Patient Information Leaflet

Ibupar forte, 400 mg, coated tablets
(Ibuprofenum)
Please read the entire leaflet before using 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 or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or worsen after 3 days, consult your doctor.

Table of Contents:

What Ibupar forte is and what it is used for
Important information before taking Ibupar forte
How to take Ibupar forte
Possible side effects
How to store Ibupar forte
Contents of the pack and other information

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

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

Therapeutic indications:

Mild to moderate pain of various origins, e.g., headache, including migraine, toothache, muscle, bone and joint pain, post-traumatic pain, neuralgia, pain associated with colds and influenza.
Fever of various causes (e.g., in the course of influenza and colds).
Painful menstruation.

2. Important information before using Ibupar forte

When not to take Ibupar forte:

if the patient is allergic 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 ulceration or perforation of the stomach and/or duodenum, bleeding, or perforation, including those occurring after use of NSAIDs,
if the patient has severe liver failure, severe kidney failure, or severe heart failure,
existing or past history of allergic reactions 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,
during concomitant use of other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors (increased risk of adverse effects),
if the patient has a bleeding disorder.

Warnings and precautions
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and which may occur without warning symptoms or may occur in patients who have previously experienced such warning symptoms. In case of gastrointestinal bleeding or ulceration, ibuprofen should be discontinued immediately. Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period. These patients should use the lowest effective dose for the shortest possible duration.
Particular caution should be exercised in patients taking concomitant medications that may increase the risk of gastric or intestinal disorders or bleeding, such as corticosteroids or anticoagulants such as acenocoumarol, or antiplatelet agents such as acetylsalicylic acid.
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased 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 Ibupar forte, discuss this with your doctor or pharmacist if:

the patient has heart conditions such as heart failure, angina (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 high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
the patient has an infection - see below, section titled "Infections".

Use of Ibupar forte in patients with edema requires caution.
Long-term, concomitant use of multiple painkillers may lead to kidney damage with 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 occurred with the use of ibuprofen. If the patient develops any of the symptoms related to these serious skin reactions described in section 4, Ibupar forte should be stopped immediately and medical help should be sought.
Patients with systemic lupus erythematosus or mixed connective tissue diseases may have an increased risk of developing aseptic meningitis.
Bronchospasm may occur in patients with active or past history of bronchial asthma or allergic conditions.
Ibuprofen may cause visual disturbances (scotoma, disturbances in color vision). In such cases, the drug should be discontinued and the patient should contact a doctor.
Ibuprofen has an antithrombotic effect. Caution is required in patients with coagulation disorders or those taking anticoagulant medications.
If any other disturbing symptoms occur during treatment with ibuprofen, the patient should discontinue the medicine and consult a doctor.
Allergic reactions to this medicine, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during ibuprofen use. If any of these symptoms are noticed, Ibupar forte should be discontinued immediately and the patient should contact a doctor or emergency medical services without delay.
Infections
Ibupar forte may mask symptoms of infection such as fever and pain. Therefore, Ibupar 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 existing infection and the symptoms of infection persist or worsen, immediate medical consultation is required.
Talk to your doctor, even if the above warnings relate to conditions that occurred in the past.
Children and adolescents
Do not use this medicine in children under 12 years of age. There is a risk of kidney function disorders in dehydrated children and adolescents.
Use of Ibupar forte in patients with impaired kidney and/or liver function:
Do not use ibuprofen without consulting a doctor.
Use of Ibupar forte in elderly patients:
Elderly patients have an increased risk of adverse effects. Dose adjustment is not required unless liver and/or kidney function is impaired. In case of impaired kidney and/or liver function, the dose should be individually adjusted.
Ibupar forte with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ibupar forte may affect the action of other medicines, or other medicines may affect the action of Ibupar forte. For example:

acetylsalicylic acid or other NSAIDs: increased risk of adverse effects,
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
diuretics: there is limited evidence of reduced effectiveness of diuretics,
anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine),
lithium and methotrexate: NSAIDs may increase serum concentrations of both lithium and methotrexate,
zidovudine: evidence suggests prolonged bleeding time in patients treated concomitantly with ibuprofen and zidovudine,
corticosteroids: concomitant use of NSAIDs and corticosteroids may increase the risk of adverse effects, especially gastrointestinal,
cardiac glycosides: NSAIDs may exacerbate symptoms of heart failure and increase serum levels of cardiac glycosides,
mifepristone: NSAIDs used within 8-12 days after mifepristone administration may reduce its efficacy,
cyclosporine: concomitant use of NSAIDs and cyclosporine increases the risk of nephrotoxic effects,
quinolone antibiotics: concomitant use of NSAIDs with quinolone antibiotics increases the risk of seizures.

