to treat the following conditions:
In adults:
• ‘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 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 tablets can also be used to
stop ulcers from forming if you are taking
NSAIDs.
• Too much acid in the stomach caused by
a growth in the pancreas (Zollinger-Ellison
syndrome).

2.

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
OMEPRAZOLE TABLETS

Do not take Omeprazole tablets
• If you are allergic (hypersensitive) to
omeprazole or any of the other ingredients
of Omeprazole tablets.
• 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)
Do not take Omeprazole tablets if any of
the above applies to you. If you are not sure,
talk to your doctor or pharmacist before taking
Omeprazole tablets.
Warnings and precautions
Omeprazole tablets may hide the symptoms of
other diseases. Therefore, if any of the
following happen to you before you start
taking Omeprazole tablets 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 ever had a skin reaction after
treatment with a medicine similar to
Omeprazole tablets 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 Omeprazole
tablets. Remember to also mention any
other ill-effects like pain in your joints.
Omeprazole may reduce magnesium level in
blood, especially if you are taking it for more
than 3 months; Talk to your doctor if you are
taking Digoxin or water tablets, as they may
increase the risk of low magnesium level.
Taking a proton pump inhibitor like
Omeprazole tablets, 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 tablets 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.
Other medicines and Omeprazole tablets
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 tablets can affect the way some
medicines work and some medicines can
have an effect on Omeprazole tablets.
Do not take Omeprazole tablets 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 tablets
• 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 tablets
• Rifampicin (used to treat tuberculosis)
• Atazanavir (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)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots
(thrombi))
• Erlotinib (used to treat cancer)
• 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
Omeprazole tablets treatment
If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well as
Omeprazole tablets 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 tablets with food and
drink
You can take your tablets 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 or pharmacist for
advice before taking this medicine.
Omeprazole is excreted in breast milk but is
not likely to influence the child when
therapeutic doses are used.
Your doctor will decide whether you can take
Omeprazole tablets if you are breast-feeding.
Driving and using machines
Omeprazole tablets are 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.
Important information about some of the
ingredients of Omeprazole tablets
Omeprazole tablets contain lactose. If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

TO TAKE OMEPRAZOLE
TABLETS
3. HOW
Always take Omeprazole tablets 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 tablets 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 GORD such as
heartburn and acid regurgitation:
• If your doctor has found that your food pipe
(gullet) has been slightly damaged, the
recommended 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 recommended dose once the gullet
has healed is 10 mg once a day.
• If your gullet has not been damaged, the
recommended dose is 10 mg once a day.
To treat ulcers in the upper part of the
intestine (duodenal ulcer):
• The recommended 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 recommended 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 treat duodenal and stomach ulcers
caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):
• The recommended dose is 20 mg once a
day for 4–8 weeks.
To prevent duodenal and stomach ulcers if
you are taking NSAIDs:
• The recommended dose is 20 mg once a
day.
To treat ulcers caused by Helicobacter
pylori infection and to stop them coming back:
• The recommended dose is 20 mg
Omeprazole tablets 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 recommended 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:
This formulation is not suitable for
children.
Taking this medicine
• It is recommended that you take your
tablets in the morning.
• You can take your tablets with food or on
an empty stomach.
• Swallow your tablets whole with half a
glass of water. Do not chew or crush the
tablets. This is because the tablets are
coated with enteric coating which stops
the medicine from being broken down by
the acid in your stomach. It is important
not to damage the tablets
If you take more Omeprazole tablets than
you should
If you take more Omeprazole tablets than
prescribed by your doctor, talk to your doctor
or pharmacist straight away.
If you forget to take Omeprazole tablets
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, Omeprazole tablets can
cause side effects, although not everybody
gets them.
If you notice any of the following rare but
serious side effects, stop taking
Omeprazole tablets 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 ‘StevensJohnson 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).
• Dizziness, tingling feelings such as “pins
and needles”, feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the
liver is working.
• Skin rash, lumpy rash (hives) and itchy
skin.
• Generally feeling unwell and lacking
energy.
• Fractures of the hip, wrist and 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
Very rare side effects (may affect up to 1 in
10,000 people)
• 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.
Not Known (Frequency cannot be estimated
from the available data)
• Inflammation in the gut (leading to
diarrhoea)
• Hypomagnesaemia (low level of
magnesium in the blood).
• Rash, possibly with pain in the joints.
If you are on Omeprazole tablets 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.
Omeprazole tablets 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 get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
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.

TO STORE OMEPRAZOLE
TABLETS
5. HOW
• Keep out of the reach and sight of children.
• Do not use Omeprazole tablets after the
expiry date which is stated on the pack after
EXP. The expiry date refers to the last day
of that month.
• Do not store above 30°C.
• Store this blister in the original package
or keep the bottle tightly closed in order
to protect from moisture.
• 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.

OF THE PACK AND
6. CONTENTS
OTHER INFORMATION
What Omeprazole tablets contains
The active substance is omeprazole.
Omeprazole tablets contain 10 mg, 20 mg and
40 mg of omeprazole.
The other ingredients are lactose
monohydrate, sodium starch glycolate, sodium
stearyl fumarate, sodium stearate,
hypromellose acetate succinate, brownish
pink colour [contains propylene glycol,
titanium dioxide (E171), red iron oxide (E172),
hypromellose and yellow iron oxide (E172)],
talc, triethyl citrate, monoethanolamine,
sodium laurilsulfate and traces of carnauba
wax.
What Omeprazole tablets looks like and
contents of the pack
1. Omeprazole 10 mg gastro-resistant tablets
are brownish-pink film coated capsule
shaped tablets.
Blisters of 28 tablets
2. Omeprazole 20 mg gastro-resistant tablets
are brownish-pink film coated capsule
shaped tablets.
Blisters of 28 tablets
3. Omeprazole 40 mg gastro-resistant tablets
are brownish-pink film coated capsule
shaped tablets.
Blisters of 7, 28 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Dexcel® - Pharma Ltd., 7 Sopwith Way,
Drayton Fields, Daventry, Northamptonshire,
NN11 8PB, UK.
Distributed by:
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
This leaflet was last revised in October 2015.
CP.OMP.JNT.T.DX.V3P1

Pantone Blue
280 C

OMEPRAZOLE 10/20/40mg GASTRO-RESISTANT TABLETS

To prevent the duodenal and stomach
ulcers from coming back:
• The recommended dose is 10 mg or 20
mg once a day. Your doctor may increase
the dose to 40 mg once a day.

Dimensions: 155mm x 480mm

PATIENT INFORMATION LEAFLET

Colours

CP.OMP.JNT.T.DX.V3P1

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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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