Package leaflet: Information for the patient

Ibumax 400 mg, coated tablets
Ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

Table of contents

What Ibumax 400 mg is and what it is used for
What you need to know before taking Ibumax 400 mg
How to take Ibumax 400 mg
Possible side effects
How to store Ibumax 400 mg
Contents of the pack and other information

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

Ibumax 400 mg contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties.
Ibumax 400 mg is indicated for:

Mild to moderate pain of various origins:
- Headaches (including migraines)
- Toothaches
- Muscular, joint, and bone pain
- Neuralgia
- Pain associated with colds and influenza
Painful menstruation
Fever of various origins (e.g., due to influenza, colds, or other infectious diseases)

2. Information before using Ibumax 400 mg

When not to use Ibumax 400 mg:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs),
with active or past history of gastric or duodenal ulcer, gastrointestinal perforation or bleeding, including events occurring after NSAID use,
in patients who have previously experienced allergic symptoms such as rhinitis, urticaria or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs,
in severe hepatic insufficiency, severe renal insufficiency or severe heart failure,
when taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increases the risk of adverse effects),
during the last three months of pregnancy,
in patients with bleeding disorders.

Warnings and precautions
Before starting treatment with Ibumax 400 mg, discuss this with your doctor or pharmacist.

if the patient has systemic lupus erythematosus or mixed connective tissue disease,
history of allergic reactions after taking acetylsalicylic acid,
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if the patient has hypertension and/or cardiac dysfunction,
if the patient has renal impairment,
if the patient has hepatic impairment,
if the patient has coagulation disorders (ibuprofen may prolong bleeding time),
if the patient has active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after administration of the drug,
patients taking other medications (especially anticoagulants, diuretics, cardiac glycosides or corticosteroids).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be life-threatening and which may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, ibuprofen treatment must be discontinued. Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of treatment. Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms occur, Ibumax 400 mg must be stopped immediately and medical help must be sought without delay. Long-term, concomitant use of painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy). The use of anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment. Before taking Ibumax 400 mg, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA).
the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or if the patient smokes.
the patient has an infection – see below, section titled “Infections”.

Skin reactions
Serious skin reactions have been reported with ibuprofen use, including 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). If any of the symptoms related to these serious skin reactions described in section 4 occur, Ibumax 400 mg must be stopped immediately and medical assistance must be sought.
Infections
Ibumax 400 mg may mask signs of infection such as fever and pain. Therefore, Ibumax 400 mg may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms persist or worsen, immediate medical advice must be sought.
Elderly patients have an increased risk of adverse effects associated with ibuprofen use compared to younger patients.
The frequency and severity of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Children
This medicine is not recommended for use in children under 12 years of age.
There is a risk of renal failure in dehydrated adolescents.
Ibumax 400 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Ibumax 400 mg if taking other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other analgesics, or acetylsalicylic acid (in analgesic 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 drugs (i.e., blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan),
corticosteroids (such as prednisolone or dexamethasone),
methotrexate (an anticancer drug),
lithium (an antidepressant),
zidovudine (an antiviral drug).

Some other medicines may also be affected by or may affect treatment with Ibumax 400 mg. Therefore, always consult your doctor or pharmacist before taking Ibumax 400 mg with other medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibumax 400 mg if you are in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Ibumax 400 mg may lead to impaired kidney and heart function in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. Ibumax 400 mg should not be used during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. If Ibumax 400 mg is taken by a woman from week 20 of pregnancy for longer than a few days, it may cause impaired kidney function in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of the ductus arteriosus in the baby’s heart. If treatment is required for longer than a few days, additional fetal monitoring should be recommended.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. Since there have been no reports of harmful effects of ibuprofen on infants, discontinuation of breastfeeding is not necessary during short-term use of ibuprofen in low doses.
Fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect female fertility. This effect is transient and reverses after stopping treatment. In case of difficulty conceiving, consult your doctor before taking ibuprofen.
Driving and operating machinery
There are no data on the effect of Ibumax 400 mg on the ability to drive, operate machinery or on psycho-physical performance when used at recommended doses and for the recommended duration.
Ibumax 400 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ibumax 400 mg

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms
of an infection (such as fever and pain) persist or worsen, consult a physician immediately (see
section 2).
This medicine is intended for oral use only, in adults and adolescents aged over 12 years.
Adults and adolescents over 12 years of age: 1 tablet every four hours. No more than three tablets
should be taken within 24 hours (maximum daily dose 1200 mg in divided doses).
If this medicinal product is used for longer than 3 days in adolescents, or if symptoms worsen,
medical advice should be sought.
Elderly patients: no dose adjustment is required.
Do not exceed the recommended dose!
If the effect of Ibumax 400 mg seems too strong or too weak, consult a physician.
This medicine is intended for short-term use only.
Use the lowest effective dose for the shortest possible duration. This helps reduce the risk of
adverse effects.
Do not take the medicine for more than 3 days unless otherwise directed by a physician.
Overdose of Ibumax 400 mg
Overdose is rare.
In cases of severe poisoning, metabolic acidosis may occur and the prothrombin time (INR) may be
prolonged.
Acute renal failure or liver damage may occur.
In patients with asthma, worsening of asthma symptoms may occur.
If a patient has taken more than the recommended dose of Ibumax 400 mg, or if a child has
accidentally ingested the medicine, always consult a physician or go to the nearest hospital to
assess potential health risks and receive advice on appropriate actions.
Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood),
gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus (ringing in the
ears), disorientation, and nystagmus. Restlessness, drowsiness, disorientation, or coma may also
occur. Seizures may occur rarely in patients. After ingestion of large doses, drowsiness, chest pain,
palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in
urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
Additionally, prothrombin time (INR) may be prolonged, likely due to interference with blood
clotting factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening
of asthma symptoms may occur. Moreover, low blood pressure and breathing difficulties may occur.
There is no specific antidote. Symptomatic and supportive treatment should be given, aimed at
removing the drug from the body. The physician should monitor vital signs and consider administering
activated charcoal orally within 1 hour of overdose. In cases of frequent or prolonged seizures,
intravenous diazepam or lorazepam should be administered. In patients with asthma, bronchodilators
should be administered.
Missed dose of Ibumax 400 mg
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help should be sought:

Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, peeling skin, and ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes 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 unknown.
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) – frequency unknown.

Adverse effects occurring not very often (in 1 to 10 out of 1000 patients taking the medicine):

Headache, indigestion, abdominal pain, nausea, urticaria, itching.

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

Diarrhoea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, restlessness, irritability and feeling of fatigue,
Oedema resulting from kidney and urinary tract disorders.

Adverse effects occurring very rarely (less than 1 in 10,000 patients taking the medicine):

Black, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease,
Gastric and/or duodenal ulceration, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients,
In isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis,
Decreased urine output, oedema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
Liver function disorders, particularly during prolonged use,
Abnormal blood morphology parameters (anaemia, leukopenia – reduced white blood cell count, thrombocytopenia – reduced platelet count, pancytopenia – haematological disorder characterised by deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis – reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, haemorrhagic diathesis (e.g. bruising, petechiae, purpura, nosebleeds),
Severe hypersensitivity reactions such as: facial and laryngeal oedema, dyspnoea, tachycardia – cardiac arrhythmia, hypotension – sudden drop in blood pressure, shock, worsening of asthma and bronchospasm,
In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever and disorientation.

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

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

Treatment with NSAIDs at high doses has been associated with oedema, arterial hypertension and heart failure.
Use of medicines such as Ibumax 400 mg may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibumax 400 mg

No special storage instructions are required.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibumax 400 mg contains
1 coated tablet contains:
active substance: ibuprofen, 400 mg.
excipients: pregelatinized starch, corn, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, stearic acid, colloidal anhydrous silica, coating:

hypromellose, polyethylene glycol 4000, polidextrose, 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 a HDPE container with LDPE closure, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Tel: +358 3 615 600

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Vitabalans Sp. z o.o.
ul. Narbutta 5 m 1
02-564 Warsaw
[email protected]