Ibufen mini Iunior

Leaflet accompanying the packaging: patient information

Ibufen mini Junior, 100 mg, soft capsules

Ibuprofen

Read the leaflet carefully 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 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Ibufen mini Junior belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory effects and is intended for children aged 4 to 12 years with a body weight of 16 to 40 kilograms.

What Ibufen mini Junior is used for

The medicine is intended for use in the following cases:

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

2. Important information before taking Ibufen mini Junior

When not to take Ibufen mini Junior:

• if the patient is hypersensitive 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 or currently has dyspnea, asthma, rhinitis, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs);
• if the patient has or has had stomach ulcers or gastrointestinal bleeding (or has had two or more such episodes in the past);
• if the patient has or has had bleeding or perforation of the gastrointestinal tract associated with previous use of NSAIDs;
• if the patient has severe liver, kidney, or heart failure;
• in children under 4 years of age or with a body weight below 16 kilograms;
• if the patient has cerebral hemorrhage or other active bleeding;
• if the patient has blood coagulation disorders;
• if the patient is severely dehydrated (due to vomiting, diarrhea, or insufficient fluid intake).
• Ibuprofen is contraindicated in the third trimester of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Before starting to take Ibufen mini Junior, the patient should discuss it with their doctor or pharmacist.
During the use of ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), and chest pain.
If any of these symptoms are observed, the patient should immediately stop taking Ibufen mini Junior and seek medical help immediately.
The patient should inform their pharmacist or doctor if they have an infection - see below, the section titled "Infections".
Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, particularly 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 mini Junior, the patient should discuss their treatment with their doctor or pharmacist:

• if the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes;
• if the patient has skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if the patient has inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• if the patient has kidney function disorders;
• if the patient has liver function disorders;
• after major surgical procedures;
• if the patient has asthma or allergic disease, as breathing difficulties may occur;
• if the patient has nasal mucosa inflammation, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may occur in the form of asthma attacks (so-called analgesic asthma), angioedema, or urticaria;
• if chickenpox is diagnosed - see below, the section titled "Infections".
• when taking such medications as Ibufen mini Junior, as it may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible (see section 3 of the leaflet);
• if the patient has blood coagulation disorders;
• if the patient is taking Ibufen mini Junior for a long time - regular monitoring of liver and kidney function parameters and blood morphology is required.

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 immediately stop taking Ibufen mini Junior and seek medical help.
Infections
Ibufen mini Junior may mask the symptoms of infection, such as fever and pain. Therefore, Ibufen mini Junior 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.
Avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse reactions (see section "Ibufen mini Junior and other medicines").
Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse reactions. Elderly individuals are more likely to experience adverse reactions.
Chronic use of (various) painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase in the case of physical exertion associated with salt loss and dehydration. Therefore, this should be avoided. There is a risk of kidney function disorders in dehydrated children.
After long-term use of painkillers, headaches may occur, which should not be treated with increased doses of the medicine.

Children

The use of Ibufen mini Junior in children under 4 years of age or with a body weight below 16 kilograms is contraindicated.

Ibufen mini Junior and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibufen mini Junior may affect the action of other medicines or other medicines may affect the action of Ibufen mini 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-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• analgesics;
• other nonsteroidal anti-inflammatory drugs (NSAIDs);
• diuretics;
• zydovudine;
• lithium and methotrexate;
• corticosteroids;
• cyclosporine;
• digoxin;
• selective serotonin reuptake inhibitors;
• phenytoin;
• tacrolimus;
• mifepristone;
• quinolone antibiotics;
• antidiabetic medicines (sulfonylurea derivatives). Also, some other medicines may be affected or have an effect on treatment with Ibufen mini Junior. Therefore, before taking Ibufen mini Junior with other medicines, the patient should always consult their doctor or pharmacist.

Ibufen mini Junior with food, drink, and alcohol

The medicine should be taken during or after meals, with a large amount of fluid.
During the use of the medicine, the patient should not drink alcohol due to the possibility of exacerbating adverse reactions from the gastrointestinal tract and the central nervous system.

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 their doctor or pharmacist before taking this medicine.
Ibufen mini Junior is intended for children (see section 1 of the leaflet). The data presented below concern the active substance - ibuprofen.
Pregnancy
Ibufen mini Junior should not be used during the last 3 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 patient's and their child's tendency to bleed and cause delayed or prolonged labor.
Ibufen mini Junior should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Ibufen mini Junior 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 in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
The medicine passes into breast milk, but it can be used during breastfeeding if taken in recommended doses and for the shortest possible time.
Fertility
The medicine belongs to a group of nonsteroidal anti-inflammatory drugs, which may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

Ibufen mini Junior does not affect or has a negligible effect on the ability to drive and use machines if taken for a short period and in recommended doses.

