Skip to Content

UK Edition. Click here for US version.

OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES

Active substance(s): OMEPRAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
Omeprazole 10 mg and 20 mg
Gastro-resistant capsules
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K
 eep this leaflet. You may need to read
it again.
• I f you have any further questions, ask
your doctor or pharmacist.
• T his 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.
• I f 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 capsules are
and what they are used for
2 What you need to know before
you take Omeprazole capsules
3 How to take Omeprazole capsules
4 Possible side effects
5 How to store Omeprazole capsules
6 Contents of the pack and other
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),
prevention of reoccurrence of ulcers.
• 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 What you need to know before

you take Omeprazole capsules

Do not take Omeprazole capsules and tell
your doctor if you:
• are allergic to omeprazole or any of the
other ingredients of this medicine (listed in
section 6).
• 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.

Warnings and precautions

Talk to your doctor or pharmacist before
taking 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.
• 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.
Tell your doctor before taking this medicine,
if you are due to have a specific blood test
(Chromogranin A).
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.

Other medicines and Omeprazole
capsules

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:
•K
 etoconazole, itraconazole or voriconazole
(used to treat infections caused by a fungus)
• Digoxin (used to treat heart problems)
•D
 iazepam (used to treat anxiety, relax
muscles or in epilepsy)
•P
 henytoin (used in epilepsy). If you are
taking phenytoin, your doctor will need to
monitor you when you start or stop taking
Omeprazole
•M
 edicines 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)
•M
 ethotrexate (used to treat arthritis, Crohn’s
or psoriasis)
• S t John’s wort (Hypericum perforatum) (used
to treat mild depression)
•C
 ilostazol (used to treat intermittent
claudication)
• Saquinavir (used to treat HIV infection)
•C
 lopidogrel (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.

Omeprazole with food and drink

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

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. 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 capsules contain sucrose
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.

3 How to take Omeprazole capsules
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 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:
• I f your doctor has found that your food pipe
(gullet) has been slightly damaged, the
recommended dose is 20mg once a day for
4-8 weeks. Your doctor may tell you to take
a dose of 40mg for a further 8 weeks if your
gullet has not yet healed.
• The recommended dose once the gullet has
healed is 10mg once a day.
• I f your gullet has not been damaged, the
recommended dose is 10mg once a day.
To treat ulcers in the upper part of the
intestine (duodenal ulcer):
• The recommended dose is 20mg 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.
• I f the ulcer does not fully heal, the dose
can be increased to 40mg once a day for 4
weeks.
To treat ulcers in the stomach (gastric ulcer):
• The recommended dose is 20mg 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.
• I f the ulcer does not fully heal, the dose
can be increased to 40mg once a day for 8
weeks.
To prevent the duodenal and stomach
ulcers from coming back:
• The recommended dose is 10mg or 20mg
once a day. Your doctor may increase the
dose to 40mg once a day.

Continued top of next column
BBBA0080

Continued over page

Omeprazole 10mg & 20mg Capsules PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0080

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
06.10.16
25.10.16
S.Anson

Date sent:
06.10.16
Date received: 07.10.16

Dimensions:
140 x 540
Min Body Text Size: 8pts
Supplier:
Liconsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

To treat duodenal and stomach ulcers
caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):
• The recommended dose is 20mg once a day
for 4–8 weeks.
To prevent duodenal and stomach ulcers if
you are taking NSAIDs:
• The recommended dose is 20mg once a day.
To treat ulcers caused by Helicobacter
pylori infection and to stop them coming
back:
• The recommended dose is 20mg
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 recommended dose is 60mg 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 10kg 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.
Paitents with kidney or liver problems
• Dose adjustment is not required in patients
with kidney problems
• Patients with liver problems may require an
smaller dose of 10-20mg a day.
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 Omeprazole
capsules 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.
Symptoms of an overdose may include
feeling or being sick, dizziness, stomach
pain, diarrhoea, headache, depression and
confusion.

If you forget to take Omeprazole
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 Omeprazole
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.
If you have any further questions on the
use of this medicine, ask your 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
Omeprazole and contact a doctor
immediately:

Rare side effects (may affect up to 1 in
1,000 people)
• Sudden wheezing, swelling of your lips,
tongue and throat or body, rash, fainting
or difficulties in swallowing (severe allergic
reaction).
Very rare side effects (may affect up to 1 in
10,000 people)
• 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,
including jaundice.
• Changes in blood count including
agranulocytosis (lack of white blood cells),
symptoms include sudden sore throat,
fever, mouth ulcers, unexplained bruising or
bleeding, tiredness.
• 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.

Side effects may occur with certain
frequencies, which are defined as follows:
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
Common side effects (may affect up to 1 in
10 people)
• Headache.
• E ffects on your stomach or gut: diarrhoea,
stomach pain, constipation, wind
(flatulence).
• F eeling 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).
•D
 izziness, tingling feelings such as “pins and
needles”, feeling sleepy.
• Spinning feeling (vertigo).
•C
 hanges in blood tests that check how the
liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
Rare side effects (may affect up to 1 in
1,000 people)
•B
 lood problems such as a reduced number
of white cells or platelets. This can cause
weakness, bruising or make infections more
likely.
• L ow 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.
• S uddenly feeling wheezy or short of breath
(bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• J oint pains (arthralgia) or muscle pains
(myalgia).
• S evere kidney problems (interstitial
nephritis).
• Increased sweating.
Very rare side effects (may affect up to 1 in
10,000 people)
• Aggression.
• S eeing, feeling or hearing things that are
not there (hallucinations).
• S evere liver problems leading to liver failure
and inflammation of the brain.
• Muscle weakness.
• Enlarged breasts in men.
• Hypomagnesaemia
Do not be concerned by this list of possible
side effects. You may not get any of them.
Not known (frequency cannot be
estimated from the available data)
• I f 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.
• I nflamed colon causing watery diarrhoea
(microscopic colitis).
• Rash, possible with pain in the joints.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. 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

capsules

Store below 25°C. Store in the original
package to protect from moisture. Keep
this medicine out of the sight and reach 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.
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 capsules contain

• T he active substance (the ingredient that
makes the capsule work) is Omeprazole.
Each capsule contains either 10mg or 20mg
of omeprazole.
• T he 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 7, 10, 14, 15, 20, 21, 28, 30, 50,
56, 60, 84, 90, 98, 100 capsules (blister packs);
30, 90 (tablet containers).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Liconsa S.A., Avda. Miralcampo, No. 7,
Poligono Industrial Miralcampo, 19200
Azuqueca de Henares (Guadalajara)
Date of revision: October 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
BBBA0080

Omeprazole 10mg & 20mg Capsules PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0080

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
06.10.16
25.10.16
S.Anson

Date sent:
06.10.16
Date received: 07.10.16

Dimensions:
140 x 540
Min Body Text Size: 8pts
Supplier:
Liconsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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.

Hide