Patient Information Leaflet

Ibupar, 200 mg, coated tablets
(Ibuprofen)
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 3 days, you should contact your doctor.

Table of contents:

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

1. What Ibupar is and what it is used for

Ibupar 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.

Indications:

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

2. Important information before using Ibupar

When not to take Ibupar:

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 ulcer or duodenal ulcer, gastrointestinal perforation or bleeding, including cases occurring after use of NSAIDs,
if the patient has severe liver failure, severe kidney failure or severe heart failure,
if the patient has experienced 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,
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 in patients who previously experienced such warning
signs. If gastrointestinal bleeding or ulceration occurs, ibuprofen should be discontinued.
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 by patients who are concurrently taking other medicines
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
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 Ibupar, 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 is a smoker.
the patient has an infection - see below, section titled "Infections".

Use of Ibupar in patients with edema requires caution.
Long-term, concurrent use of multiple painkillers may lead to kidney damage with risk of kidney
failure.
Serious skin reactions have been reported with the use of ibuprofen, 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). If the patient develops any of the symptoms associated with
these serious skin reactions described in section 4, Ibupar should be stopped immediately and
medical help should be sought.
Patients with systemic lupus erythematosus or mixed connective tissue disorders may have an
increased risk of developing aseptic meningitis.
Bronchospasm may occur in patients with active or previous bronchial asthma or allergic disorders.
Ibuprofen may cause visual disturbances (scotoma, colour vision disturbances). In such cases,
the medicine should be discontinued and the patient should contact a doctor.
Ibuprofen has an anticoagulant effect. Caution is required in patients with coagulation disorders
and in those taking anticoagulant medicines.
If any other disturbing symptoms occur during treatment with ibuprofen, the medicine should be
discontinued and the patient should consult a doctor.
Allergic reactions to ibuprofen have occurred during treatment, including breathing difficulties,
facial and neck swelling (angioedema), chest pain. If any of these symptoms are observed,
Ibupar should be stopped immediately and urgent contact should be made with a doctor or
emergency medical services.
Infections
Ibupar may mask the signs of infection such as fever and pain. Therefore, Ibupar may delay the
initiation of appropriate treatment for infection, potentially leading to an increased 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 consultation is required.
Talk to your doctor, even if the above warnings refer to conditions experienced 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
impairment in dehydrated children and adolescents.
Use of Ibupar in patients with kidney and/or liver impairment
Do not use ibuprofen without consulting a doctor.
Use of Ibupar 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 with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines you 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: 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: limited evidence suggests reduced effectiveness of diuretics,
anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine),
lithium and methotrexate: NSAIDs may increase plasma 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 plasma concentrations of cardiac glycosides,
mifepristone: NSAIDs used 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 Ibupar treatment.
Therefore, always consult your doctor or pharmacist before taking Ibupar with other medicines.
Ibupar 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 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 mother and child and may delay
or prolong labour. During the first six months of pregnancy, Ibupar should not be used unless
the doctor considers its use absolutely necessary. If treatment is required 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 disturbances in the unborn
child if taken for longer than a few days. This may lead to reduced amniotic fluid volume
(oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child'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 taken by the mother at recommended doses for pain and fever treatment 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
treatment.
Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive motor vehicles or
operate machinery.
Ibupar contains lactose and sucrose. If the patient has been previously diagnosed with an
intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine also contains carmine red, which may cause allergic reactions.

3. How to use Ibupar
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 the patient feels worse, consult a doctor.
Recommended dose
Adults and children over 12 years of age:
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 1200 mg (6 tablets) per day.
If pain and fever worsen or new symptoms appear despite taking Ibupar, contact a doctor.
If the effect of Ibupar seems too strong or too weak, consult a 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 Ibupar than recommended
If the patient has taken more than the recommended dose of Ibupar or if a child has accidentally
taken the medicine, always contact a doctor or go to the nearest hospital to assess potential health
risks and receive advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood),
headache, tinnitus (ringing in the ears), confusion and nystagmus. After a large dose, drowsiness,
chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and
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 epigastric pain or, less commonly, diarrhea may occur. Gastrointestinal bleeding may also
occur. Severe poisoning affects the central nervous system and may also rarely present as
agitation or coma. In severe poisoning, metabolic acidosis may occur, 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.
Missing a dose of Ibupar
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 Ibupar
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking Ibupar 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, peeling of the skin, 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 generalised exanthematous pustulosis).

The frequency of the possible adverse effects 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, double vision, colour vision disturbances, urticaria, pruritus, alopecia, syndrome with abdominal pain, fever, chills, nausea and vomiting, palpitations, heart failure, hypertension, dryness of the oral mucosa, gingival ulceration, rhinitis.
Rare: diarrhoea, flatulence, constipation, vomiting, gastric mucosal inflammation, dizziness, insomnia or somnolence, restlessness, nervousness and feeling of fatigue.
Very rare: tarry stools, bloody vomiting, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease, aseptic meningitis, disturbances of consciousness, depression, emotional disorders, 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), liver function disorders, positive liver function tests, especially 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 generalised exanthematous pustulosis), chest pain which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. If such symptoms occur, stop taking Ibupar immediately and seek urgent medical help. See also section 2.
Gastric and (or) duodenal ulceration, perforation, gastrointestinal bleeding, sometimes with fatal outcome, may occur, particularly in elderly people.
Taking medicines such as Ibupar may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Other adverse effects may occur in some people during treatment with Ibupar.
If any other adverse symptoms not listed in this leaflet occur, inform your doctor.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse.
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, tel.: 22 49-21-301, fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Ibupar

Keep this medicine 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Ibupar contains

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

What Ibupar looks like and contents of the pack
Round, biconvex tablets, uniformly red throughout the batch, with a smooth surface.
Packaging: PVC/Al foil blister in a cardboard box.
Ibupar is available in packages containing 2, 4, 6 or 10 coated tablets.

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