Ibupar

Leaflet accompanying the packaging: patient information

Ibupar, 200 mg, effervescent 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 a doctor or pharmacist.

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

Table of contents of the leaflet:

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

1. What is Ibupar and what is it used for

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

When not to take Ibupar:

• 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 or gastrointestinal bleeding, including bleeding caused by NSAIDs,
• if the patient has severe liver or kidney or 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 does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. 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 possible dose for the shortest possible time. Particular caution should be exercised by patients taking other medications that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants, such as acenocoumarol or antiplatelet agents like acetylsalicylic acid. 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 starting Ibupar, discuss it with your doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol, there is a history of heart disease or stroke in the patient's family, or if the patient smokes.
• the patient has an infection - see below, section entitled "Infections".

Caution is required when using the medicine in patients with edema. Long-term concurrent use of several pain-relieving medications may lead to kidney damage with a risk of kidney failure. Serious 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 use. If the patient experiences any symptoms associated with these serious skin reactions, the patient should stop taking Ibupar and seek medical attention immediately. Patients with systemic lupus erythematosus and mixed connective tissue disease may be at increased risk of developing aseptic meningitis. Patients with a history of bronchial asthma or allergic diseases may experience bronchospasm. Ibuprofen may cause vision disturbances (blurred vision, color vision disturbances). In such cases, the medicine should be discontinued and a doctor consulted. Ibuprofen has an antiplatelet effect. Caution is required in patients with bleeding disorders and those taking anticoagulant medications. If any other worrying symptoms occur during ibuprofen use, the medicine should be discontinued and a doctor consulted. Allergic reactions to ibuprofen, including difficulty breathing, facial and throat swelling (angioedema), chest pain, have been reported. If any of these symptoms occur, Ibupar should be discontinued immediately and medical help sought. InfectionsIbupar may mask the signs of infection such as fever and pain. Therefore, Ibupar may delay the initiation of appropriate infection treatment, which may lead 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 infection symptoms persist or worsen, the patient should consult a doctor immediately. The patient should discuss this with their doctor, even if the above warnings refer to past situations.

Children and adolescents

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

Using Ibupar in patients with renal or hepatic impairment

Ibuprofen should not be used without consulting a doctor.

Using Ibupar in the elderly

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

Ibupar 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 may affect the action of other medicines or other medicines may affect the action of Ibupar. For example:

• acetylsalicylic acid or other NSAIDs: the risk of side effects increases,
• blood pressure lowering medicines (ACE inhibitors, such as captopril, beta blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• diuretics: there is limited evidence of reduced diuretic efficacy,
• anticoagulant medicines (e.g. blood thinners/preventing blood clots, 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 concurrently,
• corticosteroids: concurrent use of NSAIDs and corticosteroids may increase the risk of side effects, especially gastrointestinal,
• cardiac glycosides: NSAIDs may exacerbate heart failure and increase serum glycoside levels,
• mifepristone: NSAIDs used within 8-12 days after mifepristone administration may reduce its efficacy,
• cyclosporin: concurrent use of NSAIDs and cyclosporin increases the risk of nephrotoxicity,
• quinolone antibiotics: concurrent use of NSAIDs with quinolone antibiotics increases the risk of seizures.

Also, some other medicines may be affected or have an effect on Ibupar treatment. Therefore, before taking Ibupar with other medicines, the patient should always consult a doctor or pharmacist.

Ibupar with food and drink

The medicine should be taken during or after a meal.

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 a doctor or pharmacist before taking this medicine. Ibupar should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor.During the first 6 months of pregnancy, Ibupar 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 may cause kidney function disorders 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 in the child'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 taken by the mother in recommended doses for pain and fever will have a negative effect on the infant. This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is reversible and disappears after the end of therapy.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive vehicles or operate machinery. Ibupar contains lactose and sucrose.If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine. The medicine also contains cochineal red, which may cause allergic reactions.

3. How to take Ibupar

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The medicine is taken orally. If after 3 days there is no improvement or the patient feels worse, they should consult a doctor. Recommended dose Adults and children over 12 years: The initial dose is 200 to 400 mg (1 to 2 tablets) as a single dose or 200 to 400 mg (1 to 2 tablets) every 4 to 6 hours as needed. Do not exceed a dose of more than 1200 mg (6 tablets) per day. If, despite taking Ibupar, pain and fever worsen or new symptoms appear, the patient should consult a doctor. If the patient feels that the effect of Ibupar is too strong or too weak, they should consult a doctor. The patient should use the lowest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).

Taking a higher than recommended dose of Ibupar

If the patient has taken a higher dose of Ibupar than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears (tinnitus), dizziness, and disorientation. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, in most patients taking NSAIDs in doses higher than recommended, symptoms such as stomach pain or, less frequently, diarrhea may occur. 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, sudden decrease in blood pressure, slowing or acceleration of heart rate, and atrial fibrillation may occur. In patients with asthma, worsening of asthma symptoms may occur.

Missing a dose of Ibupar

A double dose should not be taken to make up for a missed dose. A missed dose of Ibupar should be taken as soon as possible, according to the previously established dosing schedule.

Stopping Ibupar treatment

In case of further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

• 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 swollen 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 (occurs in more than 1 in 10 people), common (occurs in 1 in 10 to 1 in 100 people), uncommon (occurs in 1 in 100 to 1 in 1,000 people), rare (occurs in 1 in 1,000 to 1 in 10,000 people), very rare (occurs in less than 1 in 10,000 people). Common: rash, including maculopapular, decreased appetite, edema (usually resolving quickly after discontinuation of the medicine). Uncommon: indigestion, stomach pain, nausea, abdominal cramps, discomfort in the abdomen, heartburn, headache, blurred vision, double vision, color vision disturbances, urticaria, itching, hair loss, syndrome of symptoms including stomach pain, fever, chills, nausea, and vomiting, palpitations, heart failure, hypertension, dryness of the oral mucosa, gingival ulcers, rhinitis. Rare: diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia or drowsiness, agitation, nervousness, and fatigue. Very rare: black stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, aseptic meningitis, impaired consciousness, depression, emotional disturbances, tinnitus, hearing disturbances, azotemia, hematuria, kidney failure, including acute kidney failure, renal papillary necrosis, decreased creatinine clearance, polyuria, decreased urine output, increased sodium levels in the blood (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 count 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, tongue, or throat swelling (angioedema), shortness of breath, 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 and seek medical help immediately. See also section 2. Peptic ulcer and/or duodenal ulcer, perforation, gastrointestinal bleeding, sometimes fatal, especially in the elderly, may occur. Taking medicines like Ibupar may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. In some people, during Ibupar use, other side effects may occur. If other side effects occur that are not listed in this leaflet, the patient should inform their doctor.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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

The medicine should be stored out of sight and reach of children. Store in the original packaging, at a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton. 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 contains

• The active substance is ibuprofen. One tablet contains 200 mg of ibuprofen.
• The other ingredients are: potato starch, lactose monohydrate, povidone 25, colloidal anhydrous silica, magnesium stearate, talc; coating: sucrose, talc, spray-dried acacia gum, cochineal red (E 124), carnauba wax, white wax.

What Ibupar looks like and contents of the packaging

Tablets are round, biconvex, red, uniform for the entire series, and have a smooth surface. Packaging: PVC/Al blister pack in a cardboard box. Ibupar is available in packs of 2, 4, 6, or 10 effervescent tablets.

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: