Package leaflet: Information for the patient

Ibuxal Forte, 400 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 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if the patient feels worse, contact the doctor.

Table of contents

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

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

Ibuxal Forte belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs)
which have analgesic, anti-inflammatory and antipyretic effects.
Indications:
Mild to moderate pain of various origins:

headaches (including migraine),
toothache,
muscle, joint and bone pain (including back pain),
pain due to injury or following surgery, including dental procedures,
painful menstruation.
Feverish conditions of various causes (e.g. in the course of influenza, colds).

2. Information before using Ibuxal Forte

When not to use Ibuxal Forte:

if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
if the patient has ever had asthma, bronchial asthma, hay fever, angioedema, or urticaria 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 after taking 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 (haemorrhagic diathesis),
if the patient has coronary artery disease,
if the patient is in the last trimester of pregnancy,
if the patient is under 12 years of age.

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

Infections
Ibuxal Forte may mask objective signs of infection such as fever and pain. Therefore, Ibuxal Forte 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 should be sought.

The use of anti-inflammatory and analgesic 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 Forte, discuss this with your doctor or pharmacist if:

the patient has heart diseases, including heart failure, ischaemic heart disease, angina pectoris (chest pain), has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic 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 been diagnosed with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) due to an increased risk of aseptic meningitis symptoms,
the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid,
the patient has been diagnosed with inherited porphyria metabolism 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 NSAID use,
the patient is dehydrated (especially in children and adolescents) due to increased risk of renal failure,
the patient has impaired liver or kidney function,
the patient has active or previous bronchial 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 coagulation disorders (ibuprofen may temporarily inhibit platelet aggregation and prolong bleeding time),
when using the medicine in elderly patients (see section 3).

Avoid using Ibuxal Forte simultaneously with other non-steroidal 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, especially during the initial treatment period.
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 with oedema, which have been associated with previous NSAID use.
Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously had kidney disease. This may lead to oedema or even heart failure or hypertension in patients predisposed to such disorders.
Prolonged 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 treatment with NSAIDs generally return to their pre-treatment condition.
During long-term ibuprofen therapy, periodic monitoring of liver and kidney function and blood morphology with smear is necessary, especially in high-risk patients.
During prolonged treatment with high doses of analgesics, 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 generalised exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If any of the symptoms associated with these serious skin reactions described in section 4 occur, Ibuxal Forte should be discontinued immediately and medical help sought.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms are observed, Ibuxal Forte should be discontinued immediately and medical help sought without delay.
Avoid alcohol consumption during treatment, as it may increase the risk of adverse effects, particularly those related to the gastrointestinal tract and nervous system.

Ibuxal Forte 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 Forte may affect other medicines, and other medicines may affect the action of this medicine.
This applies, for example, to:

anticoagulants (i.e. blood thinners or agents preventing clots, 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 Forte 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 hyperkalaemia (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 levels of this medicine due to ibuprofen,
phenytoin (an anticonvulsant): possible increased serum levels of this medicine due to ibuprofen,
corticosteroids (such as prednisolone or dexamethasone): possible increased risk of gastrointestinal ulceration or bleeding,
tacrolimus (an immunosuppressant): increased risk of nephrotoxicity,
cyclosporine (an immunosuppressant): limited data on increased risk of nephrotoxicity,
zidovudine (used in AIDS treatment): possible increased risk of joint haemorrhage or bleeding (in HIV-positive haemophilia patients),
ritonavir (used in HIV therapy): possible increased plasma levels 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 (a 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 mifepristone's effectiveness,
calcium channel antagonists: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding,
desipramine: increased desipramine toxicity typical of tricyclic antidepressants,
levofloxacin and ofloxacin: increased risk of severe central nervous system effects,
thienopyridine derivatives: increased bleeding risk due to additive antiplatelet and anticoagulant effects,
bisphosphonates: increased risk of gastrointestinal adverse effects,
anticoagulant medicines (i.e. blood thinners or agents preventing clots, such as aspirin – acetylsalicylic acid, warfarin, ticlopidine): possible increased anticoagulant effects,
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): reduced efficacy of diuretics and other antihypertensive agents,
products containing Ginkgo biloba or Filipendula ulmaria: possible increased bleeding risk 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 Forte.
Therefore, always consult a doctor or pharmacist before combining Ibuxal Forte with other medicines.

Taking Ibuxal Forte with food, drink, and alcohol
The medicine may be taken with food or drink.
Patients with sensitive stomachs should take the medicine with food to avoid gastrointestinal discomfort.
Avoid taking ibuprofen with alcohol due to the potential for increased 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 Forte during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuxal Forte may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first six months of pregnancy, Ibuxal Forte should not be used unless the doctor considers it 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.
From the 20th week of pregnancy, Ibuxal Forte may cause foetal blood vessel constriction (ductus arteriosus) in the child's heart or kidney problems, which may lead to low amniotic fluid levels (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 be harmful to infants. However, if longer-term use is required, early weaning should be considered.

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

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

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

3. How to use Ibuxal Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for short-term oral use only.
Administration method
Oral administration.
This medicine may be taken during or apart from meals.
To avoid gastrointestinal discomfort, it is recommended to take the medicine during or after a meal.
Ibuxal Forte tablets should be taken with a glass of water.
Dosage
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms.
If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
If treatment longer than 3 days is required or if symptoms worsen, consult your doctor.
The maximum daily dose must not exceed 1200 mg.
Adults and adolescents over 12 years of age (body weight above 40 kg):
The usual dose is 400 mg (1 tablet). If needed, the dose may be repeated up to 3 times daily, with an interval of 4 hours. The maximum daily dose must not exceed 1200 mg (3 tablets per day).
Children
Ibuxal Forte must not be used in children under 12 years of age.
Elderly patients
Elderly patients have an increased risk of adverse effects.
To minimize the risk of adverse effects, the lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
Patients should be regularly monitored for gastrointestinal bleeding during ibuprofen treatment.
Patients with impaired liver or kidney function
The doctor will determine the appropriate dose for patients with impaired liver or kidney function.
Taking more Ibuxal Forte than recommended
If a patient takes more than the recommended dose of Ibuxal Forte or if a child accidentally ingests the medicine, always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on appropriate actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After a large overdose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, 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 causing such symptoms has not been precisely established. Myoclonic jerks (repetitive muscle twitches) 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 kidney failure, liver damage, hypotension, respiratory depression, bradycardia, or cyanosis may occur. In patients with asthma, worsening of asthma symptoms may occur.
If you miss a dose of Ibuxal Forte
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your 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 sought:

Red, flat, non-raised, target-like or circular skin lesions on the trunk, often with blisters in the centre, peeling of the skin, and ulceration 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).
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis).

The list of adverse effects below includes all adverse effects observed during treatment with ibuprofen, including those occurring after long-term use of high doses in patients with rheumatic disease.
Regarding the adverse reactions listed below, it should be remembered that the majority are dose-dependent and their occurrence varies individually.
Patients taking Ibuxal Forte should discontinue the medicine and immediately consult a doctor if signs or symptoms of ulceration, mucosal damage or gastrointestinal bleeding occur (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.
The most commonly observed adverse reactions involve the gastrointestinal tract. Ulceration, perforation, or gastrointestinal bleeding may occur, sometimes with fatal outcome (particularly in elderly patients). These may occur without preceding warning symptoms or may occur in patients who have previously experienced such warning symptoms. The risk of gastrointestinal bleeding is particularly dependent on the dose range 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 no more than 1 in 10 people):

Heartburn, abdominal pain, nausea, vomiting, bloating, diarrhoea, indigestion, constipation, tarry stools, vomiting blood, and minor gastrointestinal bleeding, which may exceptionally lead to anaemia.

Uncommon (occur in no more than 1 in 100 people):

Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly occurring together with a drop in 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 no more than 1 in 1000 people):

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

Very rare (occur in no more than 1 in 10,000 people):

Severe, generalised hypersensitivity reactions. These may present as, for example, facial swelling, tongue swelling, internal laryngeal swelling with impaired airway patency, respiratory insufficiency, rapid heartbeat, drop in 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 reactions, including erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction), toxic epidermal necrolysis, and exfoliative dermatitis. The highest risk of these severe reactions occurs at the beginning of therapy, in most cases within the first month of treatment. In exceptional cases, during varicella virus infection, severe skin infections and soft tissue complications may occur.
Blood dyscrasias (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, marked weakness, nosebleeds, and subcutaneous haemorrhages. During long-term 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 long-term 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. necrotising fasciitis). If signs of infection appear or worsen during ibuprofen treatment, 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 of 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 light-sensitive,
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 of Adverse Drug Reactions, 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
Adverse effects can also be reported to the representative of the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibuxal Forte

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

6. Contents of the packaging and other information

What Ibuxal Forte contains
The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
The other ingredients are: povidone K90, corn starch, pregelatinized, 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 Forte looks like and contents of the pack
Film-coated tablets, elongated, white, biconvex, with a score line on both sides,
measuring 18.9 mm ± 0.5 mm x 8.6 mm ± 0.2 mm.
The tablet can be divided into equal doses.
PVC/PVDC/Aluminium blister in a cardboard box.
Pack sizes: 10, 20, 30, 40, 50, 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
e-mail: [email protected]

Ibuxal forte