OMEPRAZOLE 40MG POWDER FOR SOLUTION FOR INFUSION

Active substance: OMEPRAZOLE

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Omeprazole 40 mg Powder for solution for infusion ( UK )

Mockup por: DDM/Sofarimex - AZEVEDOS
Prova Nº: 6
24-06-2013
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• Generally feeling unwell and lacking energy.

Omeprazole

2. BEFORE OMEPRAZOLE 40 MG POWDER FOR
SOLUTION FOR INFUSION IS GIVEN TO YOU
You must not be given Omeprazole 40 mg
powder for solution for infusion
• if you are allergic (hypersensitive) to omeprazole or
any of the other ingredients of Omeprazole 40 mg
powder for solution for infusion.
• 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 40 mg
powder for solution for infusion
Omeprazole 40 mg powder for solution for infusion
may hide the symptoms of other diseases. Therefore,
if any of the following happen to you before you are
given Omeprazole 40 mg powder for solution for
infusion 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.
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).
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 40 mg powder for
solution for infusion can affect the way some
medicines work and some medicines can have an
effect on Omeprazole 40 mg powder for solution for
infusion.
You must not be given Omeprazole 40 mg powder
for solution for infusion 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 40 mg powder for solution for
infusion
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)

Driving and using machines
Omeprazole 40 mg powder for solution for infusion
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 40 MG POWDER FOR
SOLUTION FOR INFUSION IS GIVEN TO YOU

Not known
• 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.

• Omeprazole 40 mg powder for solution for
infusion can be given to adults including the elderly.
• There is limited experience with Omeprazole 40 mg
powder for solution for infusion for intravenous use
in children.
Being given Omeprazole 40 mg powder for
solution for infusion
• Omeprazole 40 mg powder for solution for
infusion 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.

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.

If you are given more Omeprazole 40 mg
powder for solution for infusion than you
should
If you think you have been given too much
Omeprazole 40 mg powder for solution for infusion,
talk to your doctor straight away.

Omeprazole 40 mg powder for solution for infusion
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole 40 mg powder for
solution for infusion can cause side effects, although
not everybody gets them.
If you notice any of the following rare but
serious side effects, stop using Omeprazole 40
mg powder for solution for infusion 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.

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 40 MG
POWDER FOR SOLUTION FOR INFUSION
• Keep out of the reach and sight of children.
• Do not use Omeprazole 40 mg powder for solution
for infusion 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.

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

• Keep the vial in the outer carton in order to protect
from light.

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.

Omeprazole 40 mg powder for solution for infusion
(powder for infusion) comes in a vial.
Omeprazole is available in pack sizes of 5 or 10 vials.
Not all pack sizes may be marketed.
The dry powder in the vial is made into a solution
before it is given to you.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratórios Azevedos - Indústria Farmacêutica, S.A
Estrada Nacional 117-2, Alfragide
2614-503 Amadora
Portugal
Manufacturer:
Sofarimex Indústria Química e Farmacêutica, S.A.
Av. das Indústrias- Alto do Colaride-Agualva
2735-213-Cacém
Portugal
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Finland

Omeprazol Azevedos 40 mg
infuusiokuiva-aine, liuosta varten
Germany
Omeprazol Azevedos 40 mg Pulver zur
Herstellung einer Infusionslösung
Italy
Omeprazolo Azevedos
Portugal
Omeprazol Azevedos 40 mg Pó para
solução para perfusão
United Kingdom
Omeprazole 40 mg
powder for solution for infusion
This leaflet was last approved in 05/2013
---------------------------------------------------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
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.
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.

• 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.
• 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.
5

Omeprazole 40 mg powder for solution for infusion
can be used as an alternative to oral therapy.

Your doctor will decide whether you can take
Omeprazole 40 mg powder for solution for infusion
if you are breastfeeding.

20

Omeprazole 40 mg powder for solution for infusion
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.

What Omeprazole 40 mg powder for solution
for infusion contains
- The active substance is omeprazole. Each vial of
powder for solution for infusion contains omeprazole sodium equivalent to 40 mg of omeprazole. The other ingredients are disodium edetate and
sodium hydroxide.
What Omeprazole 40 mg powder for solution
for infusion looks like and contents of the pack

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.

Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Serviços Centrais:
Estrada da Quinta, 148
Manique de Baixo
2645-436 Alcabideche
www.grupoazevedos.com
000000.00

5

1. WHAT OMEPRAZOLE 40 MG POWDER FOR
SOLUTION FOR INFUSION IS AND WHAT IT IS
USED FOR

Pregnancy and breast-feeding
Before you are given Omeprazole 40 mg powder for
solution for infusion, tell your doctor if you are
pregnant or trying to get pregnant. Your doctor will
decide whether you can be given Omeprazole 40 mg
powder for solution for infusion during this time.

Laetus reading direction

In this leaflet:
1. What Omeprazole 40 mg powder for solution for
infusion is and what it is used for
2. Before Omeprazole 40 mg powder for solution for
infusion is given to you
3. How Omeprazole 40 mg powder for solution for
infusion is given to you
4. Possible side effects
5. How to store Omeprazole 40 mg powder for
solution for infusion
6. Further information

• 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 treatment.
If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well as Omeprazole
40 mg powder for solution for infusion to treat
ulcers caused by Helicobacter pylori infection, it is
very important that you tell your doctor about any
other medicines you are taking.

Insert Laetus
Code

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.

6. FURTHER INFORMATION

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole 40 mg powder for solution for infusion

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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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