Instructions Nurofen for children rectal suppositories 60 mg blister No. 10
Composition
active ingredient: ibuprofen;
1 suppository contains 60 mg of ibuprofen;
excipient: solid fat.
Dosage form
Suppositories.
Main physicochemical properties: torpedo-shaped, smooth suppositories of white or almost white color.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. ATC code M01A E01
Pharmacological properties
Pharmacodynamics. The mechanism of action is to inhibit the synthesis of prostaglandins - mediators of pain, inflammation and temperature reactions. The drug has analgesic, anti-inflammatory and antipyretic effects. In addition, ibuprofen inhibits platelet aggregation.
The clinical efficacy of ibuprofen has been demonstrated in the treatment of mild to moderate pain, such as teething pain and toothache, headache, earache, sore throat, postoperative pain, soft tissue injuries and fever, including fever following vaccination, as well as pain and fever associated with colds and flu.
Pharmacokinetics. After rectal administration, ibuprofen is rapidly and almost completely absorbed, with peak plasma concentrations occurring within 45 minutes. Ibuprofen binds to plasma proteins and penetrates into the synovial fluid. Ibuprofen is metabolized in the liver to two inactive metabolites, which are rapidly and almost completely excreted by the kidneys. Some is excreted unchanged. The half-life is 2 hours.
Indication
For the symptomatic treatment of mild to moderate pain. For the symptomatic treatment of fever. Nurofen® for Children, suppositories, is recommended when oral administration is not possible, for example in case of vomiting.
Contraindication
Hypersensitivity to ibuprofen or other NSAIDs or to any of the excipients.
History of hypersensitivity reactions (e.g. bronchospasm, angioedema, bronchial asthma, rhinitis or urticaria) after taking acetylsalicylic acid (aspirin), ibuprofen or other NSAIDs.
Active or recurrent gastric ulcer/bleeding (two or more severe episodes of confirmed ulcer or bleeding).
History of gastrointestinal bleeding or perforation associated with NSAID use.
Severe liver failure, severe kidney failure or severe heart failure.
Severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
The last trimester of pregnancy.
Cerebrovascular or other bleeding in the active phase.
Hematopoietic disorders of unknown etiology.
Contraindicated in children weighing less than 6 kg and under 3 months of age.
Interaction with other medicinal products and other types of interactions
Ibuprofen, like other NSAIDs, should not be used in combination with:
acetylsalicylic acid (aspirin), as this may increase the risk of adverse reactions, unless a doctor prescribes low-dose acetylsalicylic acid according to clinical standards.
Experimental data suggest that ibuprofen may inhibit the antiplatelet effect of low-dose aspirin when used concomitantly. However, the limited data and uncertainty regarding the extrapolation of ex vivo data to clinical practice preclude firm conclusions regarding the routine use of ibuprofen. Therefore, such clinically significant effects are considered unlikely with non-routine use of ibuprofen.
other NSAIDs, including selective cyclooxygenase-2 inhibitors. The simultaneous use of two or more NSAIDs should be avoided, as this may increase the risk of side effects.
Ibuprofen (like other NSAIDs) should be used with caution in combination with the following drugs:
corticosteroids: increased risk of ulcers and bleeding in the gastrointestinal tract;
Anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin;
Phenytoin: Concomitant use of ibuprofen with phenytoin may increase serum levels of these drugs. When used correctly (maximum 3 days), monitoring of phenytoin serum levels is usually not necessary.
Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effect of these drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the concomitant use of ACE inhibitors, beta-blockers or angiotensin II antagonists and cyclooxygenase inhibitors may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, this combination should be used with caution, especially in the elderly. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and periodically thereafter. Diuretics may increase the risk of nephrotoxicity of NSAIDs.
Lithium: There is evidence of a potential increase in plasma lithium levels. When used correctly (maximum 3 days), monitoring of serum lithium levels is usually not necessary.
Probenecid and sulfinpyrazone: medicines containing probenecid or sulfinpyrazone may delay the elimination of ibuprofen;
Potassium-sparing diuretics: simultaneous use of ibuprofen and potassium-sparing diuretics may lead to hyperkalemia (it is recommended to monitor serum potassium levels);
Cardiac glycosides, such as digoxin: NSAIDs may exacerbate cardiac dysfunction, reduce glomerular filtration rate and increase plasma levels of glycosides. Concomitant use of ibuprofen with digoxin may increase serum levels of these drugs. When used correctly (maximum 3 days), monitoring of serum digoxin levels is usually not necessary;
Methotrexate: there is a possibility of increasing the levels of methotrexate in the blood plasma. The use of ibuprofen within 24 hours before or after the administration of methotrexate may lead to an increase in the concentration of methotrexate and an increase in its toxic effect;
Tacrolimus: possible increased risk of nephrotoxicity when used simultaneously with tacrolimus;
Cyclosporine: there are limited data on a possible interaction leading to an increased risk of nephrotoxicity;
Zidovudine: Increased risk of hematological toxicity with concomitant use of zidovudine and NSAIDs. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia when treated concomitantly with zidovudine and ibuprofen.
Sulfonylureas: Clinical studies have shown an interaction between NSAIDs and antidiabetic agents (sulfonylureas). Although no interactions between ibuprofen and sulfonylureas have been described to date, monitoring of blood glucose levels is recommended as a precautionary measure when these drugs are used concomitantly.
Quinolone antibiotics: Animal data suggest that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of developing seizures.
CYP2C9 inhibitors: Concomitant use of ibuprofen with CYP2C9 inhibitors may increase the exposure of ibuprofen (CYP2C9 substrate). A study with voriconazole and fluconazole (CYP2C9 inhibitors) has shown an increase in exposure of S (+)-ibuprofen by approximately 80-100%. When ibuprofen is co-administered with strong CYP2C9 inhibitors, a reduction in ibuprofen doses is recommended, especially when high doses of ibuprofen are co-administered with voriconazole or fluconazole;
Mifepristone: NSAIDs should not be used earlier than 8 to 12 days after mifepristone administration, as they may reduce its effectiveness.
Application features
Side effects associated with ibuprofen can be minimized by using the lowest effective dose necessary to treat symptoms for the shortest period of time.
Elderly patients have an increased incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Elderly patients are at increased risk of adverse reactions.
Caution should be exercised in patients with the following conditions:
systemic lupus erythematosus, as well as mixed connective tissue disease – due to an increased risk of aseptic meningitis;
congenital disorder of porphyrin metabolism, such as acute intermittent porphyria;
gastrointestinal disorders and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with NSAID therapy;
renal failure – due to the possibility of worsening kidney function;
liver dysfunction;
immediately after major surgical interventions;
hay fever, nasal polyps or chronic obstructive airway diseases – due to an increased risk of allergic reactions such as asthma attacks (so-called analgesic asthma), angioedema or urticaria;
history of allergic reactions to other substances – due to an increased risk of hypersensitivity reactions to ibuprofen.
The concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Effects on the cardiovascular and cerebrovascular systems.
Patients with a history of hypertension and/or heart failure should start treatment with caution (consultation with a doctor is necessary), since cases of fluid retention, hypertension and edema have been reported with ibuprofen therapy, as with other NSAIDs.
Clinical trial data and epidemiological data suggest that ibuprofen, especially at high doses (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤1200 mg/day) are associated with an increased risk of myocardial infarction.
Cases of Kounis syndrome have been reported in patients treated with ibuprofen. Kounis syndrome is defined as cardiovascular symptoms caused by an allergic or hypersensitivity reaction associated with narrowing of the coronary arteries, potentially leading to myocardial infarction.
Effect on the gastrointestinal tract.
There are reports of cases of gastrointestinal bleeding, perforation, ulceration, which can be fatal, which occurred at any stage of treatment with NSAIDs, regardless of the presence of warning symptoms or the presence of severe gastrointestinal disorders, disorders of the rectum and anus in history.
The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing doses of NSAIDs, in the presence of a history of peptic ulcer disease, especially complicated by bleeding or perforation, and in elderly patients. In these patients, treatment should be started at the lowest dose.
