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OMEPRAZOLE 10 MG GASTRO-RESISTANT HARD CAPSULES

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Omeprazole 10 mg, 20 mg and 40 mg
gastro-resistant capsules, hard
Package leaflet: Information for the patient

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.

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

2

Omeprazole Capsules

3

How to take Omeprazole Capsules

Do not take Omeprazole Capsules
• 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).

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.

Do not take Omeprazole capsules if any of the above
applies to you. If you are not sure, talk to your doctor
or pharmacist before taking Omeprazole capsules.

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.

The recommended doses are given below

Warnings and precautions
Talk to your doctor or pharmacist before taking
Omeprazole Capsules.
• if you are due to have a specific blood test
(Chromogranin A).
• 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
To treat ulcers in the upper part of the intestine
exposed to the sun tell your doctor as soon as you
(duodenal ulcer):
can, as you may need to stop your treatment with
Omeprazole Capsules. Remember to also mention any • The recommended dose is 20 mg once a day for 2
weeks. Your doctor may tell you to take the same
other ill-effects like pain in your joints.
dose for a further 2 weeks if your ulcer has not yet
Omeprazole Capsules may hide the symptoms of other
healed.
diseases. Therefore, if any of the following happen to • If the ulcers do not fully heal, the dose can be
you before you start taking Omeprazole Capsules or
increased to 40 mg once a day for 4 weeks.
while you are taking it, talk to your doctor straight away:
To treat ulcers in the stomach (gastric ulcer):
• You lose a lot of weight for no reason and have
• The recommended dose is 20 mg once a day for 4
problems swallowing.
weeks. Your doctor may tell you to take the same
• You get stomach pain or indigestion.
dose for a further 4 weeks if your ulcer has not yet
• You begin to vomit food or blood.
healed.
• You pass black stools (blood-stained faeces).

If
the ulcers do not fully heal, the dose can be
• You experience severe or persistent diarrhoea, as
increased to 40 mg once a day for 8 weeks.
omeprazole has been associated with a small
increase in infectious diarrhoea.
To prevent the duodenal and stomach ulcers from
• You have severe liver problems.
coming back:
• You have reduced body stores or risk factors for
• The recommended dose is 10 mg or 20 mg once a
reduced vitamin B12 and receive omeprazole
day. Your doctor may increase the dose to 40 mg
long-term treatment. As with all acid reducing
once a day.
agents, omeprazole may lead to a reduced
To treat duodenal and stomach ulcers caused by
absorption of vitamin B12.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
If you take Omeprazole Capsules on a long-term basis • The recommended dose is 20 mg once a day for 4 (longer than 1 year) your doctor will probably keep
8 weeks.
you under regular surveillance. You should report any
To prevent duodenal and stomach ulcers if you are
new and exceptional symptoms and circumstances
taking NSAIDs:
whenever you see your doctor.
• The recommended dose is 20 mg once a day.
Taking a proton pump inhibitor like omeprazole
To treat ulcers caused by Helicobacter pylori
especially over a period of more than one year, may
slightly increase your risk of fracture in the hip, wrist infection and to stop them coming back:
or spine. Tell your doctor if you have osteoporosis or if • The recommended dose is 20 mg twice a day for
one week.
you are taking corticosteroids (which can increase
• Your doctor will also tell you to take two antibiotics
the risk of osteoporosis).
among amoxicillin, clarithromycin and
metronidazole.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.

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)
Use in children
• Rash, possibly with pain in the joints
To treat symptoms of GORD such as heartburn and
• If you are on Omeprazole capsules for more than
acid regurgitation:
three months it is possible that the levels of
• Children over 1 year of age and with a body weight
magnesium in your blood may fall. Low levels of
of more than 10 kg may take Omeprazole Capsules.
magnesium can be seen as fatigue, involuntary
The dose for children is based on the child’s weight
muscle contractions, disorientation, convulsions,
and the doctor will decide the correct dose.
dizziness or increased heart rate. If you get any of
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
correct dose.
Omeprazole Capsules may in very rare cases affect
• Your doctor will also prescribe two antibiotics
the white blood cells leading to immune deficiency. If
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
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 has 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.

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 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

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 outer and inner pack after EXP. The
expiry date refers to the last day of that month.
Blister:
Do not store above 30oC. Store in the original package
in order to protect from moisture

Container:
Do not store above 30oC. Keep the bottle tightly closed
If you take more Omeprazole Capsules than you 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
20 mg capsules in 250 ml container only
pharmacist straight away.
The in-use storage time after first opening is 6 months
If you forget to take Omeprazole Capsules
Do not use this medicine if you notice visible signs of
If you forget to take a dose, take it as soon as you
deterioration.
remember it. However, if it is almost time for your next
dose, skip the missed dose. Do not take a double dose Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
to make up for a forgotten dose.
away medicines you no longer use. These measures
If you have any further questions on the use of this
will help protect the environment.
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 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).
• Benign polyps in the stomach.
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.
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

6

Contents of the pack and other information

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 looks 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 02/2017
PL00289/1469
PL00289/1470
PL00289/1471

54001-K

Expand Transcript

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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