Skip to Content

OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES

Active substance: OMEPRAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

OMEPRAZOLE
10, 20 & 40 mg
GASTRO-RESISTANT
CAPSULES
(omeprazole)

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your doctor or
I
pharmacist.
•  his medicine has been prescribed for you. Do not
T
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• f you get any side effects, talk to your doctor or
I
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.  hat Omeprazole is and what it is used for.
W
2.  hat you need to know before you take Omeprazole.
W
3.  ow to take Omeprazole.
H
4.  ossible side effects.
P
5.  ow to store Omeprazole.
H
6.  ontents of the pack and other information.
C
1. WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR
Omeprazole 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.
•  lcers in the upper part of the intestines (duodenal
U
ulcer) or stomach (gastric ulcer).
•  o stop ulcers in the upper part of the intestines
T
(duodenal ulcer) or stomach (gastric ulcer) from
coming back.
•  lcers which are also infected with a bacteria called
U
‘Helicobacter pylori’. If you have this condition, your
doctor may also prescribe antibiotics to treat the
infection and allow the ulcer to heal.
•  lcers caused by medicines called NSAIDs
U
(non-steroidal anti inflammatory drugs). Omeprazole
can also be used to stop ulcers from forming if you
are taking NSAIDs.
•  oo much acid in the stomach caused by a growth in
T
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:
•  lcers which are infected with bacteria called
U
‘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:
•  re allergic to omeprazole or any of the other
a
ingredients of this medicine (listed in Section 6).
•  re allergic to medicines containing other proton
a
pump inhibitors (e.g. pantoprazole, lansoprazole,
rabeprazole, esomeprazole).
•  re taking a medicine containing nelfinavir (used for
a
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 or nurse 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 or pharmacist before taking
Omeprazole:
•  ou lose a lot of weight for no reason and have
Y
problems swallowing.
•  ou get stomach pain or indigestion.
Y
•  ou begin to vomit food or blood.
Y
•  ou pass black stools (blood-stained faeces).
Y
•  ou experience severe or persistent diarrhoea, as
Y
omeprazole has been associated with a small increase
in infectious diarrhoea.
•  ou have severe liver problems.
Y
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.
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).
Other medicines and Omeprazole
Tell your doctor or pharmacist if you are taking or 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.

Tell your doctor or pharmacist if you are taking, have
recently taken, or might take any of the following
medicines:
•  etoconazole, itraconazole, posaconazole or
K
voriconazole (used to treat infections caused by
a fungus).
•  igoxin (used to treat heart problems).
D
•  iazepam (used to treat anxiety, relax muscles or
D
in epilepsy).
•  henytoin (used in epilepsy). If you are taking
P
phenytoin, your doctor will need to monitor you
when you start or stop taking Omeprazole.
•  edicines that are used to thin your blood, such
M
as warfarin or other vitamin K blockers. Your doctor
may need to monitor you when you start or stop
taking Omeprazole.
•  ifampacin (used to treat tuberculosis).
R
•  tazanavir (used to treat HIV infections).
A
•  acrolimus (in cases of organ transplantation).
T
•  t John’s Wort (Hypericum perforatum) (used to treat
S
mild depression).
•  ilostazol (used to treat intermittent claudication).
C
•  aquinavir (to treat HIV infections).
S
•  lopidogrel (used to prevent blood clots (thrombi)).
C
•  rlotinib (used to treat different types of cancer).
E
•  ethotrexate (a chemotherapy medicine used in high
M
doses to treat cancer) – 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.
Tell your doctor or the medical staff if you undergo a
test for tumours.
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 if you are breast-feeding.
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.
Important information about some of the ingredients
of Omeprazole
Omeprazole 20mg contains Tartrazine (E102) and
Allura red (E129).
Omeprazole 40mg contains Sunset Yellow (E110) and
Allura red (E129). May cause allergic reactions.
This medicine 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 or
pharmacist has told you. You should 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.
Adults:
To treat symptoms of GERD such as heartburn and
acid regurgitation:
• f your doctor has found that your food pipe (gullet)
I
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.
•  he recommended dose once your gullet has healed
T
is 10 mg once a day.
• f your gullet has not been damaged, the
I
recommended dose is 10 mg once a day.
To treat ulcers in the upper part of the intestine
(duodenal ulcer):
•  he recommended dose is 20 mg once a day for
T
2 weeks. Your doctor may tell you to take the same
dose for a further 2 weeks if your ulcer has not
yet healed.
• f the ulcer does not fully heal, the dose can be
I
increased to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
•  he recommended dose is 20 mg once a day for
T
4 weeks. Your doctor may tell you to take the same
dose for a further 4 weeks if your ulcer has not yet
healed.
• f the ulcers do not fully heal, the dose can be
I
increased to 40 mg once a day for 8 weeks.
To prevent duodenal and stomach ulcers from
coming back:
•  he recommended dose is 10 mg or 20 mg once a
T
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):
•  he recommended dose is 20 mg once a day for 4 to
T
8 weeks.
To prevent duodenal and stomach ulcers if you are
taking NSAIDs
•  he recommended dose is 20 mg once a day.
T
To treat ulcers caused by Helicobacter pylori infection
and to stop them coming back:
•  he recommended dose is 20 mg Omeprazole twice
T
a day for one week.
•  our doctor will also tell you to take two antibiotics
Y
among amoxicillin, clarithromycin and metronidazole.

