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

Very Common: affects more than 1 user in 10

Read all of this leaflet carefully before you
start using this medicine. Common: affects 1 to 10 users in 100
Keep this leaflet. You may need to read it Uncommon: affects 1 to 10 users in 1,000
again. Rare: affects 1 to 10 users in 10,000
If you have any further questions, ask your
Very Rare: affects less than 1 user in
doctor or pharmacist.
10,000
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, Not Known: frequency cannot be estimated
please tell your doctor or pharmacist. from the available data
Other side effects include:
Common side effects
In this leaflet: Headache
1. What Omeprazole Injection is and what it is Effects on your stomach or gut: diarrhoea,
used for stomach pain, constipation, wind (flatulence)
2. Before Omeprazole Injection is used Feeling sick (nausea) or being sick (vomiting).
3. How Omeprazole Injection is used
4. Possible side effects Uncommon side effects
5. How to store Omeprazole Injection Swelling of the feet and ankles
6. Further information Disturbed sleep (insomnia)
Dizziness, tingling feelings such as pins and
needles, feeling sleepy
1. What Omeprazole Injection is and Spinning feeling (vertigo)
what it is used for Changes in blood tests that check how the liver is
working
Omeprazole contains the active substance Skin rash, lumpy rash (hives) and itchy skin
omeprazole. It belongs to a group of medicines Generally feeling unwell and lacking energy
called proton pump inhibitors. They work by reducing Fracture in the hip, wrist or spine.1
the amount of acid that your stomach produces.
Rare side effects
Omeprazole powder and solvent for solution for Blood problems such as a reduced number of
injection can be used as an alternative to oral therapy. white cells or platelets. This can cause weakness,
bruising or make infections more likely
Allergic reactions, sometimes very severe, including
2. Before Omeprazole Injection is used 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
You must not be given Omeprazole Feeling agitated, confused or depressed
if you are allergic (hypersensitive) to omeprazole Taste changes
or any of the other ingredients of Omeprazole Eyesight problems such as blurred vision
if you are allergic to other proton pump inhibitor Suddenly feeling wheezy or short of breath
medicines (e.g. pantoprazole, lansoprazole, (bronchospasm)
rabeprazole, esomeprazole) Dry mouth
if you are taking a medicine containing nelfinavir An inflammation of the inside of the mouth
(used for HIV infection). An infection called thrush which can affect the
gut and is caused by a fungus
If you are not sure, talk to your doctor, nurse or Liver problems, including jaundice which can
pharmacist before you are given this medicine. cause yellow skin, dark urine, and tiredness
Hair loss (alopecia)
Take special care with Omeprazole Skin rash on exposure to sunshine
Omeprazole may hide the symptoms of other Joint pains (arthralgia) or muscle pains (myalgia)
diseases. Therefore, if any of the following happen to Severe kidney problems (interstitial nephritis)
you before you are given Omeprazole or after you Increased sweating.
are given it, talk to your doctor straight away:
You lose a lot of weight for no reason and have Very rare side effects
problems swallowing Changes in blood count including agranulocytosis
You get stomach pain or indigestion (lack of white blood cells)
You begin to vomit food or blood Aggression
You pass black stools (blood-stained faeces) Seeing, feeling or hearing things that are not there
You experience severe or persistent diarrhoea, as (hallucinations)
omeprazole has been associated with a small Severe liver problems leading to liver failure and
increase in infectious diarrhoea inflammation of the brain
You have severe liver problems. Sudden onset of a severe rash or blistering or
peeling skin. This may be associated with a high
Using other medicines fever and joint pains (Erythema multiforme, Stevens-
Please tell your doctor, nurse or pharmacist if you Johnson syndrome, toxic epidermal necrolysis)
are taking or have recently taken any other Muscle weakness
medicines, including medicines obtained without a Enlarged breasts in men
prescription. This is because Omeprazole can affect Low levels of magnesium in the blood.2
the way some medicines work and some medicines
can have an effect on Omeprazole.
1
Taking a proton pump inhibitor like Omeprazole,
especially over a period of more than one year, may
You must not be given Omeprazole if you are taking slightly increase your risk of fracture in the hip, wrist
a medicine containing nelfinavir (used to treat HIV or spine. Tell your doctor if you have osteoporosis or
infection). if you are taking corticosteroids (which can increase
the risk of osteoporosis).
Tell your doctor or pharmacist if you are taking any of
the following medicines:
2
If you are on Omeprazole for more than three months
Ketoconazole, itraconazole or voriconazole (used it is possible that the levels of magnesium in your
to treat infections caused by a fungus) blood may fall. Low levels of magnesium can be
Digoxin (used to treat heart problems) seen as fatigue, involuntary muscle contractions,
Diazepam (used to treat anxiety, relax muscles or disorientation, convulsions, dizziness, increased
in epilepsy) heart rate. If you get any of these symptoms, please
Phenytoin (used in epilepsy). If you are taking tell your doctor promptly. Low levels of magnesium
phenytoin, your doctor will need to monitor you can also lead to a reduction in potassium or calcium
when you start or stop taking Omeprazole levels in the blood. Your doctor may decide to perform
Medicines that are used to thin your blood, such regular blood tests to monitor your levels of magnesium.
as warfarin or other vitamin K blockers.
Your doctor may need to monitor you when you Irreversible visual impairment has been reported in
start or stop taking Omeprazole isolated cases of critically ill patients who have received
Rifampicin (used to treat tuberculosis) Omeprazole intravenous injection, especially at high
Atazanavir (used to treat HIV infection) doses, but no causal relationship has been established.
Tacrolimus (in cases of organ transplantation)
Omeprazole may in very rare cases affect the white
St Johns wort (Hypericum perforatum) (used to
blood cells leading to immune deficiency. If you have
treat mild depression)
an infection with symptoms such as fever with a
Cilostazol (used to treat intermittent claudication)
severely reduced general condition or fever with
Saquinavir (used to treat HIV infection)
symptoms of a local infection such as pain in the
Clopidogrel (used to prevent blood clots (thrombi)).
neck, throat or mouth or difficulties in urinating, you
If your doctor has prescribed the antibiotics must consult your doctor as soon as possible so that
amoxicillin and clarithromycin as well as Omeprazole a lack of white blood cells (agranulocytosis) can be
to treat ulcers caused by Helicobacter pylori ruled out by a blood test. It is important for you to
infection, it is very important that you tell your doctor give information about your medicine at this time.
about any other medicines you are taking.
Do not be concerned by this list of possible side effects.
Pregnancy and breast-feeding You may not get any of them. If any of the side effects
Before you are given Omeprazole, tell your doctor if get serious, or if you notice any side effects not listed
you are pregnant or trying to get pregnant. Your in this leaflet, please tell your doctor or pharmacist.
doctor will decide whether you can be given
Omeprazole during this time.
5. How to store Omeprazole Injection
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 Keep out of the reach and sight of children.
take Omeprazole if you are breast-feeding. Do not store above 25C. Store in the original
package in order to protect from light.
Driving and using machines
Omeprazole is not likely to affect your ability to drive Do not use Omeprazole 40 mg powder for solution
or use any tools or machines. Side effects such as for injection after the expiry date which is state on
dizziness and visual disturbances may occur (see the label after EXP. The expiry date refers to the last
section 4). If affected, you should not drive or day of that month.
operate machinery.
After preparation of the solution by your doctor or
nurse, it must be stored below 25C and used within
3. How Omeprazole Injection is used four hours.
The reconstituted solution should not be used if
particles are present.
Omeprazole can be given to adults including the The contents of the vial is meant for single use; any
elderly product that has remained in the vial has to be
There is limited experience with Omeprazole for discarded. Medicines should not be disposed of via
intravenous use in children. wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
Being given Omeprazole These measures will help to protect the environment.
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 6. Further information
into one of your veins.

If you are given more Omeprazole than you What Omeprazole contains
should Each vial of powder for solution for injection contains
If you think you have been given too much the active ingredient omeprazole sodium, equivalent
Omeprazole, talk to your doctor straight away. to omeprazole 40 mg.

Each vial also contains sodium hydroxide.

4. Possible side effects
Each vial is for one injection when mixed with one
ampoule containing the solvent for injection. The
Like all medicines, Omeprazole can cause side solvent for injection contains macrogol 400, citric
effects, although not everybody gets them. acid monohydrate and water for injections.

If you notice any of the following rare but serious What Omeprazole looks like and contents of the
side effects, stop using Omeprazole and contact pack
a doctor immediately: The powder for solution for injection is a white to
Sudden wheezing, swelling of your lips, tongue almost white powder. The solvent for solution for
and throat or body, rash, fainting or difficulties to injection is clear solution.
swallow (severe allergic reaction)
Omeprazole powder and solvent for solution for
Reddening of the skin with blisters or peeling.
injection are available in packsizes of 1, 5 and 10.
There may also be severe blisters and bleeding in
the lips, eyes, mouth, nose and genitals. This Marketing Authorisation Holder:
could be Stevens-Johnson syndrome or toxic Sandoz Ltd,
epidermal necrolysis Frimley Business Park, Frimley,
Yellow skin, dark urine and tiredness which can Camberley, Surrey, GU16 7SR, UK.
be symptoms of liver problems.
Manufacturer:
Side effects may occur with certain frequencies, Lek Pharmaceuticals d.d.,
which are defined as follows: Verovkova 57, 1526 Ljubljana, Slovenia.
This leaflet was last approved in 04/2012 (to be
amended after approval).

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A healthy decision Ref: V018 - SPC & PIL update according to decision of PhVWP
Proof no. Date prepared: Prepared by:
Sandoz Ltd,
Frimley Business Park, Frimley,
005.0 30/04/2012 TB
Camberley, Surrey, GU16 7SR, RA Approved? Date approved: Approved by:
United Kingdom. Yes 01/05/2012 MS

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The following information is intended for medical Concomitant administration of omeprazole (40 mg
or healthcare professionals only: once daily) and atazanavir 300 mg/ritonavir 100 mg
to healthy volunteers resulted in a 75% decrease of
1. Name of the medicinal product the atazanavir exposure. Increasing the atazanavir
dose to 400 mg did not compensate for the impact of
Omeprazole 40 mg powder and solvent for solution omeprazole on atazanavir exposure. The
for injection. co-administration of omeprazole (20 mg once daily)
with atazanavir 400 mg/ritonavir 100 mg to healthy
2. Qualitative and quantitative composition volunteers resulted in a decrease of approximately
30% in the atazanavir exposure as compared to
Each vial of powder for injection contains omeprazole
atazanavir 300 mg/ritonavir 100 mg once daily.
sodium, equivalent to 40 mg omeprazole.
Digoxin
For a full list of excipients, see section 6.1.
Concomitant treatment with omeprazole (20 mg
4.1. Therapeutic indications daily) and digoxin in healthy subjects increased the
Omeprazole for intravenous use is indicated as an bioavailability of digoxin by 10%. Digoxin toxicity has
alternative to oral therapy for the following indications: been rarely reported. However caution should be
exercised when omeprazole is given at high doses in
Adults elderly patients.
Treatment of duodenal ulcers Therapeutic drug monitoring of digoxin should be
Prevention of relapse of duodenal ulcers then be reinforced.
Treatment of gastric ulcers
Prevention of relapse of gastric ulcers Clopidogrel
In combination with appropriate antibiotics, In a crossover clinical study, clopidogrel (300 mg
Helicobacter pylori (H. pylori) eradication in peptic loading dose followed by 75 mg/day) alone and with
ulcer disease omeprazole (80 mg at the same time as clopidogrel)
Treatment of NSAID-associated gastric and were administered for 5 days. The exposure to the
duodenal ulcers active metabolite of clopidogrel was decreased by
Prevention of NSAID-associated gastric and 46% (Day 1) and 42% (Day 5) when clopidogrel and
duodenal ulcers in patients at risk omeprazole were administered together. Mean
Treatment of reflux esophagitis inhibition of platelet aggregation (IPA) was
Long-term management of patients with healed diminished by 47% (24 hours) and 30% (Day 5)
reflux esophagitis when clopidogrel and omeprazole were administered
Treatment of symptomatic gastro-esophageal together. In another study it was shown that
reflux disease administering clopidogrel and omeprazole at
Treatment of Zollinger-Ellison syndrome. different times did not prevent their interaction that is
likely to be driven by the inhibitory effect of
4.2. Posology and method of administration omeprazole on CYP2C19. Inconsistent data on the
Posology clinical implications of this PK/PD interaction in
Alternative to oral therapy terms of major cardiovascular events have been
In patients where the use of oral medicinal products reported from observational and clinical studies.
is inappropriate, Omeprazole IV 40 mg once daily is
recommended. In patients with Zollinger-Ellison Other active substances
Syndrome the recommended initial dose of The absorption of posaconazole, erlotinib,
Omeprazole given intravenously is 60 mg daily. Higher ketoconazole and itraconazole is significantly
daily doses may be required and the dose should be reduced and thus clinical efficacy may be impaired.
adjusted individually. When doses exceed 60 mg For posaconazole and erlotinib concomitant use
daily, the dose should be divided and given twice daily. should be avoided.

