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OMEPRAZOLE 40MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): OMEPRAZOLE

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Omeprazole 40 mg Powder
for solution for infusion

3026
22.12.17[4]

(omeprazole sodium)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using 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, nurse or pharmacist.
- If you get any of the side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section
4.
This medicine is available using above name but will be referred to as
Omeprazole throughout the leaflet.
What is in this leaflet:
1. What Omeprazole is and what it is used for
2. What you need to know before you use Omeprazole
3. How to use Omeprazole
4. Possible side effects
5. How to store Omeprazole
6. Contents of the pack and other 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.
Omeprazole can be used as an alternative to oral therapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OMEPRAZOLE
Do not use Omeprazole:
- if you are allergic (hypersensitive) to omeprazole or any of the other
ingredients of this medicine (listed in section 6).
- 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).
Do not use Omeprazole if any of the above applies to you. If you are not
sure, talk to your doctor, nurse or pharmacist before you are given this
medicine.
Warnings and precautions
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.
- If you have ever had a skin reaction after treatment with a medicine similar to
Omeprazole Azevedos 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 Azevedos. Remember to also mention any other ill-effects like pain in
your joints.
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).
Tell your doctor before taking this medicine, if:
- You are due to have a specific blood test (Chromogranin A).
Other medicines and Omeprazole
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, 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 epilepsy)
- Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will
need to monitor you when you start or stop taking Omeprazole 40 mg
Powder for solution for infusion.
- 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)
- 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 treatment.
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
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask to your doctor or pharmacist for advice before
taking this medicine.
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 breastfeeding.
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 TO USE OMEPRAZOLE
- 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 use 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, this medicine 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 ʻStevens-Johnson syndromeʼ or ʻtoxic epidermal necrolysisʼ
- Yellow skin, dark urine and tiredness which can be symptoms of liver
problems.
Other side effects include:
Common side effects (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 side effects (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.

Rare side effects (may affect up to 1 in 1000 people)
- 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 (may affect up to 1 in 10000 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 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.
Not known (frequency cannot be estimated from the available data)
- Inflammation in the gut (leading to diarrhoea).
- 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 or 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
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store. By reporting side effects, you can
help provide more information on the safety of this medicine.
5. HOW TO STORE OMEPRAZOLE
Keep this medicine out of the sight and the reach of children.
Do not use this medicine after the expiry date which is stated on the vial and
carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vial in the outer carton in order to protect from light.
Shelf life after reconstitution: Solution for infusion reconstituted with sodium
chloride 9 mg/ml (0.9%) should be used within 12 hours after preparation.
Solution for infusion reconstituted with glucose 50 mg/ml (5%) should be
used within 6 hours after preparation. From a microbiological point of view,
the product should be used immediately unless it has been reconstituted
under controlled and validated aseptic conditions.

Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Omeprazole contains
The active substance is omeprazole.
Each vial contains 40mg omeprazole (as omeprazole sodium).
After reconstitution and dilution, 1ml contains 0.4mg omeprazole (as
omeprazole sodium).
The other ingredients are disodium edetate and sodium hydroxide.
What Omeprazole looks like and contents of the pack
Omeprazole 40mg powder for solution for infusion comes in a vial.
The white to off-white dry powder in the vial is made into a solution before it
is given to you.
Omeprazole is available in pack sizes of 5 or 10 vials.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Sofarimex Indústria Química e Farmacêutica, S.A., Av.
das Indústrias- Alto do Colaride-Agualva, 2735-213-Cacém, Portugal and
are procured from within the EU by Product Licence holder Star
Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, HA1 1XD. Repackaged
by Servipharm Ltd.
POM

PL 20636/3026

Leaflet revision and issue date (Ref) 22.12.17[4]

The following information is intended for medical or healthcare
professionals only.
The entire contents of each vial is to be dissolved in approximately 5 ml and
then immediately diluted to 100ml. Sodium chloride 9 mg/ml (0.9%) solution
for infusion or glucose 50mg/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.
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.
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.
The solution for infusion is to be administered in an intravenous infusion for
20-30 minutes.

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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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