Package leaflet: Information for the patient

Ibenal Max, 600 mg, coated tablets
Ibuprofenum

Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

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

The active substance in Ibenal Max is ibuprofen.
Ibenal Max belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) which have anti-inflammatory, analgesic, and antipyretic effects.
Ibenal Max is used in the treatment of:

Rheumatoid arthritis (including juvenile rheumatoid arthritis and Still's disease), ankylosing spondylitis, osteoarthritis, and seronegative spondyloarthropathies (degenerative joint diseases not of rheumatoid origin);
Extra-articular rheumatic disorders (not directly related to joints), such as bursitis, tendinitis, tenosynovitis, and lumbago;
Soft tissue injuries, such as sprains and strains;
Mild to moderate pain of various origins: headache, migraine, toothache (including pain after dental procedures), postoperative pain, and dysmenorrhoea.

2. Important information before using Ibenal Max

When not to use Ibenal Max:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
if the patient has ever previously experienced allergic symptoms such as runny nose, urticaria, swelling or asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
in patients with active or recurrent peptic ulcer or duodenal ulcer, gastrointestinal perforation (gut wall rupture) or gastrointestinal bleeding, including cases occurring after use of NSAIDs,
in patients with severe liver or kidney failure,
in patients with severe heart failure,
in women during the last three months of pregnancy,
if the patient has bleeding in the brain (cerebral hemorrhage) or other bleeding,
in dehydrated patients (dehydration caused by vomiting, diarrhea or insufficient fluid intake),
in patients with bleeding disorders (tendency to bleed).

Warnings and precautions
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a
slight increase in the risk of heart attack or stroke, particularly when used at high
doses. Do not exceed the recommended dose or duration of treatment.
Before starting treatment with Ibenal Max, the patient should consult a doctor or
pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
the patient suffers from hypertension, diabetes, has elevated cholesterol levels, has a family history of heart disease or stroke, or if the patient smokes,
the patient has connective tissue disorders such as systemic lupus erythematosus or mixed connective tissue disease,
the patient has chronic inflammatory bowel conditions (ulcerative colitis, Crohn's disease),
the patient has kidney function disorders,
the patient has liver function disorders,
the patient has recently undergone major surgery,
the patient has blood clotting disorders,
the patient suffers or has suffered from bronchial asthma or has allergies, as the medicine may cause bronchospasm,
the patient is taking other medicines: corticosteroids (anti-inflammatory drugs), diuretics, heart medications, especially drugs used for blood clots or prevention of clot formation; medical advice should be sought before combining ibuprofen with these medicines,
there is a risk of gastrointestinal bleeding, ulceration or perforation (gut wall rupture), which may be life-threatening. These reactions may occur without warning symptoms. If gastrointestinal bleeding or ulceration occurs, Ibenal Max must be discontinued immediately,
the patient has an infection – see the section titled "Infections" below.

Concomitant use of Ibenal Max with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to increased risk of adverse effects.
Patients with current or past gastrointestinal disorders, particularly elderly individuals, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
Long-term, simultaneous use of various painkillers may lead to kidney damage and even kidney failure (so-called analgesic nephropathy).
Ibenal Max belongs to a group of medicines that may adversely affect fertility in women (nonsteroidal anti-inflammatory drugs). This effect is reversible and resolves after discontinuation of treatment.
Skin reactions
Severe skin reactions associated with the use of Ibenal Max have been reported.
If any skin rash, mucosal lesions, blisters or other allergic symptoms appear, the patient should stop taking Ibenal Max immediately and seek medical help without delay, as these may be early signs of a very serious skin reaction. See section 4.
Ibenal Max may mask symptoms of existing infection or fever.
Infections
Ibenal Max may conceal symptoms of infection such as fever and pain. Therefore, Ibenal Max
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 ongoing infection and infection symptoms persist or worsen, immediate consultation with a doctor is required.
Ibenal Max should be avoided during chickenpox.
Use in elderly patients
Elderly patients are more susceptible to adverse effects than younger individuals.
Children and adolescents
Do not administer to children weighing less than 40 kg.
In dehydrated children and adolescents, there is a risk of kidney function impairment.
Ibenal Max and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Ibenal Max may affect the action of other medicines or other medicines may affect the action of Ibenal Max. For example:

blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, ticlopidine, warfarin),
diuretics,
lithium, used in psychiatric disorders,
methotrexate, used in cancer diseases,
zidovudine and ritonavir, used in HIV (human immunodeficiency virus) infections,
corticosteroids, used in inflammatory conditions,
cyclosporine (a medicine preventing transplant rejection),
selective serotonin reuptake inhibitors,
tacrolimus, used in the treatment of, e.g., atopic dermatitis,
pentoxifylline, used in treating circulation disorders in upper and lower limbs,
bisphosphonates, used in osteoporosis, Paget's disease and to reduce blood calcium levels,
probenecid or sulfinpyrazone, used in the treatment of gout,
baclofen (a muscle relaxant),
cholestyramine, used in treating high cholesterol levels,
quinolone antibiotics,
sulfonylurea derivatives (used in diabetes treatment),
aminoglycosides (medicines against certain types of bacteria),
mifepristone,
cardiac glycosides,
alcohol.

When antifungal antibiotics are used, consider reducing the dose of ibuprofen, as these medicines may increase the bioavailability of active ibuprofen.
Other medicines may also influence or be influenced by treatment with Ibenal Max.
Therefore, always consult a doctor or pharmacist before using Ibenal Max with other medicines.
Ibenal Max with food and drink
Ibenal Max should be taken after a meal and accompanied by a large amount of water.
In patients with gastrointestinal complaints, it is recommended to take Ibenal Max with food.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
During the first six months of pregnancy, Ibenal Max is not recommended unless absolutely necessary.
During the last three months of pregnancy, use of Ibenal Max is contraindicated, as it may increase the risk of complications in mother and child before and after delivery.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
To date, no cases of adverse effects in breastfed infants have been reported.
Discontinuation of breastfeeding is not necessary during short-term treatment with ibuprofen at recommended doses.
Fertility
This medicine may impair fertility. If the patient plans pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Ibuprofen generally does not affect the ability to drive or operate machinery.
However, adverse effects associated with high doses of the medicine, such as fatigue, drowsiness, dizziness and visual disturbances, may in individual cases impair the ability to drive or operate machinery.

3. How to use Ibenal Max

This medicine should always be used according to the doctor's instructions. If in doubt, consult a doctor or pharmacist.
Adults
The recommended dose is 1200–1800 mg per day, i.e. 1 tablet 2 or 3 times daily. In some patients, an effective dose may be as low as 600–1200 mg, i.e. 1 or 2 tablets per day. In severe or acute conditions, increasing the dose and maintaining it at this level until symptoms improve may be beneficial; however, the maximum recommended dose of 2400 mg per day, i.e. 4 tablets per day, must not be exceeded.
For elderly patients, dosage adjustment is not usually necessary.
Use in children and adolescents
Children over 12 years of age (>40 kg body weight)
The recommended dose is 20 mg/kg body weight per day, given in divided doses. In juvenile rheumatoid arthritis, a dose of up to 40 mg/kg body weight per day in divided doses may be used.
Other strengths of the medicine are available which may be more suitable for use in the required indications and in this age group according to body weight.
Tablets should be taken after meals and swallowed with water. In patients with gastrointestinal complaints, it is recommended to take the medicine during meals.
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).
Use of a higher than recommended dose of Ibenal Max
If a patient has taken more than the recommended dose of Ibenal Max or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for assessment of possible health risks and advice on actions to take.
Symptoms may include: nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, feeling cold and breathing difficulties have occurred.
Missed dose of Ibenal Max
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Taking medicines such as ibuprofen may be associated with a small increased risk of
myocardial infarction or stroke.
Medicines such as Ibenal Max are generally well tolerated. In some patients,
the following adverse effects have been reported:
Common (occurring in more than 1 in 100 patients):

dyspepsia, abdominal pain, diarrhoea, constipation, nausea, vomiting (gastrointestinal disturbances usually decrease when the medicine is taken with food),
fatigue, headache,
rash.

Uncommon (occurring in more than 1 in 1,000 patients but less than 1 in 100 patients):

asthma, urticaria, pruritus, rhinitis,
purpura,
insomnia, mild anxiety, disturbances of hearing and vision, which resolve after discontinuation of treatment,
mucosal oedema of the oral cavity and pharynx (angioedema), gastrointestinal bleeding, gastric ulceration.

Rare (occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients):

renal function impairment, fluid retention (oedema),
changes in blood morphology parameters (leukopenia, thrombocytopenia, aplastic anaemia),
heart failure, hypertension,
ulcerative colitis, pancreatitis, perforations, melaena, flatulence, haematemesis, exacerbation of ulcerative colitis and Crohn's disease,
aseptic meningitis, dizziness, depression, disorientation, visual disturbances, tinnitus,
anaphylactic reactions (hypersensitivity reactions with fever, rash, oedema and hypotension),
skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes severe), erythema, photosensitivity, alopecia.

Very rare (occurring in less than 1 in 10,000 patients):

liver disorders,
palpitations, heart failure, myocardial infarction.

Frequency not known (frequency cannot be estimated from available data):

red scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, administration of Ibenal Max should be discontinued and immediate medical advice sought. See also section 2.
skin becomes sensitive to light.

Severe skin reactions known as DRESS syndrome may also occur.
Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and eosinophilia
(a type of white blood cell).
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 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 Ibenal Max

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Medicines should 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 pack and other information

What Ibenal Max contains

The active substance in Ibenal Max is ibuprofen (Ibuprofenum).
The other components are: tablet core: hydroxypropyl cellulose, crospovidone, pregelatinized starch, microcrystalline cellulose, stearic acid, anhydrous colloidal silicon dioxide; tablet coating: polyvinyl alcohol partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc; gloss coating: potassium aluminium silicate, titanium dioxide (E 171), hypromellose.

What Ibenal Max looks like and contents of the pack
Ibenal Max coated tablets are white to creamy white, oval-shaped, with a smooth surface.
Blister packs made of PVC/PVDC/Aluminium in a cardboard box.
The pack contains 6, 10, 12, 20, 24, 30, 50, 60 or 100 coated tablets.

Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106