Package leaflet: information for the patient

Ibumax Forte 600 mg, film-coated tablets
Ibuprofenum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician 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, contact your doctor.

Table of contents of the leaflet

What Ibumax Forte 600 mg is and what it is used for
Important information before taking Ibumax Forte 600 mg
How to take Ibumax Forte 600 mg
Possible side effects
How to store Ibumax Forte 600 mg
Contents of the pack and other information

1. What Ibumax Forte 600 mg is and what it is used for

Ibumax Forte 600 mg contains ibuprofen – an active substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which has analgesic, antipyretic, and anti-inflammatory properties.
The indications for use of this medicine are:

headaches (including migraines),
toothaches,
muscular, joint, and bone pain (including back pain),
pain due to injury or following surgery, including dental procedures,
neuralgic pain,
painful menstruation

2. Important information before using Ibumax Forte 600 mg

When not to use Ibumax Forte 600 mg:

if the patient is allergic to the active substance, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
in patients who previously experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma during treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
in patients who have previously experienced gastrointestinal perforation (ulceration) or bleeding related to prior NSAID therapy,
in the presence of active or recurrent peptic ulcer or duodenal ulcer and/or gastrointestinal bleeding (previous serious bleeding, two or more independent episodes of confirmed ulceration or bleeding),
in severe hepatic or severe renal impairment,
in severe heart failure or coronary artery disease,
in patients with bleeding disorders (tendency to bleed),
during the last three months of pregnancy,
in the presence of cerebral haemorrhage or other active bleeding,
if the patient is significantly dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake),
in patients under 18 years of age.

Warnings and precautions
Ibumax Forte 600 mg should be used in adults with concomitant chronic diseases only after consultation with a doctor.
Before starting Ibumax Forte 600 mg, discuss with your doctor or pharmacist:

if the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has experienced any stroke (including mini-stroke or transient ischaemic attack - TIA),
if the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or is a smoker,
if the patient has systemic lupus erythematosus or mixed connective tissue disease,
if the patient has experienced allergic reactions after taking acetylsalicylic acid,
if the patient has congenital porphyria metabolism disorders (e.g. acute intermittent porphyria),
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if the patient has hypertension and/or impaired heart function,
if the patient has impaired kidney function,
if the patient has impaired liver function,
if the patient has fluid retention and oedema associated with NSAID use,
if the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid at daily doses exceeding 75 mg,
if the patient has active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after administration of the drug,
if the patient is taking other medications (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids),
if dehydration is present – due to increased risk of renal impairment,
immediately after major surgical procedures,
in patients taking other medications (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids), or if the patient has coagulation disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time),
when using the medicine in elderly patients (see section 3).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with previous such symptoms. If gastrointestinal bleeding or ulceration occurs, ibuprofen should be discontinued immediately.
Patients with a history of gastrointestinal disorders, especially elderly patients, should contact their doctor if they experience any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, Ibumax Forte 600 mg should be discontinued immediately and medical help should be sought without delay.
Long-term, concomitant use of analgesic drugs may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Use of anti-inflammatory and analgesic drugs such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Ibuprofen may cause sodium, potassium, and fluid retention in patients without prior kidney disease. This may lead to oedema or even heart failure or hypertension in predisposed patients.
Avoid concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors.

Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient develops any symptoms related to these severe skin reactions described in section 4, Ibumax Forte 600 mg should be discontinued immediately and medical assistance should be sought.

Inform your pharmacist or doctor if:
the patient has an infection – see below, section titled “Infections”.

Infections
Ibumax Forte 600 mg may mask signs of infection such as fever and pain. Consequently, Ibumax Forte 600 mg may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella.
If the patient is taking this medicine during an ongoing infection and infection symptoms persist or worsen, immediate medical consultation is required.

Exercise particular caution and consult a doctor or pharmacist before using the medicine in patients with hypertension and/or heart failure with fluid retention, or hypertension and oedema previously associated with NSAID use.
Long-term use of ibuprofen, especially in combination with other analgesics, may cause permanent kidney damage and risk of renal failure.
Patients at highest risk of such reactions include those with impaired kidney function, heart failure, impaired liver function, those taking diuretics and antihypertensives (ACE inhibitors), and elderly patients. Patients who discontinue NSAID therapy generally return to their pre-treatment state.
With long-term ibuprofen treatment, periodic monitoring of liver and kidney function and blood cell counts is necessary, especially in high-risk patients.
With long-term, high-dose analgesic treatment, headache may occur, which should not be treated with increased doses of medication.
Ibuprofen may mask signs or symptoms of infection (fever, pain, swelling).
Avoid using this medicine during varicella (chickenpox).
Alcohol consumption should be avoided during treatment, as it may increase adverse effects, particularly those related to the gastrointestinal tract and nervous system.
Elderly patients have an increased risk of adverse effects from ibuprofen compared to younger patients.
The frequency and severity of adverse effects can be reduced by using the lowest therapeutic dose for the shortest possible duration.
Consult a doctor even if the above warnings relate to conditions experienced in the past.

Children
Do not use in children and adolescents under 18 years of age.

Ibumax Forte 600 mg and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not use Ibumax Forte 600 mg if taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), other analgesics, or acetylsalicylic acid (at analgesic doses).
Ibumax Forte 600 mg may affect the action of other medicines or other medicines may affect the action of Ibumax Forte 600 mg, for example:

diuretics and potassium-sparing agents,
antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
methotrexate (used in cancer or rheumatic diseases), as methotrexate effects may be increased,
lithium (used in depression), as lithium effects may be increased,
cardiac glycosides (e.g. digoxin), as ibuprofen may increase plasma levels of this drug,
phenytoin (antiepileptic), as ibuprofen may increase plasma levels of this drug,
corticosteroids (such as prednisolone or dexamethasone), as they may increase the risk of gastrointestinal ulceration or bleeding,
tacrolimus (immunosuppressant), as there is increased risk of nephrotoxicity,
cyclosporine (immunosuppressant), as limited data suggest increased risk of nephrotoxicity,
zidovudine (used in AIDS treatment), as use may increase the risk of joint bleeding or bleeding leading to swelling (in HIV-positive haemophilia patients),
ritonavir (used in HIV therapy): ritonavir may increase plasma levels of NSAIDs,
antibiotics (quinolones or aminoglycosides),
sulfonylurea derivatives (antidiabetic drugs): clinical interactions between these drugs and NSAIDs may occur; blood glucose monitoring is recommended,
probenecid and sulfinpyrazone (used in gout treatment): may delay ibuprofen elimination,
cholestyramine: may delay and reduce absorption of NSAIDs,
voriconazole and fluconazole (antifungals): may increase exposure to NSAIDs,
baclofen (muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen,
aminoglycosides (type of antibiotics): NSAIDs may reduce aminoglycoside excretion,
mifepristone: do not use NSAIDs within 8–12 days after mifepristone administration, as they may weaken mifepristone's effect,
calcium channel blockers: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding,
desipramine: increased desipramine toxicity typical of tricyclic antidepressants,
levofloxacin and ofloxacin: increased risk of serious central nervous system effects,
thienopyridine derivatives: increased bleeding risk due to additive antiplatelet and anticoagulant effects,
bisphosphonates: increased risk of gastrointestinal adverse effects,
anticoagulant drugs (i.e. blood thinners or those 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).

Concomitant use of ibuprofen with herbal preparations such as Japanese pagoda tree (Ginkgo biloba) and meadowsweet (Filipendula ulmaria) may increase bleeding risk due to antiplatelet effects. Concurrent use of ibuprofen and products containing Chinese ephedra (Ephedra sinica) may increase the risk of gastrointestinal mucosal damage.

Other medicines may also interact with or affect treatment with Ibumax Forte 600 mg. Therefore, always consult a doctor or pharmacist before using Ibumax Forte 600 mg with other medicines.

Taking Ibumax Forte 600 mg with food, drink, and alcohol
Food reduces gastrointestinal absorption of ibuprofen.
When taking high-dose ibuprofen with alcohol, symptoms such as fatigue and headache may occur.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ibumax Forte 600 mg during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Ibumax Forte 600 mg may impair kidney and heart function in the unborn child. It may increase bleeding tendency in both mother and child and may delay or prolong labour. Ibumax Forte 600 mg should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. If Ibumax Forte 600 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 amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the fetal heart. If treatment beyond a few days is required, additional fetal monitoring should be recommended.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. There are no reports of harmful effects of ibuprofen on infants; therefore, discontinuation of breastfeeding is not necessary with short-term, low-dose ibuprofen use. However, if prolonged ibuprofen use is recommended, earlier weaning may be considered.

Fertility
Ibuprofen may impair fertility. If the patient plans to conceive or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
Short-term use of Ibumax Forte 600 mg at the recommended dose has no effect or negligible effect on the ability to drive and operate machinery.
If visual disturbances, fatigue, dizziness, or other nervous system adverse effects occur, driving and operating machinery are not recommended.

Ibumax Forte 600 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 Forte 600 mg

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for oral use only, in adult patients.
For short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
If it is necessary to use the medicine for longer than 3 days or if the patient's condition worsens, the patient should contact a doctor.

Adults:
The recommended dose is 600 mg of ibuprofen (1 tablet) as a single dose. If needed, the single dose of 600 mg (1 tablet) may be repeated, maintaining an interval of 6–8 hours. The maximum daily dose without consulting a doctor should not exceed 1200 mg (2 tablets).
Ibumax Forte 600 mg should only be used if the patient does not experience improvement after using ibuprofen at a dose of 400 mg (maximum 1200 mg ibuprofen per day). In such a case, a 600 mg dose of ibuprofen may be taken, provided that a 6–8 hour interval has elapsed since the 400 mg dose.

Elderly patients:
Do not use without consulting a doctor. Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with caution, especially in elderly patients, who are more susceptible to adverse effects and at increased risk of potentially fatal gastrointestinal bleeding, ulcers, and perforation.

Renal or hepatic impairment:
Do not use without consulting a doctor. Dose adjustment is not required in patients with mild to moderate renal or hepatic dysfunction. However, in these patients, the lowest effective dose should be used for the shortest possible duration necessary to control symptoms.

Use of a higher than recommended dose of Ibumax Forte 600 mg
Overdose cases are rare.
In 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 Forte 600 mg or if a child has accidentally ingested the medicine, medical advice should always be sought from a doctor or the nearest hospital to assess potential health risks and receive guidance on necessary 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), confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures may occur rarely. After 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 may be reported.
Additionally, prothrombin time (INR) may be prolonged, likely due to impaired blood clotting factor function. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Hypotension and breathing difficulties may also occur.
There is no specific antidote (antidote). Symptomatic and supportive treatment should be administered, aimed at removing the drug from the body. The doctor should monitor vital signs and consider administering activated charcoal orally within 1 hour of overdose.
In case of overdose symptoms, the medicine should be discontinued immediately and medical advice should be sought from a doctor or hospital emergency department.

Missed dose of Ibumax Forte 600 mg
Do not take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Patients taking this medicine should discontinue use and immediately consult a doctor
if signs or symptoms of ulceration, mucosal damage, or
gastrointestinal bleeding (black, tarry stools, vomiting blood), acute abdominal pain,
blurred vision or other eye-related symptoms, skin rash or other allergic reactions,
weight gain or swelling occur.
If any of the following symptoms occur in a patient, ibuprofen use should be stopped immediately and medical help sought:

Red, flat, non-raised patches on the trunk resembling targets or circular lesions, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genital organs, 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 fever, and enlarged 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 generalized exanthematous pustulosis) – frequency unknown.

The most commonly observed adverse reactions are gastrointestinal.
Ulceration, perforation (punch-through), or gastrointestinal bleeding may occur, sometimes with fatal outcomes (particularly in elderly patients). These may occur without preceding warning symptoms or in patients who previously experienced such warning signs.
The risk of gastrointestinal bleeding is particularly dependent on the dose and duration of ibuprofen use.
Taking ibuprofen, especially long-term at high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke).

Common (occurs in 1 to 10 out of 100 treated patients):

Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, indigestion, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia.

Uncommon (occurs in 1 to 10 out of 1,000 treated patients):

Allergic reactions with skin rash and itching, as well as asthma attacks (possibly occurring together with low blood pressure); in such cases, the medicine should be discontinued and a doctor consulted immediately,
Headache, drowsiness, dizziness, insomnia, restlessness, irritability, or fatigue,
Visual disturbances,
Gastrointestinal ulcers, potentially with bleeding and perforation, oral mucosal ulcers, exacerbation of ulcerative colitis, Crohn's disease, gastric mucositis, black tarry stools, vomiting blood.

Rare (occurs in 1 to 10 out of 10,000 treated patients):

Tinnitus (ringing in the ears),
Kidney tissue damage (papillary necrosis) and increased blood uric acid levels.

Very rare (occurs in fewer than 1 out of 10,000 treated patients):

Severe, generalized allergic reactions. These may present as, for example, facial swelling, tongue swelling, laryngeal edema with impaired airway patency, respiratory failure, rapid heartbeat, low blood pressure, up to life-threatening shock. If any of these symptoms occur, even after the first dose of the medicine, immediate medical attention is required,
Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, marked weakness, nosebleeds, and subcutaneous hemorrhages. During prolonged treatment, regular monitoring of blood morphology parameters is recommended,
Development of edema, particularly with hypertension or kidney failure, nephrotic syndrome, interstitial nephritis associated with acute kidney failure. Therefore, kidney function should be monitored regularly during long-term treatment,
Liver function disorders, liver damage (especially after prolonged use), liver failure, acute hepatitis. Therefore, liver function should be monitored regularly during long-term treatment,
Palpitations, heart failure, myocardial infarction,
Hypertension,
Esophagitis, pancreatitis, development of diaphragm-like intestinal strictures,
Psychotic reactions, depression,
Infections associated with conditions that are the reason for using non-steroidal anti-inflammatory drugs (e.g., necrotizing fasciitis). If signs of infection appear or worsen during ibuprofen use, the patient should immediately consult a doctor. The doctor will assess whether anti-infective treatment (antibiotic therapy) is indicated. Aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disturbances in consciousness has been observed during ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be particularly susceptible,
In exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur.

Frequency not known:

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

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects
not listed in this leaflet, inform your doctor or pharmacist. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Ibumax Forte 600 mg

No special storage conditions are required.
The medicine should be stored out of 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ibumax Forte 600 mg contains
1 coated tablet contains: active substance: ibuprofen, 600 mg.
Excipients: pregelatinized starch, corn; hypromellose; magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate; stearic acid; colloidal anhydrous silica; coating:

hypromellose, macrogol 4000, polidextrose, titanium dioxide (E 171).

What Ibumax Forte 600 mg looks like and contents of the pack:
Ibumax Forte 600 mg: 10 coated tablets (in HDPE container with LDPE closure) in a cardboard box. 10 coated tablets (Aluminium/PVC blisters) 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]

Ibumax forte 600 mg