Patient Information Leaflet

Iburapid, 400 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.
Keep this leaflet for future reference.
If you need advice or further information, please consult a 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 a doctor.

Table of Contents

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

1. What Iburapid is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have therapeutic effects including anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) properties.
Iburapid is used in the following conditions:
mild to moderate pain of various origins (e.g. headache, including tension headache and migraine, toothache, neuralgia, muscle, joint and bone pain, pain associated with influenza and common cold),
fever of various causes (e.g. during influenza, common cold or other infectious diseases),
painful menstrual periods.

2. Important information before using Iburapid

When not to use Iburapid
if the patient is allergic to ibuprofen or any of the other ingredients of this medicine
(listed in section 6),
if the patient is allergic to medicines in the NSAID group, including acetylsalicylic acid, or to other
substances; history of aspirin-induced asthma, angioedema
(a skin and mucous membrane disease characterized by swelling), bronchospasm,
rhinitis (nasal congestion) or urticaria associated with taking
acetylsalicylic acid or other NSAIDs,
if the patient has severe renal and/or hepatic impairment,
in case of active or past peptic ulcer disease of the stomach and/or duodenum,
perforation or bleeding, including events occurring after NSAID use,
in severe heart failure (NYHA class IV),
if the patient has severe hypertension,
if the patient has cerebral haemorrhage or any other active bleeding,
if the patient has unexplained blood disorders,
if the patient has severe dehydration (caused by vomiting, diarrhoea or
inadequate fluid intake),
in case of haemorrhagic diathesis (tendency to bleed, e.g. in the skin, mucous membranes, nose,
gastrointestinal tract) and when taking anticoagulant medicines,
when taking other NSAIDs simultaneously, including COX-2 inhibitors,
during the last three months of pregnancy,
in adolescents with body weight below 40 kg and in children.

Warnings and precautions
Before starting to use Iburapid, discuss this with your doctor or pharmacist.
Exercise particular caution:
in patients with impaired liver and/or kidney function or circulatory system; in patients with
renal dysfunction, the lowest effective dose should be used, with simultaneous monitoring of
kidney function,
in patients with bronchial asthma or allergies – taking the medicine may cause bronchospasm,
in patients who have experienced nasal polyps, nasal catarrh and chronic obstructive
respiratory diseases, due to increased risk of allergic reactions;
allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma),
in patients with systemic lupus erythematosus or mixed connective tissue disease, there is an increased risk of developing aseptic meningitis,
during chickenpox, the use of Iburapid should be avoided,
in patients with inherited blood disorders (acute intermittent porphyria),
in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), symptoms may worsen,
in patients with cardiac arrhythmias, hypertension, myocardial infarction or
heart failure in history, fluid retention in the body may occur due to worsening of kidney function,
in patients taking anticoagulants or with coagulation disorders, ibuprofen may prolong bleeding time,
in patients with disorders in red blood cell production,
in patients with diabetes,
immediately after major surgery,
if the patient has an infection — see below, section titled “Infections”.

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 the use of ibuprofen. If the patient experiences any of the symptoms associated with these serious skin reactions described in section 4, Iburapid should be discontinued immediately and medical help should be sought.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms are noticed, Iburapid should be stopped immediately and the patient should contact a doctor or emergency medical services without delay.

Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Elderly patients
In patients aged over 65 years, the risk of adverse effects is higher than in younger patients.
During long-term treatment, especially in patients with a history of gastrointestinal disorders, particularly in those over 65 years of age, there is a risk of gastrointestinal bleeding, ulceration or perforation. If any unusual gastrointestinal symptoms occur, especially during the initial treatment period, the medicine should be discontinued immediately and a doctor should be informed.
Caution should be exercised when using Iburapid in patients who are simultaneously taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulants like warfarin (acenocoumarol) or antiplatelet agents like acetylsalicylic acid.
Concurrent, long-term use of various painkillers may lead to kidney damage with risk of renal failure.
During long-term treatment with Iburapid, regular monitoring of liver function, kidney function and blood morphology is required.

Skin reactions
Severe skin reactions associated with the use of Iburapid have been reported. If any skin rash, mucosal changes, blisters or other signs of allergy appear, the use of Iburapid should be discontinued and immediate medical help should be sought, as these may be early signs of a very serious skin reaction. See section 4.

Infections
The medicine may mask symptoms of an existing infection. Iburapid may conceal objective signs of infection such as fever and pain. Therefore, Iburapid 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 consultation with a doctor is required.

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

Taking anti-inflammatory and 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 using Iburapid, the patient should discuss treatment with 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, has 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 ischaemic attack – TIA),
the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

During long-term use of painkillers, headache may occur, which should not be treated by increasing the dose of the medicine. The medicine should be discontinued and a doctor consulted if headaches occur frequently despite taking Iburapid.

Using the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Iburapid, as an over-the-counter product, is recommended for short-term use, although long-term use may be considered on a doctor's advice.

If new symptoms occur or existing symptoms worsen, contact a doctor or pharmacist.

Iburapid and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.

Iburapid may affect the action of other medicines or other medicines may affect the action of Iburapid.

Iburapid should be used cautiously in combination with:
acetylsalicylic acid, other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors or glucocorticosteroids; using these medicines together with ibuprofen may increase the risk of gastrointestinal adverse effects,
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan) and diuretics: ibuprofen (like other NSAIDs) may reduce the effectiveness of these medicines,
potassium-sparing diuretics: there is a risk of increased potassium levels in the blood,
anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine): limited clinical data suggest that NSAIDs may enhance the effect of medicines reducing blood coagulation,
lithium: there is evidence of potential increased lithium levels in blood plasma during concomitant use of ibuprofen (similarly to other NSAIDs),
methotrexate: there is a risk of increased methotrexate levels in blood plasma during concomitant use of ibuprofen (similarly to other NSAIDs),
phenytoin: there is a risk of increased phenytoin levels in blood plasma during concomitant use of ibuprofen (similarly to other NSAIDs),
cardiac glycosides (e.g. digoxin): due to the possibility of enhanced digoxin effect,
serotonin reuptake inhibitors (SSRIs): due to increased risk of gastrointestinal bleeding,
aminoglycosides: ibuprofen may slow down elimination of aminoglycosides from the body, enhancing their toxic effects,
tacrolimus, cyclosporine: there is a risk of kidney damage,
cholestyramine: cholestyramine administered simultaneously with ibuprofen reduces its absorption – a minimum 2-hour interval should be maintained,
probenecid or sulfinpyrazone: due to possible delayed elimination of ibuprofen,
quinolone antibiotics: due to increased risk of seizures,
sulfonylurea derivatives: due to possible interaction,
zidovudine: there is evidence of increased risk of joint haemorrhages and haematomas in haemophilic, HIV-positive patients taking zidovudine and ibuprofen simultaneously,
mifepristone: NSAIDs should not be used during 8–12 days after mifepristone administration, as they may reduce its effectiveness.

Some other medicines may also be affected by or affect treatment with Iburapid. Therefore, always consult a doctor or pharmacist before using Iburapid with other medicines.

Iburapid with food, drink and alcohol
Tablets should be swallowed whole with water.
In patients with gastrointestinal discomfort, it is recommended to take Iburapid during meals.
Alcohol consumption should be avoided, as it may intensify adverse effects of Iburapid, especially on the gastrointestinal tract and central nervous system.

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

Pregnancy
Iburapid should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both mother and child and may result in delayed or prolonged labour. Iburapid should not be taken during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment during this period or during attempts to conceive is necessary, the lowest possible dose should be used for the shortest possible time.
Iburapid taken for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is necessary, the doctor may recommend additional monitoring.

Breastfeeding
This medicine passes into breast milk, but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.

Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. Use of this medicine is not recommended in women trying to conceive. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Generally, ibuprofen has no effect or only a negligible effect on the ability to drive and operate machinery. However, due to the possibility of adverse effects such as fatigue, drowsiness, dizziness (reported as common) and visual disturbances (reported as uncommon) occurring with high doses, ability to drive and operate machinery may be impaired in individual cases. This effect may be intensified by concomitant alcohol consumption.

Iburapid contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Iburapid contains carmine (E 124) and azorubine (E 122)
The medicine may cause allergic reactions.

Iburapid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Iburapid

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 risk of adverse effects can be minimized by using the lowest effective dose for the shortest
duration necessary to control symptoms.
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 your doctor immediately (see
section 2).

Adults and adolescents (aged 12 years and older) with body weight of 40 kg or more:
The initial dose of ibuprofen is 400 mg (1 tablet). If necessary, an additional dose of 400 mg
ibuprofen (1 tablet) may be taken. The interval between doses should be adjusted according to
symptoms, taking into account the maximum recommended daily dose. The interval should not be
shorter than 6 hours. Do not exceed a total daily dose of 1200 mg ibuprofen (3 tablets) within 24
hours.

For migraine headache, the dose is 400 mg (1 tablet) as a single dose, and if necessary, 400 mg
(1 tablet) every 4 to 6 hours. The maximum daily dose of ibuprofen should not exceed 1200 mg
(3 tablets). The use of this medicine should be limited to a maximum of two or three days per week.

Method of administration
Oral use.
Tablets should be swallowed whole with water.
In patients with gastrointestinal disorders, it is recommended to take Iburapid during meals.

Do not use this medicine in patients weighing less than 40 kg.
Do not use this medicine in patients under 12 years of age.

Patients aged 65 years and older
If you are elderly, you should always consult your doctor before starting Iburapid due to an increased
risk of adverse effects. Your doctor will advise on appropriate use of the medicine.

Impaired liver or kidney function
If you suffer from reduced kidney or liver function, always consult your doctor before using Iburapid.
Your doctor will advise on appropriate use of the medicine.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Taking more than the recommended dose of Iburapid
If you have taken more than the recommended dose of Iburapid, or if a child has accidentally taken
the medicine, you should immediately contact a doctor, pharmacist, or go to the nearest hospital to
assess potential health risks and receive advice on necessary actions.
Adverse effects of varying severity have been observed.

Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with blood), abdominal
pain or diarrhoea. Tinnitus, ringing in the ears, disorientation, nystagmus, headache and gastrointestinal
bleeding may also occur. After ingestion of a large dose, drowsiness, periodic agitation, chest pain,
palpitations, loss of consciousness, coma, convulsions (especially in children), weakness and dizziness,
blood in urine, low blood potassium levels, feeling cold and breathing difficulties, muscle spasms (especially
in children), kidney failure, and liver damage may occur. In patients with asthma, the condition may worsen.

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

Stopping Iburapid
If you have any further questions about 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.
If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help sought:

Red, flat, disc-shaped or circular rash on the trunk, often with blisters in the centre, peeling of the skin, and ulceration in the mouth, throat, nose, genital organs and eyes. 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 fever, and enlarged lymph nodes (DRESS syndrome).

Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Edema, hypertension, and heart failure have been reported with the use of NSAIDs.

Taking medicines containing ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and prolonged use of the drug.

Adverse effects occurring not very often (in less than 1 in 100 people):
rash,
dyspepsia, abdominal pain, nausea,
headache,
visual disturbances,
urticaria and itching.

Adverse effects occurring rarely (in less than 1 in 1,000 people):
diarrhea, bloating, constipation, vomiting, gastric mucosal inflammation,
depression, disorientation, hallucinations, insomnia,
dizziness, restlessness, irritability, and fatigue,
toxic amblyopia,
tinnitus,
decreased hemoglobin and hematocrit levels, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium concentration, increased serum uric acid concentration.

Adverse effects occurring very rarely (in less than 1 in 10,000 people):
blood count abnormalities (anaemia, leucopenia – reduced number of white blood cells, leukocytes, thrombocytopenia – reduced number of platelets, pancytopenia – deficiency of all normal blood cells: red, white and platelets, agranulocytosis – lack of a certain type of white blood cells, granulocytes), liver function disorders, particularly during long-term use, erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction), toxic epidermal necrolysis, melena, haematemesis, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. Peptic ulcer of the stomach and (or) duodenum, gastrointestinal bleeding and perforation, particularly in patients over 65 years of age, aseptic meningitis,

edema, dysuria (discomfort during urination), decreased urine output, renal failure, renal papillary necrosis, increased serum urea concentration, increased serum sodium concentration (sodium retention),
severe hypersensitivity reactions such as facial, tongue and laryngeal swelling, dyspnoea, tachycardia (rapid heartbeat), hypotension (sudden drop in blood pressure), shock,
worsening of asthma and bronchospasm.
In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, and disorientation have been observed during ibuprofen treatment.
Edema, hypertension, and heart failure associated with the use of NSAIDs at high doses.

Adverse effects with unknown frequency (frequency cannot be determined from available data):

Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, administration of Iburapid should be discontinued immediately and medical help sought without delay. See also section 2.
Skin becomes sensitive to light.

Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include widespread skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell).

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a 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.: +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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Iburapid

Do not store above 25°C.
Store in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if the blister appears damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Iburapid contains
The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
The other ingredients (excipients) are:
Tablet core: microcrystalline cellulose, monohydrate lactose, maize starch, sodium croscarmellose,
povidone K30, talc, dimethicone, colloidal anhydrous silica.
Tablet coating: Opadry 03F240028 Pink: talc, hypromellose, titanium dioxide (E 171), macrogol
6000, carmine red (E 124), azorubine (E 122).
What Iburapid looks like and contents of the pack
Film-coated tablet
Shiny purple, biconvex, round film-coated tablets, embossed on one side with the mark "R-06",
packed in blisters, placed in a cardboard box. One blister contains 10 tablets.
Pack sizes:
10 tablets – 1 blister containing 10 tablets
20 tablets – 2 blisters containing 10 tablets each
30 tablets – 3 blisters containing 10 tablets each
40 tablets – 4 blisters containing 10 tablets each
50 tablets – 5 blisters containing 10 tablets each
60 tablets – 6 blisters containing 10 tablets each
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw
Tel. +48 22 822 93 06
e-mail: [email protected]
Importer
Wörwag Pharma Operations Spółka z ograniczoną odpowiedzialnością
General Marian Langiewicza Street 58
95-050 Konstantynów Łódzki
Tel./Fax: 42 654 00 70 / 42 654 02 91