Ibenal Max

Package Leaflet: Information for the Patient

Ibenal Max, 600 mg, Coated Tablets

Ibuprofen

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Important information for the patient.

• You should keep this leaflet, so you can read it again later if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

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

• rheumatoid arthritis (including juvenile rheumatoid arthritis and Still's disease), ankylosing spondylitis, osteoarthritis, and seronegative spondyloarthropathies (degenerative joint diseases with a different basis than rheumatoid arthritis);
• non-articular rheumatic disorders (not directly related to the joints), such as bursitis, tendinitis, tendon sheath inflammation, and lower back pain;
• soft tissue injuries, such as sprains and strains;
• pain of various origins with mild to moderate intensity: headache, migraine, toothache (including post-dental surgery pain), post-operative pain, painful menstruation.

2. Important information before taking Ibenal Max

When not to take Ibenal Max:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had an allergic reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as nasal congestion, hives, swelling, or asthma,
• in patients with active or recurrent peptic ulcer or gastrointestinal bleeding, also those that occurred after taking NSAIDs,
• in patients with severe liver or kidney failure,
• in patients with severe heart failure,
• in women in the last three months of pregnancy,
• if you have bleeding in the brain (cerebral hemorrhage) or other bleeding,
• in patients who are dehydrated (dehydration caused by vomiting, diarrhea, or insufficient fluid intake),
• in patients with a bleeding disorder (tendency to bleed).

Warnings and precautions

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Ibenal Max, you should discuss your treatment with your doctor or pharmacist if:

• you have heart disease, such as heart failure, angina pectoris (chest pain), you have had a heart attack, bypass surgery, or have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if you have had a stroke (including mini-stroke or transient ischemic attack - TIA),
• you have high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or if you smoke,
• you have connective tissue diseases, such as lupus or mixed connective tissue disease,
• you have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease),
• you have kidney function disorders,
• you have liver function disorders,
• you have recently undergone major surgery,
• you have blood clotting disorders,
• you have asthma or have had an allergic reaction, as taking the medicine may cause bronchospasm,
• you are taking other medications: corticosteroids (anti-inflammatory medications), diuretics, cardiac medications, and especially medications used for blood clots or to prevent blood clots); consult your doctor before taking ibuprofen with these medications,
• there is a risk of gastrointestinal bleeding, ulceration, or perforation (puncture) of the gastrointestinal tract, which can be fatal. These reactions do not have to be preceded by warning signs. If gastrointestinal bleeding or ulceration occurs, Ibenal Max should be discontinued immediately,
• you have an infection - see below under "Infections".

You should avoid taking Ibenal Max at the same time as other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse reactions.
Patients with existing or previous gastrointestinal disorders, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
Concomitant, long-term use of different pain medications may lead to kidney damage and even kidney failure (so-called analgesic nephropathy).
Ibenal Max belongs to a group of medications that may adversely affect female fertility (non-steroidal anti-inflammatory drugs). This effect is temporary and disappears after the end of treatment.
Skin reactions
Severe skin reactions have been reported with the use of Ibenal Max.
If you experience: any skin rash, changes in the mucous membranes, blisters, or other signs of an allergic reaction, you should stop taking Ibenal Max and seek medical attention immediately, as these may be the first signs of a very severe skin reaction. See section 4.
Ibenal Max may mask the symptoms of an existing infection or fever.
Infections
Ibenal Max may hide the symptoms of an infection, such as fever and pain. As a result, Ibenal Max may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medication during an infection and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
During chickenpox, you should avoid taking Ibenal Max.
Use in the elderly
The elderly are more likely to experience adverse reactions than younger people.

Children and adolescents

Do not give to children with a body weight below 40 kg.
In dehydrated children and adolescents, there is a risk of kidney function disorders.

Ibenal Max and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
Ibenal Max may affect the action of other medications or other medications may affect the action of Ibenal Max. For example:

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

In the case of antifungal antibiotics, it is recommended to reduce the administered doses of ibuprofen, as these medications may increase the availability of active ibuprofen.
Also, some other medications may be affected or have an effect on the treatment with Ibenal Max.
Therefore, before taking Ibenal Max with other medications, you should always consult your doctor or pharmacist.

Ibenal Max with food and drink

Ibenal Max should be taken after a meal and washed down with a large amount of water.
In people with gastrointestinal disorders, it is recommended to take Ibenal Max during a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Pregnancy
During the first six months of pregnancy, Ibenal Max should not be taken unless it is absolutely necessary.
During the last three months of pregnancy, taking Ibenal Max is contraindicated, as it may increase the risk of complications in the mother and child during and after delivery.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
So far, no cases of adverse reactions have been reported in breastfed children.
Stopping breastfeeding is not necessary during short-term treatment with ibuprofen in recommended doses.
Fertility
This medicine may make it more difficult to become pregnant. If you plan to become pregnant or are having trouble becoming pregnant, you should inform your doctor.

Driving and using machines

Ibuprofen does not affect the ability to drive or use machines in general.
However, side effects that occur with high doses of the medication, such as fatigue, drowsiness, dizziness, and vision disturbances, may impair the ability to drive or use machines in individual cases.

3. How to take Ibenal Max

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Adults
The recommended dose is 1200-1800 mg per day, i.e., 1 tablet 2 or 3 times a day. In some patients, a dose of 600-1200 mg, i.e., 1 or 2 tablets per day, is effective. In severe or acute conditions, it may be beneficial to increase the dose and maintain it at this level until the symptoms subside; however, do not exceed the maximum recommended dose, i.e., 2400 mg per day, i.e., 4 tablets per day.
In the case of the elderly, a dose change is not necessary.

Use in children and adolescents

Children over 12 years old (>40 kg body weight)
The recommended dose is 20 mg/kg body weight per day in divided doses. In juvenile rheumatoid arthritis, a dose of 40 mg/kg body weight per day in divided doses is permissible.
Other strengths of the medication may be more suitable for use in the required indications and in this age group in relation to body weight.
Tablets should be taken after a meal and washed down with water. In people with gastrointestinal disorders, it is recommended to take the medication during a meal.
The smallest effective dose should be used for the shortest period necessary to alleviate the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen during the infection, you should consult your doctor immediately (see section 2).

Taking a higher dose of Ibenal Max than recommended

If you have taken more than the recommended dose of Ibenal Max or a child has accidentally taken the medication, you should always consult your doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do.
Symptoms may include: nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties have occurred.

Missing a dose of Ibenal Max

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ibenal Max can cause side effects, although not everybody gets them.
Taking medications like ibuprofen may be associated with a slightly increased risk of heart attack or stroke.
Medications like Ibenal Max are generally well-tolerated. In some patients, the following side effects have been reported:

• indigestion, stomach pain, diarrhea, constipation, nausea, vomiting (gastrointestinal disorders decrease when the medication is taken during a meal),
• fatigue, headache,
• rash.

Uncommon(occurring in more than 1 in 1000 patients, but less than 1 in 100 patients):

• asthma, hives, itching, rhinitis,
• purpura,
• insomnia, mild anxiety, hearing and vision disturbances, which disappear after the end of treatment,
• swelling of the mucous membranes of the mouth and throat (angioedema), gastrointestinal bleeding, stomach ulcers.

Rare(occurring in more than 1 in 10,000 patients, but less than 1 in 1000 patients):

• kidney function disorders, fluid retention (edema),
• changes in blood count parameters (leukopenia, thrombocytopenia, aplastic anemia),
• heart failure, high blood pressure,
• ulcerative colitis, pancreatitis, perforations, melena, bloating, bloody vomiting, exacerbation of ulcerative colitis and Crohn's disease,
• aseptic meningitis, dizziness, depression, disorientation, blurred vision, tinnitus,
• anaphylactic reactions (hypersensitivity reactions with fever, rash, swelling, and low blood pressure),
• skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes severe), erythema, photosensitivity, hair loss.

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

• liver disorders,
• palpitations, heart failure, heart attack.

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

• red, scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Ibenal Max and seek medical attention immediately. See also section 2.
• skin becomes sensitive to light.

Severe skin reactions known as DRESS syndrome may also occur. The symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Ibenal Max

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ibenal Max contains

• The active substance of Ibenal Max is ibuprofen (Ibuprofenum).
• Other ingredients are: tablet core:hydroxypropyl cellulose, crospovidone, pregelatinized starch, microcrystalline cellulose, stearic acid, anhydrous colloidal silica; tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc; gloss coating: aluminum-potassium silicate, titanium dioxide (E 171), hypromellose.

What Ibenal Max looks like and contents of the pack

Ibenal Max coated tablets are white to cream-colored, oval, with a smooth surface.
Blisters of PVC/PVDC/Aluminum in a cardboard box.
The pack contains 6, 10, 12, 20, 24, 30, 50, 60, or 100 coated tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of the last revision of the leaflet: