Ibuprom for children

Package leaflet: Information for the patient

Ibuprom dla dzieci, 100 mg/5 ml, oral suspension
Ibuprofenum
Please read the entire leaflet carefully before using 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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• This medicine may be given to children under 6 months of age only after consultation with a doctor.
• Contact your doctor if symptoms worsen or do not improve: ⦁ within 24 hours in children under 6 months of age or ⦁ within 3 days in children over 6 months of age.

Table of contents of the leaflet:

1. What Ibuprom dla dzieci is and what it is used for
2. Important information before taking Ibuprom dla dzieci
3. How to take Ibuprom dla dzieci
4. Possible side effects
5. How to store Ibuprom dla dzieci
6. Contents of the package and other information

1. What Ibuprom dla dzieci is and what it is used for

The active substance in this medicine is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, anti-inflammatory and antipyretic properties.
This medicine is intended for use in infants and children in the following conditions:

• fever of various origins (including viral infections and post-vaccination reactions),
• mild to moderate pain of various origins: headache, sore throat and muscle pain (e.g. during viral infections); muscle, joint and bone pain due to musculoskeletal injuries (strains, sprains); pain due to soft tissue injuries, postoperative pain; toothache, pain following dental procedures, teething pain; ear pain occurring in middle ear inflammation.

2. Important information before using Ibuprom dla dzieci

When not to use Ibuprom dla dzieci:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) or to other similar pain-relieving medicines (from the NSAID group),
• in patients who have previously experienced allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), such as nasal congestion, urticaria, or bronchial asthma,
• in patients with active or past history of gastric or duodenal ulcer, gastrointestinal perforation or bleeding, including cases occurring after use of NSAIDs,
• in patients with severe liver failure, severe kidney failure, or severe heart failure,
• in patients currently taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects),
• during the last three months of pregnancy,
• in patients with bleeding disorders.

Warnings and precautions
Before starting treatment with Ibuprom dla dzieci, consult a doctor or pharmacist,
especially if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• allergic reactions after taking acetylsalicylic acid,
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart function disorders,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders,
• active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine,
• hereditary fructose intolerance (due to possible conversion of maltitol, one of the excipients, into fructose).

In dehydrated children, there is a risk of impaired kidney function.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and not always preceded by warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately.
Patients with a history of gastrointestinal disorders, particularly elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial period of treatment.
Concurrent and long-term use of various painkillers may lead to kidney damage with risk of kidney failure (analgesic nephropathy).
Use of medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with prolonged use of high doses of the medicine.

Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms associated with these severe skin reactions described in section 4 occur, discontinue Ibuprom dla dzieci immediately and seek medical help.

Do not use higher doses or longer treatment duration than recommended. If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms appear, contact a doctor.
Use of anti-inflammatory/pain-relieving 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 Ibuprom dla dzieci, 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 heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection – see below, section titled "Infections".

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 Ibuprom dla dzieci immediately and contact a doctor or emergency medical services without delay.

Infections
Ibuprom dla dzieci may mask symptoms of infection such as fever and pain. Therefore, Ibuprom dla dzieci 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 this medicine is taken during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.

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 the medicine.
Consult a doctor even if the above warnings refer to conditions experienced in the past.

Ibuprom dla dzieci and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Ibuprom dla dzieci may affect the action of other medicines, or other medicines may affect the action of Ibuprom dla dzieci. Examples include:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine – increased risk of bleeding,
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan, diuretics such as indapamide) – their effect may be weakened and kidney function may deteriorate,
• painkillers, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs – increased risk of adverse effects, especially gastrointestinal,
• cardiac glycosides – increased blood levels,
• zidovudine – increased risk of joint bleeding or bleeding leading to swelling in patients with hemophilia,
• lithium and methotrexate – increased toxicity,
• corticosteroids – increased risk of gastrointestinal ulcers or bleeding.

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

Ibuprom dla dzieci and food
Food does not affect the absorption of the medicine.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Ibuprom dla dzieci during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Ibuprom dla dzieci may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. During the first 6 months of pregnancy, Ibuprom dla dzieci should not be used unless a doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprom dla dzieci, if taken for longer than a few days, may lead to kidney dysfunction in the unborn child (which may result in low levels of amniotic fluid surrounding the baby – oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts, but there are no known cases of adverse effects in breastfed infants.

Fertility
Effect of the medicinal product on fertility – see section Warnings and precautions.

Driving and operating machinery
When used short-term and at recommended doses, the medicine has no effect or negligible effect on the ability to drive or operate machinery.

Ibuprom dla dzieci contains liquid maltitol, sodium, sodium benzoate (E 211), and benzyl alcohol

Maltitol
The medicine contains liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking the medicine.

Sodium benzoate (E 211)
The medicine contains 1 mg of sodium benzoate per 1 ml of suspension.

Benzyl alcohol
The medicine contains 0.000826 mg of benzyl alcohol in 5 ml of suspension. Benzyl alcohol may cause allergic reactions. Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's advice. Patients with liver or kidney disease and women who are pregnant or breastfeeding should consult a doctor, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Sodium
The medicine contains 17.96 mg of sodium (0.78 mmol) (main component of table salt) in 5 ml of suspension. This corresponds to 0.89% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ibuprom dla dzieci

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

An oral syringe with a graduated scale to facilitate dosing is supplied with the pack.

The recommended daily dose of Ibuprom dla dzieci is 20 mg to 30 mg of ibuprofen per kilogram of body weight, given in divided doses according to the following schedule:

Infants aged 3 to 6 months (body weight 5–7.6 kg): 3 times 2.5 ml per day (corresponding to 150 mg of ibuprofen per day).

Infants aged 6 to 12 months (body weight 7.7–9 kg): 3 to 4 times 2.5 ml per day (corresponding to 150–200 mg of ibuprofen per day).

Children aged 1 to 3 years (body weight 10–15 kg): 3 times 5 ml per day (corresponding to 300 mg of ibuprofen per day).

Children aged 4 to 6 years (body weight 16–20 kg): 3 times 7.5 ml per day (corresponding to 450 mg of ibuprofen per day).

Children aged 7 to 9 years (body weight 21–29 kg): 3 times 10 ml per day (corresponding to 600 mg of ibuprofen per day).

Children aged 10 to 12 years (body weight 30–40 kg): 3 times 15 ml per day (corresponding to 900 mg of ibuprofen per day).

The lowest effective dose should be used 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).

Allow an interval of 6 to 8 hours between doses.

Children under 6 months of age should only be given this medicine after consulting a doctor. Medical advice should be sought if symptoms worsen or do not improve within 24 hours.

If use of the medicine is required for more than 3 days in children over 6 months of age, or if the patient's condition worsens, consult a doctor.

Do not exceed the recommended dose.

This medicine is intended for short-term use only.

Shake well before use. The medicine may be administered directly or diluted in water or juice.

In patients with a sensitive gastrointestinal tract, it is recommended to take the medicine with food or milk.

Renal or hepatic impairment

Dose adjustment is not required in mild to moderate renal or hepatic impairment (for patients with severe renal or hepatic impairment, see section 2. Important information before using Ibuprom dla dzieci).

Overdose of Ibuprom dla dzieci

Symptoms of overdose:

If a patient has taken more than the recommended dose of Ibuprom dla dzieci or if a child has accidentally ingested the medicine, seek immediate medical advice from a doctor or the nearest hospital to assess potential health risks and receive guidance on necessary actions.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures may occur rarely. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Prolongation of prothrombin time/INR may also occur, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. In asthmatic patients, asthma may be exacerbated. Additionally, hypotension and breathing difficulties may occur.

Treatment of overdose: Treatment is symptomatic and supportive, aimed at removing excess medicine from the body. The doctor will monitor heart function and vital signs as long as they remain stable. Activated charcoal may be administered orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor may administer intravenous diazepam or lorazepam. In asthmatic patients, bronchodilators will be administered.

Missed dose of Ibuprom dla dzieci

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The risk of side effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Your child may experience one of the known side effects associated with NSAID medicines. If any side effects occur, or if you have any doubts, stop giving the medicine and consult a doctor as soon as possible. Elderly patients taking this medicine belong to a group at increased risk of problems related to side effects.
STOP TAKING THE MEDICINE IMMEDIATELY and seek medical help
if any of the following symptoms occur:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or dark particles that look like coffee grounds.

• symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock; these symptoms may occur even after the first dose of the medicine.

• red, flat, target-like or circular skin lesions, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• widespread rash, high fever and swollen lymph nodes (DRESS syndrome).

• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If any of the side effects occur or worsen, or if any side effects not listed in this leaflet occur,
stop using the medicine and consult a doctor.
Common side effects (occurring in 1 to 10 out of 100 patients):

• heartburn, abdominal pain, nausea and indigestion, vomiting, bloating with gas, diarrhoea, constipation.

Uncommon side effects (occurring in 1 to 10 out of 1,000 patients):

• gastritis, colitis and exacerbation of Crohn's disease, headache, dizziness, insomnia, restlessness, irritability, fatigue, visual disturbances, gastric ulcers which may bleed or perforate, oral ulceration and (or) skin swelling and irritation, hypersensitivity reactions with rash and itching, asthma attacks (possibly with drop in blood pressure).

Rare side effects (occurring in 1 to 10 out of 10,000 patients):

• tinnitus (ringing in the ears).

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

• oesophagitis or pancreatitis, intestinal obstruction;
• in exceptional cases, severe skin infections during chickenpox (varicella);
• reduced urine output than usual and swelling (possible acute kidney failure or inflammatory condition, which may also present with cloudy urine, blood in urine, back pain, leg swelling or general malaise);
• problems with blood cell production (initial symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unexplained or unusual bruising);
• psychotic reactions, depression;
• worsening of inflammatory condition due to infection;
• swelling, high blood pressure, palpitations, heart failure, heart attack;
• liver function disorders or hepatitis, which may present as yellowing of the skin and eyes, pale stools and dark urine;
• aseptic meningitis with symptoms such as neck stiffness, headache, malaise, fever or altered consciousness has been observed during ibuprofen use. Patients with pre-existing autoimmune diseases (SLE, mixed connective tissue disease) are at higher risk of experiencing adverse reactions. Immediate medical advice should be sought if these symptoms occur.

Side effects with unknown frequency (frequency cannot be estimated from available data)

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

Taking ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If any side effects occur, including any possible side effects not listed in this leaflet, consult your doctor or pharmacist.
Side 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ibuprom dla dzieci

Keep the medicine out of sight and reach of children.
Use the opened container within 6 months.
After first opening, store the medicine below 25°C.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What the medicine Ibuprom dla dzieci contains

• The active substance is ibuprofen. Each 1 ml of oral suspension contains 20 mg of ibuprofen.
• The other ingredients are: sodium benzoate (E 211), citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose 15 cP, xanthan gum, liquid maltitol, glycerol, strawberry flavour (containing substances identical to natural flavours, natural flavours, maltodextrin, triethyl citrate, propylene glycol and benzyl alcohol), purified water.

What Ibuprom dla dzieci looks like and contents of the packaging
A viscous, almost white suspension.
Packaging: 100 ml, 150 ml or 200 ml bottle. An oral dosing syringe is included in the package to facilitate dosing. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław
Manufacturer
Farmasierra Manufacturing, S.L.
Ctra. Irún, Km. 26,200
San Sebastián de los Reyes, 28709 Madrid, Spain
Farmalider, S.A.
C/Aragoneses, 2, Alcobendas, 28108 Madrid, Spain
Delpharm Bladel B.V.
Industrieweg 1
5531 AD Bladel, The Netherlands
Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117
Villamarchante, Valencia, 46191, Spain
For further information about this medicine, please contact the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel.: +48 (22) 543 60 00