IBUPROFEN 400 mg /100 Ml Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: patient information
3. Ibuprofen B. Braun, 400 mg/100 mL, solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Ibuprofen B. Braun and what is it used for
5. Important information before using Ibuprofen B. Braun
   1. When not to use Ibuprofen B. Braun:
   2. Warnings and precautions
   3. Children and adolescents
   4. Ibuprofen B. Braun and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
6. How to use Ibuprofen B. Braun
   1. Method of administration
   2. Use of a higher dose of Ibuprofen B. Braun than recommended
7. Possible side effects
   1. Reporting side effects
8. How to store Ibuprofen B. Braun
9. Contents of the packaging and other information
   1. What Ibuprofen B. Braun contains
   2. What Ibuprofen B. Braun looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: 11-10-2024

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Ibuprofen B. Braun, 400 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
and for the short-term symptomatic treatment of fever - 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 taking 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 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 medications, such as ibuprofen, may be associated with a slight increase in the 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 have been reported, including breathing problems, facial and neck swelling (angioedema), and chest pain. 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:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has 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 ischemic attack - TIA);
• the patient has high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or smokes;
• the patient has recently undergone major surgery;
• the patient has ever had stomach or duodenal ulcers, stomach or duodenal bleeding, or stomach or duodenal perforation. In these cases, the doctor will consider the appropriateness of prescribing a medicine to protect the stomach;
• the patient has asthma or other respiratory diseases;
• the patient is being treated for an infection - see "Procedure in case of infections";
• the patient has kidney or liver disease, is over 60 years old, or is taking ibuprofen for a long time - in this case, the doctor may regularly subject the patient to check-ups. The doctor will inform the patient about the frequency of these check-ups;
• the patient is dehydrated, e.g., due to diarrhea, and should drink plenty of fluids and contact their doctor immediately, as ibuprofen may cause kidney failure due to dehydration;
• the patient has Crohn's disease or ulcerative colitis - as ibuprofen may exacerbate the course of these diseases;
• the patient notices any injuries, swelling, or redness of the skin, starts to experience breathing difficulties (dyspnea), and should stop the infusion and contact their doctor or nurse immediately;
• the patient has chickenpox - as the use of this medicine may lead to complications;
• the patient has been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria);
• the patient consumes alcohol at about the same time as this medicine is administered, which may increase the risk of adverse effects on the stomach, intestines, and nervous system;
• the patient has 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 manifest as 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 controls 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;
• the patient should avoid concomitant use of this medicine and other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Procedure in case of infections
Ibuprofen B. Braun may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that the use of Ibuprofen B. Braun may delay proper treatment of the infection, which may lead to an increased risk of complications. This phenomenon has been observed in patients with bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to control the symptoms.
Generally, habitual use (of several types) of painkillers can lead to permanent severe kidney damage.
Long-term use of painkillers can 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 discontinuation of this medicine);
• blood glucose level (may decrease);
• creatinine clearance (may decrease);
• hematocrit or hemoglobin level (may decrease);
• blood urea nitrogen and serum creatinine and potassium levels (may increase);
• increased liver transaminase activity. The patient should inform their doctor if they are to undergo laboratory tests and are 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

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some other medicines may interact with Ibuprofen B. Braun or 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 that prevent blood clots, such as acetylsalicylic acid, warfarin, ticlopidine);
• cardiac glycosides, such as digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), and lithium salts (used to treat depression) may increase their blood levels when used concomitantly with ibuprofen;
• methotrexate (used to treat certain cancers and rheumatic diseases) taken at the same time as ibuprofen (with an interval of up to 24 hours between administration of one and the other) may increase its blood level and enhance the risk of toxic effects;
• mifepristone (a medicine used to terminate pregnancy);
• selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, may also increase the risk of gastrointestinal bleeding;
• blood pressure-lowering medicines (ACE inhibitors, such as captopril; beta-adrenergic blockers, such as atenolol; angiotensin II receptor antagonists, such as losartan);
• corticosteroids (e.g., hydrocortisone) (used in inflammatory diseases) - as they increase the risk of stomach and intestinal ulcers and bleeding;
• diuretics (diuretics, e.g., bendroflumethiazide) - as NSAIDs may weaken their effect and increase the risk of kidney damage (concomitant use of potassium-sparing diuretics with ibuprofen may lead to increased potassium levels in the blood);
• 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, such as glibenclamide (medicines used to treat diabetes). When using these medicines with Ibuprofen B. Braun, it is recommended to monitor blood glucose levels;
• quinolone antibiotics, such as ciprofloxacin - due to the increased risk of seizures;
• voriconazole, fluconazole (CYP2C9 inhibitors used in fungal infections) may increase the blood level of ibuprofen;
• zidovudine (used in HIV infection) - due to the increased risk of joint effusions and bruising;
• aminoglycoside antibiotics (a type of antibiotic). NSAIDs may impair the elimination of aminoglycoside antibiotics;
• preparations containing Ginkgo biloba extract (herbal preparations often used in dementia) may increase the risk of bleeding.

Also, some other medicines may be affected by or have an effect on 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 during the first 6 months of pregnancy is not recommended unless the doctor considers it absolutely necessary. If it is necessary to use ibuprofen during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time.
Intravenous ibuprofen treatment 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 necessary, 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 more difficult to conceive. If the patient plans to conceive or is having difficulty conceiving, they should inform 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 machinery. This is especially important when consuming alcohol.
Ibuprofen B. Braun contains sodium.One 100 mL vial contains 358 mg of sodium (the main component of common salt). This corresponds to 17.9% 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 400 mg intravenously (infusion administered directly into a vein), and a second dose of 400 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 effects on the kidneys.
Use should be limited to situations where oral administration is not appropriate.
Patients must switch to oral treatment as soon as possible.
This 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 a change in color are observed.

Use of a higher dose of Ibuprofen B. Braun than recommended

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, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing problems may occur.
It may also lead to a drop in blood pressure, blue discoloration of the skin or mucous membranes (cyanosis), gastrointestinal 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 seek medical attention as soon as possible. Elderly people using this medicine are at increased risk of these side effects.
The most common adverse events are related to the gastrointestinal system (stomach and intestines). There may be development of gastrointestinal ulcers (stomach or intestinal ulcers), perforation (puncture of the stomach or intestinal wall), or gastrointestinal bleeding, which 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. Less frequently, gastritis has been reported. In particular, the risk of gastrointestinal bleeding is dose- and duration-dependent.

• red, non-raised, patchy, or circular spots on the torso, often with blisters in the center, peeling skin, ulcers of the 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 fever, and swollen lymph nodes (DRESS syndrome);
• red, scaly, widespread rash with bumps under the skin and blisters, usually accompanied by fever, occurring at the beginning of treatment (acute generalized exanthematous pustulosis).

With the use of NSAIDs, very rare cases of worsening of inflammatory conditions caused by infections (e.g., development of necrotizing fasciitis) have been reported.
In exceptional cases, during chickenpox, severe skin infections and complications in the subcutaneous tissue may occur.
Very common side effects (may occur in more than 1 in 10 people):

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

Common side effects (may occur in 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 occur in up to 1 in 100 people):

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

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

• Reversible toxic amblyopia (double vision).
• Hearing problems.
• Constriction of the esophagus (vascular constriction in the esophagus), complications of diverticulitis, non-specific hemorrhagic colitis. In case of gastrointestinal bleeding, anemia may develop.
• Kidney tissue damage (renal papillary necrosis), especially with long-term use, increased blood urea levels.
• Jaundice or liver dysfunction, liver damage, 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 occur in up to 1 in 10,000 people):

• Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral ulcers, flu-like symptoms, increased fatigue, nosebleeds, and subcutaneous bleeding.
• Palpitations (rapid heart rate), 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).
• Esophagitis or pancreatitis, intestinal stricture.
• Asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing.
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reactions (facial edema, tongue edema, edema of the inner part of the larynx, and accompanying airway narrowing, shortness of breath, rapid heart rate, blood pressure drop, and life-threatening shock).

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

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
• Liver failure.
• Reactions at the injection site, 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).
• Red scaly rash with bumps 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 side effects occur, including any not listed in this leaflet, the patient should inform their doctor.
Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 sight and reach of children.
There are no special storage precautions.
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.
The batch number is on the packaging after the abbreviation "Lot".
Do not use this medicine if particles or a change in color 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 400 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, free from particles.
The solution is contained in LDPE vials with a Twincap closure, in packs of 10 and 20 vials.
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

To obtain more detailed information, the patient should contact their 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