Ibuprofen eubioco

Leaflet attached to the packaging: patient information

IBUPROFEN eubioco, 200 mg, coated tablets

Ibuprofen

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.
The medicine should always be taken exactly as described in this patient leaflet or as advised by the doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

• Pain of various origins of mild to moderate severity: headache, migraine, toothache, tension headache, muscle pain, joint and bone pain, pain associated with flu and colds, neuralgia.
• Fever of various origins (including flu, colds, or other infectious diseases).
• Painful menstruation.

The medicine is intended for short-term use.

2. Important information before taking IBUPROFEN eubioco

When not to take IBUPROFEN eubioco

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had symptoms of hypersensitivity after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as rhinitis, urticaria, angioedema, or asthma,
• if the patient has or has had stomach or duodenal ulcer, perforation (hole) or gastrointestinal bleeding (two or more episodes), also related to previous NSAID treatment,
• in patients with severe liver or kidney impairment,
• in patients with severe heart failure,
• if the patient has had bleeding from the brain or other active bleeding,
• in patients taking other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors) at the same time, as there is an increased risk of side effects,
• in women in the last three months of pregnancy,
• in patients with a bleeding disorder (tendency to bleed).

When to exercise special caution when taking IBUPROFEN eubioco

• if the patient has connective tissue diseases, such as systemic lupus erythematosus and mixed connective tissue disease.
• if the patient has or has had intestinal disease (ulcerative colitis, Crohn's disease),
• if the patient has high blood pressure and/or heart disease,
• if the patient has kidney disease,
• if the patient has liver disease,
• immediately after major surgery,
• if the patient has bleeding disorders,
• if the patient has asthma or has had an allergic reaction, as taking the medicine may cause bronchospasm,
• consuming alcohol while taking ibuprofen increases the risk of side effects,
• when the patient is taking other medicines (corticosteroids, diuretics, cardiac glycosides, and especially anticoagulants), they should consult their doctor before taking ibuprofen with these medicines,
• there is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal, these reactions do not have to be preceded by warning signs, in case of gastrointestinal bleeding or ulceration, the medicine should be stopped immediately,
• patients with existing or previous gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period,
• concomitant, long-term use of different painkillers may lead to kidney damage and even kidney failure (analgetic nephropathy),
• this medicine belongs to a group of medicines that may adversely affect female fertility (non-steroidal anti-inflammatory drugs). This effect is transient and disappears after the end of treatment,
• in case of chickenpox, it is recommended to avoid taking the medicine.

Ibuprofen treatment has been associated with severe skin reactions, 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). The patient should stop taking IBUPROFEN eubioco and immediately consult a doctor if they experience any symptoms related to severe skin reactions described in section 4.
Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. The patient should not exceed the recommended dose and duration of treatment. If symptoms persist, worsen, or do not improve after 3 days for fever and 4 days for pain, or if new symptoms occur, the patient should consult a doctor.
During ibuprofen treatment, symptoms of an allergic reaction to this medicine have been reported, including difficulty breathing, face and neck swelling (angioedema), and chest pain. If the patient experiences any of these symptoms, they should stop taking IBUPROFEN eubioco and consult a doctor or emergency department immediately.
Before taking IBUPROFEN eubioco, the patient should discuss their treatment with a doctor or pharmacist if:

• they have heart disease, such as heart failure, angina (chest pain), have had a heart attack, have had coronary artery bypass grafting, have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or have had a stroke (including mini-stroke or transient ischemic attack - TIA),
• they have high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if they smoke.
• they have an infection - see below, section "Infections".

IBUPROFEN eubioco and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.
IBUPROFEN eubioco may affect the action of other medicines or other medicines may affect the action of IBUPROFEN eubioco. For example:

• blood-thinning medicines (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Other medicines may also be affected or have an effect on IBUPROFEN eubioco treatment.
Therefore, before taking IBUPROFEN eubioco with other medicines, the patient should always consult their doctor or pharmacist.
IBUPROFEN eubioco should not be taken with the following medicines:

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

Infections

IBUPROFEN eubioco may mask the symptoms of an infection, such as fever and pain. Therefore, IBUPROFEN eubioco may delay the use of appropriate infection treatment and 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 infection symptoms persist or worsen, they should immediately consult a doctor.

Taking IBUPROFEN eubioco with food and drink

IBUPROFEN eubioco should be taken with a large amount of water.
In patients with gastrointestinal disorders, it is recommended to take the medicine during meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Taking IBUPROFEN eubioco during the last three months of pregnancy is contraindicated, as it may increase the risk of complications for the mother and child before and after birth and cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may affect the mother's and child's tendency to bleed and cause the delivery to be late or longer than expected.
In the first six months of pregnancy, IBUPROFEN eubioco should not be taken unless it is necessary and recommended by a doctor.
If the patient needs to take the medicine during this period or while trying to conceive, they should use the smallest dose for the shortest possible time.
IBUPROFEN eubioco taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If the patient needs to take the medicine for longer than a few days, the doctor may recommend additional monitoring. Breastfeeding Ibuprofen may pass into breast milk in small amounts. So far, no cases of side effects have been reported in breastfed children. Stopping breastfeeding is not necessary during short-term treatment with ibuprofen in recommended doses.

• The medicine belongs to a group of NSAIDs that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.

Fertility
The medicine belongs to a group of NSAIDs that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.

Driving and using machines

There is no data on the effect of IBUPROFEN eubioco on the ability to drive and use machines.

Sodium

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

3. How to take IBUPROFEN eubioco

IBUPROFEN eubioco should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.

Usual dose:

Adults and adolescents over 12 years: the initial dose is two tablets, then if necessary, one or two tablets can be taken after 4 hours. Do not take more than six tablets (1200 mg of ibuprofen) in 24 hours. A 4-hour interval should be maintained between doses.
In the case of elderly patients, dose adjustment is not necessary.
Tablets should be taken after a meal and washed down with water. In patients with gastrointestinal disorders, it is recommended to take the medicine during meals.
Children
The medicine should not be taken by children under 12 years of age.
The medicine is intended for oral use only and short-term use. The patient should take the smallest effective dose for the shortest period necessary to relieve symptoms.
The medicine should not be taken for more than 3 days without a doctor's recommendation. If the patient is taking the medicine for an infection and the infection symptoms persist or worsen, or if new symptoms occur, they should immediately consult a doctor (see section 2).

Taking a higher dose of IBUPROFEN eubioco than recommended

If the patient has taken a higher dose of IBUPROFEN eubioco than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case. The doctor may order gastric lavage. Activated charcoal can be given orally within 1 hour of overdose.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, confusion, and nystagmus. It may also cause agitation, drowsiness, disorientation, or coma. Seizures have occasionally occurred in patients. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missing a dose of IBUPROFEN eubioco

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

Stopping IBUPROFEN eubioco treatment

If the patient has any further doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, IBUPROFEN eubioco can cause side effects, although not everybody gets them.
Taking medicines like 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 for a short period and in doses available without a prescription, the following side effects have occurred:

• Frequent (occurring in more than 1 in 100 patients but less than 1 in 10 patients): indigestion, stomach pain, nausea, headaches, hives, itching.
• Uncommon (occurring in more than 1 in 1,000 patients but less than 1 in 100 patients): diarrhea, bloating, constipation, vomiting, stomach inflammation, dizziness, insomnia, agitation or fatigue.
• Rare (occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients): worsening of ulcerative colitis and Crohn's disease (chronic inflammatory bowel diseases), stomach and duodenal ulcers, perforations (holes) and gastrointestinal bleeding (symptoms are black stools, bloody vomiting), sometimes fatal, especially in the elderly, acute kidney failure, kidney necrosis with edema, especially during long-term use, liver function disorders, especially during long-term use, anemia, decreased white blood cell count, decreased platelet count, disorder characterized by a lack of red blood cells, white blood cells, and platelets (pancytopenia), decreased granulocyte count (agranulocytosis) - the first symptoms of blood disorders are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding (e.g., bruising, petechiae, purpura, nosebleeds), severe skin reactions (erythema multiforme, toxic epidermal necrolysis), face, tongue, and larynx swelling, shortness of breath, increased heart rate (tachycardia), decreased blood pressure (hypotension), worsening of asthma symptoms and bronchospasm, palpitations, heart failure, heart attack.
• Frequency not known (frequency cannot be estimated from the available data): skin becomes sensitive to light, red scaly rash with thickening under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking IBUPROFEN eubioco and seek medical help immediately. See also section 2.

In patients with autoimmune diseases (in which the immune system destroys its own tissues, such as systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, single cases of symptoms have been reported that occur in aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.
Severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
Chest pain may occur, which can be a symptom of a potentially severe allergic reaction called Kounis syndrome.
When taking ibuprofen for other indications and long-term, other side effects may occur.
The patient should stop taking IBUPROFEN eubioco and immediately seek medical help if they experience any of the following symptoms:

• red, flat, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can 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, widespread rash with thickening under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, the patient should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +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 use of the medicine.

5. How to store IBUPROFEN eubioco

Store in a place inaccessible and invisible to children.
There are no special storage precautions.
Do not take IBUPROFEN eubioco after the expiry date stated on the packaging.
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 pack and other information

What IBUPROFEN eubioco contains

• The active substance of the medicine is ibuprofen (Ibuprofenum).
• The medicine also contains povidone, maize starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, 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.
A carton box contains:

• 10 tablets (1 PVC/Aluminum blister) or 20 tablets (2 PVC/Aluminum blisters)
• 60 tablets in an HDPE container with an LDPE cap
• 60 tablets in an HDPE container with a PE screw cap and a sealing plug. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
phone: +48 89 648 00 78

Date of last revision of the leaflet: