Ibuprofen B. Braun

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Ibuprofen B. Braun, 600 mg/100 mL, solution for infusion

Ibuprofen

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ibuprofen B. Braun and what is it used for
• 2. Important information before using 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 packaging and other information

1. What is Ibuprofen B. Braun and what is it used for

Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
This medicine is indicated for use in adults for the short-term symptomatic treatment of moderate acute pain
in situations where 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 hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had dyspnea, asthma, skin rash, hay fever, or facial edema after using ibuprofen, acetylsalicylic acid, or other similar painkillers (from the NSAID group);
• if the patient has a condition that causes a tendency to bleed or active bleeding;
• if the patient currently has (or has had more than twice in the past) stomach or gastric ulcer bleeding;
• if the patient has ever had gastric or intestinal bleeding or perforation while taking NSAIDs;
• if the patient has cerebral bleeding or other active bleeding;
• if the patient has severe kidney, liver, or heart disease;
• if the patient is severely dehydrated (due to vomiting, diarrhea, or inadequate fluid intake);
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Ibuprofen B. Braun, the patient should discuss it with their 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, especially when used in high doses. Do not exceed the recommended dose and 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 generalized exanthematous pustulosis (AGEP), have been reported 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 using Ibuprofen B. Braun and seek medical attention immediately.
Allergic reactions to this medicine, including breathing problems, facial swelling, and chest pain, have been reported. If any of these symptoms occur, the patient should stop using Ibuprofen B. Braun immediately and contact their doctor or emergency services.
Before using Ibuprofen B. Braun, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries) or have had a stroke (including mini-stroke or transient ischemic attack - TIA);
• they have high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or if they smoke;
• they have recently undergone major surgery;
• they have ever had stomach or duodenal ulcers, stomach or duodenal bleeding, or perforation. In these cases, the doctor will consider the need to prescribe a medicine to protect the stomach;
• they have asthma or other respiratory diseases;
• they are being treated for an infection - see "Procedure in case of infections";
• they have kidney or liver disease, are over 60 years old, or are taking ibuprofen for a long time - in these cases, the doctor may regularly perform control tests. The doctor will inform the patient about the frequency of these tests;
• they are dehydrated, for example due to diarrhea, in which case they should drink plenty of fluids and contact their doctor immediately, as ibuprofen may cause kidney failure due to dehydration;
• they have Crohn's disease or ulcerative colitis - as ibuprofen may worsen the course of these diseases;
• they notice any injuries, swelling, or redness of the skin, experience difficulty breathing (dyspnea), or the infusion should be stopped immediately and the doctor or nurse contacted;
• they have chickenpox - as the use of this medicine may lead to complications;
• they have been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria);
• they consume alcohol at about the same time as this medicine is administered, which may increase the risk of adverse reactions in the stomach, intestines, and nervous system;
• they have hay fever, nasal polyps, or chronic respiratory diseases with breathing difficulties of an obstructive type - as these patients are at increased risk of allergic reactions.

Allergic reactions can occur in the form of asthma attacks (so-called analgesic asthma), sudden swelling (angioedema), or rash;
It is very important that the patient receives the smallest possible dose that provides relief and control of pain and that they do not receive this medicine for longer than necessary to control the symptoms;
There have been reports of aseptic meningitis during the use of this medicine. The risk of this complication is higher in patients with systemic lupus erythematosus and similar connective tissue diseases;
Avoid concurrent use of this medicine and other NSAIDs, including selective cyclooxygenase-2 inhibitors.

• Other medicines that may interact with Ibuprofen B. Braun or be affected by it include:

Other medicines may also be affected by or affect the treatment with Ibuprofen B. Braun. Therefore, before using Ibuprofen B. Braun with other medicines, the patient should always consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or nurse before using this medicine.
Pregnancy
This medicine should not be given to women during the last 3 months of pregnancy. It may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong or delay labor.
The use of ibuprofen is not recommended during the first 6 months of pregnancy, unless the doctor considers it absolutely necessary. If it is necessary to use ibuprofen during this period or while trying to conceive, the smallest possible dose should be used for the shortest possible time.
Intravenous treatment with ibuprofen should not last longer than 3 days. If ibuprofen is administered for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios). It may also cause narrowing of the blood vessel (ductus arteriosus) in the child's heart. If the use of ibuprofen for a longer period than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk, but it can be used during breastfeeding if the recommended dose is used and for the shortest possible time. However, if this medicine is used in doses higher than 1200 mg per day or for a long time, the doctor may recommend stopping breastfeeding.
Fertility
Ibuprofen may make it harder to get pregnant. If the patient plans to get pregnant or is having trouble getting pregnant, they should tell their doctor.

