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OMEPRAZOLE 40MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): OMEPRAZOLE SODIUM

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SZ00000LT000

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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 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 or pharmacist.
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

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

Omeprazole contains the active substance
omeprazole. It belongs to a group of medicines
called ʻproton pump inhibitorsʼ. They work by reducing
the amount of acid that your stomach produces.

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

2. Before Omeprazole Injection is used

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).
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.
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).

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 Johnʼs 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)).
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.
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 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.

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. How Omeprazole Injection is used

• 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.

Very Common:
Common:
Uncommon:
Rare:
Very Rare:
Not Known:

affects more than 1 user in 10

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

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

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.

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, StevensJohnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Enlarged breasts in men
• Low levels of magnesium in the blood.2
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).

1

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.

2

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 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.

Do not be concerned by this list of possible side effects.
You may not get any of them. If any of the side effects
get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

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.

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.

6. Further information

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.

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

Like all medicines, Omeprazole can cause side
effects, although not everybody gets them.

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.

4. Possible side effects

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 ʻStevens-Johnson syndromeʼ or ʻtoxic
epidermal necrolysisʼ
• 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:

Each vial also contains sodium hydroxide.

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.

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

This leaflet was last approved in 04/2012 (to be
amended after approval).

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: V018 - SPC & PIL update according to decision of PhVWP
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Date prepared:
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Prepared by:
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RA Approved?
Yes

Date approved:
01/05/2012

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

1. Name of the medicinal product

Omeprazole 40 mg powder and solvent for solution
for injection.

2. Qualitative and quantitative composition

Each vial of powder for injection contains omeprazole
sodium, equivalent to 40 mg omeprazole.
For a full list of excipients, see section 6.1.

4.1. Therapeutic indications
Omeprazole for intravenous use is indicated as an
alternative to oral therapy for the following indications:

Adults
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics,
Helicobacter pylori (H. pylori) eradication in peptic
ulcer disease
• Treatment of NSAID-associated gastric and
duodenal ulcers
• Prevention of NSAID-associated gastric and
duodenal ulcers in patients at risk
• Treatment of reflux esophagitis
• Long-term management of patients with healed
reflux esophagitis
• Treatment of symptomatic gastro-esophageal
reflux disease
• Treatment of Zollinger-Ellison syndrome.

4.2. Posology and method of administration
Posology
Alternative to oral therapy
In patients where the use of oral medicinal products
is inappropriate, Omeprazole IV 40 mg once daily is
recommended. In patients with Zollinger-Ellison
Syndrome the recommended initial dose of
Omeprazole given intravenously is 60 mg daily. Higher
daily doses may be required and the dose should be
adjusted individually. When doses exceed 60 mg
daily, the dose should be divided and given twice daily.
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. For
instructions on reconstitution of the product before
administration, see section 6.6.

Special populations
Impaired renal function
Dose adjustment is not needed in patients with
impaired renal function.

Impaired hepatic function
In patients with impaired hepatic function a daily
dose of 10-20 mg may be sufficient.
Elderly (> 65 years old)
Dose adjustment is not needed in the elderly.

Paediatric patients
There is limited experience with Omeprazole for
intravenous use in children.
4.3. Contraindications
Hypersensitivity to omeprazole, substituted
benzimidazoles or to any of the excipients.

Omeprazole like other proton pump inhibitors (PPIs)
should not be used concomitantly with nelfinavir (see
section 4.5).

4.4. Special warnings and precautions for use
In the presence of any alarm symptoms (e.g.,
significant unintentional weight loss, recurrent
vomiting, dysphagia, haematemesis or melena) and
when gastric ulcer is suspected or present,
malignancy should be excluded, as treatment may
alleviate symptoms and delay diagnosis.
Co-administration of atazanavir with proton pump
inhibitors is not recommended (see section 4.5). If
the combination of atazanavir with a proton pump
inhibitor is judged unavoidable, close clinical
monitoring (e.g. virus load) is recommended in
combination with an increase in the dose of
atazanavir to 400 mg with 100 mg of ritonavir;
omeprazole 20 mg should not be exceeded.

Omeprazole, as all acid-blocking medicines, may
reduce the absorption of vitamin B12
(cyanocobalamin) due to hypo- or achlorhydria. This
should be considered in patients with reduced body
stores or risk factors for reduced vitamin B12
absorption on long-term therapy.

Omeprazole is a CYP2C19 inhibitor. When starting
or ending treatment with omeprazole, the potential
for interactions with drugs metabolised through
CYP2C19 should be considered. An interaction is
observed between clopidogrel and omeprazole (see
section 4.5). The clinical relevance of this interaction
is uncertain. As a precaution, concomitant use of
omeprazole and clopidogrel should be discouraged.
Treatment with proton pump inhibitors may lead to
slightly increased risk of gastrointestinal infections
such as Salmonella and Campylobacter.

Severe hypomagnesaemia has been reported in
patients treated with proton pump inhibitors like
omeprazole for at least three months, and in most
cases for a year. Serious manifestations of
hypomagnesaemia such as fatigue, tetany, delirium,
convulsions, dizziness and ventricular arrhythmia
can occur but they may begin insidiously and be
overlooked. In most affected patients,
hypomagnesaemia improved after magnesium
replacement and discontinuation of the proton pump
inhibitor.
For patients expected to be on prolonged treatment or
who take proton pump inhibitors with digoxin or drugs
that may cause hypomagnesaemia (e.g., diuretics),
health care professionals should consider measuring
magnesium levels before starting proton pump inhibitor
treatment and periodically during treatment.

Proton pump inhibitors, especially if used in high
doses and over long durations (>1 year), may
modestly increase the risk of hip, wrist and spine
fracture, predominantly in the elderly or in presence
of other recognised risk factors. Observational
studies suggest that proton pump inhibitors may
increase the overall risk of fracture by 10-40%. Some
of this increase may be due to other risk factors.
Patients at risk of osteoporosis should receive care
according to current clinical guidelines and they should
have an adequate intake of vitamin D and calcium.
As in all long-term treatments, especially when
exceeding a treatment period of 1 year, patients
should be kept under regular surveillance.

4.5. Interaction with other medicinal products
and other forms of interaction
Effects of omeprazole on the pharmacokinetics of
other active substances
Active substances with pH dependent absorption

The decreased intragastric acidity during treatment
with omeprazole might increase or decrease the
absorption of active substances with a gastric pH
dependent absorption.
Nelfinavir, atazanavir
The plasma levels of nelfinavir and atazanavir are
decreased in case of co-administration with
omeprazole.

Concomitant administration of omeprazole with
nelfinavir is contraindicated (see section 4.3).
Co-administration of omeprazole (40 mg once daily)
reduced mean nelvinavir exposure by ca. 40% and
the mean exposure of the pharmacologically active
metabolite M8 was reduced by ca. 75-90%. The
interaction may also involve CYP2C19 inhibition.
Concomitant administration of omeprazole with
atazanavir is not recommended (see section 4.4).

Concomitant administration of omeprazole (40 mg
once daily) and atazanavir 300 mg/ritonavir 100 mg
to healthy volunteers resulted in a 75% decrease of
the atazanavir exposure. Increasing the atazanavir
dose to 400 mg did not compensate for the impact of
omeprazole on atazanavir exposure. The
co-administration of omeprazole (20 mg once daily)
with atazanavir 400 mg/ritonavir 100 mg to healthy
volunteers resulted in a decrease of approximately
30% in the atazanavir exposure as compared to
atazanavir 300 mg/ritonavir 100 mg once daily.

Digoxin
Concomitant treatment with omeprazole (20 mg
daily) and digoxin in healthy subjects increased the
bioavailability of digoxin by 10%. Digoxin toxicity has
been rarely reported. However caution should be
exercised when omeprazole is given at high doses in
elderly patients.
Therapeutic drug monitoring of digoxin should be
then be reinforced.

Clopidogrel
In a crossover clinical study, clopidogrel (300 mg
loading dose followed by 75 mg/day) alone and with
omeprazole (80 mg at the same time as clopidogrel)
were administered for 5 days. The exposure to the
active metabolite of clopidogrel was decreased by
46% (Day 1) and 42% (Day 5) when clopidogrel and
omeprazole were administered together. Mean
inhibition of platelet aggregation (IPA) was
diminished by 47% (24 hours) and 30% (Day 5)
when clopidogrel and omeprazole were administered
together. In another study it was shown that
administering clopidogrel and omeprazole at
different times did not prevent their interaction that is
likely to be driven by the inhibitory effect of
omeprazole on CYP2C19. Inconsistent data on the
clinical implications of this PK/PD interaction in
terms of major cardiovascular events have been
reported from observational and clinical studies.
Other active substances
The absorption of posaconazole, erlotinib,
ketoconazole and itraconazole is significantly
reduced and thus clinical efficacy may be impaired.
For posaconazole and erlotinib concomitant use
should be avoided.

Active substances metabolised by CYP2C19
Omeprazole is a moderate inhibitor of CYP2C19, the
major omeprazole metabolising enzyme. Thus, the
metabolism of concomitant active substances also
metabolised by CYP2C19, may be decreased and the
systemic exposure to these substances increased.
Examples of such drugs are R-warfarin and other
vitamin K antagonists, cilostazol, diazepam and
phenytoin.
Cilostazol
Omeprazole, given in doses of 40 mg to healthy
subjects in a cross-over study, increased Cmax and
AUC for cilostazol by 18% and 26% respectively,
and one of its active metabolites by 29% and 69%
respectively.

Phenytoin
Monitoring phenytoin plasma concentration is
recommended during the first two weeks after initiating
omeprazole treatment and, if a phenytoin dose
adjustment is made, monitoring and a further dose
adjustment should occur upon ending omeprazole
treatment.

Unknown mechanism
Saquinavir
Concomitant administration of omeprazole with
saquinavir/ritonavir resulted in increased plasma levels
up to approximately 70% for saquinavir associated
with good tolerability in HIV-infected patients.

Tacrolimus
Concomitant administration of omeprazole has been
reported to increase the serum levels of tacrolimus.
A reinforced monitoring of tacrolimus concentrations
as well as renal function (creatinine clearance)
should be performed, and dosage of tacrolimus
adjusted if needed.

Effects of other active substances on the
pharmacokinetics of omeprazole

Inhibitors of CYP2C19 and/or CYP3A4
Since omeprazole is metabolised by CYP2C19 and
CYP3A4, active substances known to inhibit
CYP2C19 or CYP3A4 (such as clarithromycin and
voriconazole) may lead to increased omeprazole
serum levels by decreasing omeprazoleʼs rate of
metabolism. Concomitant voriconazole treatment
resulted in more than doubling of the omeprazole
exposure. As high doses of omeprazole have been
well-tolerated adjustment of the omeprazole dose is
not generally required. However, dose adjustment
should be considered in patients with severe hepatic
impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4
Active substances known to induce CYP2C19 or
CYP3A4 or both (such as rifampicin and St Johnʼs
wort) may lead to decreased omeprazole serum
levels by increasing omeprazoleʼs rate of metabolism.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Powder for solution for injection: sodium hydroxide
Solvent for solution for injection: Macrogol 400, citric
acid monohydrate, water for injections.
6.2. Incompatibilities
Omeprazole powder for solution for injection must
not be mixed with other medicinal products, except
the solvent for injection mentioned in section 6.6.
The reconstituted product must not be mixed with
other medicinal products.
6.3. Shelf life
Powder for solution for injection: 2 years.
Solvent for solution for injection: 3 years.
Reconstituted solution: 4 hours when stored below
25°C.

6.4. Special precautions for storage
Powder and solvent for solution for injection: do not
store above 25°C. Store in the original package in
order to protect from light

For storage conditions of the reconstituted medicinal
product, see section 6.3.

Chemical and physical in-use stability has been
demonstrated for 4 hours at 25°C. From a
microbiological point of view, the product should
be used immediately. If not used immediately,
in-use storage times and conditions prior to use
are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8°C,
unless reconstitution has taken place in
controlled and aseptic conditions.

6.5. Nature and contents of container
Powder for solution for injection:
10 ml colourless glass vial Type I with a rubber stopper,
and an aluminium cramping cap with propylene cap.
Solvent for solution for injection:
10 ml colourless glass ampoule Type I.

Pack sizes: 1, 5 or 10.

Not all pack sizes may be marketed

6.6. Instructions for use and handling
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. Omeprazole powder for injection
should only be dissolved with the solvent for
injection provided. No other solvents for intravenous
injection should be used.
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.

SZ00000LT000

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: V018 - SPC & PIL update according to decision of PhVWP
Proof no.
005.0

Date prepared:
30/04/2012

Prepared by:
TB

RA Approved?
Yes

Date approved:
01/05/2012

Approved by:
MS
Fonts:
Helvetica

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

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 7pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

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.

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