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OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE

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Omeprazole 10mg and 20mg
Gastro-resistant Capsules
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.

Index
1  What Omeprazole capsules are
and what they are used for
2 B
 efore you take
3 H
 ow to take
4 P
 ossible side effects
5 H
 ow to store
6 F
 urther information
1  What Omeprazole capsules are

and what they are 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-oesophageal 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 10kg
• ‘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  Before you take

Do not take Omeprazole capsules and tell
your doctor if you:
• are allergic (hypersensitive) to omeprazole
or any of the other ingredients of
Omeprazole.
• are allergic to medicines containing other
proton pump inhibitors (e.g. pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
• are taking a medicine containing nelfinavir
(used for HIV infection)
If you are not sure, talk to your doctor or
pharmacist before taking Omeprazole.

Take special care with Omeprazole
capsules

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.
• If you are going into hospital for any tests.
Talk to your doctor as you may need to stop
taking this medicine for a short while.
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). Your doctor will
probably keep you under regular surveillance.
You should report any new and exceptional
symptoms and circumstances whenever you
see your doctor.
Talk to your doctor before taking Omeprazole
Capsules if you have ever had a skin reaction
after treatment with a medicine similar to
Omeprazole Capsules 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 Capsules.
Remember to also mention any other illeffects like pain in your joints.

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 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 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 (used to treat HIV infection)
• Tacrolimus (in cases of organ
transplantation)
• Methotrexate (used to treat arthritis, Crohn’s
or psoriasis)
• 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 caused
by Helicobacter pylori infection, it is very
important that you tell your doctor about any
other medicines you are taking.

Taking Omeprazole with food and
drink

You can take your capsules with food or on an
empty stomach.

Pregnancy and breast-feeding

Before taking Omeprazole, tell your doctor if
you are pregnant or trying to get pregnant.
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.

Sugar intolerance

Omeprazole capsules contain 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.

Tests

Your doctor will try to find out what is
causing your symptoms before prescribing
Omeprazole capsules. You may be given an
endoscopic examination (looking down the
stomach through a small camera inserted
down the gullet) in order to exclude the
possibility of stomach cancer, or to confirm
reflux oesophagitis. You may also have tests to
check if you have Helicobacter pylori infection,
and if these are positive you will be given
treatment to clear if it possible.

Special considerations

Omeprazole may reduce the absorption of
vitamin B12 (cobalamin), which should be
taken into account in patients with cobalamin
shortage.

3H
 ow to take

Always take Omeprazole capsules exactly as
your doctor has told you. If you are not sure,
check with your doctor or pharmacist.
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.
Doses:
• Adult
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.

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AAAI3342

Continued over page

Omeprazole 10mg & 20mg Gastro-resistant capsules PIL - UK

colours/plates:
1. Black

item no: AAAI3342

dimensions: 140x540

print proof no: 2

pharmacode:

origination date: 01.10.15

min pt size: 7pt

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 11.12.15

Technical Approval

revised by: DR

date sent: 05.10.15

supplier: Liconsa

technically app. date: 06.10.15

Non Printing Colours
1.
2.
3.

To treat duodenal and stomach ulcers
caused by NSAIDs (Non-Steroidal AntiInflammatory 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 (ZollingerEllison 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:
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 put the contents into a glass of still
(non-fizzy) water, 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.

If you take more than you should

If you (or someone else) swallow a lot of
capsules at the same time, or you think a child
may have swallowed any, contact your nearest
hospital casualty department or tell your
doctor immediately. Take this leaflet and any
remaining capsules that you have to show the
doctor.

If you forget to take the capsules

Do not take a double dose to make up for a
forgotten dose. If you forget to take a dose
take it as soon as you remember it and then
take the next dose at the right time.
If you stop taking the capsules
Do not stop treatment early otherwise your
symptoms may reappear. Talk to your doctor
before you stop taking the capsules and
follow his advice.

4 Possible side effects

Like all medicines, Omeprazole capsules 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.
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
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:

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.
• 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, Stevens-Johnson syndrome,
toxic epidermal necrolysis).
• Muscle weakness.
• Enlarged breasts in men.
• Hypomagnesaemia
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.
Do not be concerned by this list of possible
side effects. You may not get any of them.

Frequency not known:

• 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.
• Inflamed colon causing watery diarrhoea
(microscopic colitis).
• Rash, possibly with pain in the joints
If you notice any side effects, they get worse,
or if you notice any not listed, please tell your
doctor or pharmacist.

5  How to store

Store below 25°C. Store in the original
package to protect from moisture. Keep out
of the reach and sight of children.
Do not use Omeprazole capsules after the
expiry date stated on the carton. The expiry
date refers to the last day of that month.
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.

6F
 urther information
What Omeprazole capsules contain

• The active substance (the ingredient that
makes the capsule work) is Omeprazole.
Each capsule contains either 10mg or 20mg
of the active.
• The other ingredients are sugar spheres
(consisting of corn starch and sucrose),
sodium lauryl sulfate, disodium phosphate,
mannitol, hypromellose, polyethylene
glycol 6000, talc, polysorbate 80, titanium
dioxide, Eudragit L30-D55 (poly(methacrylic
acid, ethyl acrylate)). Capsules consist of
gelatin and contain the colours quinoline
yellow (E104) and titanium dioxide (E171).

What Omeprazole capsules look like
and contents of the pack
10mg capsules are hard gelatine capsules
of size 3, Opaque yellow cap and body,
containing white to off-white spherical
pellets.
20mg capsules are hard gelatin capsules
of size 2, Opaque yellow cap and body,
containing white to off-white spherical
pellets.
Pack sizes are 28 capsules.

Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK

Manufacturer

Liconsa S.A., Avda. Miralcampo,
No. 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares (Guadalarja)
Date of revision: November 2015

If you would like a
leaflet with larger
text, please contact
01271 311257.

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.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAI3342

Omeprazole 10mg & 20mg Gastro-resistant capsules PIL - UK

colours/plates:
1. Black

item no: AAAI3342

dimensions: 140x540

print proof no: 2

pharmacode:

origination date: 01.10.15

min pt size: 7pt

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 11.12.15

Technical Approval

revised by: DR

date sent: 05.10.15

supplier: Liconsa

technically app. date: 06.10.15

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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