Ibufen baby

Package leaflet: Information for the user

Ibufen Baby, 60 mg, suppositories
Ibuprofenum
Please read this 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 patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 24 hours in children aged 3–5 months, or within 3 days in children over 6 months of age, or if the patient feels worse, consult a 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 a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic and anti-inflammatory properties.
Ibufen Baby is intended for use in infants and children in the following cases:

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

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 reactions after taking acetylsalicylic acid or other NSAIDs, such as nasal inflammation (rhinitis), angioedema, urticaria, bronchospasm, or asthma,
• if the patient has active or past history of peptic ulceration or duodenal ulcer, or recurrent ulceration or gastrointestinal bleeding in the past (two or more separate episodes of confirmed ulceration or bleeding),
• if the patient has experienced upper gastrointestinal bleeding or perforation following the use of NSAIDs,
• if the patient has severe hepatic insufficiency, severe renal insufficiency, or severe heart failure,
• if the patient is in the third trimester of pregnancy,
• if the patient has a bleeding tendency,
• in infants with body weight below 6 kg (under 3 months of age).

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

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

Also consult a doctor if the patient is taking other medicines, particularly anticoagulants, diuretics, cardiac glycosides, and corticosteroids (see section "Ibufen Baby and other medicines"). Avoid concomitant use of ibuprofen with other non-steroidal anti-inflammatory drugs, 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 who previously experienced such 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 the initial treatment period.
The risk of adverse effects is higher in elderly patients than in younger patients. The frequency and severity of adverse effects can be reduced by using the lowest effective dose for the shortest possible duration.
Prolonged, concomitant use of various analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy). This risk may be increased by physical exertion leading to salt loss and dehydration. Therefore, avoid prolonged, concomitant use of multiple analgesics.
There is a risk of kidney function impairment in dehydrated children.

Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack 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 conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the 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, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Serious skin reactions
Serious skin reactions have occurred with ibuprofen use, 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 develops any symptoms related to these serious 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, thereby increasing 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.
Rare cases of toxic amblyopia (impaired 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 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 clot formation, 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),
• analgesic medicines,
• other non-steroidal anti-inflammatory drugs,
• diuretics,
• medicines used for depression (selective serotonin reuptake inhibitors (SSRI), lithium),
• zidovudine, ritonavir (medicines used in HIV treatment),
• methotrexate (a medicine used in cancer or rheumatoid arthritis treatment),
• corticosteroids (such as prednisolone),
• phenytoin (an antiepileptic medicine),
• cyclosporine, tacrolimus (medicines that suppress immune responses),
• mifepristone (a medicine used in gynecology),
• quinolone antibiotics (such as ciprofloxacin),
• cardiac glycosides (used in heart disease treatment),
• aminoglycoside antibiotics (such as streptomycin),
• probenecid, sulfinpyrazone (medicines used in gout treatment),
• oral antidiabetic medicines (such as glimepiride),
• voriconazole, fluconazole (antifungal medicines),
• cholestyramine (used in patients with high cholesterol levels).

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 the child and may delay or prolong labor.
Do not take Ibufen Baby during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required 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 treatment longer than a few days 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 infant.

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

Driving and operating machinery
The medicine does not affect 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 under 3 months of age.
Do not use in children weighing less than 6 kg.
Do not exceed the maximum daily dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of 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 per kg of body weight, divided into 3 to 4 single doses. The single dose should not exceed 10 mg per kg of body weight.
Recommended dose

In children aged 3–5 months, consult a doctor if symptoms worsen or do not improve after 24 hours.
In children over 6 months of age, consult a doctor if treatment with the medicinal product is required for more than 3 days or if symptoms worsen.
Ibufen Baby may be administered to children under 6 months of age only after consultation with a doctor.
This medicinal product is intended for short-term use only.
Use of a higher than recommended dose of Ibufen Baby
If a patient has used a higher than recommended dose of Ibufen Baby or if a child has accidentally ingested the medicinal product, always contact a doctor or go to the nearest hospital to obtain advice regarding possible health risks and actions to be taken in such a case.
Symptoms of overdose may include nausea, abdominal pain, vomiting (blood traces may occur), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, disorientation and nystagmus. Excitation, drowsiness, disorientation or coma may also occur. Seizures are occasionally reported 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, feeling cold and breathing difficulties have been reported.
Additionally, prothrombin time (INR) may be prolonged, probably due to impaired 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 initiate appropriate management.
Missed dose of Ibufen Baby
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 centre, skin peeling, mouth ulcers, ulcers in the 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 unknown.
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

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

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

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

• diarrhoea, 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, manifested by neck stiffness, headache, nausea, vomiting, fever, disorientation – reported in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease;
• blood disorders (anemia; leukopenia – decreased white blood cell count; thrombocytopenia – decreased platelet count; pancytopenia – hematologic disorder characterized by deficiency of all normal blood cells: erythrocytes, leukocytes and platelets; agranulocytosis – decreased granulocyte count). Initial symptoms include fever, sore throat, superficial mucosal ulcers in the mouth, flu-like symptoms, fatigue, nosebleeds, skin petechiae.
• severe hypersensitivity reactions manifesting as facial, tongue and laryngeal swelling; shortness of breath; rapid heartbeat; significant drop in blood pressure (anaphylaxis, angioedema or shock);
• asthma, worsening of asthma, bronchospasm, dyspnoea and wheezing;
• nervousness;
• visual disturbances;
• tinnitus, dizziness;
• oedema, hypertension, heart failure (reported in association with use of NSAIDs);
• gastric and duodenal ulcer disease, gastrointestinal perforation or bleeding, tarry stools, vomiting blood, sometimes with fatal outcome, 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 oedema, including peripheral oedema; presence of blood and/or protein in urine, interstitial nephritis, nephrotic syndrome;
• decreased hematocrit and hemoglobin levels in laboratory tests.

Frequency unknown (frequency cannot be determined 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 effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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 following 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Ibufen Baby contains

• The active substance 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 cylindrical suppositories.
Available pack sizes: 5 or 10 suppositories in PVC/PE foil blisters, 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.
Plant in Myślenice
ul. Cegielskiego 2
32-400 Myślenice