Ibumax 400 mg

Leaflet attached to the packaging: patient information

Ibumax 400 mg, coated tablets

Ibuprofen

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Ibumax 400 mg and what is it used for
• 2. Important information before taking Ibumax 400 mg
• 3. How to take Ibumax 400 mg
• 4. Possible side effects
• 5. How to store Ibumax 400 mg
• 6. Contents of the packaging and other information

1. What is Ibumax 400 mg and what is it used for

Ibumax 400 mg contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), with analgesic, antipyretic, and anti-inflammatory effects.
The indications for use of the medicine are:

• Pains of various origins of mild to moderate severity:
• headaches (including migraines)
• toothaches
• muscle, joint, and bone pain
• neuralgia
• pains accompanying colds and flu
• Painful menstruation
• Febrile conditions of various origins (including flu, colds, or other infectious diseases)

2. Important information before taking Ibumax 400 mg

When not to take Ibumax 400 mg:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) or to other nonsteroidal anti-inflammatory drugs (NSAIDs),
• with active or recurrent peptic ulcer disease, perforation, or bleeding, also occurring after taking NSAIDs,
• in patients who have experienced allergic symptoms in the form of rhinitis, urticaria, or bronchial asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• with severe liver, kidney, or heart failure,
• while taking other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (increases the risk of adverse reactions),
• during the last three months of pregnancy,
• with a bleeding disorder.

Warnings and precautions

Before starting treatment with Ibumax 400 mg, the patient should discuss it with their doctor or pharmacist.

• if the patient has been diagnosed with systemic lupus erythematosus and mixed connective tissue disease,
• symptoms of allergic reactions after taking acetylsalicylic acid,
• if the patient has been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has been diagnosed with hypertension and/or heart failure,
• if the patient has been diagnosed with kidney function disorders,
• if the patient has been diagnosed with liver function disorders,
• if the patient has been diagnosed with blood coagulation disorders (ibuprofen may prolong bleeding time),
• if the patient has been diagnosed with active or recurrent bronchial asthma or symptoms of allergic reactions in the past; after taking the medicine, bronchospasm may occur,
• patients taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients with such warning signs.
In case of gastrointestinal bleeding or ulceration, ibuprofen treatment should be discontinued.
Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
During ibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck edema (angioedema), chest pain.
If the patient notices any of these symptoms, they should immediately stop taking Ibumax 400 mg and seek medical help immediately.
Concomitant, prolonged use of painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Taking anti-inflammatory/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.
Before taking Ibumax 400 mg, the patient should discuss treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.
• the patient has an infection - see below, section "Infections".

Skin reactions
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have occurred with ibuprofen use.
If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking Ibumax 400 mg and seek medical help.
Infections
Ibumax 400 mg may mask the symptoms of infection, such as fever and pain.
Therefore, Ibumax 400 mg may delay the use of appropriate infection treatment, potentially leading to increased risk of complications.
This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.
If the patient is taking this medicine while an infection is present, and the infection symptoms persist or worsen, they should immediately consult a doctor.
In elderly patients, there is an increased risk of adverse reactions associated with ibuprofen use compared to younger patients.
The frequency and severity of adverse reactions can be reduced by using the smallest effective dose for the shortest possible duration.
The patient should consult a doctor, even if the above warnings refer to past situations.

Children

The medicine is not indicated for use in children under 12 years of age.
There is a risk of kidney failure in dehydrated adolescents.

Ibumax 400 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibumax 400 mg should not be taken if the patient is taking other nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in pain-relieving doses).
Ibumax 400 mg may affect the action of other medicines or other medicines may affect the action of Ibumax 400 mg.
For example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• corticosteroids (such as prednisolone or dexamethasone),
• methotrexate (an anticancer medicine),
• lithium (an antidepressant),
• zydovudine (an antiviral medicine).

Also, some other medicines may be affected or have an effect on Ibumax 400 mg treatment.
Therefore, before taking Ibumax 400 mg 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 pharmacist before taking this medicine.
Pregnancy
Ibumax 400 mg should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Ibumax 400 mg may lead to kidney and heart disorders in the unborn child.
It may increase the risk of bleeding in the patient and their child and cause prolonged or delayed delivery.
During the first 6 months of pregnancy, Ibumax 400 mg should not be used unless the doctor considers it absolutely necessary.
If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time.
If Ibumax 400 mg is taken by a woman from the 20th week of pregnancy for more than a few days, it may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart.
If the patient requires treatment for a longer period, they should be advised to have additional fetal monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
Since there are no reports of harmful effects of ibuprofen on infants, breastfeeding does not need to be discontinued during short-term use of ibuprofen in small doses.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility.
This effect is temporary and reverses after treatment is stopped.
If the patient is having trouble conceiving, they should consult their doctor before taking ibuprofen.

Driving and using machines

There are no data on the effect of Ibumax 400 mg on the ability to drive vehicles, operate machinery, and psychophysical performance during treatment with the recommended doses and duration.

Ibumax 400 mg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Ibumax 400 mg

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The smallest effective dose should be used for the shortest possible duration to relieve symptoms.
If the patient has an infection and the symptoms (such as fever and pain) persist or worsen, they should immediately consult a doctor (see section 2).
The medicine is intended for oral use only, in adults and adolescents over 12 years of age.
Adults and adolescents over 12 years of age: 1 tablet every 4 hours.
Do not take more than 3 tablets in 24 hours (maximum daily dose 1200 mg in divided doses).
If the product is used in adolescents for more than 3 days, or if symptoms worsen, they should consult a doctor.
Elderly patients: no dose adjustment is required.
Do not exceed the recommended dose!
If the patient feels that the effect of Ibumax 400 mg is too strong or too weak, they should consult their doctor.
The medicine is intended for short-term use.
The smallest effective dose should be used for the shortest possible duration, which reduces the risk of adverse reactions.
Do not take the medicine for more than 3 days unless the doctor advises otherwise.

Taking a higher dose of Ibumax 400 mg than recommended

Overdose cases are rare.
During severe poisonings, metabolic acidosis may occur, and the prothrombin time (INR) may be increased.
The following may occur: acute kidney failure or liver damage.
In patients with asthma, worsening of asthma symptoms may occur.
If the patient has taken a higher dose of Ibumax 400 mg than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess potential health risks and get advice on what to do.
Overdose symptoms may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus (ringing in the ears), and disorientation.
Stimulation, drowsiness, disorientation, or coma may also occur.
Rarely, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties.
Additionally, the prothrombin time (INR) may be prolonged, probably due to the disruption of blood clotting factors.
Acute kidney failure and liver damage may occur.
In patients with asthma, worsening of asthma symptoms may occur.
Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. Symptomatic and supportive treatment is used, which involves removing the medicine from the body.
The doctor should monitor vital signs and consider oral administration of activated charcoal within 1 hour of overdose.
In case of frequent or prolonged seizures, intravenous diazepam or lorazepam should be administered.
In case of asthma patients, bronchodilators should be administered.

Missing a dose of Ibumax 400 mg

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Ibumax 400 mg can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical help:

• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes.
  These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - very rare.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) - frequency not known.
• Red, peeling rash with bumps under the skin and blisters, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Uncommon side effects (occurring in 1 to 10 out of 1000 patients taking the medicine):

• headache, indigestion, abdominal pain, nausea, urticaria, itching.

Rare side effects (occurring in 1 to 10 out of 10,000 patients taking the medicine):

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, stimulation, irritability, and fatigue,
• edema resulting from kidney and urinary disorders.

Very rare side effects (occurring less frequently than in 1 out of 10,000 patients taking the medicine):

• tarry stools, bloody vomiting, ulcerative stomatitis, worsening of ulcerative colitis and Crohn's disease,
• peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, and perforation, sometimes with fatal outcome, especially in the elderly,
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis),
• reduced urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the serum (sodium retention),
• liver function disorders, especially during long-term use,
• abnormal blood count results (anemia, leukopenia, thrombocytopenia, pancytopenia). The first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding tendency (e.g., bruising, petechiae, purpura, nosebleeds),
• severe hypersensitivity reactions, such as facial and laryngeal edema, dyspnea, tachycardia, hypotension, shock, and bronchospasm,
• in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), individual cases of symptoms occurring in aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, disorientation.

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

• skin becomes sensitive to light.
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Nonsteroidal anti-inflammatory drug (NSAID) treatment has been associated with edema, hypertension, and heart failure.
Taking medicines like Ibumax 400 mg may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist.
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
Al. Jerozolimskie 181C
PL-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 the medicine.

5. How to store Ibumax 400 mg

No special storage precautions are required.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging.
The expiration date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Ibumax 400 mg contains

1 coated tablet contains:active substance: ibuprofen, 400 mg.
excipients: maize starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, stearic acid, silicon dioxide, anhydrous
coating: hypromellose, macrogol 4000, polydextrose, titanium dioxide (E 171).

• hypromellose, macrogol 4000, polydextrose, titanium dioxide (E 171).

What Ibumax 400 mg looks like and contents of the pack

Ibumax 400 mg: 6, 10, 12, 20, 24, 30, 50 coated tablets (aluminum/PVC blisters) in a cardboard box. 30, 50 tablets in an HDPE container with an LDPE closure, in a cardboard box.

Marketing authorization holder and manufacturer

Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Phone: +358 3 615 600
In order to obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Vitabalans Sp. z.o.o.
ul. Narbutta 5 m 1
02-564 Warsaw
[email protected]

Date of last revision of the leaflet: