Ibufen® for children raspberry

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IBUFEN® for children, raspberry (IBUFEN for children, raspberry)

Composition:

Active ingredient: ibuprofenum;

5 ml of suspension contain 100 mg of ibuprofen;

Excipients: hypromellose, xanthan gum, glycerin, sodium benzoate (E 211), maltitol liquid, sodium citrate, citric acid monohydrate, sodium saccharin, sodium chloride, raspberry flavor, purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: a homogeneous white or almost white suspension with uniform opalescence and raspberry odor.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory and antirheumatic agents. Propionic acid derivatives. ATC code M01AE01.

Pharmacological Properties

Pharmacodynamics

Ibufen® for children, raspberry has antipyretic, analgesic, and anti-inflammatory effects.

The antipyretic mechanism is achieved through both central and peripheral components. The action of Ibufen® for children, raspberry involves inhibition of cyclooxygenase of arachidonic acid in the central nervous system (CNS), leading to reduced synthesis of prostaglandins and subsequent normalization of body temperature. The peripheral component of the antipyretic effect of Ibufen® for children, raspberry is due to inhibition of prostaglandin production in damaged tissues, thereby reducing inflammatory activity.

The effect of lowering body temperature begins as early as 30 minutes after administration, with maximum effect observed within 3 hours.

Antipyretic and analgesic effects manifest earlier and at lower doses than anti-inflammatory effects. Ibuprofen inhibits platelet aggregation.

Experimental data indicate that concomitant use of ibuprofen and low-dose acetylsalicylic acid may inhibit platelet aggregation. Some pharmacodynamic studies have shown that administration of single 400 mg doses of ibuprofen 8 hours before or within 30 minutes after immediate-release acetylsalicylic acid (81 mg) reduced the effect of acetylsalicylic acid on platelet aggregation or thromboxane production. Although uncertainty remains regarding extrapolation of these data to clinical settings, the possibility that chronic, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.

Pharmacokinetics

After oral administration, more than 80% of ibuprofen is absorbed in the gastrointestinal tract, reaching peak plasma concentration within 1–2 hours. It binds to plasma proteins (primarily albumins) by more than 90%. The drug slowly penetrates into the joint cavity. Maximum concentration in synovial fluid is observed 5–6 hours after oral administration.

Ibuprofen is metabolized mainly in the liver into two inactive metabolites, which are rapidly and almost completely excreted by the kidneys.

It does not accumulate in the body. 60–90% is excreted in urine as metabolites and their conjugates with glucuronic acid. A small amount (10%) is excreted unchanged. The elimination half-life is 2 hours. After a single dose, the drug is completely eliminated within 24 hours.

Renal impairment.

Since ibuprofen and its metabolites are primarily excreted by the kidneys, the pharmacokinetics of the drug may be altered in patients with varying degrees of renal impairment. In patients with impaired renal function, lower plasma protein binding, higher total plasma levels of ibuprofen and unbound (S)-ibuprofen, increased AUC values for (S)-ibuprofen, and elevated enantiomeric AUC (S/R) ratios have been observed compared to healthy control volunteers. In patients with end-stage renal disease undergoing dialysis, the mean fractional excretion of ibuprofen was approximately 3%, compared to 1% in healthy volunteers. Severe renal dysfunction may lead to accumulation of ibuprofen metabolites. The clinical significance of this effect is unknown. Metabolites may be removed by hemodialysis.

Hepatic impairment.

Alcoholic liver disease with mild to moderate hepatic dysfunction did not result in significant changes in pharmacokinetic parameters. Liver disease may alter the distribution kinetics of ibuprofen. In patients with cirrhosis and moderate hepatic impairment (Child–Pugh class 6–10), an approximately two-fold increase in elimination half-life was observed, and the enantiomeric AUC (S/R) ratio was significantly lower compared to healthy control volunteers, indicating impaired metabolic inversion of (R)-ibuprofen to the active (S)-enantiomer.

Clinical characteristics.

Indications.

Symptomatic treatment of fever and pain of various origins in children aged from 3 months to 12 years with body weight of at least 5 kg (including fever after immunization, acute respiratory viral infections, influenza, teething pain, pain after tooth extraction, toothache, headache, sore throat, pain due to ligament sprain, and other types of pain, including those of inflammatory origin).

Contraindications.

• Hypersensitivity to ibuprofen or to any of the excipients of the medicinal product;
• History of hypersensitivity reactions (e.g., bronchospasm, bronchial asthma, rhinitis, angioedema or urticaria) following administration of ibuprofen, acetylsalicylic acid, or other NSAIDs;
• Active peptic ulcer or gastrointestinal bleeding, or history of recurrent episodes (two or more confirmed episodes of peptic ulcer or bleeding);
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy;
• Severe hepatic impairment, severe renal impairment, or severe heart failure (NYHA functional class IV);
• Severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake);
• Third trimester of pregnancy;
• Cerebrovascular or other hemorrhages;
• Hemorrhagic diathesis, bleeding disorders of unknown etiology, or coagulation disorders.

Interaction with other medicinal products and other forms of interaction.

Ibuprofen (like other nonsteroidal anti-inflammatory drugs (NSAIDs)) must not be used concomitantly with:

• acetylsalicylic acid or other NSAIDs: due to the high risk of adverse reactions, except when low-dose acetylsalicylic acid (not exceeding 75 mg per day) has been prescribed by a physician. Experimental data indicate that concomitant use of ibuprofen may inhibit the antiplatelet effect of low-dose acetylsalicylic acid. However, the limited nature of these data and uncertainty regarding extrapolation of ex vivo findings to clinical outcomes do not allow definitive conclusions regarding the systematic use of ibuprofen. Therefore, clinically significant effects are considered unlikely with occasional use of ibuprofen;
• other NSAIDs, including selective cyclooxygenase-2 inhibitors: concomitant use of two or more NSAIDs should be avoided, as this may increase the risk of adverse effects.

Ibuprofen should be used with caution in combination with the following medicinal products:

• anticoagulants: NSAIDs may enhance the therapeutic effect of anticoagulants such as warfarin;
• antihypertensive agents (ACE inhibitors and angiotensin II antagonists,
  beta-blockers): NSAIDs may reduce the efficacy of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g., dehydrated patients or elderly patients with compromised kidney function), concomitant use of ACE inhibitors or angiotensin II antagonists, beta-blockers, and cyclooxygenase-inhibiting agents may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such combinations should be prescribed with caution, especially in elderly patients. In cases of prolonged treatment, adequate hydration should be ensured and monitoring of renal function should be considered at the start of combination therapy and periodically thereafter;
• corticosteroids: increased risk of gastrointestinal adverse reactions;
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal bleeding;
• cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of glycosides;
• pentoxifylline: in patients receiving ibuprofen in combination with pentoxifylline, there may be an increased risk of hemorrhage; therefore, bleeding time should be monitored;
• lithium: data indicate that NSAIDs may increase lithium levels. With proper use (maximum duration of 4 days), serum lithium monitoring is generally not required;
• methotrexate at doses of 15 mg/week or higher: concomitant use of NSAIDs within 24 hours before or after methotrexate administration may lead to increased plasma methotrexate concentrations (likely due to reduced renal clearance of methotrexate caused by NSAIDs) and subsequent increase in its toxic effects. Therefore, ibuprofen should be avoided in patients receiving high-dose methotrexate;
• methotrexate at doses below 15 mg/week: ibuprofen increases methotrexate levels. When ibuprofen is used concomitantly with low-dose methotrexate, careful monitoring of the patient's blood count is required, especially during the first weeks of concomitant therapy. Monitoring should be intensified in cases of worsening renal function, even minimal, and in elderly patients, and renal function should be monitored to prevent possible reduction in methotrexate clearance;
• cyclosporine and tacrolimus: increased risk of nephrotoxicity may occur when NSAIDs are used concomitantly due to reduced renal prostaglandin synthesis. Renal function should be closely monitored when these drugs are used together with NSAIDs;
• mifepristone: NSAIDs should not be used earlier than 8–12 days after mifepristone administration, as they reduce its efficacy;
• sulfonylurea agents: interactions between NSAIDs and hypoglycemic agents (sulfonylureas) have been observed. NSAIDs may enhance the hypoglycemic effect of sulfonylureas by displacing them from plasma protein binding sites; therefore, blood glucose levels should be monitored when sulfonylureas are used concomitantly with ibuprofen;
• probenecid and sulfinpyrazone: medicinal products containing probenecid or sulfinpyrazone may delay the elimination of ibuprofen;
• baclofen: baclofen toxicity may develop after initiation of ibuprofen therapy;
• ritonavir: ritonavir may increase plasma concentrations of NSAIDs;
• aminoglycosides: NSAIDs may reduce aminoglycoside excretion;
• captopril: experimental studies have shown that ibuprofen inhibits captopril's sodium-excreting effect;
• voriconazole and fluconazole (CYP2C9 inhibitors): dose reduction of ibuprofen should be considered when used concomitantly with potent CYP2C9 inhibitors, especially when high doses of ibuprofen are administered. Studies with voriconazole and fluconazole (CYP2C9 inhibitors) have shown an approximately 80–100% increase in S(+)-ibuprofen exposure;
• cholestyramine: concomitant use of cholestyramine and ibuprofen delays and reduces ibuprofen absorption by 25%. Ibuprofen should be administered with a several-hour interval;
• zidovudine: increased risk of hematologic toxicity is known with concomitant use of zidovudine and NSAIDs. Evidence suggests an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia receiving concomitant zidovudine and ibuprofen therapy;
• quinolone antibiotics: concomitant use with ibuprofen may increase the risk of seizures;
• phenytoin: ibuprofen may increase the level of pharmacologically active free phenytoin;
• herbal extracts: Ginkgo biloba, when used concomitantly with NSAIDs, may potentiate the risk of bleeding;
• hydantoins and sulfonamides: increased toxicity of these medicinal products may occur. Plasma phenytoin levels may increase during concomitant ibuprofen therapy;
• thiazides, thiazide-like agents, loop diuretics, and potassium-sparing diuretics: NSAIDs may counteract the diuretic effect of these agents. Concomitant use of NSAIDs and diuretics may increase the risk of NSAID-induced nephrotoxicity (e.g., in dehydrated patients or elderly patients with impaired renal function) due to deterioration of renal blood flow. Therefore, such combinations should be used with caution, especially in elderly patients. Patients should maintain adequate fluid intake, and renal function should be monitored after initiation of concomitant therapy and periodically thereafter. As with other NSAIDs, concomitant use of potassium-sparing diuretics may be associated with elevated potassium levels; therefore, plasma potassium levels should be monitored.

Special precautions for use.

The frequency and intensity of adverse reactions can be minimized by using the lowest effective dose and for the shortest duration necessary.

Elderly individuals have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforations, which can be fatal. In elderly patients, there is an increased risk of adverse reaction outcomes. Long-term use of NSAIDs is not recommended in elderly individuals. If long-term therapy is necessary, patients should be monitored regularly.

Respiratory system effects.

Bronchospasm may occur in patients with a history of bronchial asthma or allergy.

Other NSAIDs.

Concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of adverse reactions and should therefore be avoided. Like other NSAIDs, ibuprofen may cause allergic reactions, such as anaphylactic/anaphylactoid reactions, even when the drug is used for the first time.

Systemic lupus erythematosus and mixed connective tissue diseases.

Ibuprofen should be used with caution in patients with systemic lupus erythematosus and mixed connective tissue diseases due to an increased risk of aseptic meningitis.

Cardiovascular and cerebrovascular effects.

Patients with arterial hypertension and/or a history of moderate to severe congestive heart failure should begin long-term treatment with caution (medical consultation is required), as fluid retention, arterial hypertension, and edema have been reported during therapy with ibuprofen and other NSAIDs.

Clinical trial data and epidemiological evidence suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and with prolonged treatment, may lead to a slight increase in the risk of arterial thrombotic complications (e.g., myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen (e.g., ≤1200 mg per day) increases the risk of myocardial infarction.

Long-term treatment may be prescribed to patients with uncontrolled arterial hypertension, congestive heart failure (NYHA II–III), diagnosed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease only after careful assessment of risk factors. Long-term NSAID therapy should be prescribed to patients with significant cardiovascular risk factors (such as arterial hypertension, hyperlipidemia, diabetes, smoking) only after careful consideration, and high-dose ibuprofen (2400 mg per day) should be avoided.

Cases of Kounis syndrome have been reported in patients receiving ibuprofen treatment. Kounis syndrome presents with cardiovascular symptoms associated with coronary artery spasm due to allergy or hypersensitivity reaction, which may lead to myocardial infarction.

Effects on kidneys and liver.

Caution should be exercised in patients with renal impairment due to the potential for worsening renal function. Ibuprofen should be used with caution in patients with kidney or liver disease, especially during concomitant diuretic therapy, as prostaglandin inhibition may lead to fluid retention and further deterioration of renal function. Such patients should receive the lowest possible dose of ibuprofen and have renal function monitored regularly. In cases of dehydration, adequate fluid intake should be ensured. There is a risk of renal failure in dehydrated children and adolescents.

Generally, chronic use of analgesics, especially combinations of different painkillers, may lead to chronic kidney injury with a risk of renal failure (analgesic nephropathy). The highest risk of this reaction occurs in elderly patients, patients with renal, cardiac, or hepatic impairment, and in those receiving diuretic or ACE inhibitor therapy. After discontinuation of NSAID therapy, renal function usually returns to the pre-treatment state.

Liver function impairment is possible. Like other NSAIDs, ibuprofen may cause transient increases in certain liver function parameters, as well as significant increases in AST and ALT levels. If substantial increases in these parameters occur, treatment should be discontinued.

Gastrointestinal tract effects.

NSAIDs should be used with caution in patients with chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease), as these conditions may worsen. Such patients should consult a physician.

Cases of gastrointestinal bleeding, perforation, and ulcers, potentially fatal, have been reported, occurring at any stage of NSAID treatment, regardless of the presence of warning symptoms or prior severe gastrointestinal disorders.

The risk of gastrointestinal bleeding, perforation, and ulcers increases with higher NSAID doses, in patients with a history of peptic ulcer, especially if complicated by bleeding or perforation, and in elderly patients. Such patients should start treatment with the lowest possible doses. Caution should be exercised when treating patients receiving concomitant medications that may increase the risk of gastotoxicity or bleeding, such as oral corticosteroids or anticoagulants (e.g., warfarin) or antiplatelet agents (e.g., acetylsalicylic acid). For long-term treatment in these patients, as well as in patients requiring concomitant low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combined therapy with misoprostol or proton pump inhibitors should be considered.

Patients with a history of gastrointestinal disorders, particularly elderly patients, should be informed about any unusual gastrointestinal symptoms (especially bleeding), particularly gastrointestinal bleeding at the beginning of treatment. If gastrointestinal bleeding or ulcers occur in patients receiving ibuprofen, treatment should be discontinued immediately.

Effects on female fertility.

Limited data suggest that drugs inhibiting cyclooxygenase/prostaglandin synthesis may affect ovulation. This effect is reversible upon discontinuation of treatment.

Skin and subcutaneous tissue.

Severe cutaneous adverse reactions (SCARs).

Severe cutaneous adverse reactions (SCARs) associated with ibuprofen use have been reported, including exfoliative dermatitis, erythema multiforme, Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening or fatal (see section "Adverse reactions"). Most of these reactions occurred within the first month of treatment.

If signs or symptoms indicating these reactions appear, ibuprofen should be discontinued immediately and alternative treatment considered (if necessary).

In rare cases, chickenpox may lead to severe skin and soft tissue infections. The potential influence of NSAIDs on worsening the course of these infections cannot be excluded; therefore, it is recommended to avoid the use of ibuprofen in cases of chickenpox.

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) are observed. At the first signs of hypersensitivity after ibuprofen administration, treatment should be discontinued and immediate medical attention sought.

Ibuprofen may temporarily inhibit platelet aggregation. Therefore, careful monitoring is recommended in patients with coagulation disorders.

With prolonged use of ibuprofen, liver function tests, renal function, and hematological parameters/blood counts should be monitored regularly.

Prolonged use of any analgesic for headache treatment may worsen this condition. In such cases, medical advice should be sought and treatment discontinued. Medication-overuse headache should be considered in patients suffering from frequent or daily headaches despite regular use of headache medications.

Concomitant alcohol consumption and NSAID use may intensify adverse reactions related to the active substance, particularly those affecting the gastrointestinal tract or central nervous system.

NSAIDs may mask symptoms of infection and fever.

Masking symptoms of underlying infections: ibuprofen may mask symptoms of infectious disease, potentially delaying the initiation of appropriate treatment and thereby complicating the disease course. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When ibuprofen is used for fever or pain relief during infection, monitoring of the infectious disease is recommended. In outpatient settings, patients should consult a physician if symptoms persist or worsen.

The medicinal product contains liquid maltitol and therefore should not be administered to patients with rare hereditary fructose intolerance. Due to the presence of liquid maltitol, this medicinal product may have a mild laxative effect.

The product contains sodium benzoate and may therefore cause allergic reactions (possibly delayed).

The product must not be administered to patients with rare hereditary fructose intolerance.

This medicinal product contains 1.89 mg/1 ml of sodium (9.44 mg/5 ml). Caution is advised when administering to patients on a sodium-restricted diet.

Adults should consult a physician before taking this medicinal product in the following cases: if the patient is pregnant or trying to become pregnant, if the patient is elderly, or if the patient smokes.

Effects on laboratory test results:

• Bleeding time may be prolonged up to one day after discontinuation of treatment;
• Blood glucose concentration may decrease;
• Creatinine clearance may decrease;
• Hematocrit or hemoglobin may decrease;
• Blood urea nitrogen concentration, serum creatinine, and potassium concentrations may increase;
• Liver function parameters: increased transaminase levels.

Use during pregnancy or breastfeeding.

The product is indicated for use in children under 12 years of age.

Pregnancy.

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological data indicate an increased risk of miscarriage and congenital malformations following use of prostaglandin synthesis inhibitors in early pregnancy. The risk is considered to increase with higher doses and longer duration of treatment. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk increases with higher doses and longer duration of treatment.

From the 20th week of pregnancy, use of "Ibufen® for children, raspberry" may cause oligohydramnios due to fetal renal dysfunction. Renal dysfunction may occur almost immediately after starting treatment and is usually reversible upon discontinuation of ibuprofen therapy. Additionally, arterial duct constriction has been reported after second-trimester treatment, which resolved after discontinuation of treatment. Therefore, ibuprofen should not be taken during the first two trimesters of pregnancy unless, in the physician’s opinion, the expected benefit to the patient outweighs the potential risk to the fetus. If ibuprofen is used by a woman trying to conceive or during the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. Antenatal monitoring for oligohydramnios and arterial duct constriction may be advisable after ibuprofen use for several days starting from the 20th week of pregnancy. Ibuprofen should be discontinued if signs of oligohydramnios or arterial duct constriction are detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose the following risks:

to the fetus: cardiopulmonary toxicity (characterized by premature constriction/closure of the arterial duct and pulmonary hypertension); renal dysfunction, which may progress to renal failure associated with oligohydramnios (see above);

to the mother near term and the newborn: prolonged bleeding time, antiplatelet effect that may develop even at very low doses; inhibition of uterine contractions, leading to delayed or prolonged labor.

Increased risk of edema formation in the mother is possible.

Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.

Breastfeeding period. Ibuprofen and its metabolites are excreted in breast milk in low concentrations. No adverse effects on the infant are currently known; therefore, breastfeeding usually does not need to be discontinued during short-term treatment of pain and fever at recommended doses.

Fertility.

Data indicate that drugs inhibiting cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.

The use of ibuprofen is not recommended in women attempting to conceive. For women experiencing infertility or undergoing fertility investigations, discontinuation of this medicinal product should be considered.

Ability to affect reaction speed when driving or operating machinery.

The product is indicated for use in children under 12 years of age.

When used according to recommended doses and treatment duration, the product is not expected to affect the ability to drive or operate machinery.

Dosage and Administration

Adverse effects can be minimized by using the lowest effective dose required to control symptoms, for the shortest possible duration.

For oral use. 5 ml of suspension contains 100 mg of ibuprofen.

Shake well before use to obtain a homogeneous suspension.

Take the medicine after food, with plenty of liquid.

The dosing syringe with a measuring scale supplied in the package enables accurate dosing of the medicine.

After use, the parts of the dosing syringe should be thoroughly rinsed with warm water.

The recommended daily dose is 20–30 mg per kg of body weight, divided into equal doses according to age and body weight, with intervals of 6–8 hours between doses. The recommended dose should not be exceeded. For short-term use only.

Age	Body weight (kg)	Recommended dose
3–6 months	5–7.6	2.5 ml of suspension (50 mg) not more than 3 times a day.
6–12 months	7.7–9	2.5 ml of suspension (50 mg) not more than 3–4 times a day.
1–3 years	10–16	5 ml of suspension (100 mg) not more than 3 times a day.
4–6 years	17–20	7.5 ml of suspension (150 mg) not more than 3 times a day.
7–9 years	21–30	10 ml of suspension (200 mg) not more than 3 times a day.
10–12 years	31–40	15 ml of suspension (300 mg) not more than 3 times a day.

Do not use in children under 3 months of age unless directed by a physician.

Do not use this medicinal product in children weighing less than 5 kg.

For children aged 3 to 6 months: if symptoms persist for longer than 24 hours after starting treatment or worsen (after 3 doses), consult a doctor immediately.

For children aged 6 months to 12 years: if symptoms persist for more than 3 days after starting treatment or worsen, consult a physician.

For fever following immunization (children aged 3–6 months), the recommended daily dose is 2.5 mL of suspension (50 mg), and if necessary, another 2.5 mL of suspension (50 mg) after 6 hours, but not more than 5 mL of suspension (100 mg) within 24 hours. If symptoms persist, consult a doctor.

Special patient groups.

Renal impairment: dose adjustment is not required in patients with mild to moderate renal dysfunction (for patients with severe renal impairment, see section "Contraindications").

Hepatic impairment: dose adjustment is not required in patients with mild to moderate hepatic dysfunction (for patients with severe hepatic impairment, see section "Contraindications").

In case of overdose, seek immediate medical advice.

Instructions for using the dosing syringe.

1. Unscrew the cap on the bottle (press down and turn counterclockwise).
2. Firmly insert the dosing syringe into the neck opening of the bottle.
3. Shake the bottle vigorously.
4. To fill the syringe, turn the bottle upside down, then slowly pull the plunger of the dosing syringe downward to draw the suspension up to the desired mark on the scale.
5. Turn the bottle back to its original position and carefully remove the dosing syringe by gently twisting it out.
6. Place the tip of the dosing syringe into the child's mouth, then slowly press the plunger to administer the dose.
7. After use, close the bottle by replacing and screwing on the cap, then rinse the dosing syringe with water and dry it.

Children.

The product is intended for use in children aged 3 months to 12 years weighing at least 5 kg.

Overdose.

When using Ibufen® for children at recommended doses, the risk of overdose is negligible. Serious complications related to toxic effects occur only after ingestion of doses exceeding 400 mg/kg body weight (i.e., 80 recommended single doses). The elimination half-life in overdose is 1.5–3 hours.

Symptoms. In most patients participating in clinical trials, ingestion of large amounts of NSAIDs caused only nausea, vomiting, epigastric pain, and less frequently, diarrhea. Tinnitus, headache, dizziness, and gastrointestinal bleeding may also occur. In more severe poisoning, toxic effects on the central nervous system may develop, manifesting as drowsiness, nystagmus, visual disturbances, and occasionally agitation, disorientation, or coma. Seizures may sometimes occur. In severe poisoning, hyperkalemia and metabolic acidosis may develop, along with prolonged prothrombin time/INR (likely due to interaction with circulating coagulation factors), acute renal failure, liver damage, arterial hypotension, respiratory depression, and cyanosis. In patients with bronchial asthma, asthma exacerbation may occur.

Management of overdose: There is no specific antidote.

Treatment should be symptomatic and supportive, including maintaining airway patency and monitoring vital signs until stabilization. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour after ingestion of a potentially toxic dose. If ibuprofen has already been absorbed, alkaline agents may be administered to enhance urinary excretion of the acidic ibuprofen. In cases of frequent or prolonged muscle spasms, treatment with intravenous diazepam or lorazepam is recommended. In cases of bronchial asthma, bronchodilators should be used. Seek immediate medical assistance.

Adverse Reactions

The most commonly observed adverse reactions are gastrointestinal and are mostly dose-dependent. Adverse reactions are rarely observed when the maximum daily dose is 1200 mg.

The adverse reactions reported during the use of ibuprofen are listed below by organ system and frequency of occurrence. The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), frequency not known (cannot be estimated from available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.

Infections and infestations

Very rare: Exacerbation of inflammation associated with infection (e.g., development of necrotizing fasciitis; in exceptional cases, chickenpox may lead to severe skin and soft tissue infections).

Blood and lymphatic system disorders

Very rare: Blood dyscrasias (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms: fever, sore throat, oral ulceration, influenza-like symptoms, severe exhaustion, epistaxis, skin bleeding, and bruising.

Immune system disorders

Hypersensitivity reactions¹; uncommon: urticaria, pruritus.

Very rare: Severe hypersensitivity reactions, symptoms of which may include facial, tongue, or laryngeal swelling, dyspnea, tachycardia, hypotension (anaphylactic reaction, angioedema, or shock, asthma exacerbation).

Nervous system disorders

Uncommon: Headache, dizziness, insomnia, restlessness, irritability, or fatigue.

Very rare: Aseptic meningitis².

Cardiac disorders

Very rare: Heart failure, tachycardia, edema, myocardial infarction.

Frequency not known: Kounis syndrome.

Vascular disorders

Very rare: Arterial hypertension, vasculitis.

Gastrointestinal disorders

Common: Abdominal pain, nausea, dyspepsia, diarrhea, flatulence, constipation, heartburn, vomiting, and minor gastrointestinal blood loss, which in exceptional cases may lead to anemia.

Uncommon: Gastric and/or duodenal ulcer, gastrointestinal perforation or hemorrhage, melena, hematemesis, sometimes fatal (especially in elderly patients), ulcerative stomatitis, gastritis, exacerbation of colitis, Crohn's disease.

Very rare: Esophagitis, formation of diaphragm-like intestinal strictures, pancreatitis.

Hepatic disorders

Very rare: Liver function abnormalities, hepatic injury, particularly with prolonged use, liver failure, acute hepatitis.

Skin and subcutaneous tissue disorders

Uncommon: Various skin rashes¹.

Very rare: Severe cutaneous adverse reactions (SCARs) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)¹, alopecia.

Frequency not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), photosensitivity reactions.

Respiratory, thoracic and mediastinal disorders

Frequency not known: Respiratory tract reactivity, including asthma, bronchospasm, or dyspnea¹.

Renal and urinary disorders

Rare: Acute renal function impairment, particularly with long-term use of NSAIDs, associated with increased plasma urea levels, papillary necrosis.

Very rare: Edema formation, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure.

Investigations

Rare: Decreased hemoglobin levels.

Psychiatric disorders

Very rare: Psychotic reactions, depression; with prolonged use: hallucinations, confusion.

Eye disorders

Frequency not known: With prolonged treatment, visual disturbances, optic neuritis may occur.

Ear and labyrinth disorders

Rare: Tinnitus.

General disorders

Frequency not known: Malaise and fatigue.

Description of selected adverse reactions

¹ Reports exist of hypersensitivity reactions following ibuprofen treatment. These include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactions, including bronchial asthma, asthma exacerbation, bronchospasm, or dyspnea, or (c) various skin disorders, including rashes of different types, pruritus, urticaria, purpura, angioedema, and less frequently, exfoliative and bullous dermatoses (including epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme).

² The pathogenic mechanism of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis associated with NSAID use suggest a hypersensitivity reaction (based on temporal association with drug intake and resolution of symptoms after drug discontinuation). In particular, isolated cases of aseptic meningitis symptoms (such as nuchal rigidity, headache, nausea, vomiting, fever, or disorientation) have been observed during ibuprofen treatment in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus or mixed connective tissue disease).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life

2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

After opening the bottle, store with tightly closed cap and use within 6 months.

Packaging

100 ml in a plastic (PET) bottle with a polyethylene adapter, closed with a screw cap with a tamper-evident ring and a "child-resistant" closure system.

1 bottle with a dosing syringe in a cardboard box.

Prescription status

Over-the-counter (without prescription).

Manufacturer

Pharmaceutical Works POLPHARMA S.A.

Manufacturer's address and place of business

Medana Branch in Sieradz, 10 Wladyslawa Lokietka Str., 98-200 Sieradz, Poland