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OMEPRAZOLE 40 MG GASTRO-RESISTANT TABLETS

Active substance(s): OMEPRAZOLE MAGNESIUM

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Package leaflet: Information for the patient

Omeprazole 10 mg
Gastro-resistant Tablets
Omeprazole 20 mg
Gastro-resistant Tablets
Omeprazole 40 mg
Gastro-resistant Tablets
(omeprazole)
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 gastro-resistant tablets contain 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-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. Omeprazole is also used in the long
term management of this condition.
• Ulcers in the upper part of the intestine
(duodenal ulcer) or stomach (gastric ulcer).
Omeprazole can be used to treat this condition or
prevent its reoccurrence.
• 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.
• Too much acid in the stomach caused by a growth in
the pancreas (Zollinger-Ellison syndrome).
In children:
Children over 1 year of age and weighing 10 kg or more
• ‘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.
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.

2. What you need to know before you take
Omeprazole
Do not take 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, posaconazole, 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
• 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 and saquinavir (used to treat
HIV infections)
• Tacrolimus (in cases of organ transplantation)
• Clarithromycin (an antibiotic) unless you are being
treated with this medicine for H.Pylori
• St John’s wort (Hypericum perforatum) (used to treat
mild depression)
• Cilostazol (used to treat intermittent claudication)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy medicine used
in high doses to treat cancer and inflammatory
conditions) – if you are taking a high dose of
methotrexate, your doctor may temporarily stop
your Omeprazole treatment.
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.

Pregnancy and breast-feeding

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.
Pregnancy
Omeprazole can be used during pregnancy.
Breast-feeding
Your doctor will decide whether you can take
omeprazole during this time.

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 gastro-resistant tablets contain

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

3. How to take Omeprazole
Always take this medicine exactly as your doctor or
pharmacist has told you. 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 dose is

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 but can be increased to 20 mg to
40 mg once a day.
• If your gullet has not been damaged, the
recommended dose is 10 mg once a day.

• if you are allergic (hypersensitive) 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 any medicine containing nelfinavir
(for HIV infection).

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.

Warnings and precautions

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.

Talk to your doctor or pharmacist before taking
Omeprazole if:
• You have reduced body stores or risk factors for
reduced vitamin B12 and are to receive omeprazole
long term. Omeprazole may reduce the absorption
of vitamin B12.
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 (be sick) food regularly or if you
notice your vomit contains blood (this may look like
coffee granules).
• You pass black stools (blood-stained faeces).
• 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).

During treatment

Talk to your doctor or pharmacist if you experience
severe or persistent diarrhoea, as omeprazole has
been associated with a small increase in infectious
diarrhoea.
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.

Certain diagnostic tests

Omeprazole may alter the results of some tests related
to cancer. Tell your doctor, nurse or hospital staff that
you are taking this medicine. Your doctor may advice
you to stop taking this medicine for at least five days if
you are undergoing certain tests.

Other medicines and Omeprazole

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
This is because omeprazole can affect the way some
medicines work and some medicines can have an
effect on omeprazole.

To prevent the duodenal 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.
To prevent the stomach ulcers from coming back:
• The recommended dose is 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 recommended dose is 20 mg once a day for 4 to
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 twice
a day for one week or 40 mg Omeprazole once a day
for one week.
• Your doctor will also tell you to take two
antibiotics among amoxicillin, clarithromycin and
metronidazole or tinidazole.
To treat too much acid in the stomach caused by a
growth in the pancreas (Zollinger-Ellison 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. If your doctor recommends
that you need to take more than 80 mg per day, you
should split the dose and take twice a day.
If you have severe liver problems, your doctor may
recommend a lower dose from listed above.

Use in children
To treat symptoms of GORD such as heartburn and
acid regurgitation:
• Children over 1 year of age and with a body weight
of 10 kg or more 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 to
treat ulcers specifically caused by Helicobacter pylori.
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

• I t 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 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 has trouble
swallowing the tablets

• I f you or your child have trouble swallowing
the tablets:
* Break the tablet and disperse it in a spoonful of
water (non-fizzy), any acidic fruit juice (e.g. apple,
orange or pineapple) or apple sauce.
* Always stir the mixture just before drinking (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. Do not use milk or fizzy
water. The solid pieces contain the medicine - do
not chew or crush them.
The tablet can be divided into equal doses.

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. You may suffer from symptoms such as feeling
or being sick (nausea or vomiting), feeling dizzy,
stomach pain, diarrhoea, headache, lack of interest,
feeling depressed and confusion.

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.

If you stop taking Omeprazole

Do not stop treatment early because your symptoms
have got better. Your condition may not have been
fully healed and may reoccur if you do not finish your
course of treatment.
If you have any further questions on the use of this
medicine, ask you doctor or pharmacist.

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 this medicine and
contact a doctor or go to the nearest hospital
casualty department immediately:

• S udden wheezing, swelling of your lips, tongue
and throat or body, rash, fainting or difficulties in
swallowing and breathing (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’.
• Severe liver problems leading to liver inflammation
or failure and inflammation of the brain. Symptoms
can include jaundice which can cause yellow skin,
dark urine, and tiredness.
• A reduction in your red or white blood cells or
platelets which may lead to more frequent infections
(such as sore throat and mouth ulcers), fever,
weakness, easy bruising or bleeding, pain in the
neck, throat or mouth.
• Severe kidney problems (interstitial nephritis).
You may pass little or no urine, have cloudy urine
or blood in the urine or have severe pain in the
lower back.
• Inflammation of the bowel with signs such as
abdominal pain, bloating, inability to control bowel
movement and nausea (feeling sick),
An infection called “thrush” which can affect the gut
and is caused by a fungus.

Other possible side effects:
Common: 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).

 ot known: frequency cannot be estimated from
N
the available data
• Low levels of magnesium in the blood
(hypomagnesaemia).

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 or 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.

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.

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 label or carton after EXP. The expiry date
refers to the last day of that month.
Do not store above 25˚C. Store in the original package
in order to protect from moisture.
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 protect the environment.

6. Contents of the pack and other
information
What Omeprazole contains

The active substance is omeprazole. Each
gastro-resistant tablet contains omeprazole
magnesium corresponding to 10 mg, 20 mg or 40 mg
omeprazole.
The other ingredients are sugar spheres;
crospovidone; hydroxypropylcellulose;
polysorbate 80; mannitol; povidone; talc; macrogol;
methacrylic acid – ethyl acrylate copolymer (1:1);
triethyl citrate; glycerol monostearate; titanium
dioxide (E171); sodium hydroxide; silicified
microcrystalline cellulose; silica, colloidal anhydrous;
hydrogenated vegetable oil; magnesium stearate;
sodium stearyl fumarate; hypromellose; iron oxide
yellow (E172).

What Omeprazole looks like and contents of the
pack

The 10 mg gastro-resistant tablet is yellow,
film-coated, oblong, biconvex tablet (approximately
6.8 mm x 13.2 mm) marked with ‘M’ on one side of the
tablet and ‘OM1’ on the other side.
The 20 mg gastro-resistant tablet is yellow,
film-coated, oblong, biconvex tablet (approximately
9.5 mm x 16.5 mm) marked with ‘M’ on one side of the
tablet and ‘OM2’ on the other side.
The 40 mg gastro-resistant tablet is yellow,
film-coated, oblong, biconvex tablet (approximately
11.0 mm x 20.7 mm) marked with ‘M’ on one side of
the tablet and ‘OM’ on the left side of the score and ‘4’
on the right of the score on the other side.
Omeprazole gastro-resistant tablets are available in
plastic bottles which contain 7, 14, 30, 100, 250 and
500 tablets, and blister packs which contain 7 (only for
40mg strength), 14 (only for 40mg strength), 15, 28, 30,
50 (single-unit dose) tablets.
Bottle packs of 250 and 500 tablets contain a
desiccant. Do not eat the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United
Kingdom

Manufacturers

Mylan Hungary Kft
Mylan utca 1, Komarom
H-2900 Hungary
Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13
Ireland
This leaflet was last revised in July 2015

Uncommon: 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.
• Fracture in the hip, wrist or spine
Rare: may affect up to 1 in 1,000 people
• 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, sore
mouth or ulcers.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Increased sweating.
Very rare: may affect up to 1 in 10,000 people
• Aggression.
• Seeing, feeling or hearing things that are not there
(hallucinations).
• Sudden onset of a severe rash or blistering or peeling
skin. This may be associated with a high fever and
joint pains (Erythema multiforme)
• Muscle weakness.
• Enlarged breasts in men.

605550

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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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