Ibenal forte

Patient Information Leaflet

Ibenal Forte, 400 mg, coated tablets
Ibuprofenum

Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, 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 your condition worsens, consult your doctor.

Leaflet Contents:

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 pack and other information

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

The active substance in Ibenal Forte is ibuprofen.
Ibenal Forte belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory, analgesic, and antipyretic properties.
Ibenal Forte 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 only. If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

2. Important information before using Ibenal Forte

When not to use Ibenal Forte:

• 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 reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), such as runny nose, urticaria, swelling or asthma,
• in patients with active or recurrent peptic ulcer or duodenal ulcer, gastrointestinal perforation (a hole in the digestive tract), 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 is experiencing bleeding in the brain (cerebral haemorrhage) or other bleeding,
• in dehydrated patients (dehydration caused by vomiting, diarrhoea, or insufficient fluid intake),
• in patients with haemorrhagic diathesis (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 Forte, 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 the legs due to narrowed or blocked arteries), or has experienced any stroke (including mini-stroke or transient ischaemic attack - TIA),
• the patient suffers from high blood pressure, diabetes, has elevated cholesterol levels, has 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 impaired kidney function,
• the patient has impaired liver function,
• 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, cardiac glycosides, or particularly anticoagulant drugs or those preventing blood clots; 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 digestive tract), which may be life-threatening. These reactions may occur without warning symptoms. If gastrointestinal bleeding or ulceration occurs, Ibenal Forte should be discontinued immediately,
• the patient has an infection – see the section titled “Infections” below.

Concomitant use of Ibenal Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to an increased risk of adverse effects.
Patients with current or previous gastrointestinal disorders, particularly elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
Long-term, concomitant use of various painkillers may lead to kidney damage and even kidney failure (so-called analgesic nephropathy).
Ibenal Forte belongs to a group of medicines that may adversely affect fertility in women (non-steroidal anti-inflammatory drugs). This effect is reversible and resolves after discontinuation of treatment.

Skin reactions
Severe skin reactions associated with the use of Ibenal Forte have been reported.
If any skin rash, mucosal lesions, blisters or other allergic symptoms appear, the patient should stop taking Ibenal Forte immediately and seek urgent medical help, as these may be early signs of a very serious skin reaction. See section 4.

Ibenal Forte may mask symptoms of existing infection or fever.

Infections
Ibenal Forte may conceal objective signs of infection such as fever and pain. Therefore, Ibenal Forte 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 symptoms persist or worsen, immediate medical advice should be sought.
Ibenal Forte 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 give to children under 12 years of age without medical advice.
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Ibenal Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Ibenal Forte may affect the action of other medicines, or other medicines may affect the action of Ibenal Forte. For example:

• antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
• anticoagulant drugs (blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, ticlopidine, warfarin),
• diuretics,
• lithium, used in psychiatric disorders,
• methotrexate, used in cancer treatment,
• zidovudine and ritonavir, used in HIV (human immunodeficiency virus) infections,
• corticosteroids, used in inflammatory conditions,
• cyclosporine (a drug used to prevent transplant rejection),
• selective serotonin reuptake inhibitors,
• tacrolimus, used in the treatment of, for example, atopic dermatitis,
• pentoxifylline, used in the treatment of circulatory 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 the treatment of high cholesterol levels,
• quinolone antibiotics,
• sulfonylurea derivatives (used in diabetes treatment),
• aminoglycosides (drugs against certain types of bacteria),
• mifepristone,
• cardiac glycosides,
• alcohol.

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

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

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

Pregnancy
Ibenal Forte should not be used 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 tendency to bleeding in both the mother and her child and may delay or prolong labour.
This medicine should not be used during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Ibenal Forte may cause kidney problems in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

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

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

Driving and operating machinery
Ibenal Forte 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 Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

Adults
The initial dose is 1 to 2 tablets. If needed, one or two tablets may be taken again after 4 hours. Do not exceed three tablets (1200 mg of ibuprofen) in 24 hours. An interval of at least four hours must be maintained between doses.

In elderly patients, dosage adjustment is not usually necessary.

Use in children and adolescents
Children aged 12 years and above
The initial dose is 1 to 2 tablets. If needed, one or two tablets may be taken again after 4 hours. Do not exceed three tablets (1200 mg of ibuprofen) in 24 hours. An interval of at least four hours must be maintained between doses.

This medicine should not be used in children under 12 years of age without medical advice.

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

This medicine is intended for oral use only and for short-term treatment only.

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 treatment with this medicine is required for more than 3 days in children and adults, or if symptoms worsen, consult a doctor.

Taking more than the recommended dose of Ibenal Forte
If a patient takes more than the recommended dose of Ibenal Forte, or if a child accidentally ingests the medicine, always seek medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive 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, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness and dizziness, blood in urine, feeling cold, and breathing difficulties may occur.

Missed dose of Ibenal Forte
Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning 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.
Ibenal Forte is generally well tolerated.
In some patients using ibuprofen short-term at over-the-counter doses, the following adverse effects have been reported:

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

• Dyspepsia, 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, flatulence, 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 tarry stools, vomiting blood), sometimes fatal, particularly in elderly patients;
• Acute renal failure, renal papillary necrosis with edema, especially during prolonged use;
• Liver function disorders, particularly during prolonged use;
• Anaemia (low red blood cell count), reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia), deficiency of red blood cells, white blood cells and platelets (pancytopenia), reduced number of granulocytes (agranulocytosis) – initial symptoms of blood disorders include fever, sore throat, superficial ulcers 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 swelling, swelling of the tongue and larynx, shortness of breath, rapid heartbeat (tachycardia), low blood pressure (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 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 Forte should be discontinued immediately and medical help should be 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 (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 have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.
Treatment with NSAIDs has been associated with reports of edema, hypertension, and heart failure.
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 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
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 Forte

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 stated 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 package and other information

What Ibenal Forte contains

• The active substance in Ibenal Forte is ibuprofen (Ibuprofenum). Each coated tablet contains 400 mg of ibuprofen.
• Other components 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 Forte looks like and contents of the pack
Ibenal Forte coated tablets are white to cream-coloured, oval-shaped, with a smooth surface.
Blister packs made of PVC/PVDC/Aluminum foil in cardboard boxes.
The pack contains 6, 10, 12, 20, 24, 30, 50 or 60 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
09.11.2023