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IBUPROFEN 600 MG SOLUTION FOR INFUSION

Active substance(s): IBUPROFEN / IBUPROFEN

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Package leaflet: Information for the patient
Ibuprofen 600 mg Solution for Infusion
Ibuprofen
Read all of this leaflet carefully before you are given 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 or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.
1.

What Ibuprofen is and what it is used for
What you need to know before you are given Ibuprofen
How Ibuprofen is given
Possible side effects
How to store Ibuprofen
Contents of the pack and other information
What Ibuprofen is and what it is used for

Ibuprofen belongs to the group of medicines called “nonsteroidal anti-inflammatory drugs” or (NSAIDs).
This medicine is used in adults for the short-term treatment of painful swelling and inflammation of posttraumatic soft tissue injuries or injuries after a surgical intervention in a hospital setting, when administration
by intravenous route is clinically justified whenever oral route of administration is not possible.
2.

What you need to know before you are given Ibuprofen

Ibuprofen must not be given:
-

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If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
If you have ever suffered from shortness of breath, have had asthma, skin rash, itchy runny nose or
facial swelling, when previously taking ibuprofen, acetylsalicylic acid or other similiar painkiller
(NSAIDs).
If you have a condition which increases your tendency or active bleeding.
If you have active, or history of recurrent (two or more episodes) stomach ulcer or bleeding.
If you have ever had bleeding or a tear in your stomach or gut when taking NSAIDs.
If you are suffering from bleeding in the brain (cerebrovascular bleeding) or other active bleeding.
If you suffer from severe kidney, liver or heart problems.
If you are suffering from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid
intake).
If you are in the last trimester of pregnancy.

Warnings and precautions
Talk to your doctor or nurse before using this medicine.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of
heart attack or stroke, particularly when used at high doses. The recommended dose or duration of treatment
should not be exceeded.

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Discuss your treatment with your doctor before receiving Ibuprofen:
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-

-

-

-

-

If you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack,
bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked
arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
stroke, or if you are a smoker.
If you have just had major surgery.
If you have had or developed an ulcer, bleeding or perforation of the stomach or duodenum. In these
cases, your doctor will consider of prescribing a protective medicine for the stomach.
If you have asthma or other breathing disorder.
If you are treated for an infection, because this medicine may mask fever, which is an important sign of
infection.
If you have kidney disease or liver disease, are more than 60 years old or use ibuprofen long-term, your
doctor may need to carry out checks on a regular basis. Your doctor will tell you the frequency of these
checks.
If you are dehydrated for example due to diarrhea, drink a lot of liquids and contact your doctor
immediately as ibuprofen in this case could cause kidney failure as a result of dehydration.
If you suffer from serious skin reactions such as exfoliative dermatitis (reddening and scaling of the
skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (severe life-threatening skin problems).
The use of this medicine should be stopped immediately at the first appearance of skin rash, mucosal
lesions, or any other signs of allergic reactions.
If you have Crohn's disease or ulcerative colitis because ibuprofen can worsen these conditions.
If you observe any injuries, swelling or redness of the skin, trouble breathing (asphyxiation),
immediately stop the treatment with the medicine and contact your doctor or nurse.
If you have varicella as complications can occur.
If you have hereditary disorder of the porphyrin metabolism (e.g. acute intermittent porphyria).
If you drink alcohol around the same time of receiving this medicine, side effects related to stomach,
intestines and nervous system may be increased.
If you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, you are at higher
risk of allergic reactions. The allergic reactions may present as asthma attacks (so-called analgesic
asthma), rapid swelling (Quincke´s oedema) or a rash.
It is important that you are given the lowest dose that alleviates and control pain and are not given this
medicine for longer than necessary to control your symptoms.
Allergic reactions may occur with this medicine, mainly at the start of treatment. In this case, treatment
should be discontinued.
There have been few cases of aseptic meningitis with the use of this medicine. The risk is greater if you
suffer from systemic lupus erythematosus and related connective tissue diseases.
-The use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary
to control symptoms.
In general the habitual use of (several sort of) analgesics can lead to lasting severe kidney problems.
On prolonged use of painkillers, headache may occur that must not be treated with increased doses of the
medicine.
Ibuprofen can alter the following laboratory test:
- Bleeding time (may be prolonged 1 day after the end of the treatment)
- Blood-glucose values (may be decreased)
- Creatinine clearance (may be decreased)
- Hematocrit or hemoglobin (may be decreased)
- Blood urea nitrogen, serum creatinine and serum potassium (may be increased)
- Liver function test: increased of transminases levels

