Ibufen Babi

Package Leaflet: Information for the Patient

Ibufen Baby, 60 mg, Suppositories

Ibuprofen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 24 hours in children aged 3-5 months or after 3 days in children over 6 months there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet

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

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

Ibufen Baby belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory effects.
The medicine is intended for use in infants and children in the following cases:

• Fever of various origins (including in the course of viral infections, post-vaccination reactions).
• Pains of various origins of mild to moderate severity:
• headaches, throat and muscle pains accompanying a cold and flu,
• muscle, joint, and bone pains resulting from injuries to the musculoskeletal system (sprains, twists),
• pains resulting from injuries to soft tissues, post-operative pains,
• toothaches, including pains resulting from teething,
• headaches,
• ear pains occurring in inflammatory conditions of the middle ear.

2. Important information before using Ibufen Baby

When not to use Ibufen Baby:

• if the patient is hypersensitive to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had symptoms of allergy after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as rhinitis (nasal congestion), angioedema, urticaria, bronchospasm, or asthma,
• in patients with active or recurrent peptic ulcer or gastrointestinal bleeding, or two or more distinct episodes of confirmed ulcer or bleeding in the past (gastrointestinal bleeding),
• if the patient has had gastrointestinal bleeding or perforation after using NSAIDs,
• if the patient has severe liver failure, severe kidney failure, or severe heart failure,
• if the patient is in the third trimester of pregnancy,
• if the patient has hemophilia,
• in infants under 6 kg body weight (under 3 months of age).

Warnings and precautions

Before starting treatment with Ibufen Baby, discuss it with your doctor or pharmacist.
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain.
If you notice any of these symptoms, stop using Ibufen Baby immediately and seek medical attention immediately.
Tell your pharmacist or doctor if you have an infection - see below, section "Infections".
Consult your doctor if you have:

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

You should also consult your doctor if you are taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, and corticosteroids (see section "Ibufen Baby and other medicines"). You should avoid taking ibuprofen with other non-steroidal anti-inflammatory drugs, including those called selective 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 signs or may occur in patients who have had such warning signs.
If gastrointestinal bleeding or ulceration occurs, stop the medicine immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
In elderly patients, the risk of adverse reactions due to the use of the medicine is higher than in younger patients. The frequency and severity of adverse reactions can be reduced by using the smallest effective dose for the shortest possible period.
Concomitant, prolonged use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion resulting in salt loss and dehydration.
Therefore, concomitant, prolonged use of different painkillers should be avoided.
There is a risk of kidney function disorders in dehydrated children.
Taking anti-inflammatory/analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
Before using Ibufen Baby, the patient should discuss the treatment with a doctor or pharmacist if:

• the patient has heart diseases, 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).
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.

Severe skin reactions
Ibuprofen has been associated with severe skin reactions, 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 of the symptoms associated with these severe skin reactions described in section 4, stop using Ibufen Baby immediately and seek medical attention.
Infections
Ibufen Baby may mask the symptoms of infection, such as fever and pain. Therefore, Ibufen Baby 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, consult a doctor immediately.
During treatment with ibuprofen, single cases of toxic amblyopia (visual acuity impairment) have been reported, so any vision disturbances should be reported to a doctor.
Taking the medicine for the shortest period necessary to relieve symptoms reduces the risk of adverse reactions.

Ibufen Baby and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ibufen Baby may affect the action of other medicines or other medicines may affect the action of Ibufen Baby. 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),
• analgesic medicines,
• other non-steroidal 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 (used to treat heart conditions),
• aminoglycoside antibiotics (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 or have an effect on treatment with Ibufen Baby.
Therefore, before using Ibufen Baby with other medicines, always consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Ibufen Baby 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 problems in the unborn child. It may affect the patient's and child's tendency to bleed and cause delayed or prolonged labor.
Do not take Ibufen Baby during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the smallest effective dose of the medicine for the shortest possible time. Ibufen Baby 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 around the baby (oligohydramnios) or narrowing of the blood vessel (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 very unlikely to have a negative effect on the breastfed baby.
Fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine has no effect on the ability to drive vehicles and use machines if used for a short period and in accordance with the recommendations.

3. How to use Ibufen Baby

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
Rectal administration.
Do not use in children under 3 months of age.
Do not use in children under 6 kg body weight.
Do not exceed the maximum daily dose.
Use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Children - the maximum daily dose of ibuprofen is 20-30 mg/kg body weight, divided into 3 to 4 single doses. Do not exceed a single dose of 10 mg/kg body weight.

In the case of children aged 3-5 months, consult a doctor if symptoms worsen or do not improve after 24 hours.
In the case of children over 6 months, consult a doctor if the medicine needs to be given for more than 3 days or if symptoms worsen.
Children under 6 months of age can only be given Ibufen Baby after consulting a doctor.
The medicine is intended for short-term use.

Using a higher dose of Ibufen Baby than recommended

If you have used a higher dose of Ibufen Baby than recommended or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Overdose symptoms 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. Rarely, patients experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported.
In addition, 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 breathing difficulties may occur.
Overdose cases are rare. Treatment is symptomatic and supportive. The doctor will take appropriate action.

Missing a dose of Ibufen Baby

Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using ibuprofen and seek medical attention immediately if you 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 enlarged 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 Baby is generally well-tolerated. During short-term use of ibuprofen in doses available without a prescription, the following adverse reactions have been observed.
Adverse reactions are listed by frequency of occurrence:
Uncommon (occurring in less than 1 in 100 patients):

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

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

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

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

• aseptic meningitis with symptoms of 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 - a hematological disorder characterized by a deficiency of all normal morphological elements of the blood: red blood cells, white blood cells, and platelets; agranulocytosis - decreased granulocyte count). The first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, skin bruising.
• severe allergic reactions with symptoms of facial swelling, tongue and laryngeal edema; shortness of breath; increased heart rate; significant decrease in blood pressure (anaphylaxis, angioedema, or shock);
• asthma, worsening of asthma, bronchospasm, shortness of breath, and wheezing;
• nervousness;
• vision disturbances;
• tinnitus, dizziness;
• edema, hypertension, heart failure (reported in association with the use of NSAIDs);
• peptic ulcer disease and duodenal ulcer, perforation, or gastrointestinal bleeding, melena, hematemesis, sometimes with a fatal outcome, especially in the elderly; ulcerative stomatitis, gastritis;
• 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 serious allergic reaction called Kounis syndrome.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or 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, you can help provide more information on the safety of this medicine.

5. How to store Ibufen Baby

Do not store above 25°C. Store in the original package to protect from light and moisture.
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.
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 pack and other information

What Ibufen Baby contains

• The active substance of the medicine is ibuprofen. Each suppository contains 60 mg of ibuprofen.
• The other ingredients are: Witepsol H 15, Witepsol W 45.

What Ibufen Baby looks like and contents of the pack

White or almost white suppositories of cylindrical shape.
Pack sizes: 5 or 10 suppositories in PVC/PE foil blisters, in a cardboard box.

Marketing authorization holder

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

Manufacturer

Farmina Sp. z o.o.
Myślenice Plant
ul. Cegielskiego 2
32-400 Myślenice

Date of the last revision of the leaflet: