Ibuprofen b. braun

Package leaflet: Information for the patient

Ibuprofen B. Braun, 400 mg/100 mL, infusion solution
Ibuprofen
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet

1. What Ibuprofen B. Braun is and what it is used for
2. Important information before receiving Ibuprofen B. Braun
3. How to use Ibuprofen B. Braun
4. Possible side effects
5. How to store Ibuprofen B. Braun
6. Contents of the pack and other information

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 (NSAIDs).
This medicine is indicated for short-term symptomatic treatment of moderate acute pain and for short-term symptomatic treatment of fever in adults, when intravenous administration is clinically justified due to the inability to use other routes of administration.

2. Important information before using Ibuprofen B. Braun

When not to use Ibuprofen B. Braun:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever previously experienced breathlessness, asthma, skin rash, nasal congestion, or facial swelling after taking ibuprofen, acetylsalicylic acid, or other similar pain-relieving medicines (NSAIDs);
• if the patient has a condition causing a tendency to bleeding or active bleeding;
• if the patient currently has (or has had more than twice in the past) a stomach ulcer or gastrointestinal bleeding;
• if the patient has ever previously experienced bleeding or perforation of the stomach or intestines while taking NSAIDs;
• if the patient has bleeding within the brain or any other active bleeding;
• if the patient suffers from severe kidney, liver, or heart disease;
• if the patient is severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake);
• if the patient is in the last trimester of pregnancy.

Warnings and precautions
Before starting treatment with Ibuprofen B. Braun, discuss this with your doctor or nurse.
Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), have been reported in association with the use of Ibuprofen B. Braun. If the patient notices any symptoms related to these severe skin reactions described in section 4, they should stop taking Ibuprofen B. Braun immediately and seek medical help without delay.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, treatment with Ibuprofen B. Braun should be stopped immediately and the patient should contact a doctor or emergency services without delay.
Before using Ibuprofen B. Braun, the patient should discuss treatment with their doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA);
• the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• the patient has recently undergone major surgery;
• the patient has ever had a stomach or duodenal ulcer, gastrointestinal bleeding, or perforation of the stomach or duodenum. In such cases, the doctor may consider prescribing a medicine to protect the stomach;
• the patient has asthma or other respiratory disorders;
• the patient is being treated for an infection – see section “Management during infections”;
• the patient has kidney or liver disease, is over 60 years old, or is taking ibuprofen long-term – in such cases, the doctor may perform regular monitoring tests. The doctor will inform the patient about the frequency of these tests;
• the patient is dehydrated, e.g. due to diarrhoea; in this case, the patient should drink plenty of fluids and contact a doctor promptly, as ibuprofen may cause kidney failure due to dehydration;
• the patient has Crohn’s disease or ulcerative colitis – because ibuprofen may worsen these conditions;
• the patient notices any injury, swelling, or redness of the skin, or develops breathing difficulties (dyspnoea), administration of the medicine should be stopped immediately and the patient should contact a doctor or nurse;
• the patient has chickenpox – as complications may occur with use of this medicine;
• the patient has a diagnosed congenital porphyria metabolism disorder (e.g. acute intermittent porphyria);
• the patient consumes alcohol around the same time as taking this medicine, which may increase the risk of adverse effects in the stomach, intestines, and nervous system;
• the patient has hay fever, nasal polyps, or chronic respiratory diseases with obstructive breathing disorders – as these patients have an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), sudden swelling (angioedema), or skin rash;
• it is very important that the patient receives the lowest effective dose providing relief from pain and that the medicine is not used for longer than necessary to control symptoms;
• several cases of aseptic meningitis have been reported during treatment with this medicine. The risk of this complication is higher in patients with systemic lupus erythematosus and similar connective tissue diseases;
• concurrent use of this medicine with other NSAIDs, including selective COX-2 inhibitors, should be avoided.

Management during infections
Ibuprofen B. Braun may mask symptoms of infection such as fever and pain. Therefore, treatment with Ibuprofen B. Braun may delay appropriate treatment of infections, potentially increasing the risk of complications. This has been observed in patients with bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is using this medicine during an infection and infection symptoms persist or worsen, medical advice should be sought immediately.
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to control symptoms.
Generally, habitual use of (multiple types of) painkillers may lead to permanent, severe kidney damage.
Long-term use of painkillers may cause headaches, which should not be treated with increased doses of this medicine.
Ibuprofen may affect the following laboratory tests:

• bleeding time (may be prolonged for up to 24 hours after stopping this medicine);
• blood glucose levels (may decrease);
• creatinine clearance (may decrease);
• haematocrit or haemoglobin concentration (may decrease);
• blood urea nitrogen levels and serum creatinine and potassium levels (may increase);
• increased hepatic aminotransferase activity. The patient should inform their doctor if they are scheduled for laboratory tests and are currently taking or have recently taken ibuprofen.

Children and adolescents
The safety and efficacy of Ibuprofen B. Braun in children and adolescents have not been established. This medicine should not be used in children and adolescents (under 18 years of age).

Ibuprofen B. Braun and other medicines
Inform your doctor or nurse about all medicines currently or recently taken, as well as any medicines you plan to take.
Below are some medicines that may interact with Ibuprofen B. Braun or whose effects may be affected by it. For example:
­ other NSAIDs, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to additive effects;
­ anticoagulant medicines (blood thinners and medicines preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine);
­ cardiac glycosides, e.g. digoxin (used in heart failure treatment), phenytoin (used in epilepsy treatment), and lithium salts (used in depression treatment) may have increased blood concentrations when used concomitantly with ibuprofen;
­ methotrexate (used in the treatment of certain malignant tumours and rheumatic diseases) taken at the same time as ibuprofen (within 24 hours of each other) may increase its blood concentration and intensify its toxic effects;
­ mifepristone (a medicine used for medical abortion);
­ antidepressants of the SSRI class, e.g. fluoxetine, may also increase the risk of gastrointestinal bleeding;
­ antihypertensive medicines (ACE inhibitors, e.g. captopril; beta-blockers, e.g. atenolol; angiotensin II receptor antagonists, e.g. losartan);
­ corticosteroids (e.g. hydrocortisone) (used in inflammatory diseases) – as they increase the risk of stomach and intestinal ulcers and gastrointestinal bleeding;
­ diuretics (water tablets, e.g. bendroflumethiazide) – because NSAIDs may reduce the effectiveness of these medicines and increase the risk of kidney damage (concomitant use of potassium-sparing diuretics with ibuprofen may lead to elevated blood potassium levels);
­ medicines containing probenecid or sulfinpyrazone may slow down the elimination of ibuprofen from the body;
­ cyclosporine and tacrolimus (medicines used to prevent transplant rejection) may increase the risk of kidney damage;
­ sulfonylurea derivatives, e.g. glibenclamide (medicines used in diabetes treatment). Blood glucose monitoring is recommended during concomitant use;
­ quinolone antibiotics, e.g. ciprofloxacin – due to increased risk of seizures;
­ voriconazole, fluconazole (CYP2C9 inhibitors used in fungal infections) may increase ibuprofen blood levels;
­ zidovudine (used in HIV infection) – due to increased risk of joint haemorrhages and bruising;
­ aminoglycoside antibiotics (a class of antibiotics). NSAIDs may impair the elimination of aminoglycoside antibiotics;
­ herbal preparations containing Ginkgo biloba extract (herbal remedies often used in dementia) may increase the risk of bleeding.
Other medicines may also interact with or be affected by Ibuprofen B. Braun. Therefore, always consult a doctor or pharmacist before using Ibuprofen B. Braun with other medicines.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or nurse before using this medicine.
Pregnancy
This medicine must not be given to women during the last three months of pregnancy. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
Ibuprofen is not recommended during the first six months of pregnancy unless the doctor considers it absolutely necessary. If ibuprofen is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
Intravenous ibuprofen treatment should not last longer than 3 days. If ibuprofen is administered beyond the 20th week of pregnancy for more than a few days, it may cause impaired kidney function in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios). It may also cause narrowing of a blood vessel (ductus arteriosus) in the child's heart. If ibuprofen treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration. However, if this medicine is used at doses exceeding 1200 mg per day or for prolonged periods, the doctor may recommend discontinuing breastfeeding.
Fertility
Ibuprofen may impair fertility. If the patient is planning to conceive or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
When this medicine is used occasionally or for a short duration, no special precautions are required. However, during prolonged treatment, adverse effects such as fatigue and dizziness may impair the ability to drive or operate machinery. This is particularly important when alcohol is consumed concurrently.

Ibuprofen B. Braun contains sodium. One 100 ml bottle contains 358 mg of sodium (the main component of table salt). This corresponds to 17.9% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ibuprofen B. Braun

This medicine may only be prescribed by a doctor and must be administered solely by a doctor or nurse in a setting where appropriate equipment is available.
The recommended dose for adults is 400 mg intravenously (an intravenous infusion given directly into a vein). A subsequent dose of 400 mg may be administered after 6 to 8 hours, depending on the patient's condition and response to treatment. The maximum daily dose of 1200 mg must not be exceeded.
The doctor will administer the lowest effective dose to the patient for the shortest possible duration necessary to relieve symptoms. If the patient has a concurrent infection, medical advice must be sought immediately if symptoms (such as fever and pain) persist or worsen. Additionally, the doctor will ensure that the patient receives adequate fluid intake to minimize the risk of renal adverse effects.
Use should be restricted to situations where oral administration is not appropriate. Patients should switch to oral therapy as soon as possible.
This medicine is indicated for short-term treatment of acute symptoms and should not be used for longer than 3 days.
Method of administration
Intravenous administration. The solution should be given as a 30-minute intravenous infusion. The solution should be visually inspected prior to use. Do not use if particulate matter or discoloration is observed.
Overdose of Ibuprofen B. Braun
If the patient suspects that a higher than recommended dose of ibuprofen has been administered, contact a doctor or nurse immediately.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
There may also be a drop in blood pressure, bluish discoloration of the skin or mucous membranes (cyanosis), gastrointestinal bleeding, as well as disturbances in liver and kidney function.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. The patient may experience one or more of the adverse effects so far identified as typical for NSAIDs (see below). If any of the listed adverse effects occur, treatment with this medicine should be discontinued and medical advice should be sought as soon as possible. Elderly patients taking this medicine are at increased risk of developing problems associated with these adverse effects.

