Ibupar forte

Leaflet accompanying the packaging: patient information

Ibupar 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 directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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 is Ibupar forte and what is it used for
• 2. Important information before taking Ibupar forte
• 3. How to take Ibupar forte
• 4. Possible side effects
• 5. How to store Ibupar forte
• 6. Contents of the packaging and other information

1. What is Ibupar forte and what is it used for

Ibupar forte is a nonsteroidal anti-inflammatory drug (NSAID) with weak to moderate analgesic and antipyretic effects. Ibuprofen is absorbed from the gastrointestinal tract. The maximum concentration of ibuprofen in serum occurs 1 to 2 hours after oral administration. Food and antacids do not interfere with the absorption of ibuprofen. Indications for use:

• Mild to moderate pain of various origins, e.g., headache, including migraine, toothache, muscle, bone, and joint pain, post-traumatic pain, neuralgia, pain accompanying colds and flu.
• Fever of various origins (including flu and colds).
• Painful menstruation.

2. Important information before taking Ibupar forte

When not to take Ibupar forte:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has active or a history of peptic ulcer disease, perforation, or bleeding, including those caused by NSAIDs,
• if the patient has severe liver or kidney failure, or severe heart failure,
• if the patient has existing or a history of allergic symptoms such as rhinitis, urticaria, or bronchial asthma after taking acetylsalicylic acid or other NSAIDs,
• if the patient is in the last three months of pregnancy,
• while taking other nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors (increased risk of side effects),
• if the patient has a bleeding disorder.

Warnings and precautions

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning symptoms or may occur in patients with no such warning symptoms. If gastrointestinal bleeding or ulceration occurs, ibuprofen should be discontinued. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period. These patients should use the lowest effective dose for the shortest possible duration. Particular caution is advised in patients taking concomitant medications that may increase the risk of gastrointestinal irritation or bleeding, such as corticosteroids or anticoagulants, such as acenocoumarol or antiplatelet agents like acetylsalicylic acid. The use of NSAIDs, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible. Before starting treatment with Ibupar 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, or has peripheral artery disease (poor circulation in the legs due to narrowed or blocked arteries) or has had a stroke (including a mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection - see below, the section titled "Infections".

Cautious use is advised in patients with edema. Concomitant long-term use of several painkillers may lead to kidney damage with a risk of kidney failure. Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen. If the patient experiences any symptoms associated with these severe skin reactions, they should stop taking Ibupar forte and seek medical attention immediately. Patients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of developing aseptic meningitis. Patients with a history of bronchial asthma or allergic diseases may experience bronchospasm. Ibuprofen may cause visual disturbances (blurred vision, disturbances in color vision). If this occurs, the patient should stop taking the medicine and consult their doctor. Ibuprofen has an antiplatelet effect. Caution is advised in patients with bleeding disorders or those taking anticoagulant medications. If the patient experiences any other worrying symptoms, they should stop taking the medicine and consult their doctor. Allergic reactions to ibuprofen, including difficulty breathing, facial swelling, and chest pain, have been reported. If the patient experiences any of these symptoms, they should stop taking Ibupar forte and seek medical attention immediately.

Infections

Ibupar forte may mask the symptoms of infection, such as fever and pain. Therefore, Ibupar forte may delay the diagnosis of an infection, leading to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Children and adolescents

The medicine should not be used in children under 12 years of age. There is a risk of renal impairment in dehydrated children and adolescents.

Using Ibupar forte in patients with renal or hepatic impairment:

Ibuprofen should not be used without consulting a doctor.

Using Ibupar forte in the elderly:

In elderly patients, there is an increased risk of side effects. No dose adjustment is required unless there is impaired liver or kidney function. In cases of impaired liver or kidney function, the dose should be determined individually.

Ibupar forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Ibupar forte may interact with other medicines or other medicines may interact with Ibupar forte. For example:

• acetylsalicylic acid or other NSAIDs: increased risk of side effects,
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• diuretics: there is limited evidence of reduced diuretic effect,
• anticoagulant medicines (e.g., blood thinners or anti-clotting agents, such as acetylsalicylic acid, warfarin, ticlopidine),
• lithium and methotrexate: NSAIDs may increase serum lithium and methotrexate levels,
• zydovudine: there is evidence of prolonged bleeding time in patients treated with ibuprofen and zidovudine,
• corticosteroids: concomitant use of NSAIDs and corticosteroids may increase the risk of side effects, particularly gastrointestinal,
• cardiac glycosides: NSAIDs may increase the signs of heart failure and increase the serum levels of cardiac glycosides,
• mifepristone: NSAIDs used within 8-12 days after mifepristone administration may reduce its effectiveness,
• cyclosporine: concomitant use of NSAIDs and cyclosporine increases the risk of nephrotoxicity,
• quinolone antibiotics: concomitant use of NSAIDs and quinolone antibiotics increases the risk of seizures.

Other medicines may also be affected by or have an effect on Ibupar forte. Therefore, before taking Ibupar forte with other medicines, the patient should always consult their doctor or pharmacist.

Ibupar forte with food and drink

The medicine should be taken with or after food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Ibupar forte should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery.

It may cause kidney or heart problems in the unborn baby.

It may increase the risk of bleeding in the mother and child and cause prolongation

or prolongation of labor.During the first 6 months of pregnancy, Ibupar forte should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibupar forte may cause kidney problems in the unborn baby if taken for more than a few days.This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart.

If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Ibuprofen and its metabolites pass into breast milk in small amounts. It is unlikely that the medicine, when taken by the mother in recommended doses for pain and fever relief, will have a negative effect on the baby. This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is reversible and disappears after the end of treatment.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive vehicles or operate machinery.

Ibupar forte contains sunset yellow FCF (E 110) lake and carmoisine (E 124)

The medicine may cause allergic reactions.

Ibupar forte contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Ibupar forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine is taken orally. If there is no improvement after 3 days or if the patient feels worse, they should consult their doctor. Recommended dose: Adults and children over 12 years: The initial dose is 400 mg (1 tablet) as a single dose or 400 mg (1 tablet) every 4 to 6 hours as needed. The dose should not exceed 1200 mg (3 tablets) per day. If, despite taking Ibupar forte, the pain and fever worsen or new symptoms occur, the patient should consult their doctor. If the patient feels that the effect of Ibupar forte is too strong or too weak, they should consult their doctor. The patient should use the lowest effective dose for the shortest possible duration. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

Taking a higher dose of Ibupar forte than recommended

If the patient has taken a higher dose of Ibupar forte than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital for advice on possible harm and actions to take. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears (tinnitus), and dizziness. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, most patients taking NSAIDs in higher-than-recommended doses may experience symptoms such as stomach pain or, less frequently, diarrhea. Gastrointestinal bleeding may also occur. Severe poisoning affects the central nervous system and is also characterized by very rare agitation or coma. During severe poisonings, metabolic acidosis may occur, and the prothrombin time (INR) may be increased. Acute kidney failure or liver damage may occur, as well as a sudden decrease in blood pressure, slowed or accelerated heart rate, and atrial fibrillation. In patients with asthma, worsening of asthma symptoms may occur.

Missing a dose of Ibupar forte

The patient should not take a double dose to make up for a missed dose. The missed dose should be taken as soon as possible, according to the previously established dosing schedule.

Stopping treatment with Ibupar forte

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibupar forte can cause side effects, although not everybody gets them. The patient should stop taking Ibupar forte and seek medical help immediately if they experience any of the following symptoms:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• red, peeling, widespread rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The frequency of possible side effects listed below is defined as follows: very common (affects more than 1 in 10 people), common (affects 1 to 10 people in 100), uncommon (affects 1 to 10 people in 1,000), rare (affects 1 to 10 people in 10,000), very rare (affects less than 1 in 10,000 people). Common: rash, including maculopapular, decreased appetite, edema (usually resolving quickly after discontinuation of the medicine). Uncommon: dyspepsia, abdominal pain, nausea, epigastric pain, abdominal cramps, discomfort in the abdomen, heartburn, headache, blurred vision, disturbed vision, color vision disturbances, urticaria, pruritus, alopecia, syndrome of symptoms including abdominal pain, fever, chills, nausea, and vomiting, palpitations, heart failure, hypertension, dryness of the mucous membranes, gingival ulceration, rhinitis. Rare: diarrhea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia or drowsiness, excitement, nervousness, and fatigue. Very rare: melena, hematemesis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, aseptic meningitis, impaired consciousness, depression, emotional disturbances, tinnitus, hearing disturbances, azotemia, hematuria, renal failure, including acute renal failure, renal papillary necrosis, decreased creatinine clearance, polyuria, decreased urine output, increased serum sodium levels (sodium retention), liver function disorders, positive liver function tests, especially during long-term use, hepatitis, jaundice, agranulocytosis, aplastic anemia, hemolytic anemia, sometimes with a positive Coombs test, blood disorders (eosinophilia, leukopenia, neutropenia), thrombocytopenia with or without purpura, decreased hemoglobin or hematocrit levels, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute hypersensitivity reactions such as facial edema, lingual edema, laryngeal edema, dyspnea, hypotension, tachycardia, or anaphylactic shock, bronchospastic reactions, asthma exacerbation, bronchospasm. Frequency not known: skin becomes sensitive to light, red scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis), chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. If such symptoms occur, the patient should stop taking Ibupar forte and seek medical attention immediately. See also section 2. Gastrointestinal ulceration, perforation, or bleeding may occur, sometimes with a fatal outcome, especially in the elderly. Taking medicines like Ibupar forte may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. In some patients, while taking Ibupar forte, other side effects may occur. If the patient experiences any other side effects not mentioned in this leaflet, they should inform their doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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, Tel.: +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 Ibupar forte

The medicine should be stored out of sight and reach of children. It should be stored in its original packaging, at a temperature below 25°C. The medicine should not be used after the expiry date stated on the packaging. 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 Ibupar forte contains

• The active substance is ibuprofen. One tablet contains 400 mg of ibuprofen.
• The other ingredients are: microcrystalline cellulose (101), potato starch, anhydrous colloidal silica, sodium carmellose, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate; coating: macrogol (4000), hypromellose (E 5), hypromellose (E 15), hydroxypropylcellulose, sunset yellow FCF (E 110) lake, carmoisine (E 124).

What Ibupar forte looks like and contents of the pack

The tablets are red, with a uniform surface, round, and biconvex. The immediate packaging is a blister pack containing 10 coated tablets. The single pack contains 1, 2, or 3 blisters in a cardboard box.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel. 22 732 77 00

Manufacturer

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów

Date of last revision of the leaflet: