Ibenal

Package Leaflet: Information for the Patient

Ibenal, 200 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.
This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, you may need to read it again.
• If you need advice or further information, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

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

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

• pain of various origins of mild to moderate severity: headache, migraine, toothache (including post-dental surgery pain), muscle, joint, and bone pain, pain associated with flu and colds, neuralgia;
• fever of various origins (e.g., in the course of flu, colds, or other infectious diseases);
• painful menstruation.

The medicine is intended for short-term use. If after 3 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking Ibenal

When not to take Ibenal:

• 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 nonsteroidal anti-inflammatory drugs, such as nasal congestion, urticaria, angioedema, or asthma,
• in patients with active or recurrent peptic ulcer disease, perforation (hole) or gastrointestinal bleeding, also those that occurred after taking NSAIDs,
• in patients with severe liver or kidney impairment,
• in patients with severe heart failure,
• in women in the last three months of pregnancy,
• if you have cerebral bleeding (bleeding from brain vessels) or other bleeding,
• in dehydrated patients (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 like ibuprofen may be associated with a slightly 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, 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 artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA),
• you have high blood pressure, diabetes, high cholesterol levels, or if there is a history of heart disease or stroke in your family, or if you smoke,
• you have connective tissue diseases, such as systemic lupus erythematosus and 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 bleeding disorders,
• you have asthma or have had an allergic reaction, as taking the medicine may cause bronchospasm,
• you are taking other medicines: corticosteroids (anti-inflammatory medicines), diuretics, cardiac glycosides, and especially medicines used in blood clots or to prevent blood clots; you should consult your doctor before taking ibuprofen with these medicines,
• 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 should be discontinued immediately,
• you have an infection - see below under "Infections".

You should avoid taking Ibenal at the same time as other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of side effects.
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-relieving medications may lead to kidney damage, and even kidney failure (so-called analgesic nephropathy).
Ibenal belongs to a group of medicines 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. If you experience:

• any skin rash, changes in mucous membranes, blisters, or other signs of allergy, you should stop taking Ibenal and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.

Ibenal may mask the symptoms of an existing infection or fever.
Infections
Ibenal may hide the signs of infection, such as fever and pain. Therefore, Ibenal may delay the use of appropriate infection treatment, which can 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 medicine 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.
Use in the elderly
Elderly patients are more prone to side effects than younger patients.

Children and adolescents

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

Ibenal and other medicines

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

• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• anticoagulant medicines (i.e., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, ticlopidine, warfarin),
• diuretics,
• lithium, used in psychiatric disorders,
• methotrexate, used in cancer,
• zydovudine and ritonavir, used in HIV infection (human immunodeficiency virus),
• corticosteroids, used in inflammatory conditions,
• cyclosporin (a medicine to prevent 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 (medicines against certain types of bacteria),
• mifepristone,
• cardiac glycosides,
• alcohol.

Also, some other medicines may be affected by or have an effect on the treatment with Ibenal. Therefore, before taking Ibenal with other medicines, you should always consult your doctor or pharmacist.

Ibenal with food and drink

Ibenal should be taken with a large amount of water.
In patients with gastrointestinal disorders, it is recommended to take Ibenal during meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
During the first six months of pregnancy, Ibenal should not be used unless it is absolutely necessary.
During the last three months of pregnancy, the use of Ibenal is contraindicated, as it may increase the risk of complications for the mother and child during and after delivery.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
So far, no cases of side effects have been reported in breastfed children.
It is not necessary to stop breastfeeding during short-term treatment with ibuprofen in recommended doses.
Fertility
This medicine belongs to a group of medicines (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 has no effect on driving or using machines if taken in recommended doses and for the recommended duration.

3. How to take Ibenal

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
Adults
The initial dose is 1 to 2 tablets, then if necessary, you can take one or two tablets every 4 hours. Do not take more than six tablets (1200 mg of ibuprofen) in 24 hours.
A 4-hour interval should be maintained between doses.
In the elderly, 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, you can take one or two tablets every 4 hours. Do not take more than six tablets (1200 mg of ibuprofen) in 24 hours.
A 4-hour interval should be maintained between doses.
Children from 6 to 12 years of age (body weight > 20 kg)
1 tablet 1 to 3 times a day. The interval between two doses should be 6 hours (children aged 10-12 years) or 8 hours (children under 10 years of age).
Tablets should be taken with water. In patients with gastrointestinal disorders, it is recommended to take the medicine during meals.
The medicine is intended for oral use only and short-term use.
You should use the smallest effective dose for the shortest necessary period to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should consult your 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, you should contact your doctor.

Overdose of Ibenal

If you have taken more than the recommended dose of Ibenal or a child has accidentally taken the medicine, you should always consult your doctor or go to the nearest hospital to get an opinion on possible health risks 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 urine, feeling cold, and breathing difficulties have occurred.

Missed dose of Ibenal

You should not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ibenal can cause side effects, although not everybody gets them.
Ibenal 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, excitement, irritability, fatigue.

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

• worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), gastric and duodenal ulcer disease, perforations (holes) and gastrointestinal bleeding (symptoms are black stools, bloody vomiting), sometimes fatal, especially in the elderly;
• sudden kidney failure, necrosis of part of the kidney 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), a disorder involving a deficiency of red blood cells, white blood cells, and platelets (pancytopenia), decreased number of white blood cells called granulocytes (agranulocytosis) - the first signs 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);

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 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 lymph nodes, 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 aseptic meningitis, such as stiffness of the neck, headache, nausea, vomiting, fever, and disorientation.
With the use of NSAIDs, reports have been received of edema, hypertension, and heart failure.
Taking medicines like ibuprofen may be associated with a slightly increased risk of heart attack or stroke.
When using ibuprofen for other indications and long-term, other side effects may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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:
Aleje 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 medicine.

5. How to store Ibenal

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. You should 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 contains

• The active substance of Ibenal is ibuprofen (Ibuprofenum).
• The other ingredients are: tablet core:hydroxypropylcellulose, 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 looks like and contents of the pack

Ibenal coated tablets are white to creamy, 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 96 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 package leaflet: