IBUXAL MAX

Package leaflet: Information for the patient

Ibuxal Max, 600 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used 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 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, you should contact your doctor.

Table of contents

1. What Ibuxal Max is and what it is used for
2. Important information before taking Ibuxal Max
3. How to take Ibuxal Max
4. Possible side effects
5. How to store Ibuxal Max
6. Contents of the pack and other information

1. What Ibuxal Max is and what it is used for

Ibuxal Max belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, anti-inflammatory and antipyretic properties.
Indications:
For short-term use in adults for the relief of acute, moderate pain of various origins, such as:

• headaches (including migraines),
• toothaches,
• muscular, joint and bone pain (including back pain),
• traumatic and postoperative pain, including pain following dental procedures,
• neuralgia,
• painful menstruation.

2. Important information before using Ibuxal Max

When not to use Ibuxal Max:

• if the patient is allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had asthma, hay fever, nasal congestion, swelling (angioedema), or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs),
• if the patient has severe heart failure,
• if the patient has severe liver or kidney function disorders,
• if the patient has bleeding into the brain or any other active bleeding,
• if the patient has ever experienced gastrointestinal bleeding or perforation following the use of NSAIDs,
• if the patient has, currently or in the past, recurrent peptic ulcers and/or duodenal ulcers or gastrointestinal bleeding (at least two confirmed episodes of ulcers or bleeding),
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or inadequate fluid intake),
• if the patient has a bleeding tendency (bleeding diathesis),
• if the patient has coronary artery disease,
• if the patient is in the last trimester of pregnancy,
• if the patient is under 18 years of age.

Warnings and precautions
Ibuxal Max should be used in adults with concomitant chronic diseases only after consultation with a doctor.
Taking the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects.
Inform the pharmacist or doctor if the patient has an infection – see below, section titled “Infections”.

Infections
Ibuxal Max may mask signs and symptoms of infection such as fever and pain. Therefore, Ibuxal Max may delay the initiation of appropriate treatment for infection, potentially increasing 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 ongoing infection and symptoms persist or worsen, medical advice should be sought immediately.

The use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a slightly increased risk of myocardial infarction or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Before starting Ibuxal Max, discuss with your doctor or pharmacist if:

• the patient has heart disease, including heart failure, ischemic heart disease, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (circulatory problems in legs or feet 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, a family history of heart disease or stroke, or if the patient smokes,
• the patient has autoimmune diseases (e.g. systemic lupus erythematosus, mixed connective tissue disease), due to increased risk of aseptic meningitis,
• the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid,
• the patient has congenital porphyria disorders (e.g. acute intermittent porphyria),
• the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease),
• the patient has fluid retention and oedema associated with previous use of NSAIDs,
• the patient is dehydrated (especially in children and adolescents), due to increased risk of kidney failure,
• the patient has impaired liver or kidney function,
• the patient has active or past asthma or allergic reactions (bronchospasm may occur after taking the medicine),
• the patient has undergone major surgery,
• the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids), or if the patient has bleeding disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time),
• when using the medicine in elderly patients (see section 3).

Avoid using Ibuxal Max simultaneously with other nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.

Patients with a history of gastrointestinal disorders, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, particularly during the initial treatment period.

Exercise particular caution and consult a doctor or pharmacist before using Ibuxal Max in patients with hypertension and/or heart failure with fluid retention, or with a history of oedema or hypertension associated with previous NSAID use.

Ibuprofen may cause sodium, potassium, and fluid retention in patients who previously did not have kidney disease. This may lead to oedema or even heart failure or hypertension in predisposed patients.

Long-term use of ibuprofen, especially in combination with other painkillers, may cause permanent kidney damage and risk of kidney failure.

Patients at highest risk of such reactions include those with impaired kidney function, heart failure, liver dysfunction, those taking diuretics and antihypertensive drugs (ACE inhibitors), and elderly patients. Patients who discontinue NSAID therapy generally return to their pre-treatment condition.

During long-term ibuprofen treatment, periodic monitoring of liver and kidney function, as well as blood counts with blood smear, is required, especially in high-risk patients.

During long-term treatment with high doses of painkillers, headaches may occur, which should not be treated with increased doses of medication.

Serious skin reactions such as 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 ibuprofen use. If the patient experiences any of the symptoms related to these serious skin reactions described in section 4, Ibuxal Max must be discontinued immediately and medical help sought.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, Ibuxal Max must be discontinued immediately and the patient should contact a doctor or emergency medical services without delay.

Ibuprofen may mask signs or symptoms of infection (fever, pain, swelling).

Avoid alcohol consumption during treatment, as it may increase the risk of adverse effects, particularly those affecting the gastrointestinal tract and nervous system.

Ibuxal Max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Ibuxal Max may affect other medicines, and other medicines may affect the action of this medicine. This includes, for example:

• anticoagulants (i.e. blood thinners or agents preventing clot formation, e.g. acetylsalicylic acid, warfarin, ticlopidine),
• antihypertensive medicines (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, or angiotensin II receptor antagonists, e.g. losartan).

Always consult a doctor or pharmacist before combining Ibuxal Max with other medicines.

In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib): possible increased risk of adverse effects. Concurrent use of multiple NSAIDs may increase the risk of gastrointestinal ulceration and bleeding due to synergistic effects,
• diuretics and potassium-sparing agents: possible occurrence of hyperkalemia (excessively high blood potassium levels),
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants): increased risk of gastrointestinal adverse effects,
• methotrexate (used in cancer or rheumatic disease treatment): possible increased methotrexate effects,
• lithium (used in depression treatment): possible increased lithium effects,
• cardiac glycosides (e.g. digoxin): possible increased serum concentration of this medicine due to ibuprofen,
• phenytoin (antiepileptic): possible increased serum concentration of this medicine due to ibuprofen,
• corticosteroids (e.g. prednisolone or dexamethasone): possible increased risk of gastrointestinal ulceration or bleeding,
• tacrolimus (immunosuppressant): increased risk of nephrotoxicity,
• cyclosporine (immunosuppressant): limited data on increased risk of nephrotoxicity,
• zidovudine (used in AIDS treatment): possible increased risk of joint bleeding or haemorrhage (in patients with haemophilia and positive HIV antibody test),
• ritonavir (used in HIV therapy): possible increased plasma concentration of NSAIDs,
• quinolone antibiotics: possible increased risk of seizures,
• sulfonylurea derivatives (antidiabetic agents): possible clinical interaction with NSAIDs; blood glucose monitoring is recommended,
• probenecid and sulfinpyrazone (used in gout treatment): possible delayed elimination of ibuprofen,
• cholestyramine: possible delayed and reduced absorption of NSAIDs,
• voriconazole and fluconazole (antifungal agents): possible increased exposure to NSAIDs,
• baclofen (muscle relaxant): possible toxic effects of baclofen after starting ibuprofen,
• aminoglycosides (a class of antibiotics): possible reduced elimination of aminoglycosides,
• mifepristone: NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce its effectiveness,
• calcium channel antagonists: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding,
• desipramine: increased toxicity typical of tricyclic antidepressants,
• levofloxacin and ofloxacin: increased risk of severe central nervous system effects,
• thienopyridine derivatives: increased risk of bleeding due to additive antiplatelet and anticoagulant effects,
• bisphosphonates: increased risk of gastrointestinal adverse effects, reduced efficacy of diuretics and other antihypertensive agents,
• anticoagulant medicines (i.e. blood thinners or agents preventing clot formation, such as aspirin – acetylsalicylic acid, warfarin, ticlopidine): possible increased anticoagulant effect,
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan): reduced efficacy of diuretics and other antihypertensive agents,
• products containing Ginkgo biloba or Filipendula ulmaria: possible increased risk of bleeding due to antiplatelet effects. Concurrent use of ibuprofen and products containing Ephedra sinica may increase the risk of gastrointestinal mucosal damage.

Other medicines may also influence or be influenced by Ibuxal Max. Therefore, always consult a doctor or pharmacist before combining Ibuxal Max with other medicines.

Taking Ibuxal Max with food, drink, and alcohol
The medicine can be taken with food or drink.
In patients with sensitive stomachs, taking the medicine with food is recommended to avoid gastrointestinal discomfort.
Avoid taking ibuprofen with alcohol, as this may increase the risk of adverse effects.

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

Pregnancy
Do not use Ibuxal Max during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuxal Max may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. Ibuxal Max should not be used during the first six months of pregnancy unless considered absolutely necessary by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Ibuxal Max may cause narrowing of the fetal blood vessel (ductus arteriosus) in the baby’s heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. Short-term use of ibuprofen at doses used for pain relief is unlikely to harm the infant. However, if prolonged use of ibuprofen is required, earlier weaning from breastfeeding should be considered.

Fertility
Ibuprofen may impair fertility. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her doctor.

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

Ibuxal Max contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning it is considered “sodium-free”.

3. How to use Ibuxal Max

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.
Recommended dose:
Adults:
The recommended dose is 600 mg of ibuprofen (1 tablet) as a single dose.
If necessary, the single dose of 600 mg (1 tablet) may be repeated, maintaining an interval of 6–8 hours. The maximum daily dose without prior consultation with a doctor must not exceed 1200 mg (2 tablets).
Ibuxal Max should only be used if the patient does not experience improvement after taking ibuprofen at a dose of 400 mg (maximum 1200 mg of ibuprofen per day). In such a case, a dose of 600 mg of ibuprofen may be taken, provided that an interval of 6–8 hours is maintained from the previous 400 mg dose.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
If it is necessary to use the medicine for longer than 3 days, or if symptoms worsen, consult a doctor.

Special patient groups
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.
Patients with 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 impairment. However, in these patients, it is recommended to use the lowest effective dose for the shortest duration necessary to control symptoms.
Children and adolescents
The use of Ibuxal Max is contraindicated in children and adolescents under 18 years of age.

Method of administration
Ibuxal Max is intended for oral use. Tablets should be swallowed whole with a glass of water.
Patients with a sensitive stomach are advised to take Ibuxal Max with food.

Taking more than the recommended dose of Ibuxal Max
If a patient takes more than the recommended dose of Ibuxal Max or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital to assess potential health risks and receive advice on appropriate actions. Cases of overdose are rare.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, cold sensation, and breathing difficulties may occur.
In children, a single dose exceeding 400 mg/kg body weight may cause symptoms of overdose. In adults, the dose that may cause such symptoms has not been precisely established. Myoclonic jerks (repetitive muscle spasms) may occur in children. In severe poisoning, metabolic acidosis (disturbance of acid-base balance) may occur, and prothrombin time (a coagulation parameter) may be prolonged. Acute renal failure, liver damage, hypotension, respiratory depression, bradycardia, or cyanosis may occur. In patients with asthma, worsening of asthma symptoms may occur.

Treatment
There is no specific antidote. Treatment is symptomatic and supportive. Oral activated charcoal may be considered within 1 hour of overdose.
If symptoms of overdose occur, discontinue the medicine immediately and contact a doctor or emergency department.

Missed dose of Ibuxal Max
Do not take a double dose to make up for a missed dose.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

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, non-elevated, target-like or circular spots on the trunk, often with blisters in the centre, peeling of the skin, and mucosal 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).
• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

The list of adverse effects below includes all adverse effects observed during ibuprofen treatment, including those occurring after long-term use at high doses in patients with rheumatic disease.
With regard to the adverse reactions listed below, it should be remembered that they are mostly dose-dependent and their occurrence varies individually.
Patients taking Ibuxal Max should discontinue the medicine and immediately consult a doctor if signs or symptoms of ulceration, damage to the mucous membrane or bleeding from the gastrointestinal tract (black, tarry stools, vomiting blood), acute upper abdominal pain, blurred vision or other eye-related symptoms, skin rash or other hypersensitivity reactions, weight gain or oedema occur.
The most commonly observed adverse reactions involve the gastrointestinal tract. Ulceration, perforation (gut wall penetration), or gastrointestinal bleeding may occur, sometimes with fatal outcomes (particularly in elderly patients). These may occur without preceding warning symptoms or may occur in patients who have 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).
Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Common ( occur in up to 1 in 10 people ):

• heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, indigestion, constipation, black tarry stools, vomiting blood and minor gastrointestinal bleeding, which may exceptionally lead to anaemia.

Uncommon ( occur in up to 1 in 100 people ):

• hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly occurring in combination with low blood pressure); in such cases, the medicine should be discontinued and immediate medical advice sought,
• 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 mucosal inflammation.

Rare ( occur in up to 1 in 1000 people ):

• tinnitus (ringing in the ears),
• kidney tissue damage (papillary necrosis) and increased blood uric acid levels.

Very rare ( occur in up to 1 in 10,000 people ):

• severe, systemic hypersensitivity reactions. These may present as, for example, facial swelling, tongue swelling, internal swelling of the larynx with impaired airway patency, respiratory insufficiency, rapid heartbeat, low blood pressure, up to life-threatening shock. If any of the above symptoms occur, which may happen even after the first dose of the medicine, immediate medical assistance is required,
• severe skin adverse effects, including erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction) and toxic epidermal necrolysis, as well as exfoliative dermatitis. The highest risk of these severe reactions occurs at the beginning of therapy, in most cases during the first month of treatment. In exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur,
• blood-forming system disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever and sore throat,
• oral ulcers, flu-like symptoms, marked weakness, nosebleeds and subcutaneous haemorrhages. During prolonged treatment, blood morphology parameters should be monitored regularly,
• development of oedema, particularly with hypertension or renal failure, nephrotic syndrome, interstitial nephritis associated with acute renal failure. For this reason, kidney function should be monitored regularly during prolonged treatment,
• liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis,
• palpitations, heart failure, myocardial infarction, hypertension,
• oesophagitis, 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. development of necrotising fasciitis). If signs of infection appear or worsen during ibuprofen use, the patient should immediately consult a doctor. The doctor will assess whether antimicrobial treatment (antibiotic therapy) is indicated. During ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or disturbances in consciousness have been observed. 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 ( frequency cannot be estimated from available data ):

• severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, increased eosinophil count (a type of white blood cell), acute generalised exanthematous pustulosis (AGEP),
• skin becomes sensitive to light,
• Kounis syndrome (a heart condition characterised by allergic myocardial infarction).

Reporting of adverse effects
If any adverse effects occur, including any 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
02-222 Warszawa
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 representative of the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Ibuxal Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Ibuxal Max contains
The active substance is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
The other ingredients are: povidone K90, corn starch, pregelatinized corn starch, microcrystalline cellulose (type 102), sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
Coating composition: hypromellose type 2910, talc, macrogol 6000, titanium dioxide (E 171).

What Ibuxal Max looks like and contents of the pack
Coated, elongated, white tablets, biconvex on both sides, with a break line on one side and smooth on the other, measuring 21.1 mm ± 0.5 mm x 9.1 mm ± 0.2 mm.
The break line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
PVC/PVDC/Aluminium blister pack in a cardboard box.
Pack sizes: 10 coated tablets.

Marketing authorisation holder and manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
tel.: +48 61 66 51 500
e-mail: [email protected]