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OMEPRAZOLE 20 MG GASTRO-RESISTANT HARD CAPSULES

Active substance(s): OMEPRAZOLE

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TEVA UK Ref:

231-30-54001-I LEA OMEPRAZOLE A/S CAPS TUK
Version:

1

PAGE 1: FRONT FACE (INSIDE OF REEL)

Package leaflet: Information for the patient

Omeprazole 10 mg, 20 mg and 40 mg
gastro-resistant hard capsules

Omeprazole may interfere with some test
(chromogranin A). To avoid this interference the
omeprazole should be temporarily stopped five days
before testing.

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.

Other medicines and Omeprazole Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines that you buy without a
prescription. This is because Omeprazole Capsules
can affect the way some medicines work and some
medicines can have an effect on Omeprazole
Capsules.

Warnings and precautions
Talk to your doctor or pharmacist 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 ill-effects like pain in your joints.

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.
• If your gullet has not been damaged, the usual dose
is 10 mg once a day.

Do not take Omeprazole Capsules if you are taking a
medicine containing nelfinavir (used to treat HIV
infection).
Tell your doctor or pharmacist if you are taking any of
What is in this leaflet:
the following medicines:
1. What Omeprazole Capsules are and what they are • Ketoconazole, itraconazole, posaconazole or
voriconazole (used to treat infections caused by a
used for
fungus)
2. What you need to know before you take
• Digoxin (used to treat heart problems)
Omeprazole Capsules
• Diazepam (used to treat anxiety, relax muscles or in
3. How to take Omeprazole Capsules
epilepsy)
4. Possible side effects
• Phenytoin (used in epilepsy). If you are taking
5. How to store Omeprazole Capsules
phenytoin, your doctor will need to monitor you
6. Contents of the pack and other information
when you start or stop taking Omeprazole Capsules
Omeprazole Capsules are and what • Medicines that are used to thin your blood, such as
1 What
they are used for
warfarin or other vitamin K blockers. Your doctor
may need to monitor you when you start or stop
Omeprazole Capsules contains the active substance
taking Omeprazole Capsules
omeprazole. It belongs to a group of medicines called
• Rifampicin (used to treat tuberculosis)
‘proton pump inhibitors’. They work by reducing the
• Atazanavir (used to treat HIV infection)
amount of acid that your stomach produces.
• Tacrolimus (in cases of organ transplantation)
Omeprazole Capsules are used to treat the following • St John’s wort (Hypericum perforatum) (used to
conditions:
treat mild depression)
• Cilostazol (used to treat intermittent claudication)
In adults:
• ‘Gastro-oesophageal reflux disease’ (GORD). This is • Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi)
where acid from the stomach escapes into the
gullet (the tube which connects your throat to your • Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in
stomach) causing pain, inflammation and
high doses to treat cancer) – if you are taking a
heartburn.
high dose of methotrexate, your doctor may
• Ulcers in the upper part of the intestine (duodenal
temporarily stop your Omeprazole Capsules
ulcer) or stomach (gastric ulcer).
treatment.
• Ulcers which are infected with bacteria called
‘Helicobacter pylori’. If you have this condition, your If your doctor has prescribed the antibiotics
doctor may also prescribe antibiotics to treat the
amoxicillin and clarithromycin as well as Omeprazole
infection and allow the ulcer to heal.
Capsules to treat ulcers caused by Helicobacter pylori
• Ulcers caused by medicines called NSAIDs
infection, it is very important that you tell your doctor
(Non-Steroidal Anti-Inflammatory Drugs).
about any other medicines you are taking.
Omeprazole Capsules can also be used to stop
Omeprazole Capsules with food and drink
ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth You can take your capsules with food or on an empty
stomach.
in the pancreas (Zollinger-Ellison syndrome).
Pregnancy and breast-feeding
In children:
If you are pregnant or breast-feeding, think you may
Children over 1 year of age and ≥10 kg
• ‘Gastro-oesophageal reflux disease’ (GORD). This is be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
where acid from the stomach escapes into the
gullet (the tube which connects your throat to your medicine.
stomach) causing pain, inflammation and
Omeprazole is excreted in breast milk but is not likely
heartburn. In children, the symptoms of the
to influence the child when therapeutic doses are
condition can include the return of stomach
used. Your doctor will decide whether you can take
contents into the mouth (regurgitation), being sick
Omeprazole Capsules if you are breast-feeding.
(vomiting) and poor weight gain.
Driving and using machines
Children and adolescents over 4 years of age
Omeprazole Capsules are not likely to affect your
• Ulcers which are infected with bacteria called
ability to drive or use any tools or machines. Side
‘Helicobacter pylori ’. If your child has this
effects such as dizziness and visual disturbances may
condition, your doctor may also prescribe
occur (see section 4). If affected, you should not drive
antibiotics to treat the infection and allow the ulcer or operate machinery.
to heal.
Omeprazole Capsules contain sucrose
What
you
need
to
know
before
you
take
Omeprazole Capsules contain sucrose. If you have
2
been told by your doctor that you have an intolerance
Omeprazole Capsules
to some sugars, contact your doctor before taking this
Do not take Omeprazole Capsules
medicinal product.
• if you are allergic to omeprazole or any of the other
ingredients of this medicine (listed in section 6).
3 How to take Omeprazole Capsules
• if you are allergic to medicines containing other
Always take this medicine exactly as your doctor or
proton pump inhibitors (e.g. pantoprazole,
pharmacist has told you. Check with your doctor or
lansoprazole, rabeprazole, esomeprazole).
pharmacist if you are not sure. Your doctor will tell
• if you are taking a medicine containing nelfinavir
you how many capsules to take and how long to take
(used for HIV infection).
them for. This will depend on your condition and how
Do not take Omeprazole capsules if any of the above old you are.
applies to you. If you are not sure, talk to your doctor
The recommended doses are given below
or pharmacist before taking Omeprazole capsules.

Omeprazole Capsules may hide the symptoms of other
diseases. Therefore, if any of the following happen to
you before you start taking Omeprazole Capsules or
while you are taking them, 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.
• You have reduced body stores or risk factors for
reduced vitamin B12 and receive omeprazole
long-term treatment. As with all acid reducing
agents, omeprazole may lead to a reduced
absorption of vitamin B12.

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 ulcers do 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 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 ulcers do 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 recommended dose is 10 mg or 20 mg once a
If you take Omeprazole Capsules on a long-term basis
day. Your doctor may increase the dose to 40 mg
(longer than 1 year) your doctor will probably keep
once a day.
you under regular surveillance. You should report any
To treat duodenal and stomach ulcers caused by
new and exceptional symptoms and circumstances
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
whenever you see your doctor.
• The recommended dose is 20 mg once a day for
Taking a proton pump inhibitor like omeprazole
4 - 8 weeks.
especially over a period of more than one year, may
To prevent duodenal and stomach ulcers if you are
slightly increase your risk of fracture in the hip, wrist
taking NSAIDs:
or spine. Tell your doctor if you have osteoporosis or if
• The recommended dose is 20 mg once a day.
you are taking corticosteroids (which can increase
the risk of osteoporosis).

14 March 2016

TEVA UK Ref:

231-30-54001-I LEA OMEPRAZOLE A/S CAPS TUK
1

Version:

PAGE 2: REAR FACE (OUTSIDE OF REEL)

To treat ulcers caused by Helicobacter pylori
infection and to stop them coming back:
• The recommended dose is 20 mg 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 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.

Very rare: may affect up to 1 in 10,000 people
• 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
• Muscle weakness
• Enlarged breasts in men.

Not known: frequency cannot be estimated from the
available data
• Inflammation in the gut (leading to diarrhoea)
• Rash, possibly with pain in the joints
Use in children
• If you are on Omeprazole capsules for more than
To treat symptoms of GORD such as heartburn and
three months it is possible that the levels of
acid regurgitation:
magnesium in your blood may fall. Low levels of
• Children over 1 year of age and with a body weight
magnesium can be seen as fatigue, involuntary
of more than 10 kg may take Omeprazole Capsules.
muscle contractions, disorientation, convulsions,
The dose for children is based on the child’s weight
dizziness or increased heart rate. If you get any of
and the doctor will decide the correct dose.
these symptoms, please tell your doctor promptly.
To treat ulcers caused by Helicobacter pylori
Low levels of magnesium can also lead to a
infection and to stop them coming back:
reduction in potassium or calcium levels in the
• Children aged over 4 years may take Omeprazole
blood. Your doctor may decide to perform regular
Capsules. The dose for children is based on the
blood tests to monitor your levels of magnesium.
child’s weight and the doctor will decide the
Omeprazole
Capsules may in very rare cases affect
correct dose.
the
white
blood
cells leading to immune deficiency. If
• Your doctor will also prescribe two antibiotics
called amoxicillin and clarithromycin for your child. you have an infection with symptoms such as fever
with a severely reduced general condition or fever
Taking this medicine
with symptoms of a local infection such as pain in the
• It is recommended that you take your capsules in
neck, throat or mouth or difficulties in urinating, you
the morning.
must consult your doctor as soon as possible so that a
• You can take your capsules with food or on an
lack of white blood cells (agranulocytosis) can be
empty stomach.
ruled out by a blood test. It is important for you to give
• Swallow your capsules whole with half a glass of
information about your medicine at this time.
water. Do not chew or crush the capsules. This is
because the capsules contain coated pellets which Reporting of side effects
If you get any side effects, talk to your doctor or
stop the medicine from being broken down by the
acid in your stomach. It is important not to damage pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
the pellets.
effects directly via the Yellow Card Scheme at:
What to do if you or your child have trouble
www.mhra.gov.uk/yellowcard
swallowing the capsules
By reporting side effects you can help provide more
• If you or your child have trouble swallowing the
information on the safety of this medicine.
capsules:
• Open the capsules and swallow the contents
5 How to store Omeprazole Capsules
directly with half a glass of water or put the
contents into a glass of still (non-fizzy) water, any Keep this medicine out of the sight and reach of
acidic fruit juice (e.g. apple, orange or pineapple) children.
or apple sauce.
Do not use this medicine after the expiry date which is
• Always stir the mixture just before drinking it (the stated on the outer and inner pack after EXP. The
mixture will not be clear). Then drink the mixture expiry date refers to the last day of that month.
straight away or within 30 minutes.
Blister:
• To make sure that you have drunk all of the
Do not store above 30oC. Store this blister in the
medicine, rinse the glass very well with half a
original
package in order to protect from moisture
glass of water and drink it. The solid pieces
contain the medicine - do not chew or crush
them.
Container:
If you take more Omeprazole Capsules than you
Do not store above 30oC. Keep the bottle tightly closed
should
in order to protect from moisture.
If you take more Omeprazole Capsules than
The in-use storage time after first opening is 90 days.
prescribed by your doctor, talk to your doctor or
pharmacist straight away.
20 mg capsules in 250 ml container only
The in-use storage time after first opening is 6 months
If you forget to take Omeprazole Capsules
If you forget to take a dose, take it as soon as you
Do not use this medicine if you notice visible signs of
remember it. However, if it is almost time for your next deterioration.
dose, skip the missed dose. Do not take a double dose
Do not throw away any medicines via wastewater or
to make up for a forgotten dose.
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
4 Possible side effects
will help protect the environment.
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
6 Contents of the pack and other information
If you notice any of the following rare but serious
side effects, Stop taking Omeprazole capsules 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 may be
associated with a high fever and joint pains and
could be ‘Erythema multiforme’, ‘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: 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: 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 (see section 2).
Rare: 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
• 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.
• Hair loss (alopecia)
• Skin rash on exposure to sunshine
• Joint pains (arthralgia) or muscle pains (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating.

What Omeprazole Capsules contains
• The active substance is omeprazole. Each
capsule contains gastro-resistant granules of
10 mg, 20 mg or 40 mg omeprazole.
• The other ingredients are:
Capsule core - Sugar spheres (sucrose and corn
starch), Sodium starch glycolate, Sodium laurilsulfate,
Povidone K-30, Trisodium phosphate dodecahydrate,
Hypromellose, Methacrylic acid-ethyl acrylate
copolymer, Triethyl citrate, Titanium dioxide (E171),
Talc, Sodium hydroxide
Capsule coating - Red iron oxide (E172) (10 mg only),
Erytrosine (E127), Indigo carmine (E132) (20 & 40 mg
only), Titanium dioxide (E171), water, gelatin, Quinoline
yellow (E104)
Printing ink - Shellac, Propylene glycol, Sodium
hydroxide, Polyvinylpyrollidone, Titanium dioxide
(E171)
What Omeprazole Capsules look like and contents of
the pack
10 mg Capsules: have an orange body marked with
‘10’ and red cap marked with ‘O’
20 mg Capsules: have an orange body marked with
‘20’ and blue cap marked with ‘O’
40 mg Capsules: have an orange body marked with
‘40’ and blue cap marked with ‘O’
Pack sizes:
Blisters:
Packs of 5, 7, 14, 15, 20, 21, 25, 28, 30, 35, 42, 50, 50x1
hospital pack, 56, 60, 98, or 100 capsules
Not all pack sizes may be marketed.
Containers:
Packs of 5, 7, 14, 15, 20, 21, 28, 30, 42, 50, 56 (2x28), 60
(2x30), 84 (2x42), 90, 90 (3x30), 98 (7x14), 100 (2x50), 250
(5x50) or 500 (10x50) capsules.
For 20 mg
250 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG
Manufacturer
Teva Pharma S.L.U.
C/C, n. 4, Poligono Industrial Malpica, 50016
Spain
This leaflet was last revised in 03/2016
PL00289/1469
PL00289/1470
PL00289/1471

54001-I

14 March 2016

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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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