Patient Information Leaflet

Iburapid, 200 mg, coated tablets
Ibuprofenum
Please read this 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 the 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 possible side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement or if you feel worse after 3 days, you should consult your 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: anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing).
Iburapid is used in the following conditions:
mild to moderate pain of various origins (e.g. headache, including tension headache and migraine, toothache, neuralgia, muscular, joint and bone pain, pain associated with influenza and colds),
fever of various causes (e.g. during influenza, colds or other infectious diseases),
painful menstruation.

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 NSAIDs, including acetylsalicylic acid, or to other
substances; history of aspirin-induced asthma, angioedema
(a skin and mucous membrane disease characterised by swelling), bronchospasm,
rhinitis (nasal catarrh) or urticaria associated with the use of acetylsalicylic
acid or other NSAIDs,
if the patient has severe renal and (or) hepatic insufficiency,
in case of active or past history of peptic ulcer of the stomach and (or) duodenum,
perforation or bleeding, including events occurring after use of NSAIDs,
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 disorders of the blood-forming system,
if the patient has severe dehydration (caused by vomiting, diarrhoea or
inadequate fluid intake),
in case of haemorrhagic diathesis (tendency to bleed in areas such as the skin, mucous
membranes, nose, gastrointestinal tract) and when taking anticoagulant drugs,
when taking other NSAIDs simultaneously, including COX-2 inhibitors,
during the last three months of pregnancy,
in children with body weight below 20 kg.

Warnings and precautions
Before starting to use Iburapid, consult a doctor or pharmacist.
Exercise particular caution:
in patients with impaired liver and (or) kidney or circulatory system function; in patients with
renal dysfunction, the lowest effective dose should be used, with simultaneous monitoring of
renal function,
in patients with bronchial asthma or allergies – taking the medicine may cause bronchospasm,
in patients with a history of hay fever, nasal polyps 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 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, history of myocardial infarction or
heart failure, fluid retention may occur due to worsening renal function,
in patients taking anticoagulants or with coagulation disorders, ibuprofen may prolong bleeding time,
in patients with disorders of red blood cell formation,
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 any of the symptoms associated with these serious skin reactions described in section 4 occur, Iburapid must be discontinued immediately and medical help sought.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If any of these symptoms occur, Iburapid must be discontinued immediately and the doctor or emergency medical services contacted without delay.

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

Elderly patients
In patients aged over 65 years, the risk of adverse effects is higher than in younger patients.
With long-term use of the medicine, especially in patients with a history of gastrointestinal disorders, particularly in those aged over 65 years, there is a risk of gastrointestinal haemorrhage, ulceration or perforation. If any unusual gastrointestinal symptoms occur, especially during the initial treatment period, the medicine should be discontinued immediately and the doctor informed.

Caution should be exercised when using Iburapid in patients 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.

Concomitant, long-term use of various analgesics 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 allergic symptoms appear, the use of Iburapid should be discontinued and immediate medical help sought, as these may be the first 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, thereby increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an 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.

The use of anti-inflammatory and analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. The recommended dose and duration of treatment should not be exceeded.

Before using Iburapid, the patient should consult a doctor or pharmacist if:
the patient has heart diseases such as heart failure, angina pectoris (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 history of 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 is a smoker.

With long-term use of analgesics, 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 only, although use on a doctor's recommendation is not excluded.

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

Iburapid and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Iburapid may affect the action of other medicines, and 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; concomitant use of these drugs with ibuprofen may increase the risk of gastrointestinal adverse effects,
antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan) and diuretics: ibuprofen (like other NSAIDs) may reduce the effectiveness of these drugs,
potassium-sparing diuretics: risk of increased potassium concentration in blood,
anticoagulant drugs (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine): limited clinical data suggest that NSAIDs may enhance the effect of drugs reducing blood coagulation,
lithium: evidence suggests potential increase in lithium plasma concentrations during concomitant use of ibuprofen (similarly to other NSAIDs),
methotrexate: risk of increased methotrexate plasma concentration during concomitant use of ibuprofen (similarly to other NSAIDs),
phenytoin: risk of increased phenytoin plasma concentration during concomitant use of ibuprofen (similarly to other NSAIDs),
cardiac glycosides (e.g. digoxin): due to possible potentiation of digoxin effects,
serotonin reuptake inhibitors (SSRIs): due to possible increased risk of gastrointestinal bleeding,
aminoglycosides: ibuprofen may slow down elimination of aminoglycosides from the body, increasing their toxic effects,
tacrolimus, cyclosporine: 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: evidence suggests increased risk of joint haemorrhage and bruising in haemophilic, HIV-positive patients taking zidovudine and ibuprofen concomitantly,
mifepristone – NSAIDs should not be used within 8–12 days after administration of mifepristone, as they may reduce its effectiveness.

Other medicines may also interact with or be affected by 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 complaints, Iburapid should be taken during meals.
Alcohol consumption should be avoided, as it may exacerbate adverse effects of Iburapid, particularly on the gastrointestinal tract and central nervous system.

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

Pregnancy
Iburapid should not be taken during the last 3 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 dose for the shortest possible duration should be used.
Iburapid taken for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby'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 female fertility. Use of this medicine is not recommended in women attempting to conceive. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Generally, ibuprofen has no effect or 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) 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, he or she 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, i.e. 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 minimised by using the lowest effective dose for the shortest
duration necessary to control symptoms.
Use the lowest effective dose for the shortest period necessary to relieve symptoms. If symptoms
of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see
section 2).

Adults and adolescents (aged 12 years and older) weighing 40 kg or more:
The initial dose of ibuprofen is 200 mg (1 tablet) or 400 mg (2 tablets). If necessary, additional
doses of 200 mg (1 tablet) or 400 mg of ibuprofen (2 tablets) may be taken. The interval between
doses should be adjusted according to symptom severity, while respecting the maximum
recommended daily dose. The interval should not be less than 6 hours for a 400 mg dose (2
tablets) and not less than 4 hours for a 200 mg dose (1 tablet). Do not exceed a total daily dose of
1200 mg of ibuprofen (6 tablets) within 24 hours.

Dosage for migraine headache: 400 mg (2 tablets) as a single dose, and if necessary, 400 mg (2
tablets) every 4 to 6 hours. The maximum daily dose of ibuprofen should not exceed 1200 mg (6
tablets). Treatment should be limited to a maximum of two or three days per week.

Use in children
Children weighing 20 to 29 kg (aged 6 to 9 years): 1 tablet of 200 mg.
If needed, 1 tablet every 6 to 8 hours.
Do not exceed 3 tablets per day (600 mg).

Children weighing 30 to 39 kg (aged 10 to 12 years): 1 tablet of 200 mg.
If needed, 1 tablet every 4 to 6 hours.
Do not exceed 4 tablets per day (800 mg).

Method of administration
Oral use.
Swallow the tablets whole with water.
For patients with gastrointestinal disorders, it is recommended to take Iburapid during meals.
Do not use Iburapid in children weighing less than 20 kg.
Do not use Iburapid in children under 6 years of age.

Patients over 65 years of age
If the patient is elderly, always consult a doctor before starting Iburapid, due to an increased risk of
adverse effects. The doctor will advise on appropriate use of the medicine.

Liver and kidney function disorders
If the patient suffers from impaired kidney or liver function, always consult a doctor before using
Iburapid. The 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.

Use of a higher than recommended dose of Iburapid
If you have taken more than the recommended dose of Iburapid, or if a child has accidentally
ingested the medicine, always contact your doctor, pharmacist, or go to the nearest hospital for
advice on possible health risks and what actions to take.
Adverse effects of varying severity have been observed.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), and
abdominal pain or diarrhoea. Tinnitus, ringing in the ears, disorientation, and nystagmus may also
occur, as well as headache and gastrointestinal bleeding. After ingestion of a large dose, drowsiness,
periodic agitation, chest pain, palpitations, loss of consciousness, coma, seizures (especially in
children), weakness, and dizziness may occur. Other symptoms include blood in the urine, low blood
potassium levels, feeling cold, breathing difficulties, muscle spasms (especially in children), kidney
failure, and liver damage. 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 should be sought:

Red, flat, non-elevated, target-like or circular skin lesions on the trunk, often with blisters in the center, 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 body temperature, 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 generalized exanthematous pustulosis).

Edema, hypertension, and heart failure have been reported during treatment with NSAIDs.

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

Adverse effects occurring not very commonly (in less than 1 in 100 people):

Skin rash,
Dyspepsia, abdominal pain, nausea,
Headache,
Visual disturbances,
Urticaria and itching.

Adverse effects occurring rarely (in less than 1 in 1,000 people):

Diarrhea, flatulence, 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 (anemia, leukopenia – reduced number of white blood cells, 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 called granulocytes), liver function disorders, especially during long-term use, erythema multiforme, Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction), toxic epidermal necrolysis, tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Peptic ulcer of the stomach and/or duodenum, gastrointestinal bleeding and perforation, especially 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 swelling, swelling of the tongue and larynx, shortness of breath, 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, disorientation, edema, hypertension, and heart failure associated with the use of NSAIDs at high doses have been observed.

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

Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with Iburapid should be discontinued immediately and medical help should be 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, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform 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.: +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 authorization holder.
Reporting adverse effects helps to 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 is damaged.
Medicines must not be disposed of via household waste or sewage systems. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the package and other information

What Iburapid contains
The active substance is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
The other components (excipients) are:
Tablet core: microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose,
povidone K30, talc, dimethicone, colloidal anhydrous silica.
Tablet coating: Opadry 03F240028 Pink: talc, hypromellose, titanium dioxide (E 171), polyethylene glycol
6000, carmine red (E 124), azorubine (E 122).
What Iburapid looks like and contents of the pack
Coated tablet
Shiny purple, biconvex, round coated tablets, packed in blisters, in a cardboard box. One blister contains 10 tablets.
Pack sizes:
10 tablets – 1 blister of 10 tablets
20 tablets – 2 blisters of 10 tablets
30 tablets – 3 blisters of 10 tablets
40 tablets – 4 blisters of 10 tablets
50 tablets – 5 blisters of 10 tablets
60 tablets – 6 blisters of 10 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw
Phone: +48 22 822 93 06
e-mail: [email protected]
Importer
Wörwag Pharma Operations Spółka z ograniczoną odpowiedzialnością
General Marian Langiewicza 58 Street
95-050 Konstantynów Łódzki
Phone/fax: 42 654 00 70 / 42 654 02 91