Driving and using machines

In the case of single or short-term use of this medicine, there is no need to take any precautions. However, in the case of longer treatment, the occurrence of side effects, such as fatigue and balance disorders, may impair the ability to drive vehicles and/or operate machines. This is especially important when consuming alcohol.
Ibuprofen B. Braun contains sodium.This medicine contains 360 mg of sodium (the main component of common salt) per vial. This corresponds to 18.0% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ibuprofen B. Braun

This medicine can only be prescribed by a doctor and can only be administered by a doctor or nurse in a place where proper equipment is available.
The recommended dose for adults is 600 mg intravenously (infusion administered directly into a vein), and a second dose of 600 mg can be administered after 6 to 8 hours, depending on the patient's condition and response to treatment. The maximum daily dose should not exceed 1200 mg.
The doctor will administer the smallest effective dose to the patient for the shortest possible time necessary to relieve the symptoms. If the patient has a concurrent infection, they should consult their doctor immediately if the symptoms (such as fever and pain) persist or worsen. Additionally, the doctor will ensure that the patient receives sufficient fluids to minimize the risk of adverse reactions in the kidneys.
Use should be limited to situations where oral administration is not appropriate.
Patients must switch to oral treatment as soon as possible.
The medicine is indicated for short-term treatment of acute symptoms and should not be used for more than 3 days.

Method of administration

Intravenous administration. The solution should be administered in an intravenous infusion lasting 30 minutes. Before use, a visual inspection of the solution should be performed. Do not use if particles or color changes are observed.

Overdose of Ibuprofen B. Braun

If the patient thinks they have been given a higher dose of ibuprofen than they should have, they should contact their doctor or nurse.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, dizziness, and disorientation. After taking a large dose, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties.
It may also lead to a drop in blood pressure, bluish discoloration of the skin or mucous membranes (cyanosis), gastric or intestinal bleeding, and liver or kidney dysfunction.

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 smallest effective dose for the shortest possible time necessary to treat the symptoms. The patient may experience one or more of the identified side effects typical of NSAIDs (see below). If any of the listed side effects occur, the patient should stop using this medicine and contact their doctor as soon as possible. Elderly people using this medicine are at increased risk of experiencing these side effects.
The most common adverse events observed are related to the gastrointestinal system (stomach and intestines). There may be development of gastrointestinal ulcers (stomach or intestinal ulcers), perforation, or gastrointestinal bleeding, which in some cases can be fatal, especially in elderly patients. Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, vomiting blood, oral ulceration, exacerbation of ulcerative colitis and Crohn's disease. Rarely, gastric mucosal inflammation has been reported.
In association with the use of NSAIDs, there have been reports of edema (fluid accumulation in tissues), hypertension, and heart failure. The use of such medicines as ibuprofen may be associated with a slightly increased risk of heart attack or stroke.
Very rarely, severe allergic reactions (including infusion site reactions, anaphylactic shock), as well as severe skin reactions, hair loss, photosensitivity reactions, and allergic vasculitis have been reported.

• The patient should stop using ibuprofen and seek medical attention immediately if they notice any of the following symptoms:

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

• Fatigue or insomnia, headache, balance disorders.
• Heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding that may rarely lead to anemia.

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

• Dizziness.
• Skin rash.
• Pain and burning sensation at the infusion site.
• Gastrointestinal ulcers, which may lead to bleeding and perforation. Oral ulceration, exacerbation of ulcerative colitis and Crohn's disease.

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

• Insomnia, restlessness, irritability, or fatigue, anxiety, and agitation.
• Visual disturbances.
• Tinnitus (ringing or buzzing in the ears).
• Reduced urine production and, especially in patients with hypertension or kidney disease, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure.
• Urticaria, itching, purpura (including allergic purpura), skin rash.
• Allergic reactions with skin and mucous membrane lesions and itching, as well as asthma attacks (which may be accompanied by a drop in blood pressure).

Rare side effects (may affect up to 1 in 1,000 people):

• Reversible toxic amblyopia (double vision).
• Hearing problems.
• Esophageal or pancreatic inflammation, intestinal stricture. In case of gastrointestinal bleeding, anemia may develop.
• Kidney tissue damage (renal papillary necrosis), especially with long-term use, increased blood urea nitrogen and creatinine levels.
• Jaundice or liver dysfunction, especially with long-term use, acute liver failure.
• Psychotic reactions, nervousness, irritability, confusion, or disorientation and depression.
• Stiffness of the neck.

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 mouth ulcers, flu-like symptoms, increased fatigue, nosebleeds, and subcutaneous bleeding.
• Rapid heartbeat (tachycardia), heart failure, myocardial infarction.
• Hypertension.
• Aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever, or confusion). This is especially true for patients with autoimmune diseases (SLE, mixed connective tissue disease).
• Esophageal or pancreatic inflammation, intestinal stricture.
• Asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing.
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reactions (facial swelling, tongue swelling, swelling of the inner part of the larynx, and accompanying narrowing of the airways, shortness of breath, rapid heartbeat, drop in blood pressure, and life-threatening shock).

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

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
• Liver failure.
• Infusion site reactions, such as swelling, hematoma, or bleeding.
• Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• A red, scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop using Ibuprofen B. Braun and seek medical attention immediately. See also section 2.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ibuprofen B. Braun

The medicine should be stored out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the label after the abbreviation "EXP".
The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after the abbreviation "Lot".
Do not use this medicine if particles or color changes are observed.

6. Contents of the packaging and other information

What Ibuprofen B. Braun contains

• The active substance of the medicine is ibuprofen. Each 100 mL vial contains 600 mg of ibuprofen.
• The other ingredients 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, colorless to pale yellow solution for infusion that does not contain particles.
The solution is contained in 100 mL LDPE bottles with a Twincap closure, in packs of 10 and 20 bottles.
Not all pack sizes may be marketed.

Marketing authorization 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 more detailed information, please contact the local representative of the marketing authorization holder:

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 11-10-2024