Ibenal Forte

Leaflet attached to the packaging: patient information

Ibenal Forte, 400 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

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

• pain of various origins with mild to moderate severity: headache, migraine, toothache (including toothache after dental procedures), muscle, joint, and bone pain, pain associated with flu and colds, neuralgia;
• fever of various origins (including flu, colds, or other infectious diseases);
• painful menstruation.

The medicine is intended for short-term use. If there is no improvement after 3 days or if the patient feels worse, they should consult their doctor.

2. Important information before taking Ibenal Forte

When not to take Ibenal Forte:

• 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 had an allergic reaction to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as nasal congestion, urticaria, angioedema, or asthma,
• in patients with active or recurrent peptic ulcer disease, perforation (hole) or bleeding in the gastrointestinal tract, 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 the patient has cerebral bleeding (bleeding from brain vessels) or other bleeding,
• in dehydrated patients (dehydration caused by vomiting, diarrhea, or insufficient fluid intake),
• in patients with hemorrhagic diathesis (tendency to bleed).

Warnings and precautions

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

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or smokes,
• the patient has connective tissue diseases, such as systemic lupus erythematosus and mixed connective tissue disease,
• the patient has chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease),
• the patient has kidney problems,
• the patient has liver problems,
• the patient has recently undergone major surgery,
• the patient has bleeding disorders,
• the patient has asthma or has been diagnosed with an allergy, as taking the medicine may cause bronchospasm,
• the patient is taking other medications: corticosteroids (anti-inflammatory medications), diuretics, cardiac glycosides, and especially medications used in thrombosis or to prevent thrombosis formation; the patient should consult their doctor before taking ibuprofen with these medications,
• there is a risk of gastrointestinal bleeding, ulceration, or perforation (hole) 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 Forte should be discontinued immediately,
• the patient has an infection - see below under "Infections".

It is recommended to avoid taking Ibenal Forte at the same time as other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of side effects.
Patients with existing or past gastrointestinal diseases, 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-relieving medications may lead to kidney damage, even kidney failure (so-called analgesic nephropathy).
Ibenal Forte belongs to a group of medications that may adversely affect female fertility (nonsteroidal 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 Forte.
If the following occur: any skin rash, changes in mucous membranes, blisters, or other signs of an allergic reaction, the patient should stop taking Ibenal Forte and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
Ibenal Forte may mask the symptoms of an existing infection or fever.
Infections
Ibenal Forte may hide the objective symptoms of an infection, such as fever and pain. As a result, Ibenal Forte may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
During chickenpox, the patient should avoid taking Ibenal Forte.
Use in the elderly
Elderly patients are more prone to side effects than younger patients.

Children and adolescents

Do not give to children under 12 years of age without a doctor's recommendation.
In dehydrated children and adolescents, there is a risk of kidney function disorder.

Ibenal Forte and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Ibenal Forte may affect the action of other medications or other medications may affect the action of Ibenal Forte. For example:

• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• anticoagulant medications (i.e., blood thinners/preventing thrombosis formation, such as aspirin/acetylsalicylic acid, ticlopidine, warfarin),
• diuretics,
• lithium, used in psychiatric disorders,
• methotrexate, used in cancer diseases,
• zidovudine 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,
• quinolone antibiotics,
• sulfonylurea derivatives (used in the treatment of diabetes),
• aminoglycosides (medications against certain types of bacteria),
• mifepristone,
• cardiac glycosides,
• alcohol.

Also, some other medications may be affected or have an effect on treatment with Ibenal Forte.
Therefore, before taking Ibenal Forte with other medications, the patient should always consult their doctor or pharmacist.

Ibenal Forte with food and drink

Ibenal Forte should be taken with a large amount of water.
In patients with gastrointestinal disorders, it is recommended to take the medicine with a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Ibenal Forte should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and their child and cause delayed or prolonged labor.
The medicine should not be taken during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is necessary during this period or during attempts to become pregnant, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibenal Forte may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
So far, no cases of side effects have been reported in breastfed children.
Discontinuation of breastfeeding is not necessary during short-term treatment with ibuprofen in recommended doses.
Fertility
This medicine belongs to a group of medications (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

Ibenal Forte does not affect driving or using machines if taken in recommended doses and for the recommended period.

3. How to take Ibenal Forte

This medicine should always be taken exactly as described in the patient leaflet or as advised by the doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
Adults
The initial dose is 1 to 2 tablets, then, if necessary, one or two tablets can be taken after 4 hours. Do not take more than three tablets (1200 mg of ibuprofen) in 24 hours.
A 4-hour interval should be maintained between doses.
In elderly patients, a dose change is not necessary.

Use in children and adolescents

Children over 12 years of age
The initial dose is 1 to 2 tablets, then, if necessary, one or two tablets can be taken after 4 hours. Do not take more than three tablets (1200 mg of ibuprofen) in 24 hours.
A 4-hour interval should be maintained between doses.
The medicine should not be taken in children under 12 years of age without a doctor's recommendation.
Tablets should be taken with water. In patients with gastrointestinal disorders, it is recommended to take the medicine with a meal.
The medicine is intended for oral use only and for short-term use.
The smallest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
If it is necessary to administer the medicine to children and adults for more than 3 days or if the symptoms worsen, the patient should contact their doctor.

Taking a higher dose of Ibenal Forte than recommended

If the patient has taken a higher dose of Ibenal Forte than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible health risk and advice on what to do in such a case.
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 problems have occurred.

Missing a dose of Ibenal Forte

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ibenal Forte can cause side effects, although not everybody gets them.
Ibenal Forte is generally well-tolerated.
In some patients taking ibuprofen for a short period in doses available without a prescription, the following side effects have occurred:
Uncommon(occurring in more than 1 in 1000 patients, but less than 1 in 100 patients):

• indigestion, stomach pain, nausea;
• headache;
• urticaria, itching.

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

• diarrhea, bloating, constipation, vomiting, gastritis;
• dizziness, insomnia, agitation, irritability, fatigue.

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

• worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), peptic ulcer disease of the stomach and/or duodenum, perforations (holes) and bleeding in the gastrointestinal tract (symptoms include black stools, bloody vomiting), sometimes with a fatal outcome, especially in the elderly;

renal failure, renal necrosis with edema, especially during long-term use;

• liver function disorders, especially during long-term use;
• anemia (anemia), decreased white blood cell count (leukopenia), decreased platelet count (thrombocytopenia), disorder characterized by a deficiency of red blood cells, white blood cells, and platelets (pancytopenia), decreased number of white blood cells called granulocytes (agranulocytosis) - the first symptoms of blood disorders are fever, sore throat, superficial ulcers of the mucous membrane of the mouth, flu-like symptoms, severe fatigue, unexplained bleeding (e.g., bruising, petechiae, purpura, nosebleeds);
• severe skin reactions (erythema multiforme, toxic epidermal necrolysis);
• facial edema, tongue and laryngeal edema, dyspnea, tachycardia, hypotension, worsening of asthma symptoms and bronchospasm;
• palpitations, heart failure, myocardial infarction.

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, the patient should stop taking Ibenal Forte and seek medical attention immediately. See also section 2.
• the skin becomes sensitive to light.

Severe skin reactions known as DRESS syndrome may also occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
In patients with autoimmune diseases (in which the immune system destroys its own tissues, such as systemic lupus erythematosus), single cases of symptoms have been reported during ibuprofen treatment, which occur in so-called aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, and orientation disorders.
With the use of NSAIDs, reports have been made of the occurrence of edema, hypertension, and heart failure.
Taking medications like ibuprofen may be associated with a small increased risk of heart attack or stroke.
When taking ibuprofen for other indications and long-term, other side effects may occur.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their 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, more information can be collected on the safety of the medicine.

5. How to store Ibenal Forte

The medicine should be stored out of sight and reach of children.
Store at 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibenal Forte contains

• The active substance of Ibenal Forte is ibuprofen (Ibuprofenum).Each coated tablet contains 400 mg of ibuprofen.
• Other ingredients are: tablet core:hydroxypropyl cellulose, crospovidone, pregelatinized starch, microcrystalline cellulose, stearic acid, colloidal anhydrous silica; tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc; coating polish: aluminum-potassium silicate, titanium dioxide (E 171), hypromellose.

What Ibenal Forte looks like and contents of the packaging

Ibenal Forte coated tablets are white to cream-colored, oval, with a smooth surface.
PVC/PVDC/Aluminum blisters in a cardboard box.
The packaging contains 6, 10, 12, 20, 24, 30, 50, or 60 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 last revision of the leaflet:

• 09.11.2023