Other medicines may also interact with or be affected by treatment with Ibupar forte.
Therefore, always consult your doctor or pharmacist before taking Ibupar forte with other medicines.
Ibupar forte with food and drink
Take the medicine during or after a meal.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take Ibupar forte if the patient is in the last three 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 tendency to bleeding in both the mother and the child and may delay or prolong labor. During the first 6 months of pregnancy, do not use Ibupar forte, unless the doctor considers its use absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Ibupar forte may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (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.
Ibuprofen and its metabolites pass into breast milk in low concentrations. It is unlikely that the medicine, when taken by the mother at recommended doses for pain and fever, will adversely affect the infant.
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
There are no data on the effect of the medicine on the ability to drive motor vehicles or operate machinery.
Ibupar forte contains orange yellow (E 110) lake and carmine red (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, meaning 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
If there is no improvement after 3 days or if symptoms worsen, consult a doctor.
Recommended dose
Adults and children over 12 years of age:
The initial dose is 400 mg (1 tablet) as a single dose or 400 mg (1 tablet) every 4 to 6 hours as needed.
Do not exceed a daily dose of 1200 mg (3 tablets).
If pain and fever worsen or new symptoms appear despite taking Ibupar forte, contact a doctor.
If you feel the effect of Ibupar forte is too strong or too weak, consult your doctor.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Taking more than the recommended dose of Ibupar forte
If a patient has taken more than the recommended dose of Ibupar forte or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital for evaluation of potential health risks and advice on what actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus (ringing in the ears), disorientation, and nystagmus. After a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low potassium levels in blood, feeling cold, and breathing difficulties may occur.
Additionally, in most patients taking NSAIDs in doses higher than recommended, symptoms such as upper abdominal pain or, less commonly, diarrhea may occur. Gastrointestinal bleeding may also occur. Severe poisoning affects the central nervous system and may also manifest as rare excitement or coma. Severe poisoning may lead to metabolic acidosis, and prothrombin time (INR) may be prolonged. Acute kidney failure or liver damage, sudden drop in blood pressure, slowed or accelerated heart rate, and atrial fibrillation may occur. In patients with asthma, worsening of asthma symptoms may occur.
Missed dose of Ibupar forte
Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible, following the previously established dosing schedule.
Stopping treatment with Ibupar forte
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will get them.
You should stop taking Ibupar forte and seek immediate medical help if any of the following symptoms occur:

Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes 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, scaly widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The frequency of possible adverse reactions listed below is defined as follows:
very common (affects more than 1 in 10 people), common (affects 1 to 10 in 100 people),
uncommon (affects 1 to 10 in 1,000 people), rare (affects 1 to 10 in 10,000 people),
very rare (affects fewer than 1 in 10,000 people).

Common: rashes, including maculopapular, decreased appetite, oedema (usually resolving quickly after discontinuation of the medicine).
Uncommon: dyspepsia, abdominal pain, nausea, epigastric pain, colicky abdominal pain, epigastric discomfort, heartburn, headache, scotoma, blurred vision, diplopia, colour vision disturbances, urticaria, pruritus, alopecia, syndrome with symptoms of abdominal pain, fever, chills, nausea and vomiting, palpitations, heart failure, arterial hypertension, dryness of the oral mucosa, gingival ulceration, rhinitis.
Rare: diarrhoea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia or somnolence, restlessness, nervousness and fatigue.
Very rare: tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, aseptic meningitis, disturbances of consciousness, depression, emotional disturbances, tinnitus, hearing disturbances, azotemia, haematuria, renal failure, including acute renal failure, renal papillary necrosis, decreased creatinine clearance, polyuria, reduced urine output, increased serum sodium concentration (sodium retention), hepatic function disorders, positive liver function tests, particularly during prolonged use, hepatitis, jaundice, agranulocytosis, aplastic anaemia, haemolytic anaemia, sometimes with positive Coombs test, blood count abnormalities (eosinophilia, leukopenia, neutropenia), thrombocytopenia with or without purpura, decreased haemoglobin or haematocrit, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute hypersensitivity reactions such as: facial, tongue or laryngeal swelling, dyspnoea, hypotension, tachycardia or anaphylactic shock, bronchospastic reactions, asthma exacerbation, bronchospasm.
Frequency not known: skin becomes light-sensitive, red scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis), chest pain which may be a sign of a potentially serious allergic reaction called Kounis syndrome. If such symptoms occur, stop taking Ibupar forte immediately and seek urgent medical help. See also section 2.

Peptic ulceration of the stomach and/or duodenum, perforation, gastrointestinal bleeding, sometimes with fatal outcome, may occur, particularly in elderly people.

Taking medicines such as Ibupar forte may be associated with a small increased risk of myocardial infarction (heart attack) or stroke.

Other adverse reactions may occur in some people during treatment with Ibupar forte. If any other adverse reactions not listed in this leaflet occur, inform your doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibupar forte

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

6. Contents of the pack and other information

What Ibupar forte contains

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
The other excipients are: microcrystalline cellulose (101), potato starch, colloidal anhydrous silica, sodium croscarmellose, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate; coating: macrogol (4000), hypromellose (E 5), hypromellose (E 15), hydroxypropyl cellulose, sunset yellow (E 110) lake, carmine red (E 124).

What Ibupar forte looks like and contents of the pack
Red tablets with a uniform surface, round and biconvex.
Primary packaging: PVC/Al foil blister containing 10 coated tablets.
The unit pack contains 1, 2 or 3 blisters in a cardboard box.
Marketing Authorisation 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