2

Tell your doctor if you are going to undergo clinical tests and you are using or you have recently used
ibuprofen.
Children and adolescents
The safety and efficacy of Ibuprofen in children and adolescents have not been established. This medicine
should not be used in children or adolescents (below 18 years of age).
Other medicines and Ibuprofen
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Ibuprofen may affect or be affected by some other medicines. For example:
- Other nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 (e.g. celecoxib) may
increase the risk of gastrointestinal ulcers and bleeding due to an additive effect.
- Medicines that are anti-coagulants (used for thinning blood/prevent clotting such as acetylsalicylic
acid, warfarin, ticlopidine).
- Cardiac glycosides such as digoxin (used to treat heart failure), phenytoin (used to treat epilepsy) or
lithium (used to treat depression), may increase their blood levels when taking with ibuprofen.
- Methotrexate (used to treat certain types of cancers or rheumatism) taken at the same time as
ibuprofen (within a range of 24 hours) can increase blood levels and risk of toxicity by methotrexate.
- Mifepristone (a medicine to terminate pregnancy).
- SSRIs-antidepressants, such as fluoxetine, may also increase the risk of bleeding of stomach and
intestines.
- Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol, angiotensin-II receptor antagonists such as losartan).
- Corticosteroids (such as hydrocortisone) (used for inflammation) because they increase the risk of
ulcer or bleeding into stomach and intestines.
- Diuretics (medicines used for urination, such as bendroflumethiazide), as NSAIDs may reduce the
effects of these medicines and it may increase the risk of kidney problems (using potassium sparing
diuretics with ibuprofen can lead to high blood levels of potassium).
- Medicines containing probenecid and sulfinpyrazone may delay the excretion of ibuprofen.
- Cyclosporin and tacrolimus (used to avoid transplant rejection) may increase the risk of kidney
damage.
- Sulfonylureas, such as glibenclamide (medicines used for diabetes). Control of blood glucose values
is recommended when these medicines are used together.
- Antibiotics of the quinolone group, such as ciprofloxacin due to an increased risk for developing
seizures (fits).
- Voriconazole, fluconazole (CYP2C9 inhibitors) (used for fungal infections) can increase blood levels
of ibuprofen.
- Zidovudine, (used for HIV infection) due to increased risk of blood accumulation in joints and
bruises.
- Aminoglycosides (a type of antibiotics). NSAIDs may decrease the excretion of aminoglycosides.
- Gingo biloba (a herbal medicine often used in dementia) may increase the risk of bleeding.
Some other medicines may also affect or be affected by the treatment with ibuprofen. You should therefore,
always seek the advice of your doctor or nurse before you are given ibuprofen with other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or nurse for advice before you are given this medicine.
You must not be given this medicine during the third trimester (last 3 months) of pregnancy.
This medicine passes into breast milk but may be used during breast-feeding if it is used at the recommended
dose and during the shortest possible time. However, if it is used at higher doses than 1200 mg daily or for
longer periods, your doctor may recommend to interrupt the breast feeding.
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Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are
planning to become pregnant or if you have problems to become pregnant.
Driving and using machines
No special precautions are necessary in short or acute treatments. However, prolonged treatment, the
occurrence of adverse effects, such as fatigue and dizziness may impair the ability to drive and / or use
machinery. This is especially important when combined with alcohol.
Ibuprofen contains sodium. This medicine contains 15.65 mmol (360 mg) sodium per bottle. To be taken
into consideration by patients on a controlled sodium diet.
3.

How Ibuprofen is given

This medicine is restricted to hospital use only. The medicine will be given to you by doctor or nurse.
The recommended dose for adults is 600 mg intravenously (a drip into a vein), another 600 mg dose can be
administered after 6 to 8 hours depending on the intensity of the condition and response to the treatment. The
maximum daily dose of 1200 mg should not be exceeded.
Your doctor will give you the lowest effective dose for the shortest time possible in order to avoid side
effects. Your doctor will also make sure that you have had enough fluids in order to minimize rhe risk of side
effects to the kidney.
Use should be limited to situations where oral administration is inappropiate. Patients must switch to oral
treatment as soon as this is possible.
This medicinal product is indicated for short-term acute treatment only and should not be used for more than
3 days.
Method of administration
For intravenous use. The solution should be administered by intravenous infusion over 30 minutes. Inspect
the solution before use. It should be discarded if any particulate matter or discoloration is observed.
If you are given more Ibuprofen than you should
If you think you have been given more ibuprofen than you should immediately consult your doctor or nurse.
Problems such as headache, dizziness, light-headedness and unconsciousness, as well as abdominal pain,
nausea and vomiting, bleeding into stomach or intestines, as well as functional problems of the liver and
kidneys, are possible. You might also suffer from low blood pressure, breathing problems and blueish
coloration of the skin or mucous membranes (cyanosis).
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects can be minimized by using the lowest effective dose for the shortest time possible to treat the
symptoms. You can get one or more of the known side effects of NSAIDs (see below). If you experience any
of these side effects, you should stop taking this medicine and consult a doctor as soon as possible. Elderly
patients who take this drug are at greater risk for developing problems associated with side effects.
The most commonly observed adverse events are gastrointestinal side effects (affecting stomach and
intestines). Peptic ulcers (stomach or intestinal ulcer), perforation (hole the wall of the stomach or intestines)
or bleeding from the stomach or intestine, sometimes fatal, particularly in the elderly may occur. Nausea,
vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood,
ulcerative stomatitis (inflammation of the oral mucosa with ulceration), exacerbation of colitis (inflammation
of large intestine) and Crohn's disease. Less frequently, gastritis (stomach inflammation) has been observed.

4

Particularly the risk of bleeding into stomach and intestines occurring is dependent on the dose range and the
duration of use.
Edema (fluid accumulation in the tissues), high blood pressure and heart failure have been reported in
association with NSAID treatment. Medicines like ibuprofen may be associated with a small increased risk of
heart attack (“myocardial infarction”) or stroke.
Very rarely severe allergic reactions (including infusion site reactions, anaphylactic shock) and serious skin
side effects such as bullous (blistering) reactions including Stevens-Johnson syndrome and toxic epidermal
necrolysis (Lyell´s shyndrome), erythema multiforme, alopecia (hair loss), sensitivity to light reactions and
allergic vasculitis (inflammation of a blood vessel) have been reported.
Exacerbation of inflammation related to infections (for example development necrotising fasciitis) coinciding
with the use of NSAIDs has been described very rarely.
In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella
infection.
Very common side effects (may affect more than 1 in 10 people):



Tiredness or sleeplessness, headache and dizziness.
Heartburn, abdominal pain, nauseas, vomiting, flatulence, diarrhea, constipation and slight blood
losses in stomach and intestines that may cause anaemia in exceptional cases.



Gastrointestinal ulcer, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation
of colitis and Crohn´s disease.

Common side effects (may affect up to 1 in 10 people):




Vertigo.
Skin eruption.
Pain and burning sensation in the admnistration site.

Uncommon side effects (may affect up to 1 in 100 people):







Insomnia (problems sleeping), agitation, irritability or tiredness, anxiety and restlessness.
Visual disturbances.
Tinnitus (ringing or buzzing in the ears).
Reduced production of urine and, particularly in patients with high blood pressure or kidney
problems, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal
insufficiency.
Urticaria, pruritus, purpura (including allergic purpura), skin rash.
Allergic reactions with skin rashes and itching, as well as asthma attacks (possibly with drop of
blood pressure).

Rare side effects (may affect up to 1 in 1,000 people):
 Reversible toxic amblyopia (double vision).
 Difficulty hearing.
 Narrowing ot the oesophagus (blood vessels in gullet), complications of diverticula of the large
bowel, unspecific haemorrhagic colitis. If there is bleeding into stomach or intestines, it can cause
anemia.
 Damage of kidney tissue (papillary necrosis), particularly in long-term therapy, increased serum uric
acid concentration in the blood.
 Yellowing of the skin or whites of the eyes, liver dysfunction, liver damage, particularly in long-term
therapy, acute hepatitis (inflammation of the livers).
 Psychotic reactions, nervousness, irritability, confusion or disorientation and depression.
 Stiff neck.
Very rare side effects (may affect up to 1 in 10,000 people):
5









Disorders of blood cell formation (anaemia, leukopenia, thrombocytopenia, pancytopenia,
agranulocytosis). The first symptoms are: fever, sore throat, surface mouth ulcers, flu-like
symptoms, severe fatigue, nasal and skin bleeding.
Palpitations (rapid heartbeat), heart failure, myocardial infarction.
Arterial hypertension
Aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or confusion). Patients with
autoimmune disorders (SLE, mixed connective-tissue disease) appear to be predisposed.
Inflammation of oesophagus (gullet) or pancreas, narrowing of the bowel.
Asthma, difficulty breathing (broncospasm), shortness of breath and wheezing.
Systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (face oedema,
swelling of the tongue, swelling of the throat with constriction of the airways, difficulty breathing,
rapid heartbeat and decreased blood pressure and life threatening shock).

Not known side effects (frequency cannot be estimated from the available data):



Liver insufficiency.
Site of injection reactions such as swelling, bruising or bleeding.

Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide more information on the safety of this medicine.
5.

How to store Ibuprofen

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers
to the last day of that month.
Do not use this medicine if you notice any particles or discoloration.
6.

Contents of the pack and other information

What Ibuprofen contains
The active substance is ibuprofen. Each 100 ml bottle contains 600 mg of ibuprofen.
The other ingredients are L-arginine, sodium chloride, hydrochloric acid, sodium hydroxide, water for
injection.
What Ibuprofen looks like and contents of the pack
Ibuprofen 400mg solution for infusion is a clear and colourless to pale yellow solution for infusion, without
any particulate matter.
The solution is contained in closed LDPE bottles of 100ml with an external cap in packs of 10 bottles and 20
bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany

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Manufacturer
B. Braun Medical, S.A.
Ctra. Terrasa, 121
Rubí
08191Barcelona – Spain
or
Farmalider S.A
c/ Aragoneses, 15
28108 –Alcobendas-Madrid
(Spain).
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.

This medicinal product is authorised in the Member States of the EEA under the following names:

AT
BE
BG
CZ
DE
DK
EE
ES
FI
FR
HU
IE
IT
LU
LV
LT
NL
NO
PL
PT
RO
SE
SI
SK
UK

Ibuprofen B. Braun 600 mg Infusionslösung
Ibuprofen B. Braun 600 mg oplossing
voor infusie.
Ибупрофен Б. Браун 600 mg инфузионен разтвор
Ibuprofen B. Braun
Ibuprofen B. Braun 600 mg Infusionslösung
Ibuprofen B. Braun
Ibuprofen B. Braun 600 mg infusioonilahus
Ibuprofeno B. Braun 600 mg solución para perfusión
Ibuprofen B. Braun
Ibuprofène B. Braun 600 mg solution pour
perfusion
Ibuprofen B. Braun 600 mg oldatosinfúzió
Ibuprofen B. Braun 600 mg solution for infusion
Ibuprofene B. Braun
Ibuprofen B. Braun 600 mg solution pour
perfusion
Ibuprofen B. Braun 600 mg šķīdums infūzijai
Ibuprofen B. Braun 600 mg infuzinistirpalas
Ibuprofen B.Braun 600 mg oplossing voor infusie
Ibuprofen B. Braun 600 mg infusjonsvæske,
oppløsning
Ibuprofen B. Braun
Ibuprofeno B. Braun 600 mg solução para
perfusão
Ibuprofen B. Braun 600 mg soluţie perfuzabilă
Ibuprofen B. Braun
Ibuprofen B. Braun 600 mg raztopina za infundiranje
Ibuprofen B. Braun
Ibuprofen 600 mg Solution for Infusion

7

This leaflet was last revised in March 2017.

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Expand Transcript

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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