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OMEPRAZOLE 40MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): OMEPRAZOLE SODIUM / OMEPRAZOLE SODIUM / OMEPRAZOLE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Omeprazole 40mg Powder for Solution for Injection
and Solvent for Omeprazole 40mg Powder for Solution for Injection
Omeprazole sodium

• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ
transplantation)
• 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)).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy
medicine used in high doses to treat
cancer) – if you are taking a high dose
of methotrexate, your doctor may
temporarily stop your Omeprazole
Injection treatment.

Read all of this leaflet carefully
before you start using this
medicine.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor, nurse or pharmacist.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, nurse or
pharmacist. See section 4.

In this leaflet:
1. What Omeprazole Injection is and
what it is used for
2. Before Omeprazole Injection is used
3. How Omeprazole Injection is used
4. Possible side effects
5. How to store Omeprazole Injection
6. Further information

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.

1. What Omeprazole Injection is
and what it is used for

Pregnancy and breast-feeding
Before you are given Omeprazole, tell
your doctor if you are pregnant or trying
to get pregnant. Your doctor will decide
whether you can be given Omeprazole
during this time.

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 excreted in breast milk
but is not likely to influence the child
when therapeutic doses are used. Your
doctor will decide whether you can take
Omeprazole if you are breast-feeding.

Omeprazole powder and solvent for
solution for injection can be used as an
alternative to oral therapy.

2. Before Omeprazole Injection
is used

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.

You must not be given Omeprazole
• if you are allergic (hypersensitive) to
omeprazole or any of the other
ingredients of Omeprazole
• if you are allergic to other proton pump
inhibitor medicines (e.g. pantoprazole,
lansoprazole, rabeprazole,
esomeprazole)
• if you are taking a medicine containing
nelfinavir (used for HIV infection).

3. How Omeprazole Injection is
used

If you are not sure, talk to your doctor,
nurse or pharmacist before you are given
this medicine.

Take special care with Omeprazole
Omeprazole may hide the symptoms of
other diseases. Therefore, if any of the
following happen to you before you are
given Omeprazole or after you are given
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.
• You are due to have a specific blood
test (Chromogranin A).
• You have ever had a skin reaction after
treatment with a medicine similar to
Omeprazole 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. Remember to also mention
any other ill-effects like pain in your
joints.
Taking a proton pump inhibitor like
Omeprazole Injection, 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).

• Omeprazole can be given to adults
including the elderly
• There is limited experience with
Omeprazole for intravenous use in
children.

Being given Omeprazole
• Omeprazole will be given to you by a
doctor who will decide how much you
need
• The medicine will be given to you as
an injection into one of your veins.
If you are given more Omeprazole
than you should
If you think you have been given too
much Omeprazole, talk to your doctor
straight away.

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 using
Omeprazole and contact a doctor
immediately:
• Sudden wheezing, swelling of your
lips, tongue and throat or body, rash,
fainting or difficulties to swallow
(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:

Using other medicines
Please tell your doctor, nurse 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.

Very
Common:

affects more than 1 user
in 10

Common:

You must not be given 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

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

Other side effects include:
Common side effects
• 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.

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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

After preparation of the solution by your
doctor or nurse, it must be stored below
25°C and used within four hours.
The reconstituted solution should not be
used if particles are present.
The contents of the vial is meant for
single use; any product that has
remained in the vial has to be discarded.
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.

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
• An infection called “thrush” which can
affect the gut and is caused by a
fungus
• 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.
• Inflammation in the gut (leading to
diarrhoea).

6. Further information
What Omeprazole contains
Each vial of powder for solution for
injection contains the active ingredient
omeprazole sodium, equivalent to
omeprazole 40 mg.
Each vial also contains sodium
hydroxide.

Each vial is for one injection when mixed
with one ampoule containing the solvent
for injection. The
solvent for injection contains macrogol
400, citric acid monohydrate and water
for injections.
What Omeprazole looks like and
contents of the pack
The powder for solution for injection is a
white to almost white powder. The
solvent for solution for injection is clear
solution.
Omeprazole powder and solvent for
solution for injection are available in
packsizes of 1, 5 and 10.
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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

Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia.

This leaflet was last revised in
03/2017.

The following information is intended
for medical or healthcare
professionals only:
Omeprazole powder for injection should
only be dissolved with the solvent for
injection provided. No other solvents for
intravenous injection should be used.

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.
• Rash, possibly with pain in the joints.

Preparation
One vial with powder for solution for
injection should be mixed with one
ampoule containing 10 ml of the solvent
for solution for injection. A clear solution
should be obtained.

Do not use if any particles are present in
the reconstituted solution.
The reconstituted solution is for single
use only.

Any unused product or waste material
should be disposed of in accordance
with local requirements.

Irreversible visual impairment has been
reported in isolated cases of critically ill
patients who have received Omeprazole
intravenous injection, especially at high
doses, but no causal relationship has
been established.

Omeprazole solution for injection must
be given only as an intravenous injection
and it must not be added to infusion
solutions. After reconstitution the
injection should be given slowly over a
period of at least 2.5 minutes at a
maximum rate of 4 ml per minute.

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.

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 (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
Injection

Keep out of the reach and sight of
children.
Do not store above 25°C.
Store in the original package in order to
protect from light.
Do not use Omeprazole 40 mg powder
for solution for injection after the expiry
date which is state on the label after
EXP. The expiry date refers to the last
day of that month.

SZ00000LT000

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draft: 5200572
laetus code: 000
mat.no.: 00000000

Ref: V027: Update SPC & PIL in accordance to PRAC rec
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Date prepared:
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Colours:
Black
Black 20%
Dimensions: 140 x 540 mm

Font size:
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Fonts:
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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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