Ibuprofen 400 mg solution for infusion – patient leaflet, side effects, dosage

1. 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 symptomatic treatment of acute moderate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified, when other routes of administration are not possible.

2. What you need to know before you are given Ibuprofen

You must not be given Ibuprofen:

• 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 (aspirin) or other similiar painkillers (NSAIDs).
• If you have a condition which increases your tendency or active bleeding.
• If you have active, or history of two or more episodes of painful sores in the stomach lining (stomach ulcer) or stomach 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 loss of total body water (caused by vomiting, diarrhoea or insufficient fluid intake).
• If you are in the last three months 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.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofen and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen and contact immediately your doctor or medical emergencies if you notice any of these signs.

Discuss your treatment with your doctor before receiving Ibuprofen:

• If you have heart problems including heart failure, chest pain (angina), or if you have had a heart attack, bypass surgery, poor circulation in the legs or feet due to narrow or blocked arteries (peripheral artery disease), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
• If you have high blood pressure, diabetes, high levels of a molecule called 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 section of the small intestine (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 have an infection - please see heading “Infections” below.
• If you have kidney disease or liver disease are more than 60 years old or use ibuprofen for a long time, your doctor may need to carry out checks on a regular basis. Your doctor will tell you the frequency of these checks.
• If you have loss of total body water e.g. due to diarrhoea, 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 have an inflammatory bowel disease affecting any part of the gastrointestinal tract from mouth to anus (Crohn’s disease) or which results in inflammation and ulcers of the colon or rectum (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 chickenpox (varicella) as complications can occur.
• If you have a genetic 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 long-term breathing problems (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 controls your pain and are not given this medicine for longer than necessary to control your symptoms.
• There have been few cases of aseptic meningitis with the use of this medicine. The risk is greater if you suffer from an autoimmune disease called systemic lupus erythematosus and related connective tissue diseases.
• The use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

Infections

Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay. In general the routinely use of several sort of painkillers 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. During prolonged ibuprofen administration, regular checking of liver values, kidney function, and blood counts is required.

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 levels of an enzyme called transaminase

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 and 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 used for thinning blood and prevent clotting (e.g. acetylsalicylic acid (aspirin), warfarin, ticlopidine).
• Cardiac glycosides which are used to treat heart failure (such as digoxin), or used to treat epilepsy (such as phenytoin) or used to treat depression (such as lithium), may increase their blood levels when taking with ibuprofen.
• Medicine used to treat certain types of cancers or rheumatism (methotrexate) taken at the same time as ibuprofen (within a range of 24 hours) can increase blood levels and risk of toxicity by methotrexate.
• Medicine to terminate pregnancy (mifepristone).
• Class of drugs used as antidepressants (SSRI-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).
• Anti-inflammatory medicine (corticosteroids, such as hydrocortisone) because they increase the risk of ulcer or bleeding into stomach and intestines.
• Medicines used to increase urine output (diuretics, 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.
• Medicines used to avoid transplantant rejection (ciclosporin and tacrolimus) may increase the risk of kidney damage.
• Medicines used for treatment of diabetes (sulfonylureas, such as glibenclamide). 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 fits (seizures).
• Medicines used for fungal infection (CYP2C9 inhibitors such as voriconazole, fluconazole) can increase blood levels of ibuprofen.
• Medicine used for treatment of HIV infection (zidovudine) due to increased risk of blood accumulation in joints and bruises.
• A type of antibiotics called aminoglycosides. 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.

Pregnancy

You must not be given this medicine during the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.

You should not receive ibuprofen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used.

IV (intravenous) ibuprofen treatment should not exceed 3 days. If taken for more than a few days from 20 weeks of pregnancy onward, ibuprofen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breast-feeding

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.

Fertility

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

This medicine, in single or short term use has no or negligible influence on the ability to drive and use machines. However, the occurrence of relevant side effects such as fatigue and vertigo can impair reactivity and the ability to drive a vehicle and/or use machines may be reduced. This particularly applies when combined with alcohol.

Ibuprofen contains sodium. This medicinal product contains 358 mg sodium (component of cooking/table salt) per 100 ml. This is equivalent to 17.9 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How Ibuprofen will be given to you

This medicine is prescribed to you only by a doctor and is only given to you by a doctor or nurse in an environment with appropriate equipment.

B|BRAUN B. Braun Melsungen AG

34209 Melsungen, Germany

0664/12632548/1124

The recommended dose for adults is 400 mg by a vein drip (a drip into a vein), every 6 to 8 hours as necessary. The maximum daily dose of 2400 mg should not be exceeded.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). Your doctor will also make sure that you have had enough fluids in order to minimize the 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 a vein drip over 30 minutes. This medicinal product is indicated for use as a single dose. Inspect the solution before use. It should be discarded if any particulate matter or discolouration is observed.

If you are given more Ibuprofen than you should

As your dose is controlled by a doctor, pharmacist or nurse, it is unlikely that you will be given too much of this solution. If you think you have been given more ibuprofen than you should immediately consult your doctor or nurse.

The symptoms of overdose can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), inability to co-ordinate muscle movements, weakness and dizziness, blood in urine, low levels of potassium in your blood, cold body feeling, and breathing problems have been reported. You might also suffer from low blood pressure, blueish colouration of the skin or mucous membranes (cyanosis), bleeding into stomach or intestines, as well as functional problems of the liver and kidneys. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 using this medicine and consult a doctor as soon as possible. Elderly patients who use 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), hole in the wall of the stomach or intestine (perforation) 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, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), exacerbation of inflammation of large intestine (colitis) and an inflammatory bowel disease affecting any part of the gastrointestinal tract from mouth to anus (Crohn’s disease). Less frequently, stomach inflammation (gastritis) has been observed. Particularly the risk of bleeding into stomach and intestines occurring is dependent on the dose range and the duration of use.

Fluid accumulation in the tissues (oedema), 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, alopecia (hair loss), skin becomes sensitive to light and allergic vasculitis (inflammation of a blood vessel) have been reported. Stop using ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).

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 chickenpox (varicella) infection. Ibuprofen, especially when received at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood. This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Very common side effects (may affect more than 1 in 10 people):

• Tiredness or sleeplessness, headache and dizziness.
• Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and slight blood losses in stomach and intestines that may cause reduced number of red blood cells (anaemia) in exceptional cases.

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

• Vertigo.
• Skin eruption.
• Pain and burning sensation at the administration site.
• Gastrointestinal ulcer, potentially with bleeding and perforation. Inflammation of the oral mucosa with ulceration (ulcerative stomatitis), exacerbation of inflammation of large intestine (colitis) and an inflammatory bowel disease affecting any part of the gastrointestinal tract from mouth to anus (Crohn’s disease).

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

• Sleeping problems (insomnia), agitation, irritability or tiredness, anxiety and restlessness.
• Visual disturbances.
• Ringing or buzzing in the ears (tinnitus ).
• Inflammation of the stomach lining.
• Reduced production of urine and formation of oedemas, particularly in patients with high blood pressure or kidney problems, symptoms due to kidney damage (nephrotic syndrome), inflammation of the kidneys (interstitial nephritis) that may be accompanied by acute renal insufficiency.
• Hives (urticaria), itch (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 double vision (toxic amblyopia).
• Difficulty hearing.
• Narrowing of the oesophagus (blood vessels in gullet), complications of pouches (diverticula) of the large bowel, unspecific acute digestive disorder caused by bacteria (haemorrhagic colitis). If there is bleeding into stomach or intestines, it can cause anaemia.

• 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 inflammation of the liver (hepatitis).
  • Psychotic reactions, nervousness, irritability, confusion or disorientation and depression.
  • Stiff neck.

Very rare side effects (may affect up to 1 in 10,000 people):

• 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.
• Rapid heartbeat (palpitations), heart failure, myocardial infarction.
• High blood pressure in the arteries (arterial hypertension)
• Inflammation of the linings of the brain, which is not caused by bacteria (aseptic meningitis). Symptoms are 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 (bronchospasm), shortness of breath and wheezing.
• An autoimmune disease called systemic lupus erythematosus, 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):

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Liver insufficiency.
• Reactions at injection sites such as swelling, bruising or bleeding.
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen 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. 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 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 Ibuprofen

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions.

The product should be used immediately after opening. For single use only. Any unused solution should be discarded. 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 discolouration.

6. Contents of the pack and other information

What Ibuprofen contains

• The active substance is ibuprofen. Each 100 ml bottle contains 400 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

Clear and colourless to pale yellow solution for infusion, without any particulate matter.

The solution is contained in closed LDPE bottles of 100 ml 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

Manufacturer

B. Braun Medical, S.A.

Ctra. Terrasa, 121

Rubí

08191 Barcelona – Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (GB and NI) under the following names:

Austria: Ibuprofen B. Braun 400 mg Infusionslösung Belgium: Ibuprofen B. Braun 400 mg oplossing voor infusie.

Bulgaria: Ибупрофен Б. Браун 400 mg/100 ml инфузионен Czech Republic: Ibuprofen B. Braun

Germany: Ibuprofen B. Braun 400 mg Infusionslösung Denmark: Ibuprofen B. Braun 400 mg infusionsvæske, opløsning Estonia: Ibuprofen B. Braun, 400 mg infusioonilahus Spain: Ibuprofeno B. Braun 400 mg solución para perfusión Finland: Ibuprofen B. Braun 400 mg infuusioneste, liuos France: Ibuprofène B. Braun 400 mg, solution pour perfusion Hungary: Ibuprofen B. Braun 400 mg oldatos infúzió Croatia: Ibuprofen B. Braun 400 mg otopina za infuziju Ireland: Ibuprofen B. Braun 400 mg solution for infusion

Italy: Ibuprofene B. Braun 400 mg Soluzione per infusione Luxembourg: Ibuprofen B. Braun

Latvia: Ibuprofen B. Braun 400 mg šķīdums infūzijām Lithuania: Ibuprofen B. Braun 400 mg infuzinis tirpalas Netherlands: Ibuprofen B. Braun 400 mg oplossing voor infusie

Norway: Ibuprofen B. Braun 400 mg infusjonsvæske, oppløsning Poland: Ibuprofen B. Braun

Portugal: Ibuprofeno B. Braun 400 mg solução para perfusão

Romania: Ibuprofen B. Braun 400 mg soluţie perfuzabilă Sweden: Ibuprofen B. Braun 400 mg infusionsvätska, lösning

Slovenia: Ibuprofen B. Braun 400 mg raztopina za infundiranje Slovakia: Ibuprofen B. Braun

United Kingdom

(GB and NI): Ibuprofen 400 mg Solution for Infusion

This leaflet was last revised in 11/2024