200 mg infusion solution
1. What Ibuprofen B. Braun is and what it is used for
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs.
This medicine is intended for adolescents and children 6 years of age or older who weigh at least 20 kg for symptomatic short-term treatment of acute pain of moderate severity, and for symptomatic short-term treatment of fever when intravenous administration is clinically justified and when other routes of administration are not possible.
Ibuprofen contained in Ibuprofen B. Braun may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you get Ibuprofen B. Braun
Ibuprofen B. Braun must not be given:
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
- if you have ever had shortness of breath, asthma , rash, itchy runny nose or swelling of the face after taking ibuprofen , acetylsalicylic acid (aspirin) or similar painkillers ( NSAIDs )
- if you have a disease that increases your tendency to bleed or have an active bleeding
- if you have a stomach ulcer or bleeding in the stomach or have had it two or more times
- if you have ever had any bleeding or holes in the stomach or intestine after taking NSAIDs -preparat
- if you have a brain haemorrhage ( cerebrovascular haemorrhage) or other active haemorrhage
- if you have severe kidney, liver, or heart problems
- if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake)
- if you are in the last three months of a pregnancy.
Warnings and cautions
Talk to your doctor or nurse before using this medicine.
Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when using high doses. The recommended dose and duration of treatment should not be exceeded.
Skin reactions
Serious skin reactions have been reported with ibuprofen. You should stop using Ibuprofen B. Braun immediately and seek medical attention if you develop any skin rash, mucous membrane ulcers, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
Discuss your treatment with a doctor before receiving Ibuprofen B. Braun:
- if you have heart problems including heart failure , angina ( angina pectoris ) or if you have had a heart attack, have had bypass surgery or have poor circulation in your legs or feet due to narrow or blocked arteries ( peripheral artery disease) or some form of stroke (including “mini-stroke” or transient ischemic attack “TIA”).
- if you have high blood pressure , diabetes or high cholesterol, heart disease or stroke in the family or if you are a smoker.
- if you have recently undergone major surgery.
- if you have had stomach ulcers , bleeding or holes in the stomach or duodenum . In these cases, the doctor may prescribe a drug that protects the stomach.
- if you have asthma or any other respiratory disease.
- if you have an infection – see the heading “Infections” below
- if you have kidney or liver disease or use ibuprofen for a long time, then your doctor may need to do regular check-ups. The doctor will tell you how often the check-ups should be done.
- if you are dehydrated e.g. due to diarrhea. You should then drink copious amounts of fluid and contact a doctor immediately as ibuprofen in this case can cause kidney failure due to dehydration.
- if you have Crohn’s disease or ulcerative colitis because ibuprofen can make these diseases worse.
- if you notice any damage, swelling or redness of the skin, difficulty breathing (asphyxia), stop treatment with the medicine immediately and contact a doctor or nurse.
- if you have chickenpox as complications may occur.
- if you have a congenital disorder of porphyrin metabolism (eg acute intermittent porphyria ).
- If you drink alcohol while you are taking this medicine, the risk of side effects in the gastrointestinal tract and central nervous system may increase.
- if you have hay fever, nasal polyps or chronic obstructive pulmonary disease (COPD) then there is an increased risk of allergic reactions. The allergic reactions can manifest themselves as asthma attacks (so-called drug asthma), sudden swelling ( Quincke’s edema ) or rash.
This medicine may cause allergic reactions, especially at the beginning of treatment. If allergic reactions occur, treatment should be discontinued.
A small number of cases of aseptic meningitis have occurred with the use of this drug. The risk is higher if you have an autoimmune disease called systemic lupus erythematosus ( SLE ) or some other connective tissue disease.
Blurred vision or impaired vision, blind spots in the visual field, and changes in color vision have been reported in patients who have used ibuprofen by mouth.
Concomitant treatment with NSAIDs, including cyclooxygenase-2 -selective inhibitors, should be avoided.
Infection is
Ibuprofen can hide signs of infection such as fever and pain. Therefore, ibuprofen may delay the appropriate treatment of infection and increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection and the symptoms of infection persist or worsen, you should contact a doctor immediately.
Side effects can be minimized by using the lowest effective dose for the shortest possible time needed to control symptoms.
In general, the habitual use of several different painkillers can lead to persistent severe kidney problems.
Long-term use of painkillers can cause headaches that should not be treated with higher doses of the medicine.
Ibuprofen may affect the following laboratory tests:
- bleeding time (may be prolonged 1 day after stopping treatment)
- blood sugar content (can be lowered)
- creatinine clearance (can be reduced)
- hematocrit or hemoglobin (may be lowered)
- blood urea (BUN), serum creatinine or serum potassium (may be increased)
- liver function test: elevated levels of transaminase s
Tell your doctor if you are going to submit laboratory samples and if you are using or have recently used ibuprofen.
This medicine is not recommended for children weighing less than 20 kg or younger than 6 years.
There is a risk of impaired kidney function in dehydrated children and adolescents.
Other drugs and Ibuprofen B. Braun
Tell your doctor or nurse if you have recently taken or might take any other medicines.
Ibuprofen B. Braun may affect or be affected by other medicines. For example:
- Other non-steroidal anti-inflammatory drugs ( NSAIDs ), including COX-2 inhibitors (eg celecoxib), may increase the risk of ulceration or bleeding in the gastrointestinal tract due to an additive effect .
- Blood thinners or anticoagulants ( anticoagulants such as acetylsalicylic acid , warfarin , ticlopidine).
- Drugs used to treat heart failure (cardiac glycosides such as digoxin ), to treat epilepsy ( phenytoin ) or to treat depression (lithium), as blood levels may increase during concomitant treatment with ibuprofen .
- Concomitant treatment with a drug used to treat certain types of cancer or rheumatism (methotrexate) and ibuprofen (within 24 hours) may increase methotrexate levels in the blood and toxicity of methotrexate.
- A drug used to terminate a pregnancy (mifepristone).
- A group of medicines used to treat depression ( SSRIs – antidepressants, such as fluoxetine ), may increase the risk of bleeding in the stomach and intestines.
- Drugs that lower high blood pressure ( ACE inhibitors eg captopril , beta blockers eg atenolol, angiotensin II receptor antagonists eg losartan ).
- Drugs used to treat inflammation ( corticosteroids such as hydrocortisone ) because they increase the risk of ulcers or bleeding in the stomach and intestines.
- Diuretics ( diuretics such as bendroflumethiazide), as NSAIDs may reduce the effect of these drugs and increase the risk of kidney problems (concomitant use of potassium-sparing diuretics and ibuprofen may lead to high blood potassium levels).
- Drugs containing probenecid and sulfinpyrazone may delay the excretion of ibuprofen .
- Medicines used to avoid rejection after organ transplantation (cyclosporine and tacrolimus) may increase the risk of kidney damage.
- Medicines used in diabetes (sulphonylureas, eg glibenclamide). Monitoring of blood glucose levels is recommended when taking these medicines at the same time.
- Quinolone antibiotics, e.g. ciprofloxacin due to an increased risk of seizures (seizures).
- Drugs used to treat fungal infections (CYP2C9 inhibitors such as voriconazole, fluconazole ) may increase the concentration of ibuprofen in the blood.
- A drug used in HIV – infection (zidovudine) because of increased risk of blood accumulation in joints and bruising.
- Chronic alcohol consumption can increase the risk of significant side effects in the stomach and intestines, including bleeding.
- One type of antibiotic ( aminoglycoside is). NSAIDs may reduce the excretion of aminoglycosides and increase their toxicity .
- Ginkgo biloba (a natural remedy for dementia) may increase the risk of bleeding.
Some other medicines may also affect or be affected by treatment with ibuprofen. You should therefore always consult your doctor or nurse before taking ibuprofen with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
If you are pregnant, you will only be given ibuprofen if your doctor considers it absolutely necessary. This medicine should not be given to you during the last 3 months of pregnancy.
This medicine passes into breast milk but may be used during breastfeeding if used at the recommended dose for as short a time as possible. However, if it is used in higher doses or for longer periods, your doctor may recommend stopping breastfeeding.
Ibuprofen can make it harder to get pregnant. Tell your doctor if you are planning to have a baby or if you have problems getting pregnant.
Driving and using machines
No special precautions are necessary for short-term or emergency treatment. In long-term treatment, however, side effects such as fatigue and dizziness may occur, which may affect the ability to drive and/or use machines. This is especially true in combination with alcohol.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ibuprofen B. Braun contains sodium
This medicine contains 179 mg of sodium (the main ingredient in table salt/table salt) per 50 ml. This corresponds to 9% of the maximum recommended daily sodium intake for adults.
3. How to get Ibuprofen B. Braun
This medicine is prescribed by a doctor and is given to you by a doctor or nurse in an environment where appropriate equipment is available.
The doctor adjusts the dose individually for you based on your body weight and your general condition.
In children and adolescents, does one of ibuprofen is based on body weight and age, 5‑10 mg/kg body weight as a single dose up to a maximum total daily dose of 30 mg/kg body weight:
- Children weighing 20-29 kg (6-9 years): 200 mg ibuprofen up to 3 times a day, do not exceed the maximum daily dose of 600 mg.
- Children weighing 30-39 kg (10-11 years): 200 mg ibuprofen up to 4 times a day, do not exceed the maximum daily dose of 800 mg.
- Adolescents weighing at least 40 kg (12-17 years): 200-400 mg ibuprofen up to 3 times a day, do not exceed the maximum daily dose of 1200 mg.
This medicine is not recommended for children weighing less than 20 kg or younger than 6 years.
When determining the dosing interval, the patient’s symptoms and the maximum daily dose should be taken into account. The dosing interval should be at least 6 hours. The recommended maximum daily dose should never be exceeded.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact your doctor immediately if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2). Your doctor will also make sure you have enough fluids to reduce the risk of side effects on your kidneys.
You should only be given this medicine if treatment with tablets is not possible. You need to switch to tablet therapy as soon as possible.
This medicine will be given to you in as short a time as possible. The treatment time should not exceed 3 days.
Method of administration
For intravenous use. The solution should be given as an intravenous infusion over 30 minutes.
Inspect the solution before use. The solution should be discarded if particles are visible.
If you are given too much Ibuprofen B. Braun
Because the dose is controlled by a doctor or nurse, it is unlikely that you will receive too much of the solution. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Symptoms may include nausea, stomach pain, vomiting (with blood), headache, ringing in the ears, confusion, lack of coordination ( ataxia ), and jerky involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and difficulty breathing have been reported.
You may also have low blood pressure, bluish discoloration of the skin or mucous membranes (cyanosis), bleeding in the stomach or intestines, and problems with liver or kidney function.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by using the lowest effective dose for the shortest possible time needed to treat the symptoms. You may experience one or more of the known side effects of NSAIDs (see below). If you experience any of these side effects, stop taking this medicine and contact your doctor as soon as possible.
The most commonly observed side effects affect the stomach and intestines. Peptic ulcers (ulcers in the stomach or intestines), holes in the gastrointestinal wall ( perforation ), or bleeding from the stomach or intestines, sometimes life-threatening, may occur. Indigestion, tar-like stools, bloody vomiting, inflammation of the mucous membranes of the mouth with ulceration (ulcerative stomatitis ), worsening inflammation of the colon ( colitis ), and Crohn’s disease have been reported. Gastritis ( gastritis ) has been observed in less common cases. In particular, the risk of gastrointestinal bleeding depends on the dose range and duration of treatment.
Fluid accumulation in the tissues ( edema ), high blood pressure, and heart failure have been reported in association with NSAID treatment. Drugs such as ibuprofen may be associated with a small increased risk of heart attack (heart attack) or stroke.
Very rare cases of severe allergic reactions (including infusion site reactions, anaphylactic shock ) and severe side effects on the skin such as Bladder-forming reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis ( Lyell’s syndrome ), erythema multiforme, and allergic inflammation of blood vessels have been reported.
Very rare cases of exacerbation of inflammation associated with infection (eg development of a tissue-destroying disease called necrotizing fasciitis) that coincide with the use of NSAIDs have been reported.
In rare cases, severe skin infections and soft tissue complications can occur during a chickenpox infection.
Very common side effects (may affect more than 1 in 10 people):
- Fatigue or insomnia, headache and dizziness.
- Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and minor blood loss in the stomach and intestines which in some cases can cause anemia .
Common side effects (may affect up to 1 in 10 people):
- Dizziness.
- Skin reaction.
- Pain and burning sensation at the site of administration.
- Ulcers in the gastrointestinal tract, possibly with bleeding and perforation . Mouth inflammation with ulcers (ulcerative stomatitis ), exacerbated colitis ( colitis ) and Crohn’s disease .
Uncommon side effects (may affect up to 1 in 100 people):
- Difficulty sleeping, agitation, irritability or fatigue, anxiety and restlessness.
- Visual disturbances.
- Earrings ( tinnitus ).
- Decreased urine production and, especially in patients with high blood pressure or kidney problems, symptoms caused by kidney damage ( nephrotic syndrome ), interstitial kidney inflammation that may be accompanied by acute renal failure .
- Hives, itching , red spots on the skin (including allergic purpura), skin rash.
- Allergic reactions with rash and itching , as well as asthma attacks (possibly with a drop in blood pressure).
Rare side effects (may affect up to 1 in 1,000 people):
- Reversible double vision (toxic amblyopia).
- Hearing loss.
- Narrowing of the esophagus (blood vessels in the esophagus), complications with pockets in the colon, nonspecific bleeding colon inflammation characterized by severe cramps and diarrhea. Bleeding in the stomach or intestines can cause anemia .
- Damage to kidney tissue (papillary necrosis ) especially during long-term treatment, increased serum uric acid concentration .
- Yellow skin and whites of the eyes, liver disorder, liver damage, especially when long term therapy, acute liver inflammation ( hepatitis ).
- Psychotic reactions, nervousness, irritability, confusion or disorientation and depression.
- Neck stiffness.
Very rare side effects (may affect up to 1 in 10,000 people):
- Blood disorders ( anemia , leukopenia , thrombocytopenia , pancytopenia, agranulocytosis ). The first symptoms are: fever, sore throat, superficial sores in the mouth, flu-like symptoms , severe fatigue, nosebleeds and bleeding in the skin.
- Rapid heart rate (palpitations), heart failure , heart attack.
- High blood pressure .
- Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or confusion). Patients with autoimmune diseases ( SLE , mixed connective tissue diseases) appear to be more sensitive.
- Inflammation of the esophagus (esophagus) or pancreas, constriction of the intestine.
- Hair loss.
- Photosensitivity and allergic inflammation of blood vessels.
- Asthma , difficulty breathing (bronchial spasm), shortness of breath and wheezing.
- An autoimmune disease called systemic lupus erythematosus, severe allergic reaction ( edema of the face, swelling of the tongue, swelling of the throat with contraction of the airways, difficulty breathing, rapid heart rate, drop in blood pressure and life-threatening shock ).
Has been reported (occurs in an unknown number of users)
- Hepatic impairment.
- Injection site reactions, e.g. swelling, bruising or bleeding.
- A severe skin reaction called DRESS syndrome can occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell ).
- Widespread red, scaly rash with bumps under the skin and blisters mainly in the folds of the skin, on the torso and arms together with fever at the beginning of the treatment ( acute generalized exanthematous pustulosis ). Stop using Ibuprofen B. Braun immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ibuprofen B. Braun
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use immediately after opening. Do not use this medicine if you notice any particles.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
6. Contents of the packaging and other information
Content declaration
- The active substance is ibuprofen . One ml of solution contains 4 mg of ibuprofen . One 50 ml bottle contains 200 mg of ibuprofen .
- The other ingredients are L- arginine , sodium chloride, hydrochloric acid (for pH adjustment ), sodium hydroxide (for pH adjustment ), water for injections.
What the medicine looks like and contents of the pack
Clear and colorless to pale yellow infusion solution, without any particles.
The solution is available in sealed 50 ml LDPE bottles with Twin cap lids. The pack sizes are 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
Postal address:
34209 Melsungen, Germany
Manufacturer
B. Braun Medical, SA
Ctra. Terrasa, 121
Rubí
08191 Barcelona
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
B. Braun Medical AB
Box 110
182 12 Danderyd