Omeprazole solution for injection must be given only Active substances metabolised by CYP2C19
as an intravenous injection and it must not be added Omeprazole is a moderate inhibitor of CYP2C19, the
to infusion solutions. After reconstitution the injection major omeprazole metabolising enzyme. Thus, the
should be given slowly over a period of at least 2.5 metabolism of concomitant active substances also
minutes at a maximum rate of 4 ml per minute. For metabolised by CYP2C19, may be decreased and the
instructions on reconstitution of the product before systemic exposure to these substances increased.
administration, see section 6.6. Examples of such drugs are R-warfarin and other
vitamin K antagonists, cilostazol, diazepam and
Special populations phenytoin.
Impaired renal function
Dose adjustment is not needed in patients with Cilostazol
impaired renal function. Omeprazole, given in doses of 40 mg to healthy
subjects in a cross-over study, increased Cmax and
Impaired hepatic function AUC for cilostazol by 18% and 26% respectively,
In patients with impaired hepatic function a daily and one of its active metabolites by 29% and 69%
dose of 10-20 mg may be sufficient. respectively.

Elderly (> 65 years old) Phenytoin

Dose adjustment is not needed in the elderly. Monitoring phenytoin plasma concentration is
recommended during the first two weeks after initiating
Paediatric patients omeprazole treatment and, if a phenytoin dose
There is limited experience with Omeprazole for adjustment is made, monitoring and a further dose
intravenous use in children. adjustment should occur upon ending omeprazole
treatment.
4.3. Contraindications
Hypersensitivity to omeprazole, substituted Unknown mechanism
benzimidazoles or to any of the excipients. Saquinavir
Concomitant administration of omeprazole with
Omeprazole like other proton pump inhibitors (PPIs) saquinavir/ritonavir resulted in increased plasma levels
should not be used concomitantly with nelfinavir (see up to approximately 70% for saquinavir associated
section 4.5). with good tolerability in HIV-infected patients.

4.4. Special warnings and precautions for use Tacrolimus

In the presence of any alarm symptoms (e.g., Concomitant administration of omeprazole has been
significant unintentional weight loss, recurrent reported to increase the serum levels of tacrolimus.
vomiting, dysphagia, haematemesis or melena) and A reinforced monitoring of tacrolimus concentrations
when gastric ulcer is suspected or present, as well as renal function (creatinine clearance)
malignancy should be excluded, as treatment may should be performed, and dosage of tacrolimus
alleviate symptoms and delay diagnosis. adjusted if needed.

Co-administration of atazanavir with proton pump Effects of other active substances on the
inhibitors is not recommended (see section 4.5). If pharmacokinetics of omeprazole
the combination of atazanavir with a proton pump
inhibitor is judged unavoidable, close clinical Inhibitors of CYP2C19 and/or CYP3A4
monitoring (e.g. virus load) is recommended in Since omeprazole is metabolised by CYP2C19 and
combination with an increase in the dose of CYP3A4, active substances known to inhibit
atazanavir to 400 mg with 100 mg of ritonavir; CYP2C19 or CYP3A4 (such as clarithromycin and
omeprazole 20 mg should not be exceeded. voriconazole) may lead to increased omeprazole
serum levels by decreasing omeprazoles rate of
Omeprazole, as all acid-blocking medicines, may metabolism. Concomitant voriconazole treatment
reduce the absorption of vitamin B12 resulted in more than doubling of the omeprazole
(cyanocobalamin) due to hypo- or achlorhydria. This exposure. As high doses of omeprazole have been
should be considered in patients with reduced body well-tolerated adjustment of the omeprazole dose is
stores or risk factors for reduced vitamin B12 not generally required. However, dose adjustment
absorption on long-term therapy. should be considered in patients with severe hepatic
impairment and if long-term treatment is indicated.
Omeprazole is a CYP2C19 inhibitor. When starting
or ending treatment with omeprazole, the potential Inducers of CYP2C19 and/or CYP3A4
for interactions with drugs metabolised through Active substances known to induce CYP2C19 or
CYP2C19 should be considered. An interaction is CYP3A4 or both (such as rifampicin and St Johns
observed between clopidogrel and omeprazole (see wort) may lead to decreased omeprazole serum
section 4.5). The clinical relevance of this interaction levels by increasing omeprazoles rate of metabolism.
is uncertain. As a precaution, concomitant use of
omeprazole and clopidogrel should be discouraged. 6. PHARMACEUTICAL PARTICULARS
Treatment with proton pump inhibitors may lead to 6.1. List of excipients
slightly increased risk of gastrointestinal infections Powder for solution for injection: sodium hydroxide
such as Salmonella and Campylobacter. Solvent for solution for injection: Macrogol 400, citric
acid monohydrate, water for injections.
Severe hypomagnesaemia has been reported in
patients treated with proton pump inhibitors like 6.2. Incompatibilities
omeprazole for at least three months, and in most Omeprazole powder for solution for injection must
cases for a year. Serious manifestations of not be mixed with other medicinal products, except
hypomagnesaemia such as fatigue, tetany, delirium, the solvent for injection mentioned in section 6.6.
convulsions, dizziness and ventricular arrhythmia The reconstituted product must not be mixed with
can occur but they may begin insidiously and be other medicinal products.
overlooked. In most affected patients,
hypomagnesaemia improved after magnesium 6.3. Shelf life
replacement and discontinuation of the proton pump Powder for solution for injection: 2 years.
inhibitor. Solvent for solution for injection: 3 years.
For patients expected to be on prolonged treatment or Reconstituted solution: 4 hours when stored below
who take proton pump inhibitors with digoxin or drugs 25C.
that may cause hypomagnesaemia (e.g., diuretics),
health care professionals should consider measuring 6.4. Special precautions for storage
magnesium levels before starting proton pump inhibitor Powder and solvent for solution for injection: do not
treatment and periodically during treatment. store above 25C. Store in the original package in
order to protect from light
Proton pump inhibitors, especially if used in high
doses and over long durations (>1 year), may For storage conditions of the reconstituted medicinal
modestly increase the risk of hip, wrist and spine product, see section 6.3.
fracture, predominantly in the elderly or in presence
Chemical and physical in-use stability has been
of other recognised risk factors. Observational
demonstrated for 4 hours at 25C. From a
studies suggest that proton pump inhibitors may
microbiological point of view, the product should
increase the overall risk of fracture by 10-40%. Some
be used immediately. If not used immediately,
of this increase may be due to other risk factors.
in-use storage times and conditions prior to use
Patients at risk of osteoporosis should receive care
are the responsibility of the user and would
according to current clinical guidelines and they should
normally not be longer than 24 hours at 2 to 8C,
have an adequate intake of vitamin D and calcium.
unless reconstitution has taken place in
As in all long-term treatments, especially when controlled and aseptic conditions.
exceeding a treatment period of 1 year, patients
6.5. Nature and contents of container
should be kept under regular surveillance.
Powder for solution for injection:
4.5. Interaction with other medicinal products 10 ml colourless glass vial Type I with a rubber stopper,
and other forms of interaction and an aluminium cramping cap with propylene cap.
Effects of omeprazole on the pharmacokinetics of
Solvent for solution for injection:
other active substances
10 ml colourless glass ampoule Type I.
Active substances with pH dependent absorption
Pack sizes: 1, 5 or 10.
The decreased intragastric acidity during treatment
Not all pack sizes may be marketed
with omeprazole might increase or decrease the
absorption of active substances with a gastric pH 6.6. Instructions for use and handling
dependent absorption. One vial with powder for solution for injection should
be mixed with one ampoule containing 10 ml of the
Nelfinavir, atazanavir
solvent for solution for injection. A clear solution
The plasma levels of nelfinavir and atazanavir are
should be obtained. Omeprazole powder for injection
decreased in case of co-administration with
should only be dissolved with the solvent for
omeprazole.
injection provided. No other solvents for intravenous
Concomitant administration of omeprazole with injection should be used.
nelfinavir is contraindicated (see section 4.3).
Do not use if any particles are present in the
Co-administration of omeprazole (40 mg once daily)
reconstituted solution.
reduced mean nelvinavir exposure by ca. 40% and
the mean exposure of the pharmacologically active The reconstituted solution is for single use only.
metabolite M8 was reduced by ca. 75-90%. The
interaction may also involve CYP2C19 inhibition. Any unused product or waste material should be
disposed of in accordance with local requirements.
Concomitant administration of omeprazole with
atazanavir is not recommended (see section 4.4). SZ00000LT000

Artwork Proof Box

A healthy decision Ref: V018 - SPC & PIL update according to decision of PhVWP
Proof no. Date prepared: Prepared by:
Sandoz Ltd,
Frimley Business Park, Frimley,
005.0 30/04/2012 TB
Camberley, Surrey, GU16 7SR, RA Approved? Date approved: Approved by:
United Kingdom. Yes 01/05/2012 MS

Helvetica
T: 01276 698020 Colours: Fonts:
F: 01276 698324
W: www.uk.sandoz.com
Black
E: sandoz.artwork@me.com Black 20%
Dimensions: 140 x 540 mm Font size: 7pt
PROPOSED Artwork/RA Checklist: Pack size Warnings
MOCK UP Product name PL number Excipients
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