Ibuprom for children forte

Patient Information Leaflet

Ibuprom dla dzieci Forte, 40 mg/ml, oral suspension
Ibuprofenum
Please read this 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 advised 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 doctor or pharmacist.
• If the patient experiences 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 a doctor if symptoms worsen or do not improve: ⦁ after 24 hours in children under 6 months of age or ⦁ after 3 days in children over 6 months of age.

Table of contents:

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

1. What Ibuprom dla dzieci Forte 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). This medicine has analgesic, anti-inflammatory and antipyretic properties.
The medicine is intended for use in infants and children in the following cases:

• fever of various origins (including viral infections and post-vaccination reactions),
• mild to moderate pain of various causes: 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 after dental procedures, teething pain; ear pain occurring in middle ear infections.

2. Important information before using Ibuprom dla dzieci Forte

When not to use Ibuprom dla dzieci Forte:

• if the patient is allergic to the active substance or to 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 such as rhinitis, urticaria, or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past history of gastric or duodenal ulcer, perforation, or gastrointestinal bleeding, including cases occurring after NSAID use,
• in patients with severe liver failure, severe renal failure, or severe heart failure,
• in patients concurrently 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 Forte, 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 previous allergic reactions; bronchospasm may occur after taking the medicine,
• hereditary fructose intolerance (due to the possibility of maltitol, one of the excipients, being converted into fructose).

In dehydrated children, there is a risk of kidney function impairment.
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, the medicine should be discontinued immediately.
Patients with a history of gastrointestinal disorders, particularly elderly individuals, 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 a risk of renal failure (analgesic nephropathy).
The use of medicines such as ibuprofen may be associated with a slight increase in the risk of myocardial infarction (heart attack) or stroke. This risk increases with prolonged use of high doses. Do not exceed the recommended dose or duration of treatment.
If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms appear, consult a doctor.

Skin reactions
Severe skin reactions have been reported with the use of ibuprofen, including 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 the patient experiences any of the symptoms related to these severe skin reactions described in section 4, Ibuprom dla dzieci Forte should be discontinued immediately and medical help should be sought.

The use of anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), or chest pain, have been reported. If any of these symptoms occur, Ibuprom dla dzieci Forte should be discontinued immediately and the patient should contact a doctor or emergency medical services without delay.

Before using Ibuprom dla dzieci Forte, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina pectoris (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 history of stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection – see below, section titled "Infections".

Infections
Ibuprom dla dzieci Forte may mask symptoms of infection such as fever and pain. Therefore, Ibuprom dla dzieci Forte may delay appropriate treatment of infection, potentially increasing the 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 existing infection and infection symptoms persist or worsen, immediate medical consultation is required.

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 relate to conditions experienced in the past.

Ibuprom dla dzieci Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Ibuprom dla dzieci Forte may affect the action of other medicines, or other medicines may affect the action of Ibuprom dla dzieci Forte. Such medicines include, for example:

• anticoagulants (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 atenolol-containing medicines, angiotensin II receptor antagonists such as losartan, diuretics such as indapamide) – their effect may be weakened and renal impairment may worsen,
• painkillers, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs – increased risk of adverse effects, especially gastrointestinal,
• cardiac glycosides – their blood concentration may increase,
• 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 ulceration or bleeding.

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

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

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, 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 Forte if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprom dla dzieci Forte may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labor. During the first 6 months of pregnancy, Ibuprom dla dzieci Forte should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From the 20th week of pregnancy, Ibuprom dla dzieci Forte, 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 the 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 has a negligible effect on the ability to drive or operate machinery.

Ibuprom dla dzieci Forte 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, they should consult a doctor before taking the medicine.

Sodium benzoate (E 211)
The medicine contains 5 mg of sodium benzoate in 5 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 medical 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 28.95 mg of sodium (1.26 mmol) (a main component of table salt) in 5 ml of suspension. This corresponds to 1.45% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ibuprom dla dzieci Forte

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.

A dosing syringe with measurement markings to facilitate dosing is included in the packaging.

The recommended daily dose of Ibuprom dla dzieci Forte is 20 mg to 30 mg per kilogram of body weight, administered in divided doses.

The dosing schedule using the dosing syringe provided in the package can be achieved as follows:

Infants weighing 5-7 kg (aged 3 to 5 months): 3 times 1-1.5 ml per day (corresponding to approximately 120-180 mg of ibuprofen per day).

Infants weighing 8-10 kg (aged 6 to 12 months): 3 times 1.75-2 ml per day (corresponding to approximately 210-240 mg of ibuprofen per day).

Children weighing 11-15 kg (aged 13 months to 3 years): 3 times 2.25-3 ml per day (corresponding to approximately 270-360 mg of ibuprofen per day).

Children weighing 16-20 kg (aged 4 to 5 years): 3 times 3.25-4 ml per day (corresponding to approximately 390-480 mg of ibuprofen per day).

Children weighing 21-29 kg (aged 6 to 8 years): 3 times 4.25-5.75 ml per day (corresponding to approximately 510-690 mg of ibuprofen per day).

Children weighing 30-40 kg (aged 9 to 11 years): 3 times 6-8 ml per day (corresponding to approximately 720-960 mg of ibuprofen per day).

In the above dosing schedule, the smaller volume corresponds to the lower body weight, and conversely, the larger volume corresponds to the higher body weight. The age ranges given are approximate.

Adults and adolescents over 12 years of age: the recommended dose for symptomatic treatment of pain and fever is 3 times 10 ml per day, until symptoms subside.

The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, immediate medical advice must be sought (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 consultation with a doctor. Medical advice should be sought if symptoms worsen or do not improve within 24 hours.

If treatment with this medicine is required for more than 3 days in children over 6 months of age, or if the patient's condition worsens, medical advice should be sought.

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 during a meal or with 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 Forte).

Overdose of Ibuprom dla dzieci Forte

Symptoms of overdose:

If a patient has taken more than the recommended dose of Ibuprom dla dzieci Forte, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on appropriate actions.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood traces), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures may occur occasionally. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur, as well as blood in the urine, low blood potassium levels, cold sensation, and breathing difficulties. Additionally, prolonged prothrombin time/INR may occur, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatics, asthma exacerbation is possible. Additionally, low blood pressure 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 considered orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor may administer intravenous diazepam or lorazepam. In patients with asthma, the doctor will administer bronchodilators.

Missed dose of Ibuprom dla dzieci Forte

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms. A child may experience one of the known adverse effects of NSAID medicines. If any adverse effects occur or if there is any doubt, administration of the medicine should be stopped and medical advice should be sought as soon as possible. Elderly patients taking this medicine belong to a group at increased risk of problems related to adverse effects.
IMMEDIATELY DISCONTINUE USE of the medicine 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 resembling 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, palpitations, 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 rash on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature 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 adverse symptom occurs or worsens, or if any adverse effects not listed in this leaflet occur,
discontinue use of the medicine and consult a doctor.
Common (occurring in 1 to 10 out of 100 patients):

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

Uncommon (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 (with possible drop in blood pressure).

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

• tinnitus (ringing in the ears).

Very rare (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 inflammation, which may also present with cloudy urine, blood in urine, back pain, leg swelling or general malaise);
• problems related to blood cell production (initial symptoms include fever, sore throat, superficial oral ulcers, flu-like symptoms, severe exhaustion, 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 with yellowing of the skin and eyes, pale stools or dark urine;
• aseptic meningitis symptoms, including neck stiffness, headache, malaise, fever or altered consciousness, have been observed during ibuprofen use.
  Patients with pre-existing autoimmune diseases (SLE, mixed connective tissue disease) are more susceptible to adverse effects. Immediate medical consultation is required if such symptoms occur.

Taking ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• skin becomes light-sensitive;
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. Reporting of adverse effects If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Ibuprom dla dzieci Forte

Keep the medicine out of sight and reach of children.
Once opened, the container should be used within 6 months.
After first opening, store the medicine at a temperature not exceeding 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 pack and other information

What Ibuprom dla dzieci Forte contains

• The active substance is ibuprofen. Each 1 ml of oral suspension contains 40 mg of ibuprofen.
• The other ingredients are: sodium benzoate (E 211), citric acid, disodium citrate dihydrate, sodium saccharin, sodium chloride, hypromellose 15 cP, xanthan gum, liquid maltitol, glycerol, thaumatin (E 957), strawberry flavour (containing substances identical to natural flavours, natural flavours, maltodextrin, triethyl citrate, propylene glycol and benzyl alcohol), purified water.

What Ibuprom dla dzieci Forte looks like and contents of the pack
A viscous, almost white suspension.
Pack sizes: 30 ml, 100 ml, 150 ml or 200 ml bottles. Each pack includes an oral dosing syringe to facilitate administration.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław, Poland
Manufacturer
Farmasierra Manufacturing, S.L.
Ctra. Irún, Km. 26,200
San Sebastián de los Reyes, 28706 Madrid, Spain
Farmalider, S.A.
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 medicinal product, please contact the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw, Poland
Tel.: +48 (22) 543 60 00