Iburapid

Leaflet accompanying the packaging: patient information

Iburapid, 200 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 your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your 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 medicinal properties: anti-inflammatory, analgesic, and antipyretic.

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 accompanying 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 you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),

if you are allergic 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 (hay fever), or urticaria associated with acetylsalicylic acid or other NSAIDs,

if you have severe kidney and/or liver failure,

in the case of stomach and/or duodenal ulcer disease (active or in history), perforation, or bleeding, also occurring after the use of NSAIDs,

in severe heart failure (class IV according to NYHA),

if you have severe hypertension,

if you have cerebral bleeding or other active bleeding,

if you have unexplained blood disorders,

if you have severe dehydration (caused by vomiting, diarrhea, or insufficient hydration),

in the case of hemorrhagic diathesis (a tendency to bleed in the skin and mucous membranes, nose, gastrointestinal tract, etc.) and taking anticoagulant medications,

in the case of concurrent use of other NSAIDs, including COX-2 inhibitors,

in the last three months of pregnancy,

in children with a body weight below 20 kg.

Warnings and precautions

Before starting Iburapid, discuss it with your doctor or pharmacist.

Be particularly cautious:

in patients with impaired liver and/or kidney function and cardiovascular system; in patients with impaired kidney function, use effective doses, 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 respiratory diseases, 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 with hereditary blood disorders (acute intermittent porphyria), in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) - may lead to exacerbation of symptoms, in patients with rhythm disorders, hypertension, myocardial infarction, or heart failure in 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 red blood cell production disorders, in patients with diabetes, immediately after major surgery, if the patient has an infection - see below, section "Infections".

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking Iburapid and seek medical attention.

Symptoms of allergic reaction to this medicine, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If you notice any of these symptoms, stop taking Iburapid immediately and contact your 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 gastrointestinal symptoms occur, especially in the initial treatment period, the medicine should be stopped immediately and the doctor should be informed.

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 various 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 reactions

Severe skin reactions have been reported with Iburapid use. If you experience any rash, mucosal lesions, blisters, or other signs of hypersensitivity, stop taking Iburapid and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.

The medicine may mask the symptoms of an existing infection.

Infections

Iburapid may hide the objective symptoms of infection, such as fever and pain. Therefore, Iburapid may delay the use of appropriate infection treatment, potentially leading to 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 consult their doctor immediately.

This medicine belongs to a group of medicines (NSAIDs) that may affect female fertility. The use of this medicine is not recommended for women trying to conceive. This effect is reversible and disappears after the end of therapy.

Taking anti-inflammatory and analgesic 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 and duration of treatment.

Before taking Iburapid, the patient should discuss the treatment with their doctor or pharmacist if:

they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA),

they have high blood pressure, diabetes, high cholesterol levels, have a history of heart disease or stroke in their family, or smoke.

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 stopped and the doctor consulted if, despite taking Iburapid, headaches occur frequently.

Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects.

Iburapid, as an over-the-counter product, is recommended for short-term use, although it does not exclude use on a doctor's recommendation.

In case of new or worsening symptoms, consult your doctor or pharmacist.

Iburapid with food, drink, and alcohol

Tablets should be swallowed whole with water.

In patients with gastrointestinal disorders, it is recommended to take Iburapid during meals.

Alcohol consumption should be avoided, as it may enhance the side effects of Iburapid, particularly gastrointestinal and central nervous system effects.

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 child or cause complications during delivery. It may cause kidney and heart disorders in the unborn child. It may affect the mother's and child's tendency to bleed and cause late or prolonged delivery. Iburapid should not be taken during the first six months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment during this period or while trying 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 disorders in the unborn child, leading to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child'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 for women trying to conceive. This effect is reversible and disappears after the end of therapy.

Driving and using machines

Basically, ibuprofen has no influence or has a 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 concurrent alcohol consumption.

Iburapid contains lactose.If the patient has previously 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 your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The occurrence of side effects can be minimized by using the smallest effective dose for the shortest period necessary to alleviate symptoms.

Use the smallest effective dose for the shortest period necessary to alleviate symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).

Adults and adolescents (from 12 years of age) with a body weight of 40 kg and above: The initial dose of ibuprofen is 200 mg (1 tablet) or 400 mg (2 tablets). If necessary, additional doses can be taken: 200 mg (1 tablet) or 400 mg ibuprofen (2 tablets). The interval between consecutive 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 for a dose of 400 mg (2 tablets) and not less than 4 hours for a dose of 200 mg (1 tablet). The total daily dose should not exceed 1200 mg ibuprofen (6 tablets).

Use in children

Children with a body weight of 20 to 29 kg (6-9 years old): 1 tablet of 200 mg.

If necessary, 1 tablet every 6-8 hours.

Do not exceed a dose of 3 tablets per day (600 mg).

Children with a body weight of 30 to 39 kg (10-12 years old): 1 tablet of 200 mg.

If necessary, 1 tablet every 4-6 hours.

Do not exceed a dose of 4 tablets per day (800 mg).

Method of administration: oral.

Tablets should be swallowed whole with water.

In patients with gastrointestinal disorders, it is recommended to take Iburapid during meals.

The medicine should not be used in children with a body weight below 20 kg.

The medicine should not be used in children under 6 years of age.

Patient over 65 years of age

If the patient is elderly, they should always consult their doctor before starting 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 you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Overdose of Iburapid

If you have taken more than the recommended dose of Iburapid or if a child has accidentally taken the medicine, always consult your doctor, pharmacist, or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.

Various degrees of side effects have been observed.

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 nystagmus, headache, and gastrointestinal bleeding. After taking a large dose, drowsiness, periodic excitement, chest pain, palpitations, loss of consciousness, coma, seizures (mainly in children), weakness, and dizziness, blood in urine, feeling cold, and breathing difficulties, convulsions (especially in children), kidney failure, liver damage.

In patients with asthma, the disease may worsen.

Missing a dose of Iburapid

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

Stopping Iburapid

In case of further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Iburapid can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, 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 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, peeling rash with bumps under the skin and blisters, usually occurring at the beginning of treatment (acute generalized exanthematous pustulosis).

NSAID use has been associated with reports of edema, hypertension, and heart failure.

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. The risk increase occurs when using large doses of the medicine and when using the medicine for a long period.

Uncommon side effects (in less than 1 in 100 people):

rash,

indigestion, abdominal pain, nausea,

headache,

vision disturbances,

urticaria and itching.

Rare side effects (in less than 1 in 1,000 people):

diarrhea, bloating, constipation, vomiting, gastric ulcer,

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.

Very rare side effects (in less than 1 in 10,000 people):

blood morphology disorders (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 colitis and Crohn's disease. Gastric and/or duodenal ulcer disease, 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 occurring in aseptic meningitis have been reported, such as neck stiffness, headache, nausea, vomiting, fever, disorientation,

edema, hypertension, heart failure associated with NSAID use in high doses,

hypertension.

Frequency not known

Red, peeling rash with bumps under the skin and blisters, usually occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, 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 increased eosinophil count (a type of white blood cell).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: 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.

Reporting side effects will help gather 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 month stated.

Do not use this medicine if you notice that the blister is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your 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)- 200 mg.

The other ingredients (excipients) are:

Core: microcrystalline cellulose, lactose monohydrate, corn 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, packaged in blisters, in a cardboard box. One blister contains 10 tablets.

Package 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 package 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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