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

The medicine contains 19.6 mg of sorbitol (E 420) in each capsule.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.
The medicine contains 10.2 mg of liquid maltitol (E 965) in each capsule.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Ibufen mini Junior

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should take the smallest effective dose for the shortest duration necessary to relieve symptoms and minimize the risk of adverse reactions. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
The medicine is intended for use in children aged 4 to 12 years with a body weight of 16 to 40 kilograms.
The use of Ibufen mini Junior in children under 4 years of age or with a body weight below 16 kilograms is contraindicated.
The medicine should be taken orally.
Children - the maximum daily dose of ibuprofen is 20-30 mg/kg body weight, divided into 3-4 single doses. The maximum daily dose should not be exceeded.
Recommended dose

The medicine should be taken during or after meals. The capsules should be swallowed whole, washed down with a glass of water. The capsules should not be chewed, sucked, or crushed.
The medicine is intended for occasional use.
If it is necessary to use this medicine for more than 3 days or if the symptoms worsen, the patient should consult their doctor.

Using Ibufen mini Junior in patients with kidney and/or liver function disorders

In patients with mild and moderate kidney and/or liver function disorders, there is no need to reduce the dose.

Taking a higher than recommended dose of Ibufen mini Junior

If the patient has taken a higher dose of Ibufen mini Junior than recommended 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 possible health risks and advice on what to do in such a case.
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 include agitation, drowsiness, disorientation, or coma. Seizures have been reported in patients. After taking high 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, asthma symptoms may worsen. Additionally, low blood pressure and breathing difficulties 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.

Missing a dose of Ibufen mini Junior

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

4. Possible side effects

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

• red, non-raised, target-like, or circular spots 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) - very rare.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Ibufen mini 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. When using ibuprofen for other indications and long-term, other side effects may occur.
Common side effects(occurring in less than 1 in 10 patients)

• Gastrointestinal symptoms, such as heartburn, abdominal pain, nausea, diarrhea, vomiting, bloating with gas, constipation, and minor gastrointestinal bleeding, which may rarely lead to anemia.

Uncommon side effects(occurring in less than 1 in 100 patients)

• Hypersensitivity reactions with skin rashes and itching, as well as asthma attacks. The patient should stop taking Ibufen mini Junior and immediately inform their doctor.
• Headache, dizziness, insomnia, agitation, irritability, fatigue.
• Visual disturbances.
• Gastrointestinal perforation or bleeding, black stools, and bloody vomiting, exacerbation of existing inflammatory bowel disease (ulcerative colitis or Crohn's disease), gastritis.

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

• Tinnitus.
• Flank pain and/or abdominal pain, blood in urine, and fever may be symptoms of kidney damage (renal papillary necrosis). Rarely, an increase in uric acid levels in the blood may also occur.

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

• Exceptional skin infections in chickenpox. Cases of worsening of infectious conditions (e.g., necrotizing fasciitis) have been reported during the use of some painkillers (NSAIDs). If symptoms of infection occur or worsen while taking Ibufen mini Junior, the patient should immediately consult their doctor. The doctor will assess whether there are indications for the use of anti-infective treatment (antibiotic therapy).
• Blood disorders, the first symptoms of which are: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, the patient should immediately stop the treatment and consult their doctor. The patient should not take pain-relieving or antipyretic medicines on their own.
• Severe hypersensitivity reactions, the symptoms of which may include: facial swelling, tongue and throat swelling, difficulty breathing, rapid heartbeat, low blood pressure, shock. If any of these symptoms occur, which may happen even after the first use of the medicine, the patient needs immediate medical help.
• Psychotic reactions, depression.
• Reports of palpitations, heart failure, myocardial infarction, stroke. Taking ibuprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
• Hypertension.
• Esophagitis, pancreatitis, formation of intestinal strictures. If the patient experiences severe abdominal pain, bloody vomiting, or black stools, they should stop the treatment and consult their doctor.
• Liver damage (the first symptom may be abnormal skin color) - concerning long-term treatment; liver failure, acute hepatitis.
• Decreased urine output and swelling (especially in patients with hypertension or impaired kidney function); edema and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis), which may lead to acute kidney failure. If the patient experiences any of the above symptoms or general malaise, they should stop taking Ibufen mini Junior and immediately consult their doctor, as they may be the first symptoms of kidney damage or kidney failure.

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.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Medical Devices, and Biocides
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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ibufen mini Junior

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
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.
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 Ibufen mini Junior contains

• The active substance of the medicine is ibuprofen. Each capsule contains 100 mg of ibuprofen.
• Other ingredients are: macrogol 600, potassium hydroxide, purified water; capsule shell: gelatin, liquid sorbitol non-crystallizing (E 420), liquid maltitol (E 965), purified water.

What Ibufen mini Junior looks like and contents of the pack

The medicine is in the form of light yellow gelatin capsules with a seam in the middle, soft, filled with a viscous liquid.
A carton contains a PVDC/PVC/Aluminum blister pack containing 15 capsules.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: