Iburapid

Leaflet accompanying the packaging: patient information

Iburapid, 400 mg, coated 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 directed by a doctor or pharmacist. The leaflet should be kept in case it needs to be read again. If advice or additional information is needed, a pharmacist should be consulted. If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4. If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Iburapid and what is it used for

Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory, and antipyretic effects. Iburapid is used in the following cases: pain of various origins of mild to moderate severity (headaches, including tension headaches and migraines, toothaches, neuralgia, muscle, joint, and bone pain, pain associated with flu and colds), fever of various origins (including during flu, colds, or other infectious diseases), painful menstruation.

2. Important information before taking Iburapid

When not to take Iburapid

if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6), if the patient is hypersensitive to NSAIDs, including acetylsalicylic acid or other substances; a history of aspirin-induced asthma, angioedema (a skin and mucous membrane disease characterized by swelling), bronchospasm, rhinitis (cold), or urticaria associated with the use of acetylsalicylic acid or other NSAIDs, if the patient has severe renal and/or hepatic impairment, in the case of active or history of peptic ulcer or gastrointestinal bleeding, in severe heart failure (NYHA Class IV), if the patient has severe hypertension, if the patient has a history of cerebrovascular bleeding or other active bleeding, if the patient has unexplained blood disorders, if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient hydration), in the case of hemorrhagic diathesis (tendency to bleed in the skin and mucous membranes, nose, gastrointestinal tract) and concomitant use of anticoagulant medications, in the case of concomitant use of other NSAIDs, including COX-2 inhibitors, in the last three months of pregnancy, in adolescents with a body weight below 40 kg and children.

Warnings and precautions

Before starting treatment with Iburapid, the patient should discuss it with their doctor or pharmacist. Particular caution should be exercised: in patients with impaired liver and/or kidney function and cardiovascular disease; in patients with impaired kidney function, effective doses should be used, as small as possible, with simultaneous monitoring of their function, in patients with asthma or allergies - taking the medicine may cause bronchospasm, in patients who have experienced hay fever, nasal polyps, and chronic obstructive pulmonary disease, due to the increased risk of allergic reactions; allergic reactions may manifest as asthma attacks (so-called analgesic asthma), in patients with systemic lupus erythematosus and mixed connective tissue disease there is an increased risk of developing aseptic meningitis during chickenpox - it is recommended to avoid taking Iburapid in patients who have these hereditary blood disorders (acute intermittent porphyria), in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) - may exacerbate symptoms, in patients with rhythm disorders, hypertension, myocardial infarction, or heart failure in their medical history - may lead to fluid retention in the body due to worsening kidney function, in patients taking anticoagulant medications and having blood 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 entitled "Infections".

• Ibuprofen may cause severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should immediately stop taking Iburapid and seek medical attention. During treatment with ibuprofen, symptoms of allergic reactions to this medicine have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms are noticed, the patient should immediately stop taking Iburapid and contact their doctor or emergency medical services.

Children and adolescents

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

Elderly patients

In patients over 65 years of age, there is a higher risk of side effects than in younger patients. During long-term use of the medicine, especially in patients with a history of gastrointestinal diseases, particularly in patients over 65 years of age, there is a risk of gastrointestinal bleeding, ulceration, or perforation. If any unusual symptoms from the gastrointestinal tract occur, especially during the initial treatment period, the patient should immediately stop taking the medicine and consult their doctor. Caution should be exercised when taking Iburapid in patients taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids or anticoagulant medications like warfarin (acenocoumarol) or antiplatelet agents like acetylsalicylic acid. Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure. During long-term use of Iburapid, regular monitoring of liver function, kidney function, and blood morphology is required. Skin reactionsSevere skin reactions have been reported with the use of Iburapid. If the patient experiences any rash, changes in the mucous membranes, blisters, or other symptoms of allergy, they should stop taking Iburapid and seek medical attention immediately, as these may be the first symptoms of a severe skin reaction. See section 4. The medicine may mask the symptoms of an existing infection. InfectionsIburapid may hide the objective symptoms of infection, such as fever and pain. Therefore, Iburapid may delay the use of appropriate infection treatment and consequently lead to an increased 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 the symptoms of the infection persist or worsen, they should immediately consult their doctor. This medicine belongs to a group of medicines (NSAIDs) that may affect female fertility. The use of this medicine is not recommended in women trying to conceive. This effect is reversible and disappears after the end of therapy. Taking anti-inflammatory and pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment. Before taking Iburapid, the patient should discuss their treatment with their doctor or pharmacist if they have: heart disease, such as heart failure, angina (chest pain), have had a heart attack, have had a bypass operation, have peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of blood vessels), or have had a stroke (including a mini-stroke or transient ischemic attack - TIA), high blood pressure, diabetes, high cholesterol, have had heart disease or stroke in their family, or smoke. During long-term use of painkillers, a headache may occur, which should not be treated by increasing the dose of the medicine. The patient should stop taking the medicine and consult their doctor if they frequently experience headaches despite taking Iburapid. Taking the medicine in the smallest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. Iburapid, as an over-the-counter medicine, is recommended for short-term use, although it does not exclude use on a doctor's recommendation. If new or worsening symptoms occur, the patient should consult their doctor or pharmacist.

Iburapid with food, drinks, and alcohol

Tablets should be swallowed whole with a glass of water. In patients with gastrointestinal disorders, it is recommended to take the medicine during meals. The patient should avoid consuming alcohol, as it may increase the side effects of Iburapid, especially from the gastrointestinal tract and central nervous system.

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 their doctor or pharmacist before taking this medicine. Iburapid should not be taken during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may affect the mother's and baby's tendency to bleed and cause late or prolonged delivery. Iburapid should not be taken during the first six months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment during this period or during an attempt to conceive is necessary, the smallest dose should be used for the shortest possible time. Iburapid taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn baby, leading to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is necessary, the doctor may recommend additional monitoring. The medicine passes into breast milk, but it can be used during breastfeeding if taken in the recommended dose and for the shortest possible time. This medicine belongs to a group of medicines (NSAIDs) that may affect female fertility. The use of this medicine is not recommended in women trying to conceive. This effect is reversible and disappears after the end of therapy.

Driving and using machines

Essentially, ibuprofen has no or negligible influence on the ability to drive and use machines. However, due to the possibility of side effects such as fatigue, drowsiness, dizziness (reported as frequent) and vision disturbances (reported as uncommon), the ability to drive and use machines may be impaired in individual cases. This effect may be enhanced by the concomitant consumption of alcohol. Iburapid contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Iburapid contains cochineal red (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, which means it is considered "sodium-free".

3. How to take Iburapid

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The occurrence of side effects can be minimized by using the smallest effective dose for the shortest period necessary to relieve symptoms. The patient should take the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2). Adults and adolescents (from 12 years of age) with a 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 of ibuprofen (1 tablet) can be taken. The interval between doses should be determined according to the symptoms and taking into account the maximum recommended daily dose. It should not be less than 6 hours. The total daily dose of ibuprofen should not exceed 1200 mg (3 tablets) within 24 hours. The dosage for migraine headache is 400 mg (1 tablet) as a single dose, and if necessary, 400 mg (1 tablet) every 4-6 hours. The maximum daily dose of ibuprofen should not exceed 1200 mg (3 tablets). The patient should limit the use of the medicine to a maximum of two or three days a week. Method of administration Oral administration. Tablets should be swallowed whole with a glass of water. In patients with gastrointestinal disorders, it is recommended to take the medicine during meals. The medicine should not be used in patients with a body weight below 40 kg. The medicine should not be used in patients under 12 years of age. Patients over 65 years of age If the patient is elderly, they should always consult their doctor before starting treatment with Iburapid, due to the higher likelihood of side effects. The doctor will recommend the appropriate use of the medicine. Impaired liver and kidney function If the patient has impaired kidney or liver function, they should always consult their doctor before taking Iburapid. The doctor will recommend the appropriate use of the medicine. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Iburapid than recommended

If the patient has taken a higher dose of Iburapid than recommended or if a child has accidentally taken the medicine, they should always consult their doctor, pharmacist, or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do. Observed side effects of varying severity have been reported. Symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood), and abdominal pain or diarrhea. They may also include tinnitus, ringing in the ears, disorientation, and vision disturbances. After taking a large dose, drowsiness, periodic excitement, chest pain, palpitations, loss of consciousness, coma, seizures (mainly in children), weakness, and dizziness have been reported. In patients with asthma, the disease may worsen. If the patient experiences any of the following symptoms, they should stop taking Iburapid and seek medical attention immediately: red, scaly rash with bumps under the skin and blisters, often located in skin folds, on the torso and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). See also section 2. The skin becomes sensitive to light. Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: widespread skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell). Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Missing a dose of Iburapid

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Iburapid

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

4. Possible side effects

Like all medicines, Iburapid can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention: red, non-raised, target-like or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, 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 swollen lymph nodes (DRESS syndrome). red, scaly rash with bumps under the skin and blisters, usually occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Iburapid and seek medical attention immediately. See also section 2. In connection with the use of NSAIDs, reports of edema, hypertension, and heart failure have been made. Taking medicines containing ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when used in high doses. Side effects that occur uncommonly (in less than 1 in 100 people): rash, indigestion, abdominal pain, nausea, headache, vision disturbances, urticaria and itching. Side effects that occur rarely (in less than 1 in 1,000 people): diarrhea, bloating, constipation, vomiting, gastritis, depression, disorientation, hallucinations, insomnia, dizziness, excitement, irritability, and fatigue, toxic optic neuropathy, tinnitus, decreased hemoglobin and hematocrit values, inhibited platelet aggregation, prolonged bleeding time, decreased serum calcium levels, increased serum uric acid levels. Side effects that occur very rarely (in less than 1 in 10,000 people): disorders of blood morphology indicators (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - deficiency of all normal blood cells: red, white, and platelets, agranulocytosis - lack of a certain type of white blood cell - 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, black stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease. Peptic ulcer and/or duodenal ulcer, gastrointestinal bleeding, and perforation, especially in patients over 65 years of age, aseptic meningitis, edema, dysuria (discomfort during urination), decreased urine output, kidney failure, renal papillary necrosis, increased serum urea levels, increased sodium levels in the blood (sodium retention), severe hypersensitivity reactions such as facial, tongue, and laryngeal edema, dyspnea, tachycardia (rapid heart rate), hypotension (sudden decrease in blood pressure), shock, exacerbation of asthma and bronchospasm. in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, single cases of symptoms of aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation, edema, hypertension, heart failure associated with the use of NSAIDs in high doses, hypertension. Frequency of unknown occurrence red, scaly rash with bumps 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). If such symptoms occur, the patient should stop taking Iburapid and seek medical attention immediately. See also section 2. The skin becomes sensitive to light. Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: widespread skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell). Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. 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 Iburapid

Do not store above 25°C. Store in the original packaging. The medicine should be stored 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 month stated. Do not use this medicine if the blister is damaged. 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 Iburapid contains

The active substance of the medicine is ibuprofen (Ibuprofenum) - 400 mg. The other ingredients (excipients) are: Core: microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose, povidone K30, talc, dimethicone, anhydrous colloidal silica. Coating: Opadry® 03F240028 Pink: talc, hypromellose, titanium dioxide (E 171), macrogol 6000, cochineal red (E 124), azorubine (E 122).

What Iburapid looks like and contents of the pack

Coated tablet Glossy purple, biconvex, round coated tablets, with "R-06" embossed on one side, packaged in blisters, in a cardboard box. One blister contains 10 tablets. Pack sizes: 10 tablets - 1 blister of 10, 20 tablets - 2 blisters of 10, 30 tablets - 3 blisters of 10, 40 tablets - 4 blisters of 10, 50 tablets - 5 blisters of 10, 60 tablets - 6 blisters of 10. Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o. ul. Koszykowa 65 00-667 Warsaw tel. +48 22 822 93 06 e-mail: [email protected]

Importer

Wörwag Pharma Operations Spółka z ograniczoną odpowiedzialnością ul. gen. Mariana Langiewicza 58 95-050 Konstantynów Łódzki tel./fax: 42 654 00 70 / 42 654 02 91

Date of last revision of the leaflet:

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