The most commonly observed adverse events involve the gastrointestinal system (stomach and intestines). Gastrointestinal ulcers (stomach or intestinal ulcers), perforation (puncturing of the stomach or intestinal wall), or bleeding from the stomach or intestines may occur, in some cases fatal, particularly in elderly patients. Nausea, vomiting, diarrhoea, bloating, constipation, indigestion, abdominal pain, black tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis, and Crohn's disease may occur. Gastric mucosal inflammation has been reported less frequently. The risk of gastrointestinal bleeding is particularly dependent on the dose range administered and duration of treatment.

Use of NSAIDs has been associated with cases of oedema (fluid accumulation in tissues), hypertension, and heart failure. Use of drugs such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke.

Very rarely, severe allergic reactions (including infusion site reactions, anaphylactic shock) and serious skin reactions, alopecia (hair loss), photosensitivity skin reactions, and allergic vasculitis have been reported.

Treatment with ibuprofen should be discontinued and immediate medical help sought if any of the following symptoms occur:

• Red, non-elevated, round or target-like skin lesions on the trunk, often with central blisters, skin peeling, and ulceration of the mouth, throat, nose, genital organs, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome);
• Widespread red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Exacerbation of infection-related inflammatory conditions (e.g. necrotizing fasciitis) has been reported with the use of NSAIDs. In exceptional cases during chickenpox, severe skin infections and complications involving subcutaneous tissue may occur.

Adverse effects very commonly occurring (may affect more than 1 in 10 people):

• Fatigue or insomnia, headache, dizziness.
• Heartburn, abdominal pain, nausea, vomiting, bloating, diarrhoea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anaemia.

Adverse effects commonly occurring (may affect up to 1 in 10 people):

• Dizziness.
• Skin rash.
• Pain and burning sensation at the site of administration.
• Gastrointestinal ulcers, which may lead to bleeding and perforation. Ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease.

Adverse effects occurring not very commonly (may affect up to 1 in 100 people):

• Insomnia, psychomotor agitation, irritability or fatigue, anxiety and motor restlessness.
• Visual disturbances.
• Tinnitus (ringing or buzzing in the ears).
• Reduced urine output, and particularly in patients with hypertension or kidney disease, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure.
• Urticaria, itching, purpura (including allergic purpura), skin rash.
• Allergic reactions with skin changes and itching, and asthma attacks (which may be accompanied by decreased blood pressure).

Adverse effects occurring rarely (may affect up to 1 in 1000 people):

• Reversible toxic visual impairment (double vision).
• Hearing problems.
• Oesophageal stricture (narrowing of oesophageal blood vessels), complications of colonic diverticulosis, non-specific haemorrhagic colitis. Anaemia may develop if gastrointestinal bleeding occurs.
• Kidney tissue damage (papillary necrosis), particularly with prolonged use of the medicine, increased serum uric acid levels.
• Jaundice (yellowing of the skin or sclera of the eyes), liver dysfunction, liver damage, particularly with prolonged use of the medicine, acute hepatitis.
• Psychotic reactions, nervousness, irritability, confusion or disorientation, and depression.
• Neck stiffness.

Adverse effects occurring very rarely (may affect up to 1 in 10,000 people):

• Blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and subcutaneous bleeding.
• Palpitations (rapid heartbeat), heart failure, myocardial infarction.
• Hypertension.
• Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or confusion). Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly predisposed.
• Oesophagitis or pancreatitis, intestinal stricture.
• Asthma, breathing difficulty (bronchospasm), dyspnoea, and wheezing.
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reactions (facial swelling, tongue swelling, swelling of the inner larynx and associated airway narrowing, dyspnoea, rapid heartbeat, decreased blood pressure, and life-threatening shock).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.
• Liver failure.
• Injection site reactions, e.g. swelling, bruising, or bleeding.
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with Ibuprofen B. Braun should be discontinued immediately and medical help sought without delay. See also section 2.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Ibuprofen B. Braun

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the label following the abbreviation "EXP".
The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
Do not use this medicine if you notice solid particles or a change in colour.

6. Contents of the pack and other information

What Ibuprofen B. Braun contains

• The active substance is ibuprofen. Each 100 mL bottle contains 400 mg of ibuprofen.
• The other components are: arginine, sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.

What Ibuprofen B. Braun looks like and contents of the pack
Ibuprofen B. Braun is a clear, colourless to pale yellow infusion solution free from visible particles.
The solution is contained in 100 mL LDPE bottles with Twincap closure, packed in packs of 10 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 further information, contact the local representative of the Marketing Authorisation Holder:
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: