OMEPRAZOLE 10MG GASTRO-RESISTANT TABLETS

Active substance: OMEPRAZOLE MAGNESIUM

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CP.OMP.JNT.T.DX.V2P5

PATIENT INFORMATION LEAFLET

OMEPRAZOLE 10mg/20mg/40mg GASTRO RESISTANT TABLETS
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. 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 gets 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 tablets are and what are they used for
2. Before you take Omeprazole tablets.
3. How to take Omeprazole tablets.
4. Possible side effects.
5. How to store Omeprazole tablets.
6. Further information

1.

WHAT OMEPRAZOLE TABLETS
ARE AND WHAT ARE THEY 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 is 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 (ZollingerEllison syndrome).

2. 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)
If you are not sure, talk to your doctor or
pharmacist before taking Omeprazole
tablets.
Take special care with Omeprazole
tablets
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.
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.
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 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 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 and breast-feeding
Before taking Omeprazole tablets, tell your
doctor if you are pregnant or trying to get
pregnant. Your doctor will decide whether
you can take Omeprazole tablets during this
time. Your doctor will decide whether you
can take Omeprazole tablets if you are
breast-feeding.
Driving and using machines
Omeprazole tablets 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.
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.

3. TABLETS

HOW TO TAKE OMEPRAZOLE

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 usual 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 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
Anti-Inflammatory 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
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
(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:
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
‘Stevens-Johnson 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: 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
Other side effects include:
Common side effects
• Headache.
• Effects on your stomach or gut:
diarrhoea, stomach pain, constipation,
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.
• Skin rash, lumpy rash (hives) and itchy
skin.
• Generally feeling unwell and lacking
energy.
• Fractures of the hip, wrist or spine.
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 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
• 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, StevensJohnson syndrome, toxic epidermal
necrolysis).
• Muscle weakness.
• Enlarged breasts in men.
Not Known
• Inflammation in the gut (leading to
diarrhoea)
• Hypomagnesaemia (low level of
magnesium in the blood).
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
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to
2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

5. HOW TO STORE OMEPRAZOLE
TABLETS
• 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.

6. FURTHER INFORMATION
What Omeprazole tablets contains
The active substance is omeprazole.
Omeprazole tablets contain 10 mg, 20 mg
and 40mg 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 (E-171), red iron oxide
(E-172), hypromellose and yellow iron oxide
(E-172)], 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 May 2013.
CP.OMP.JNT.T.DX.V2P5

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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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