Ibenal

Patient Information Leaflet

Ibenal, 200 mg, coated tablets
Ibuprofenum

Please read the entire leaflet carefully before taking this medicine, as 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
physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Leaflet Contents:

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

1. What Ibenal is and what it is used for

The active substance in Ibenal is ibuprofen.
Ibenal belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory, analgesic, and antipyretic properties.
Ibenal is used to treat:

• mild to moderate pain of various origins: headache, migraine, toothache (including pain after dental procedures), muscular, joint, and bone pain, pain associated with influenza and colds, neuralgia;
• fever of various causes (e.g., during influenza, colds, or other infectious diseases);
• painful menstruation.

This medicine is intended for short-term use. If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibenal

When not to use Ibenal:

• if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever previously experienced allergic symptoms such as rhinitis, urticaria, swelling, or asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or recurrent gastric or duodenal ulcer, gastrointestinal perforation (a hole in the gut wall), or gastrointestinal bleeding, including those 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 a bleeding tendency (bleeding diathesis).

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, the patient should discuss the treatment with a doctor or
pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker,
• 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 bronchospasm may occur after taking the medicine,
• the patient is taking other medicines: corticosteroids (anti-inflammatory drugs), diuretics, cardiac drugs, especially drugs used for blood clots or to prevent clot formation; medical advice should be sought before combining ibuprofen with these medicines,
• there is a risk of gastrointestinal bleeding, ulceration, or perforation (a hole in the gut wall), which may be life-threatening. These reactions may occur without warning symptoms. If gastrointestinal bleeding or ulceration occurs, Ibenal should be discontinued immediately,
• the patient has an infection – see the section below titled "Infections".

Concomitant use of Ibenal with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to increased risk of adverse effects.
Patients with current or past gastrointestinal disorders, especially elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period.
Prolonged, simultaneous use of various painkillers may lead to kidney damage or even kidney failure (so-called analgesic nephropathy).
Ibenal 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 have been reported. If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, the patient should stop taking Ibenal immediately and seek medical help without delay, as these may be early signs of a very serious skin reaction. See section 4.
Ibenal may mask symptoms of existing infection or fever.

Infections
Ibenal may conceal objective signs of infection such as fever and pain. Therefore, Ibenal 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 consultation is required.
Ibenal should be avoided during chickenpox.

Use in elderly patients
Elderly individuals are more susceptible to adverse effects than younger people.

Children and adolescents
Do not administer to children with body weight below 20 kg.
In dehydrated children and adolescents, there is a risk of kidney function impairment.

Ibenal and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.
Ibenal may affect the action of other medicines, or other medicines may affect the action of Ibenal. For example:

• antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan),
• anticoagulant drugs (i.e., blood thinners/preventing clot 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 (human immunodeficiency virus) infections,
• corticosteroids, used in inflammatory conditions,
• cyclosporine (a drug preventing transplant rejection),
• selective serotonin reuptake inhibitors,
• tacrolimus, used in 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 treating gout,
• baclofen (a muscle relaxant),
• cholestyramine, used in treating high cholesterol levels,
• quinolone antibiotics,
• sulfonylurea derivatives (used in diabetes treatment),
• aminoglycosides (drugs against certain types of bacteria),
• mifepristone,
• cardiac glycosides,
• alcohol.

Some other medicines may also be affected by or influence treatment with Ibenal. Therefore,
always consult a doctor or pharmacist before using Ibenal with other medicines.

Food and drink
Ibenal should be taken with a large amount of water.
In patients with gastrointestinal complaints, it is recommended to take Ibenal with food.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.

Pregnancy
During the first six months of pregnancy, use of Ibenal is not recommended unless absolutely necessary.
During the last three months of pregnancy, use of Ibenal is contraindicated because it may increase the risk of complications in both mother and child before and after delivery.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
To date, no adverse effects have been reported in breastfed infants.
Breastfeeding need not be discontinued during short-term treatment with ibuprofen at recommended doses.

Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is transient and resolves after discontinuation of therapy.

Driving and operating machinery
Ibenal has no effect on the ability to drive or operate machinery when taken at the recommended doses and for the recommended duration.

3. How to use Ibenal

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Adults
The initial dose is 1 to 2 tablets, then if needed, one or two tablets may be taken every 4 hours. Do not exceed six tablets (1200 mg of ibuprofen) in 24 hours. A four-hour interval must be maintained between doses.
For elderly patients, dosage adjustment is not usually necessary.

Use in children and adolescents
Children over 12 years of age
The initial dose is 1 to 2 tablets, then if needed, one or two tablets may be taken every 4 hours. Do not exceed six tablets (1200 mg of ibuprofen) in 24 hours. A four-hour interval must be maintained between doses.

Children aged 6 to 12 years (with body weight > 20 kg)
One tablet 1 to 3 times daily. The interval between doses should be 6 hours (for children aged 10–12 years) or 8 hours (for children under 10 years of age).

The tablets should be taken with water. In patients with gastrointestinal disorders, it is recommended to take the medicine with food.

This medicine is intended for oral use only and for short-term treatment. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

If the medicine needs to be administered to children or adults for more than 3 days, or if symptoms worsen, consult a doctor.

Overdose of Ibenal
If a patient has taken more than the recommended dose of Ibenal, or if a child has accidentally ingested the medicine, seek immediate advice from a doctor or go to the nearest hospital for assessment of potential health risks and guidance on necessary actions.

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 (especially in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties have occurred.

Missed dose of Ibenal
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, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Ibenal is generally well tolerated.
The following adverse effects have been observed in some patients using short-term ibuprofen at over-the-counter doses:

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

• Indigestion, abdominal pain, nausea;
• Headache;
• Urticaria, itching.

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

• Diarrhea, bloating, constipation, vomiting, gastritis;
• Dizziness, insomnia, restlessness, irritability, feeling of 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 of the stomach and/or duodenum, perforations (gastrointestinal perforation), and gastrointestinal bleeding (symptoms include black tarry stools, vomiting blood), sometimes with fatal outcome, particularly in elderly patients;

• Sudden kidney failure, renal tubular necrosis with edema, especially during prolonged use;

• Liver function disorders, particularly during prolonged use;

• Anaemia (anaemia), reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia), a disorder involving deficiency of red blood cells, white blood cells, and platelets (pancytopenia), reduced number of white blood cells called granulocytes (agranulocytosis) – initial signs of blood disorders include fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, severe fatigue, unexplained bleeding (e.g. bruising, petechiae, purpura, nosebleeds);

• Severe skin reactions (erythema multiforme, toxic epidermal necrolysis);

• Facial, tongue, and laryngeal swelling, shortness of breath, rapid heartbeat (tachycardia), reduced blood pressure (hypotension), worsening of asthma symptoms and bronchospasm;

• Palpitations, heart failure, myocardial infarction.

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

• Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with Ibenal should be discontinued immediately and medical help sought without delay. 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, lymph node swelling, and increased eosinophil count (a type of white blood cell).
In patients with autoimmune diseases (conditions in which the immune system attacks the body's own tissues, such as systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation, have been reported during ibuprofen treatment.
Edema, hypertension, and heart failure have been reported in connection with NSAID therapy.
Use of medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke.
Other adverse effects may occur when ibuprofen is used for other indications or over prolonged periods.

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 at 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibenal

Keep the 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Ibenal contains

• The active substance is ibuprofen (Ibuprofenum).
• The 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; gloss coating: potassium aluminium silicate, titanium dioxide (E 171), hypromellose.

What Ibenal looks like and contents of the pack
Ibenal coated tablets are white to cream-coloured, oval-shaped, with a smooth surface.
Blisters made of PVC/PVDC/Aluminium in a cardboard box.
The pack contains 6, 10, 12, 20, 24, 30, 50, 60 or 96 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