IBUFEN 125 mg Suppositories

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ibufen Baby, 125 mg, suppositories
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ibufen Baby and what is it used for
4. Important information before taking Ibufen Baby
   1. When not to take Ibufen Baby:
   2. Warnings and precautions
   3. Ibufen Baby and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
5. How to take Ibufen Baby
   1. Taking a higher dose of Ibufen Baby than recommended
   2. Missing a dose of Ibufen Baby
6. Possible side effects
   1. Reporting side effects
7. How to store Ibufen Baby
8. Contents of the packaging and other information
   1. What Ibufen Baby contains
   2. What Ibufen Baby looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Ibufen Baby, 125 mg, suppositories

Ibuprofen

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those 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 a doctor.

Table of contents of the leaflet

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

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

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

• Fever of various origins (also in the course of viral infections, in the course of post-vaccination reactions).
• Pains of various origins of mild to moderate severity:
• headaches, throat and muscle pains accompanying colds 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 middle ear inflammatory conditions.

2. Important information before taking Ibufen Baby

When not to take Ibufen Baby:

• 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 experienced symptoms of allergy after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as rhinitis (allergic rhinitis), angioedema, urticaria, bronchospasm, or asthma,
• in patients with active or recurrent gastric and/or duodenal ulcers, or a history of recurrent gastrointestinal bleeding (two or more separate episodes of proven ulceration or bleeding),
• if the patient has experienced gastrointestinal bleeding or perforation after taking NSAIDs,
• in patients with severe liver failure, severe kidney failure, or severe heart failure,
• in the third trimester of pregnancy,
• if the patient has a hemorrhagic diathesis,
• in children with a body weight below 12.5 kg.

Warnings and precautions

Before starting treatment with Ibufen Baby, 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 of the face and neck (angioedema), chest pain.
If any of these symptoms are observed, the patient should immediately stop taking Ibufen Baby and seek medical attention 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 and mixed connective tissue disease,
• diseases of the anus and rectum,
• 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".

The patient should also consult their doctor if they are taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, and corticosteroids (see section "Ibufen Baby and other medicines"). The patient should avoid taking ibuprofen with other nonsteroidal 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 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 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 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 in the case of 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/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 patient should not exceed the recommended dose and duration of treatment.
Before taking Ibufen Baby, 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 narrowing or blockage of arteries), or have had any 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 immediately stop taking Ibufen Baby and seek medical attention.
Infections
Ibufen Baby may mask the symptoms of an infection, such as fever and pain. Therefore, Ibufen Baby may delay the use of appropriate infection treatment, which can 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.
During treatment with ibuprofen, single cases of toxic amblyopia (visual acuity 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 Baby 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 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),
• pain-relieving medicines,
• other nonsteroidal anti-inflammatory drugs,
• diuretics,
• medicines used in depression (selective serotonin reuptake inhibitors (SSRIs), lithium),
• zydovudine, ritonavir (medicines used in the treatment of HIV infections),
• methotrexate (a medicine used in the treatment of 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 in the treatment of heart diseases),
• aminoglycoside antibiotics (such as streptomycin),
• probenecid, sulfinpyrazone (medicines used in the treatment of 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 taking Ibufen Baby with other medicines, the patient should always consult their doctor or pharmacist.

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.
Pregnancy
Ibufen Baby should not be taken 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 may cause delayed or prolonged labor.
Ibufen Baby 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 Baby taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, which can lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for more than a few days, 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 infant.
Fertility
This medicine belongs to a group of medicines (nonsteroidal 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 does not affect the ability to drive or use machines if taken for a short period and in accordance with the recommendations.

3. How to take Ibufen Baby

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Rectal administration.
Not to be used in children with a body weight below 12.5 kg.
Do not exceed the maximum daily dose.
Use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (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.
Recommended dose

The patient should consult their doctor if it is necessary to administer the medicine for more than 3 days or if the symptoms worsen.
The medicine is intended for short-term use.

Taking a higher dose of Ibufen Baby than recommended

If the patient has taken a higher dose of Ibufen Baby 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 the possible risk to their health and advice on what to do in such a case.
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 may 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 take a double dose 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 Baby 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 of the 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 enlarged lymph nodes (DRESS syndrome) - frequency not known.
• red, peeling rash with bumps under the skin and blisters, accompanied by 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, 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: erythrocytes, leukocytes, and platelets; agranulocytosis - decreased granulocyte count). The first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, purpura on the skin.
• severe hypersensitivity reactions with symptoms of facial swelling, tongue and laryngeal edema; dyspnea; tachycardia; significant hypotension (anaphylaxis, angioedema, or shock);
• asthma, worsening of asthma, bronchospasm, dyspnea, and wheezing;
• nervousness;
• vision disturbances;
• tinnitus, dizziness;
• edema, hypertension, heart failure (reported in connection with the use of NSAIDs);
• gastric and duodenal ulcer disease, 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 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ibufen Baby

Do not store above 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 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 packaging and other information

What Ibufen Baby contains

• The active substance of the medicine is ibuprofen. Each suppository contains 125 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.
Available packs: 5 or 10 suppositories in PVC/PE foil blisters, in a cardboard box.

Marketing authorization holder

PHARMACEUTICAL WORKS POLPHARMA S.A.
Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

FARMINA Sp. z o.o.
Myślenice Plant
Cegielskiego 2
32-400 Myślenice

Date of last revision of the leaflet: