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OMEPRAZOLE 40MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole 40 mg
Powder for Solution for Infusion

SZ90712LT05A

Omeprazole sodium

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
• 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)).

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 is and what it is
used for
2. Before Omeprazole is given to you
3. How Omeprazole is given to you
4. Possible side effects
5. How to store Omeprazole
6. Further information

1

What Omeprazole is and
what it is 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.

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 powder for solution for
infusion can be used as an alternative to
oral therapy.

2

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.

Before Omeprazole is
given to you

Your doctor will decide whether you can
take Omeprazole if you are
breast-feeding.

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).

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.

3

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 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.

• 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 infusion 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.

This medicine contains less than 1 mmol
sodium (23 mg) per 40 mg dose. This
means it is essentially “sodium-free”.

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.

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.
You must not be given Omeprazole if
you are taking a medicine containing
nelfinavir (used to treat HIV infection).

The following information is intended
for medical or healthcare
professionals only:

Preparation
1. With a syringe draw 5 ml of infusion
solution from the 100 ml infusion
bottle or bag
2. Add this volume to the vial with the
freeze-dried omeprazole, mix
thoroughly making sure all
omeprazole is dissolved
3. Draw the omeprazole solution back
into the syringe
4. Transfer the solution into the infusion
bag or bottle
5. Repeat steps 1-4 to make sure all
omeprazole is transferred from the
vial into the infusion bag or bottle.

The entire contents of each vial is to be
dissolved in approximately 5 ml and
then immediately diluted to 100 ml.
Sodium chloride 9 mg/ml (0.9%)
solution for infusion or glucose 50 mg/ml
(5%) solution for infusion must be used.
The stability of omeprazole is influenced
by the pH of the solution for infusion,
which is why no other solvent or
quantities should be used for dilution.

SZ90712LT05A

draft: 5200571
laetus code: supplier to add
mat.no.: supplier to add

How Omeprazole is given
to you

Artwork Proof Box
Ref: V022: Safety update SPC & PIL + Removal of V011 + corrections
Proof no.
007.2

Date prepared:
26/04/2016

Colours:
Black
Black 20%
Dimensions: 140 x 540 mm

Font size:
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Fonts:
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Not known (frequency cannot be
estimated from the available data)
• Rash, possibly with pain in the joints.

Side effects may occur with certain
frequencies, which are defined as follows:
Very common:

affects more than 1
user in 10

Uncommon:

affects 1 to 10 users
in 1,000

Common:
Rare:

Very rare:

Not known:

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.

affects 1 to 10 users
in 100
affects 1 to 10 users
in 10,000

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.

affects less than 1
user in 10,000

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).

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 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.

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
• Fracture in the hip, wrist or spine.1

5

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).

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 Infusion after the expiry
date which is stated on the label after
EXP. The expiry date refers to the last
day of that month.

After preparation of the solution by your
doctor or nurse, it must be stored below
25°C and used within 12 hours of
reconstitution in the physiological saline
solution or within 6 hours of reconstitution,
if a glucose solution has been used.
From a microbiological point of view, the
product should be used immediately
unless it has been reconstituted under
controlled and validated aseptic
conditions.
The reconstituted solution should not be
used if particles are present. The
content 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.

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
• Low levels of magnesium in the blood.2

6

Further information

What Omeprazole 40 mg Powder for
Solution for Infusion contains
Each vial of powder for solution for
infusion contains the active ingredient
omeprazole sodium, equivalent to
40 mg omeprazole.
Each vial also contains sodium
hydroxide and disodium edetate.
Each vial is for one infusion.

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).

What Omeprazole 40 mg Powder for
Solution for Infusion looks like and
contents of the pack
The powder for solution for infusion is a
white to almost white powder.

1

Omeprazole powder for solution for
infusion is available in pack sizes of 1,
5, 10 or 20 vials.

2
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 7doctor 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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Sandoz Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR,
UK.
Manufacturer:
Lek Pharmaceuticals d.d., Verovškova
57, 1526 Ljubljana, Slovenia.
This leaflet was revised
in 04/2016.

Alternative preparation for infusions in
flexible containers
1. Use a double-ended transfer needle
and attach to the injection
membrane of the infusion bag.
Connect the other needle-end from
the vial with freeze-dried
omeprazole
2. Dissolve the omeprazole substance
by pumping the infusion solution
back and forward between the
infusion bag and the vial
3. Make sure all omeprazole is
dissolved.

draft: 5200571
laetus code: supplier to add
mat.no.: supplier to add

How to store Omeprazole

The solution for infusion is to be
administered in an intravenous infusion
for 20-30 minutes.

SZ90712LT05A

Artwork Proof Box
Ref: V022: Safety update SPC & PIL + Removal of V011 + corrections
Proof no.
007.2

SZ90712LT05A

Date prepared:
26/04/2016

Colours:
Black
Black 20%
Dimensions: 140 x 540 mm

Font size:
9pt
Fonts:
Helvetica

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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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