Do not take Omeprazole if you are taking a medicine
containing nelfinavir (used to treat HIV infection).

Date: 23 Oct 2014
Description Omeprazole 10/20/40mg 28
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 506535

SAP No. N/A

Superceded Affiliate Item Code 10005330

Vendor Job No. 237869

TrackWise PR No. 506535

Proof No. 2

MA No. N/A

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 16:09
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 9 pt

To treat too much acid in the stomach caused by a
growth in the pancreas (Zollinger-Ellison Syndrome):
•  he recommended dose is 60 mg daily.
T
•  our doctor will adjust the dose depending on your
Y
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:
•  hildren over 1 year of age and with a body weight
C
of more than 10kg may take Omeprazole. The
recommended 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:
•  hildren aged over 4 years may take Omeprazole. The
C
recommended dose for children is based on the child’s
weight and the doctor will decide the correct dose.
•  our doctor will also prescribe two antibiotics called
Y
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:
•  pen the capsules and swallow the contents directly
O
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.
•  lways stir the mixture just before drinking it (the
A
mixture will not be clear). Then drink the mixture
straight away or within 30 minutes.
•  o make sure that you have drunk all of the medicine,
T
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 than you should
If you take more Omeprazole than prescribed by your
doctor, talk to your doctor or pharmacist straight away.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole 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 your
doctor immediately:
•  udden wheezing, swelling of the lips, tongue
S
and throat or body, rash, fainting or difficulties in
swallowing (severe allergic reaction).
•  eddening of the skin with blisters or peeling.
R
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’.
•  evere liver problems leading to liver failure and
S
inflammation of the brain. Symptoms include jaundice
which can cause yellow skin, dark urine and tiredness.
•  meprazole may in very rare cases affect the
O
white blood cells leading to immune deficiency
(agranulocytosis). If you have an infection with
symptoms of 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 a 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.
•  evere kidney problems (interstitial nephritis).
S
Other side-effects include:
Common side effects (may affect up to 1 in
10 people):
• Headache.
•  ffects on your stomach or gut: diarrhoea, stomach
E
pain, constipation, wind (flatulence).
•  eeling sick (nausea) or being sick (vomiting).
F
Uncommon side effects (may affect up to 1 in
100 people):
•  welling of the feet and ankles.
S
•  isturbed sleep (insomnia).
D
•  izziness, tingling feelings such as ‘pins and needles’,
D
feeling sleepy.
•  pinning feeling (vertigo).
S
•  hanges in blood tests that check how the liver is
C
working.
•  kin rash, lumpy rash (hives) and itchy skin.
S
•  enerally feeling unwell and lacking energy.
G
•  racture of the hip, wrist or spine.
F
Rare side effects (may affect up to 1 in 1000 people):
•  lood problems such as a reduced number of white
B
cells or platelets. This can cause weakness, bruising or
make infections more likely.
•  ow levels of sodium in the blood. This may cause
L
weakness, being sick (vomiting) and cramps.
•  eeling agitated, confused or depressed.
F
• Taste changes.
•  yesight problems such as blurred vision.
E
•  uddenly feeling wheezy or short of breath
S
(bronchospasm).
• Dry mouth.
•  n inflammation of the inside of the mouth.
A
•  n infection called “thrush” which can affect the
A
gut and is caused by a fungus.
•  iver problems, including jaundice which can cause
L
yellow skin, dark urine, and tiredness.
•  air loss (alopecia).
H
•  kin rash on exposure to sunshine.
S
•  oint pain (arthralgia) or muscle pains (myalgia).
J
• Increased sweating.

Very rare side effects (may affect up to 1 in
10,000 people):
• Aggression.
•  eeing, feeling or hearing things that are not there
S
(hallucinations).
•  udden onset of severe rash or blistering or peeling
S
skin. This may be associated with a high fever and
joint pains (Erythema mulitforme).
• Muscle weakness.
•  nlarged breasts in men.
E
Not known side effects (frequency cannot be
estimated from the available data):
• nflammation of the gut (leading to diarrhoea).
I
• f you are on omeprazole for more than three months
I
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 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
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 carton or label after 'EXP'. The expiry date
refers to the last day of that month.
Blister pack: Do not store above 25°C. Store in the
original package to protect from moisture.
HDPE bottle: Do not store above 25°C. Keep the bottle
tightly closed in order to protect from moisture.
Do not throw away 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Omeprazole contains
The active substance is omeprazole. Each gastro-resistant
capsule contains 10 mg, 20 mg or 40 mg of omeprazole.
Components of the Capsule are: Sugar Spheres (sucrose,
maize starch), Hypromellose, Sodium hydroxide,
Methacrylic acid-ethyl acrylate copolymer (1:1)
dispersion 30% (methacrylic acid-ethyl acrylate (1:1),
sodium lauryl sulphate, polysorbate 80), Talc,
Titanium dioxide (E171), Macrogol 6000, Polysorbate 80.
Components of the Capsule shell (see section 2,
Important information about some of the ingredients
of Omeprazole):
10 mg - Shell cap - Iron oxide red (E 172), Titanium
dioxide (E171), Gelatin, Sodium lauryl sulphate.
Shell Body - Titanium dioxide (E171), Gelatin, Sodium
lauryl sulphate.
20 mg - Shell cap - Titanium dioxide (E171),
Tartrazine (E102), Brilliant blue (E133), Allura red (E129),
Gelatin, Sodium lauryl sulphate.
Shell Body - Titanium dioxide (E171), Gelatin, Sodium
lauryl sulphate.
40 mg - Shell cap - Titanium dioxide (E171), Sunset
yellow (E110), Brilliant blue (E133), Allura red (E129),
Gelatin, Sodium lauryl sulphate.
Shell Body - Titanium dioxide (E171), Sunset
yellow (E110), Brilliant blue (E133), Allura red (E129),
Gelatin, Sodium lauryl sulphate.
Capsule Printing Ink - Shellac, Ammonia solution
concentrated, Iron Oxide black (E172), Potassium
Hydroxide.
What Omeprazole looks like and contents of the pack
The 10 mg capsules have a light pink cap and white
body, filled with white to off-white pellets, and are
marked ‘MYLAN’ over ‘OM10’ on both cap and body.
The 20 mg capsules have a dark pink cap and white
body, filled with white to off-white pellets, and are
marked ‘MYLAN’ over ‘OM20’ on both cap and body.
The 40 mg capsules have a dark pink cap and body,
filled with white to off-white pellets, and are marked
‘MYLAN’ over ‘OM40’ on both cap and body.
The capsules are available in plastic bottles or blister
packs which contain:
7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 112, 200, 500 in
bottles.
7, 14, 15, 21, 28, 30, 50, 56, 60, 84, 98, 100, 112, 200,
500 in blisters.
2 x 50.
250 (dose dispensing in hospitals – bottle only).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturers:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
or
Generics [UK] Limited, Potters Bar, Herts., EN6 1TL,
United Kingdom.
or
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1,
Hungary

This leaflet was last revised in
September 2014

Date: 23 Oct 2014
Description Omeprazole 10/20/40mg 28
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 506535

SAP No. N/A

Superceded Affiliate Item Code 10005330

Vendor Job No. 237869

TrackWise PR No. 506535

Proof No. 2

MA No. N/A

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

506535

Time: 16:09
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 9 pt

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