Ibuprom dla dzieci

Leaflet attached to the packaging: patient information

Ibuprom for children, 100 mg/5 ml, oral suspension

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
The medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• The medicine should only be given to children under 6 months of age after consulting a doctor.
• A doctor should be contacted 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 of the leaflet:

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

1. What is Ibuprom for children and what is it used for

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

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

2. Important information before taking Ibuprom for children

When not to take Ibuprom for children:

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6) and other similar painkillers (NSAIDs),
• in patients who have experienced allergic symptoms in the past after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as nasal congestion, urticaria, or bronchial asthma,
• in patients with active or recurrent stomach and/or duodenal ulcers, perforation, or bleeding, also those that occurred after taking NSAIDs,
• in patients with severe liver, kidney, or heart failure,
• in patients taking other nonsteroidal anti-inflammatory drugs at the same time, including COX-2 inhibitors (increased risk of side effects),
• in the last three months of pregnancy,
• in patients with bleeding disorders.

Warnings and precautions

Before starting treatment with Ibuprom for children, the patient should discuss it with their doctor or pharmacist, especially if they have previously been diagnosed with:

• lupus erythematosus or mixed connective tissue disease,
• allergic reactions after taking acetylsalicylic acid,
• gastrointestinal diseases and 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 recurrent bronchial asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur,
• congenital fructose intolerance (due to the possible conversion of maltitol, one of the medicine's excipients, into fructose).

In dehydrated children, there is a risk of kidney function disorders.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and is not always preceded by warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately.
Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial period of treatment with the medicine.
Concomitant and prolonged use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Taking medicines like 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, 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), have occurred with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions, they should discontinue Ibuprom for children and seek medical attention immediately.
Do not exceed the recommended dose and duration of treatment. If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms occur, the patient should consult their doctor.
Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Ibuprom for children, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries) or have had a stroke (including a mini-stroke or transient ischemic attack - TIA).
• they have high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or smoke.
• they have an infection - see below, section "Infections".

During ibuprofen use, allergic reactions to the medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms are noticed, the patient should discontinue Ibuprom for children and seek medical attention immediately.
Infections
Ibuprom for children may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuprom for children may delay the use of appropriate infection treatment and lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine while an infection is present, and the infection symptoms persist or worsen, they should consult their doctor immediately.
The medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the medicine is discontinued.
The patient should consult their doctor even if the above warnings refer to past situations.

Ibuprom for children and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibuprom for children may affect the action of other medicines or other medicines may affect the action of Ibuprom for children. These medicines include, for example:

• blood-thinning medicines (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine) - the risk of bleeding may increase,
• blood pressure-lowering medicines (e.g., ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics such as indapamide) - their effect may be reduced, and kidney failure may worsen,
• painkillers, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs - the risk of side effects may increase, especially those related to the gastrointestinal tract,
• cardiac glycosides - their blood levels may increase,
• zydovudine - the risk of bleeding into the joints or bleeding leading to swelling in hemophiliacs may increase,
• lithium and methotrexate - their toxicity may increase,
• corticosteroids - the risk of gastrointestinal ulcers or bleeding may increase.

Other medicines may also be affected or have an effect on treatment with Ibuprom for children. Therefore, before taking Ibuprom for children with other medicines, the patient should always consult their doctor or pharmacist.

Ibuprom for children with food

Food does not affect the absorption of the medicine.

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
Ibuprom for children should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
The medicine may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, Ibuprom for children should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprom for children, if taken for more than a few days, may cause kidney function disorders in the unborn child (which may lead to low amniotic fluid levels around the baby) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts, but no adverse effects have been reported in breastfed infants.
Fertility
The effect of the medicinal product on fertility - see section Warnings and precautions.

Driving and using machines

During short-term use and at recommended doses, the medicine does not affect or has a negligible effect on the ability to drive and use machines.

Ibuprom for children contains maltitol liquid, sodium, sodium benzoate (E 211), and benzyl alcohol

Maltitol

The medicine contains maltitol liquid. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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 per 5 ml of suspension. Benzyl alcohol may cause allergic reactions. It should not be given to young children (under 3 years of age) for more than a week without the advice of a doctor or pharmacist. Patients with liver or kidney disease and pregnant or breastfeeding women should consult their doctor, as large amounts of benzyl alcohol may accumulate in their bodies and cause side effects (metabolic acidosis).

Sodium

The medicine contains 17.96 mg of sodium (0.78 mmol) (the main component of common salt) per 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 take Ibuprom for children

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
A dosing device in the form of a syringe with a scale facilitating dosing is attached to the packaging.
The recommended daily dose of Ibuprom for children is 20-30 mg per kilogram of body weight, given in divided doses according to the following scheme:
Infants from 3 to 6 months of age (with a body weight of 5-7.6 kg):3 times 2.5 ml per day
(corresponding to 150 mg of ibuprofen per day).
Infants from 6 to 12 months of age (with a body weight of 7.7-9 kg):3-4 times 2.5 ml per day
(corresponding to 150-200 mg of ibuprofen per day).
Children from 1 to 3 years of age (with a body weight of 10-15 kg):3 times 5 ml per day
(corresponding to 300 mg of ibuprofen per day).
Children from 4 to 6 years of age (with a body weight of 16-20 kg):3 times 7.5 ml per day
(corresponding to 450 mg of ibuprofen per day).
Children from 7 to 9 years of age (with a body weight of 21-29 kg):3 times 10 ml per day
(corresponding to 600 mg of ibuprofen per day).
Children from 10 to 12 years of age (with a body weight of 30-40 kg):3 times 15 ml per day
(corresponding to 900 mg of ibuprofen per day).
The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
A 6- to 8-hour interval should be maintained between doses.

Children under 6 months of age should only be given the medicine after consulting a doctor, and the doctor's advice should be sought if symptoms worsen or do not improve after 24 hours.

If it is necessary to use the medicine in children over 6 months of age for more than 3 days or if the patient's condition worsens, the patient should consult their doctor.
A higher dose of the medicine than recommended should not be used.
The medicine is intended for short-term use only.
Shake before use. The medicine can be taken directly or dissolved in water or juice.
In patients with sensitive stomachs, it is recommended to take the medicine with food or drink milk.

Kidney or liver function disorders

In mild and moderate kidney or liver function disorders, dose reduction is not required (patients with severe kidney or liver failure, see section 2. Important information before taking Ibuprom for children).

Overdose of Ibuprom for children

Overdose symptoms:

If the patient has taken a higher dose of Ibuprom for children than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to assess the potential risk to their health and receive advice on what to do.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, and confusion. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, seizures may occur in patients. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and breathing difficulties may occur.
Treatment of overdose:Treatment is symptomatic and supportive, involving the removal of excess medicine from the body. The doctor will monitor heart function and control vital signs if they are stable. They may consider administering activated charcoal orally within 1 hour of overdose. In the event of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In the case of asthmatic patients, the doctor will administer bronchodilators.

Missed dose of Ibuprom for children

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Ibuprom for children can cause side effects, although not everybody gets them.
The occurrence of side effects can be reduced by using the smallest effective dose for the shortest duration necessary to relieve symptoms. In children, one of the known side effects of NSAIDs may occur. If side effects occur or in case of doubt, the patient should stop taking the medicine and consult their doctor as soon as possible. Elderly people taking this medicine are at a higher risk of experiencing problems related to side effects.

**STOP TAKING THE MEDICINE AND SEEK MEDICAL HELP IMMEDIATELY IF ANY OF THE FOLLOWING SYMPTOMS OCCUR:**

• symptoms of gastrointestinal bleeding, such as: severe stomach pain, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, palpitations, and a drop in blood pressure leading to shock; these symptoms may occur even after the first use of the medicine.

red, scaly, target-like, or circular patches on the torso, often with blisters in the center, peeling 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).

• a widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• a red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If any side effects occur or worsen, or if any side effects not listed in the leaflet occur, the patient should stop taking the medicine and consult their doctor.

Common (affecting 1 to 10 in 100 patients):

• heartburn, stomach pain, nausea, and indigestion, vomiting, bloating with gas, diarrhea, constipation.

Uncommon (affecting 1 to 10 in 1,000 patients):

• gastritis, colitis, worsening of Crohn's disease, headache, dizziness, insomnia, agitation, irritability, fatigue, vision disturbances, stomach ulcers that may bleed or perforate, oral ulcers, and skin swelling and irritation, allergic reactions with rash and itching, asthma attacks (with possible hypotension).

Rare (affecting 1 to 10 in 10,000 patients):

• ringing in the ears (tinnitus).

Very rare (affecting less than 1 in 10,000 patients):

• esophagitis or pancreatitis, intestinal obstruction;
• in exceptional cases, severe skin infections have occurred during chickenpox (chickenpox);
• reduced urine output and swelling (possible acute kidney failure or inflammation that may also be manifested by cloudy urine, blood in the urine, back pain, swelling of the legs, or general malaise);
• problems with blood cell production (first symptoms are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained or atypical bruising);
• psychotic reactions, depression;
• worsening of inflammatory conditions due to infection;
• swelling, high blood pressure, palpitations, heart failure, myocardial infarction;
• liver function disorders or hepatitis that may be manifested by yellowing of the skin and eyes or pale stools and dark urine;
• during ibuprofen use, symptoms of aseptic meningitis have been observed, including stiff neck, headache, malaise, fever, or changes in consciousness. Patients with existing autoimmune diseases (SLE, mixed connective tissue disease) are more likely to experience side effects. The patient should consult their doctor immediately if these 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 side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should consult their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 gather more information on the safety of the medicine.

5. How to store Ibuprom for children

The medicine should be stored out of sight and reach of children.
Once opened, the packaging should be used within 6 months.
After the first opening, the medicine should be stored at a temperature below 25°C.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprom for children contains

• The active substance of the medicine 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, maltitol liquid, glycerol, strawberry flavor (contains substances identical to natural flavors, natural flavors, maltodextrin, triethyl citrate, propylene glycol, and benzyl alcohol), purified water.

What Ibuprom for children looks like and contents of the pack

Thick, almost white suspension.
Packaging: 100 ml, 150 ml, or 200 ml bottle. A dosing device in the form of a syringe is attached to the packaging. Not all pack sizes may be marketed.

Marketing authorization 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, Netherlands
Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117
Villamarchante, Valencia, 46191, Spain
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: