Ibufen Iunior

Package Leaflet: Information for the User

Ibufen Junior, 200 mg, Soft Capsules

Ibuprofen

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• This package 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 those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Ibufen Junior and what is it used for

How the medicine works

Ibufen Junior belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory effects.

What Ibufen Junior is used for

The medicine is intended for use in children and adults in the following cases:

• Pain of various origins, mild to moderate:
• headaches (including migraines);
• toothaches;
• muscle, joint, and bone pain;
• post-traumatic pain;
• neuralgia;
• pain accompanying colds and flu;
• menstrual pain;
• ear pain occurring in middle ear infections.
• Feverish conditions of various origins (including flu, colds, or other infectious diseases).

2. Important information before taking Ibufen Junior

When not to take Ibufen Junior:

• if the patient is allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had symptoms of allergy in the form of rhinitis (allergic rhinitis), angioedema, urticaria, bronchospasm, or asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum, or recurrent ulceration or bleeding from the gastrointestinal tract (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has had gastrointestinal bleeding or perforation after taking NSAIDs;
• if the patient has severe liver, kidney, or heart failure;
• do not give to children with a body weight below 20 kg;
• if the patient has had cerebral hemorrhage or other active bleeding;
• if the patient has unexplained blood disorders, such as thrombocytopenia;
• if the patient has hemophilia;
• in the last three months of pregnancy.

Warnings and precautions

Before starting treatment with Ibufen Junior, the patient should discuss it with their doctor or pharmacist.
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), chest pain.
If any of these symptoms are noticed, the patient should stop taking Ibufen Junior immediately and contact their doctor or emergency medical services immediately.
The patient should inform their pharmacist or doctor if they have an infection - see below, section "Infections".
The patient should consult their doctor if they have:

• systemic lupus erythematosus or mixed connective tissue disease;
• symptoms of allergic reactions after taking acetylsalicylic acid;
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart function disorders;
• kidney function disorders;
• liver function disorders;
• blood coagulation disorders;
• active or recurrent asthma or symptoms of allergic reactions in the past, as bronchospasm may occur after taking the medicine;
• chickenpox - see below, section "Infections".

Care should be taken when using the medicine immediately after major surgery.
The patient should also consult their doctor if they are taking other medicines, especially anticoagulant, diuretic, cardiac, or corticosteroid medicines (see section "Ibufen Junior and other medicines").
The patient should avoid taking ibuprofen with other nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning symptoms or may occur in patients who have had such warning symptoms.
If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
In elderly patients, the risk of adverse reactions due to ibuprofen is higher than in younger patients.
Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase in case of physical exertion resulting in salt loss and dehydration.
Therefore, concomitant, long-term use of different painkillers should be avoided.
There is a risk of kidney failure in dehydrated children and adolescents.
Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before taking Ibufen Junior, the patient should discuss treatment with their doctor or pharmacist if:

• they have heart diseases, 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 narrowed or blocked arteries), or have had a stroke (including mini-stroke or transient ischemic attack - TIA);
• they have hypertension, diabetes, high cholesterol levels, have a family history of heart disease or stroke, or smoke.

Severe skin reactions
In connection with the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibufen Junior immediately and seek medical attention.
Infections
Ibufen Junior may mask the symptoms of infection, such as fever and pain. Therefore, Ibufen Junior may delay the use of appropriate infection treatment, which may 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 consult their doctor immediately.
During treatment with ibuprofen, single cases of toxic amblyopia (visual impairment) have been reported, so any vision disturbances should be reported to the doctor.
Taking the medicine for the shortest period necessary to relieve symptoms reduces the risk of adverse reactions.

Ibufen Junior and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibufen Junior may affect the action of other medicines or other medicines may affect the action of Ibufen Junior. 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 atenolol, angiotensin II receptor antagonists, such as losartan);
• pain-relieving medicines;
• other nonsteroidal anti-inflammatory drugs;
• diuretic medicines;
• antidepressant medicines (selective serotonin reuptake inhibitors (SSRIs)), lithium;
• zydovudine, ritonavir (medicines used to treat HIV infections);
• methotrexate (a medicine used to treat cancer or rheumatoid arthritis);
• corticosteroids (such as prednisolone);
• phenytoin (an antiepileptic medicine);
• cyclosporine, tacrolimus (medicines that reduce the body's immune response);
• mifepristone (a medicine used in gynecology);
• quinolone antibiotics (such as ciprofloxacin);
• cardiac glycosides, including digoxin (medicines used to treat heart conditions);
• aminoglycosides (such as streptomycin);
• probenecid, sulfinpyrazone (medicines used to treat gout);
• oral antidiabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in people with high cholesterol levels).

Also, some other medicines may be affected by or have an effect on treatment with Ibufen Junior.
Therefore, before taking Ibufen Junior with other medicines, the patient should always consult their doctor or pharmacist.

Ibufen Junior with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Ibufen Junior should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Ibufen Junior may cause kidney and heart problems in the unborn child. It may also affect the patient's and their child's tendency to bleed and cause delayed or prolonged labor.
Ibufen Junior should not be taken during the first six months of pregnancy, unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. Ibufen Junior taken for more 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 or narrowing of the ductus arteriosus in the baby's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts, but it is unlikely to affect the breastfed baby.
Fertility
The medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after treatment is stopped.

Driving and using machines

Ibufen Junior has no or negligible influence on the ability to drive and use machines if taken for a short period and as directed.

Ibufen Junior contains sorbitol (E 420), maltitol liquid (E 965), and potassium

Sorbitol (E 420)

The medicine contains 28.8 mg of sorbitol in each capsule.

Maltitol (E 965)

The medicine contains 15 mg of maltitol liquid in each capsule. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Potassium

The medicine contains 0.27 mmol (10.5 mg) of potassium in each capsule, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take Ibufen Junior

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Oral administration.
The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms and reduce the risk of adverse reactions. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The patient should not exceed the maximum daily dose.
Children - the maximum daily dose of ibuprofen is 20-30 mg/kg body weight, divided into 3 to 4 single doses.

Capsules should be swallowed whole with a glass of water. The capsules should not be chewed, sucked, or crushed.
If it is necessary to use this medicine for more than 3 days or if symptoms worsen, the patient should consult their doctor.
The medicine is intended for short-term use.
The medicine should not be used in patients with a body weight below 20 kg.
In patients with mild and moderate kidney and/or liver function disorders, there is no need to reduce the dose.
In elderly patients, dose adjustment is not required.

Overdose of Ibufen Junior

If the patient has taken more than the recommended dose of Ibufen Junior or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. They may also experience agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.
Additionally, the prothrombin time (INR) may be prolonged, probably due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and difficulty breathing may occur.
Overdose cases are rare. There is no specific antidote. Treatment is symptomatic and supportive. The doctor may consider administering activated charcoal if it has been less than one hour since the overdose.

Missed dose of Ibufen Junior

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibufen Junior can cause side effects, although not everybody gets them.
The patient should stop taking ibuprofen and seek medical attention immediately if they experience any of the following symptoms:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - very rare.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with bumps under the skin and blisters, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Ibufen Junior is generally well-tolerated, but during its use, side effects may occur.
During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed. The most common adverse reactions are related to the gastrointestinal tract.
Uncommon (occurring in less than 1 in 100 patients)

• indigestion, abdominal pain, nausea, bloating;
• headache;
• skin rashes of various types, urticaria, and itching.

Rare (occurring in less than 1 in 1,000 patients)

• diarrhea, bloating with gas, constipation, and vomiting;
• dizziness, insomnia, agitation, and fatigue.

Very rare (occurring in less than 1 in 10,000 patients)

• aseptic meningitis characterized by neck stiffness, headache, nausea, vomiting, fever, disorientation - reported in patients with existing autoimmune diseases such as systemic lupus erythematosus;
• blood disorders: anemia (anemia), leukopenia (decreased white blood cell count), thrombocytopenia (decreased platelet count), pancytopenia (hematologic disorder characterized by a deficiency of all normal morphological elements of the blood: erythrocytes, leukocytes, and platelets), agranulocytosis (decreased granulocyte count). The first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, extreme fatigue, nosebleeds, skin bleeding;
• severe allergic reactions characterized by facial swelling, tongue and throat swelling; shortness of breath; rapid heartbeat; significant decrease in blood pressure;
• asthma, worsening of asthma, bronchospasm, shortness of breath, and wheezing;
• nervousness;
• vision disturbances;
• tinnitus, dizziness;
• edema, hypertension, heart failure (reported in connection with the use of NSAIDs);
• peptic ulcer disease of the stomach and duodenum, perforation, or gastrointestinal bleeding, melena, hematemesis, sometimes with a fatal outcome, especially in the elderly; ulcerative stomatitis, gastritis, oral ulcers;
• worsening of colitis and Crohn's disease;
• liver function disorders, especially during long-term use of ibuprofen; hepatitis and jaundice;
• acute kidney failure; renal papillary necrosis, especially after long-term use of ibuprofen, associated with increased serum urea levels and edema, including peripheral edema; presence of blood and/or protein in the urine, interstitial nephritis, nephrotic syndrome;
• decreased hematocrit and hemoglobin levels in laboratory test results.

Frequency not known (frequency cannot be estimated from the available data):

• skin becomes sensitive to light;
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

In individual cases, depression and psychotic reactions have been reported.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
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 Ibufen Junior

Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
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 package and other information

What Ibufen Junior contains

• The active substance of the medicine is ibuprofen. Each capsule contains 200 mg of ibuprofen.
• The other ingredients are: macrogol 600, potassium hydroxide, purified water; capsule shell: gelatin, sorbitol liquid non-crystallizing (E 420), maltitol liquid (E 965), purified water.

What Ibufen Junior looks like and contents of the package

The medicine is in the form of light yellow gelatin capsules filled with a viscous liquid.
Packaging: aluminum/PVC/PVDC foil blister pack containing 6 or 10 capsules, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the package leaflet: