Ibuprom dla dzieci forte

Leaflet attached to the packaging: patient information

Ibuprom for children Forte, 40 mg/ml, oral suspension

Ibuprofen

Read the leaflet carefully before taking 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 a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a doctor or pharmacist.
• 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.
• Children under 6 months of age should only be given the medicine after consulting 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 of the leaflet:

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

1. What is Ibuprom for children Forte 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). This 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 Forte

When not to take Ibuprom for children Forte:

• 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 (from the NSAID group),
• in patients who have experienced allergic symptoms in the past after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• 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),
• during the last three months of pregnancy,
• in patients with bleeding disorders.

Warnings and precautions

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

• systemic 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 function disorders,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders,
• active or recurrent asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur,
• congenital fructose intolerance (due to the possibility of maltitol, one of the medicine's excipients, being converted to 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 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. Concurrent and prolonged use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). Taking ibuprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. 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, consult a doctor. 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 been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should discontinue Ibuprom for children Forte and seek medical attention immediately. Taking anti-inflammatory/painkillers, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose and duration of treatment. During ibuprofen use, symptoms of allergic reactions to this medicine have been reported, including difficulty breathing, facial and neck edema (angioedema), and chest pain. If any of these symptoms are observed, the patient should discontinue Ibuprom for children Forte and seek medical attention immediately. Before taking Ibuprom for children Forte, the patient should discuss their treatment with their doctor or pharmacist if:

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

Infections. Ibuprom for children Forte may mask the symptoms of an infection, such as fever and pain. Therefore, Ibuprom for children Forte may delay the use of appropriate infection treatment and consequently 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 during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately. This 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. Consult a doctor even if the above warnings refer to past situations.

Ibuprom for children Forte and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. Ibuprom for children Forte may affect the action of other medicines or other medicines may affect the action of Ibuprom for children Forte. Such medicines include, for example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine) - the risk of bleeding may increase,
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, diuretics, such as indapamide) - their effect may be weakened 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 joint bleeding 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.

Also, some other medicines may be affected or have an effect on treatment with Ibuprom for children Forte. Therefore, before taking Ibuprom for children Forte with other medicines, always consult a doctor or pharmacist.

Ibuprom for children Forte 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. Do not take Ibuprom for children Forte if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprom for children Forte may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in the patient and the child and cause delayed or prolonged labor. During the first six months of pregnancy, do not take Ibuprom for children Forte unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. From the 20th week of pregnancy, Ibuprom for children Forte, if taken for more than a few days, may cause kidney function disorders in the unborn child (which can lead to a low level of amniotic fluid surrounding the child) or narrowing of the arterial duct in the child'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 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 some sugars, they should consult their 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 give to small children (under 3 years of age) for more than a week without consulting a doctor or pharmacist. Patients with liver or kidney diseases and pregnant or breastfeeding women should consult their doctor, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Sodium

The medicine contains 28.95 mg of sodium (1.26 mmol) (the main component of common salt) in 5 ml of suspension. This corresponds to 1.45% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Ibuprom for children Forte

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, consult a 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 Forte is from 20 mg to 30 mg per kilogram of body weight, given in divided doses. The dosing schedule using the attached dosing device can be achieved as follows: Infants weighing 5-7 kg (aged 3-5 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 6-12 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 1-3 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 4-5 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 6-8 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 9-11 years):3 times 6-8 ml per day (corresponding to approximately 720-960 mg of ibuprofen per day). In the above dosing schedule, a smaller volume of the medicine corresponds to a lower body weight and, conversely, a larger volume of the medicine corresponds to a higher body weight. The age ranges are approximate. Adults and adolescents over 12 years of age:the recommended dose for symptomatic relief of pain and fever is 3 times 10 ml per day, until symptoms resolve. 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, consult a doctor immediately (see section 2). Maintain an interval of 6 to 8 hours between doses.

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

If children over 6 months of age need to take the medicine for more than 3 days or if their condition worsens, they should consult a doctor. Do not exceed the recommended dose of the medicine. 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 gastrointestinal tracts, 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 Forte).

Taking a higher dose of Ibuprom for children Forte than recommended

Overdose symptoms:

If the patient has taken a higher dose of Ibuprom for children Forte than recommended or if a child has accidentally taken the medicine, they should always consult a 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, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, there may be an increased prothrombin time/INR, probably due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, there may be low blood pressure and difficulty breathing.

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 case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In case of asthma, the doctor will administer bronchodilators.

Missing a dose of Ibuprom for children Forte

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 minimized 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 worsen, or if you have any doubts, stop taking the medicine and consult a doctor as soon as possible. Elderly people taking this medicine are at increased risk of side effects.

STOP TAKING THE MEDICINE AND SEEK MEDICAL ATTENTION 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, rapid heartbeat, and a drop in blood pressure leading to shock; these symptoms may occur even after the first use of the medicine.
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the 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).
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• red, peeling 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 effect occurs or worsens, or if any side effects not mentioned in the leaflet occur, stop taking the medicine and consult a doctor.

Common (affects 1 to 10 people in 100):

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

Uncommon (affects 1 to 10 people in 1,000):

• 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 (or) swelling and irritation of the skin; allergic reactions with rash and itching, asthma attacks (with possible drop in blood pressure).

Rare (affects 1 to 10 people in 10,000):

• ringing in the ears (tinnitus).

Very rare (affects less than 1 in 10,000 people):

• 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);
• blood disorders (first symptoms are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained or unusual bruising);
• psychotic reactions, depression;
• worsening of inflammatory conditions due to infection;
• swelling, high blood pressure, rapid heartbeat, heart failure, heart attack;
• liver function disorders or hepatitis, which may be manifested by yellowing of the skin and eyes or pale stools and dark urine;
• aseptic meningitis has been observed with ibuprofen use, accompanied by neck stiffness, headache, malaise, and changes in consciousness. Patients with pre-existing autoimmune diseases (SLE, mixed connective tissue disease) are more likely to experience side effects. Consult a doctor immediately if they occur.

Taking ibuprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Side effects with unknown frequency:(frequency cannot be estimated from available data):

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

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, consult a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprom for children Forte

Keep the medicine out of the sight and reach of children. Once opened, the packaging should be used within 6 months. After the 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 month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ibuprom for children Forte contains

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

What Ibuprom for children Forte looks like and what the packaging contains

Thick, almost white suspension. Packaging: 30 ml, 100 ml, 150 ml, or 200 ml bottle. A dosing device in the form of a syringe facilitating dosing 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 For more detailed information on this medicine, please 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: