Ibuprofen eubioco

Package leaflet: Information for the user

IBUPROFEN eubioco, 200 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because 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 or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Table of contents

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

1. What IBUPROFEN eubioco is and what it is used for

The active substance in IBUPROFEN eubioco is ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory, analgesic and antipyretic properties.
IBUPROFEN eubioco is used to treat:

• Mild to moderate pain of various origins: headache, migraine, toothache, tension pain, muscular, joint and bone pain, pain associated with influenza and colds, neuralgia.
• Fever of various origins (e.g. during influenza, colds or other infectious diseases).
• Painful menstruation.

This medicine is intended for short-term use only.

2. Important information before using the medicine IBUPROFEN eubioco

When not to use IBUPROFEN eubioco

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever previously experienced allergic symptoms such as runny nose, urticaria, swelling, or asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient currently has or has had peptic ulceration of the stomach and/or duodenum, perforation (gastrointestinal perforation), or gastrointestinal bleeding (two or more episodes), including those associated with previous NSAID treatment,
• in patients with severe hepatic or renal insufficiency,
• in patients with severe heart failure,
• if the patient has cerebral haemorrhage or any other active bleeding,
• in patients concurrently taking other non-steroidal anti-inflammatory drugs (including so-called COX-2 inhibitors), due to an increased risk of adverse reactions,
• in women during the last three months of pregnancy,
• in patients with haemorrhagic diathesis (tendency to bleed).

When to exercise special caution when using IBUPROFEN eubioco

• if the patient has connective tissue disorders such as systemic lupus erythematosus or mixed connective tissue disease,
• if the patient has or has ever had intestinal disease (e.g. ulcerative colitis, Crohn's disease),
• if the patient has persistently high blood pressure and/or cardiac dysfunction,
• if the patient has impaired kidney function,
• if the patient has impaired liver function,
• immediately after major surgical procedures,
• if the patient has blood coagulation disorders,
• if the patient suffers from or has suffered from bronchial asthma or has a history of allergies, as bronchospasm may occur after taking the medicine,
• alcohol consumption during ibuprofen treatment increases the risk of adverse effects,
• if the patient is taking other medicines (corticosteroids (anti-inflammatory drugs), diuretics, cardiac medications, particularly those used for blood clots or to prevent clot formation), medical advice should be sought before combining ibuprofen with these medicines,
• there is a risk of gastrointestinal haemorrhage, ulceration, or perforation (gastrointestinal perforation), which may be fatal; these reactions may occur without warning symptoms; if gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately,
• patients with current or past gastrointestinal disorders, particularly elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period,
• concurrent, long-term use of various analgesics may lead to kidney damage and even renal failure (so-called analgesic nephropathy),
• this medicine belongs to a group of drugs that may adversely affect fertility in women (non-steroidal anti-inflammatory drugs). This effect is reversible and resolves after discontinuation of treatment,
• in case of chickenpox, the use of this medicine is not recommended.

Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Treatment with IBUPROFEN eubioco should be discontinued and medical advice sought immediately if any symptoms associated with serious skin reactions described in section 4 occur.

The use of anti-inflammatory/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. If symptoms persist, worsen, or do not resolve after 3 days in the case of fever or 4 days in the case of pain, or if new symptoms occur, medical advice should be sought.

Allergic reactions to ibuprofen have been reported during treatment, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If the patient experiences any of these symptoms, treatment with IBUPROFEN eubioco should be stopped immediately and the patient should contact a doctor or emergency services.

Before using IBUPROFEN eubioco, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries), or has had a 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,
• the patient has an infection – see below, section titled "Infections".

Interaction of IBUPROFEN eubioco with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription.

IBUPROFEN eubioco may affect the action of other medicines, or other medicines may affect the action of IBUPROFEN eubioco. For example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine,
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Other medicines may also interact with or be affected by IBUPROFEN eubioco treatment. Therefore, medical advice should always be sought from a doctor or pharmacist before combining IBUPROFEN eubioco with other medicines.

IBUPROFEN eubioco should not be used with the following medicines:

• acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• digoxin used in heart failure,
• medicines used for high blood pressure,
• diuretics,
• antiplatelet medicines,
• medicines used for blood clots,
• phenytoin used in epilepsy,
• selective serotonin reuptake inhibitors used in depression,
• lithium used in psychiatric disorders,
• probenecid and sulfinpyrazone used in gout treatment,
• potassium-sparing diuretics,
• methotrexate used in cancer treatment,
• zidovudine used in HIV (human immunodeficiency virus) infection,
• corticosteroids used in inflammatory conditions,
• tacrolimus and cyclosporine used, for example, in atopic dermatitis,
• sulfonylurea derivatives used in diabetes treatment,
• quinolone antibiotics.

Infections
IBUPROFEN eubioco may mask symptoms of infection such as fever and pain. Consequently, IBUPROFEN eubioco may delay appropriate treatment of infection and thereby 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 existing infection and symptoms persist or worsen, immediate medical advice should be sought.

Taking IBUPROFEN eubioco with food and drink
IBUPROFEN eubioco should be taken with a large amount of water.
In patients with gastrointestinal discomfort, it is recommended to take the medicine with food.

Pregnancy, breastfeeding and fertility

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

Pregnancy
IBUPROFEN eubioco should not be used during the last three months of pregnancy, as it may increase the risk of complications for both mother and child before and after delivery and may cause delivery complications. The medicine may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both mother and child and may cause delayed or prolonged labour.

During the first six months of pregnancy, IBUPROFEN eubioco should not be used unless necessary and prescribed by a doctor.
If the patient needs to take the medicine during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration.

IBUPROFEN eubioco taken for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is required, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. To date, no adverse effects have been reported in breastfed infants. Breastfeeding need not be discontinued during short-term treatment with ibuprofen at recommended doses.

Fertility
This medicine belongs to a group of NSAIDs that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
There are no data available on the effects of IBUPROFEN eubioco on the ability to drive vehicles or operate machinery.

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

3. How to use IBUPROFEN eubioco

IBUPROFEN eubioco should always be used according to the instructions provided by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

The usual recommended dose is:
Adults and adolescents over 12 years of age: initial dose of two tablets, then if necessary, after 4 hours, one or two tablets may be taken. Do not exceed six tablets (1200 mg of ibuprofen) in 24 hours. An interval of four hours must be maintained between doses.

In elderly patients, dose adjustment is not usually required.

The tablets should be taken after a meal and swallowed with water. In patients with gastrointestinal disorders, it is recommended to take the medicine during a meal.

Children
This medicine must not be used in children under 12 years of age.

The medicine is intended for oral use only and for short-term treatment. The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.

Do not use the medicine for longer than 3 days without medical advice. If, during an infection, symptoms (such as fever and pain) persist or worsen, or if new symptoms occur, consult a doctor immediately (see section 2).

Use of a higher than recommended dose of IBUPROFEN eubioco
If a patient has taken more than the recommended dose of IBUPROFEN eubioco, or if a child has accidentally ingested the medicine, seek immediate medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions. The doctor may recommend gastric lavage. Activated charcoal may be administered orally within 1 hour of overdose.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion and nystagmus. Excitement, drowsiness, disorientation or coma may also occur. Seizures have been reported occasionally. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may be exacerbated. In addition, low blood pressure and breathing difficulties may occur.

There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

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

Stopping IBUPROFEN eubioco
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, IBUPROFEN eubioco may cause adverse effects, although not
everyone will experience them.
The use of medicines such as IBUPROFEN eubioco may be associated with a small increased
risk of heart attack (myocardial infarction) or stroke.
IBUPROFEN eubioco is generally well tolerated. In some patients taking
ibuprofen short-term at over-the-counter doses, the following adverse
effects have occurred:
Uncommon (occurring in more than 1 in 1,000 patients but less than 1 in 100 patients): dyspepsia, abdominal pain, nausea, headache, urticaria, itching.
Rare (occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients): diarrhoea, flatulence, constipation, vomiting, gastric mucosal inflammation, dizziness, insomnia, restlessness, irritability or fatigue.
Very rare (occurring in less than 1 in 10,000 patients): worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), peptic ulcer of the stomach and/or duodenum, perforations (punctures) and gastrointestinal bleeding (symptoms include black, tarry stools, vomiting blood), sometimes with fatal outcome, particularly in elderly patients, acute renal failure, renal necrosis with oedema, especially during prolonged use, hepatic function disorders, particularly during prolonged use, anaemia, reduced white blood cell count (leukopenia), reduced platelet count (thrombocytopenia), a disorder characterised by deficiency of red blood cells, white blood cells and platelets (pancytopenia), reduced number of white blood cells called granulocytes (agranulocytosis) – initial symptoms of blood disorders include fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, severe fatigue, unexplained bleeding (e.g. bruises, petechiae, purpura, nosebleeds), severe skin reactions (erythema multiforme, toxic epidermal necrolysis), facial, tongue and laryngeal oedema, shortness of breath, rapid heartbeat (tachycardia), reduced blood pressure (hypotension), worsening of asthma symptoms and bronchospasm, palpitations, heart failure, myocardial infarction.
Frequency unknown (frequency cannot be determined from available data): skin becomes light-sensitive, red scaly rash with subcutaneous nodules and blisters, mainly 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, treatment with IBUPROFEN eubioco must be discontinued and immediate medical help sought. See also section 2.
In patients with autoimmune diseases (in which the immune system attacks the body's own tissues, such as systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms occurring in so-called aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation, have been reported during ibuprofen treatment.
Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell).
Chest pain may occur, which could be a symptom of a potentially serious allergic reaction called Kounis syndrome.
Other adverse effects may occur when ibuprofen is used for other indications and over prolonged periods.
Treatment with IBUPROFEN eubioco must be discontinued and immediate medical help sought if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, oral, throat, nasal, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome).
• Widespread red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

If any adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 to provide more information on the safety of this medicine.

5. How to store IBUPROFEN eubioco

Keep out of the reach and sight of children.
No special storage conditions required.
Do not use IBUPROFEN eubioco after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine IBUPROFEN eubioco contains

• The active substance is ibuprofen (Ibuprofenum).
• The other ingredients are povidone, pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate, and coating: Aqua Polish P white 010.28 (hypromellose, macrogol, talc, titanium dioxide (E 171)).

What IBUPROFEN eubioco looks like and contents of the pack
IBUPROFEN eubioco is a coated tablet.
The cardboard box contains:

• 10 tablets (1 PVC/Aluminium blister) or 20 tablets (2 PVC/Aluminium blisters)
• 60 tablets in a HDPE container with LDPE cap
• 60 tablets in a HDPE container with a PE screw cap with sealing insert. Not all pack types may be available on the market.

Marketing Authorisation Holder and Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Phone: +48 89 648 00 78