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OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Omeprazole 20mg gastro-resistant capsules
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 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 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.
 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 ≥ 10 kg


‘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.

2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE OMEPRAZOLE
Do not take Omeprazole
 If you are allergic 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 a medicine containing nelfinavir
(used for HIV infection).











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 infection)
Tacrolimus (in cases of organ transplantation)
Erlotinib (used to treat cancer)
Methotrexate (used to treat rheumatoid arthritis
and some cancers)
St John’s wort (Hypericum perforatum) (used to
treat mild depression)
Cilostazol (used to treat cramp-like pain in your
legs when you walk and is caused by
insufficient blood supply in your legs)
Saquinavir (used to treat HIV infection)
Clopidogrel (used to prevent blood clots )

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.
Omeprazole with food and drink
You can take your capsules 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 for advice before taking this medicine. Your
doctor will decide whether you can take Omeprazole
during this time.
Your doctor will decide whether you can take
Omeprazole if you are breastfeeding.
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 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

Always take Omeprazole exactly as your doctor has
told you. 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 recommended doses are given below.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Omeprazole.
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 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.

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).
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.
Omeprazole may interfere with some test
(chromogranin A). To avoid this interference the
omeprazole should be temporarily stopped five days
before testing.
Other medicines and Omeprazole
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This is because Omeprazole can affect the way
some medicines work and some medicines can have
an effect on 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, 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)

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 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 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.





Use in 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. 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. 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 mix the contents
with a small amount of yoghurt, 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.




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.

Omeprazole 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.

Not known (frequency cannot be estimated from the
available data)
 Inflamation in the gut (leading to diarrhoea).
 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, 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.
Do not be concerned by this list of possible side
effects. You may not get any of them
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 Yellow Card Scheme:
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



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.

Keep this medicine out of the sight and reach of
children.



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.

Do not use this medicine after the expiry date
which is stated on the pack after “EXP:”. The
expiry date refers to the last day of that month.
HDPE bottle: Use within 3 months of opening.



Store below 25C.



Store this blister in the original package or keep
the bottle tightly closed in order to protect from
moisture. Replace cap firmly after use.



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 to
protect the environment.

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 Omeprazole 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.
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.
 Fracture of the hip, wrist or 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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Omeprazole 20mg gastro-resistant capsules
contains:
The active substance is omeprazole.
Omeprazole 20mg capsules contain 20 mg of
omeprazole.
The other ingredients are:
 Capsule content: sugar spheres (consisting of
corn starch and sucrose), sodium laurilsulfate,
Disodium phosphate, anhydrous, mannitol,
hypromellose 6 cP, macrogol 6000, talc,
polysorbate 80, titanium dioxide (E 171), and
methacrylic acid-ethylacrylate copolymer (1:1) .
 Capsule shell: gelatine, the colouring agents
quinoline yellow (E 104) and titanium dioxide (E
171).
What Omeprazole 20mg gastro-resistant capsules
looks like and contents of the pack
Opaque yellow capsule containing off-white to
cream-white spherical microgranules
Pack sizes:
Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100,
140 or 280 capsules; hospital pack of 500 capsules.
HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90,
100, 105 or 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
CHEMO IBÉRICA, S.A.
Gran Vía Carlos III, 98, 7th,
08028 Barcelona
SPAIN
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial
Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN
This leaflet was last revised in 07/2015

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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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