Ibufen baby

Package leaflet: Information for the user

Ibufen Baby, 125 mg, suppositories
Ibuprofen
Please read this leaflet carefully before using the medicine, as it contains important information for the user.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, consult your doctor.

Table of contents

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

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

• Fever of various origins (including viral infections and post-vaccination reactions).
• Mild to moderate pain of various causes:
  • Headache, sore throat, and muscle pain associated with colds and influenza,
  • Muscle, joint, and bone pain due to musculoskeletal injuries (strains, sprains),
  • Pain due to soft tissue injuries, postoperative pain,
  • Toothache, including teething pain,
  • Headache,
  • Ear pain occurring in middle ear inflammatory conditions.

2. Important information before using Ibufen Baby

When not to use Ibufen Baby:

• if the patient is allergic 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 previously experienced allergic symptoms such as rhinitis (nasal congestion), angioedema, urticaria, bronchospasm, or bronchial asthma after taking acetylsalicylic acid or other NSAIDs,
• in patients with active or past history of peptic ulcer or duodenal ulcer, or recurrent gastrointestinal ulceration or bleeding in the past (two or more separate episodes of confirmed ulceration or bleeding),
• if the patient has experienced 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 a bleeding tendency (haemorrhagic diathesis),
• in children with body weight below 12.5 kg.

Warnings and precautions
Before starting treatment with Ibufen Baby, consult a doctor or pharmacist.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, discontinue Ibufen Baby immediately and contact a doctor or emergency medical services without delay.
Inform a pharmacist or doctor if the patient has an infection – see section below titled "Infections".
Consult a doctor if the patient has been diagnosed with:

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

Also consult a doctor if the patient is taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, and corticosteroids (see section "Ibufen Baby and other medicines"). Avoid concomitant use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during initial treatment.
The risk of adverse effects is higher in elderly patients than in younger patients. The frequency and severity of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Long-term, concomitant use of various analgesics may lead to kidney damage with risk of kidney failure (analgesic nephropathy). This risk may be increased by physical exertion leading to salt loss and dehydration. Therefore, avoid long-term, concomitant use of multiple analgesics.
There is a risk of kidney function impairment in dehydrated children.
Use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibufen Baby, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, family history of heart disease or stroke, or if the patient smokes.

Severe skin reactions
Severe skin reactions have been reported with ibuprofen use, including 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 develops any symptoms related to these severe skin reactions described in section 4, discontinue Ibufen Baby immediately and seek medical help.

Infections
Ibufen Baby may mask symptoms of infection such as fever and pain. Therefore, Ibufen Baby may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and infection symptoms persist or worsen, consult a doctor immediately.
Cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen use; therefore, any visual disturbances should be reported to a doctor.
Using the medicine for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Ibufen Baby and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
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-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan),
• analgesics,
• other non-steroidal anti-inflammatory drugs,
• diuretics,
• medicines used for depression (selective serotonin reuptake inhibitors (SSRI), lithium),
• zidovudine, ritonavir (medicines used in treatment of HIV infections),
• methotrexate (a medicine used in cancer or rheumatoid arthritis treatment),
• corticosteroids (such as prednisolone),
• phenytoin (an antiepileptic medicine),
• cyclosporine, tacrolimus (immunosuppressive medicines),
• mifepristone (a medicine used in gynaecology),
• quinolone antibiotics (such as ciprofloxacin),
• cardiac glycosides (used in treatment of heart diseases),
• aminoglycoside antibiotics (such as streptomycin),
• probenecid, sulfinpyrazone (medicines used in treatment of gout),
• oral antidiabetic medicines (such as glimepiride),
• voriconazole, fluconazole (antifungal medicines),
• cholestyramine (used in patients with high cholesterol levels).

Other medicines may also influence or be influenced by treatment with Ibufen Baby.
Therefore, always consult a doctor or pharmacist before using Ibufen Baby with other medicines.

Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use Ibufen Baby during the last three 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 bleeding tendency in both the mother and her child and may delay or prolong labour.
Do not take Ibufen Baby during the first six 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 lowest effective dose for the shortest possible time. Ibufen Baby taken for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is required, 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.

Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
The medicine has no effect on the ability to drive or operate machinery when used short-term and according to recommendations.

3. How to use Ibufen Baby

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Rectal administration.
Do not use in children weighing less than 12.5 kg.
Do not exceed the maximum daily dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (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 per kg body weight, divided into 3 to 4 single doses. A single dose should not exceed 10 mg per kg body weight.
Recommended dose

Consult a doctor if administration of the medicine is necessary for more than 3 days or if symptoms worsen.
The medicine is intended for short-term use only.
Use of a higher than recommended dose of Ibufen Baby
If the patient has taken a higher than recommended dose of Ibufen Baby or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to obtain an assessment of possible health risks and advice on actions to be taken in such a case.
Symptoms of overdose may include nausea, epigastric pain, vomiting (blood may be present), gastrointestinal bleeding (see also point 4 below), diarrhoea, headache, tinnitus, disorientation, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures may occur rarely in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in urine, low blood potassium levels, cold sensation, and breathing difficulties have been reported.
Additionally, prothrombin time (INR) may be prolonged, probably due to interference with blood coagulation factors. Acute renal 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 undertake appropriate management.
Missed dose of Ibufen Baby
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital organs 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, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency not known.

The Ibufen Baby medicine is generally well tolerated. During short-term use of ibuprofen at over-the-counter doses, the following adverse reactions have been observed. Adverse reactions are listed according to frequency of occurrence:
Not common (occurring in fewer than 1 in 100 patients):

• dyspepsia, abdominal pain and nausea, local irritation of the anus;
• headache;
• various types of skin rash;
• urticaria and itching.

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

• diarrhea, bloating with gas release, constipation, vomiting;
• dizziness, insomnia, restlessness and feeling of fatigue.

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

• aseptic meningitis, characterized by neck stiffness, headache, nausea, vomiting, fever, and disorientation – reported in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease;
• blood disorders (anemia; leukopenia – reduced white blood cell count; thrombocytopenia – reduced platelet count; pancytopenia – hematological disorder involving deficiency of all normal blood cells: erythrocytes, leukocytes and platelets; agranulocytosis – reduced granulocyte count). Initial symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, skin petechiae.
• severe hypersensitivity reactions manifesting as swelling of the face, tongue and larynx; shortness of breath; rapid heartbeat; significant drop in blood pressure (anaphylaxis, angioedema or shock);
• asthma, worsening of asthma, bronchospasm, shortness of breath and wheezing;
• nervousness;
• visual disturbances;
• tinnitus, dizziness;
• edema, hypertension, heart failure (reported in connection with use of NSAIDs);
• gastric and duodenal ulcer disease, gastrointestinal perforation or bleeding, tarry stools, vomiting blood, sometimes fatal, particularly in elderly patients; ulcerative inflammation of the oral mucosa, gastric mucosal inflammation, ulceration of the oral mucosa;
• exacerbation of colitis and Crohn's disease;
• liver function disorders, particularly during prolonged use of ibuprofen; hepatitis and jaundice;
• acute renal failure; renal papillary necrosis, particularly after prolonged use of ibuprofen, associated with increased serum urea levels and edema, including peripheral edema; presence of blood and (or) protein in urine, interstitial nephritis, nephrotic syndrome;
• decreased hematocrit and hemoglobin levels in laboratory tests.

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

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

Depression and psychotic reactions have been reported in isolated cases.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibufen Baby

Do not store above 25°C. Keep in the original packaging 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibufen Baby contains

• The active substance is ibuprofen. Each suppository contains 125 mg of ibuprofen.
• Other ingredients are: Witepsol H 15, Witepsol W 45.

What Ibufen Baby looks like and contents of the pack
White or almost white, cylindrical suppositories.
Available pack sizes: 5 or 10 suppositories in PVC/PE foil blisters, packed in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Farmina Sp. z o.o.
Myślenice site
ul. Cegielskiego 2
32-400 Myślenice