For such patients, as well as for patients who require concomitant use of low doses of acetylsalicylic acid or other drugs that may increase the risk from the gastrointestinal tract, combination therapy with protective drugs (e.g. misoprostol or proton pump inhibitors) is recommended.
Patients with a history of gastrointestinal toxicity, especially the elderly, should be informed of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
Caution should be exercised when treating patients who are concomitantly taking medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (e.g. acetylsalicylic acid).
In case of gastrointestinal bleeding or ulceration in patients receiving ibuprofen, treatment should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.
Respiratory effects: Bronchospasm may occur in patients with bronchial asthma, chronic rhinitis, sinusitis, nasal polyps or allergic diseases or with a history of these diseases.
Other: Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. At the first signs of a hypersensitivity reaction after taking ibuprofen, therapy should be discontinued and a doctor should be consulted immediately for appropriate symptomatic therapy.
Ibuprofen may temporarily inhibit platelet aggregation. Therefore, it is recommended to carefully monitor the condition of patients with blood clotting disorders.
With prolonged use of ibuprofen, it is necessary to regularly check liver function indicators, kidney function, as well as hematological blood counts.
Prolonged use of any analgesic for headache may worsen this condition. In such cases, a doctor should be consulted and treatment should be discontinued. The possibility of drug overuse headache should be considered in patients who suffer from frequent or daily headaches despite (or because of) regular use of headache medications. Long-term use of high doses of analgesic medications without indication may result in headache, which should not be treated with higher doses of this medication.
The concomitant use of alcohol and NSAIDs may increase adverse reactions associated with the active substance, especially those affecting the gastrointestinal tract or central nervous system.
NSAIDs can mask symptoms of infection and fever.
When treating patients with heart failure, renal or hepatic failure who are receiving diuretics, or when treating patients after extensive surgical interventions with insufficient fluid in the body, diuresis and renal function should be carefully monitored.
Effects on the kidneys. In general, the habitual use of analgesics, especially combinations of different analgesics, can lead to long-term kidney damage with the risk of renal failure (analgesic nephropathy).
Impairment of female fertility: There is some evidence that cyclooxygenase/prostaglandin synthesis inhibitors may impair female fertility by affecting ovulation. This is reversible upon discontinuation of therapy.
Severe skin adverse reactions
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia with systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported with ibuprofen (see section 4.8). Most of these reactions occurred within the first month of treatment.
If signs and symptoms suggestive of these reactions occur, ibuprofen should be discontinued immediately and alternative treatment considered (if necessary).
In exceptional cases, chickenpox can cause severe skin and soft tissue infections. At present, it cannot be ruled out that NSAIDs may worsen these infections, and it is therefore recommended that ibuprofen be avoided in the presence of chickenpox.
Masking the symptoms of underlying infections.
Nurofen® for children may mask the symptoms of an infectious disease, which may delay the initiation of appropriate treatment and thereby complicate the course of the disease. This has been observed in bacterial community-acquired pneumonia and bacterial complications of chickenpox. When Nurofen® for children is used for fever or for pain relief in infections, monitoring for the infectious disease is recommended. In outpatient settings, the patient should seek medical advice if symptoms persist or worsen.
Use during pregnancy or breastfeeding
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/fetal development. Epidemiological data suggest an increased risk of miscarriage, congenital heart defects and gastroschisis following use of prostaglandin synthesis inhibitors in early pregnancy.
The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is thought to increase with increasing dose and duration of therapy. In animals, the use of prostaglandin synthesis inhibitors has resulted in an increase in the incidence of pre- and post-implantation loss and embryo/fetal lethality. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals treated with prostaglandin synthesis inhibitors during organogenesis.
From the 20th week of pregnancy onwards, ibuprofen may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after initiation of treatment and is usually reversible after discontinuation of treatment. In addition, there have been reports of narrowing of the ductus arteriosus following treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, ibuprofen should not be given during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus should be considered after exposure to ibuprofen for several days, starting from the 20th week of gestation. Ibuprofen should be discontinued if oligohydramnios or narrowing of the ductus arteriosus is detected.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:
Risks to the fetus:
cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction (see above);
Risks for the mother at the end of pregnancy and for the newborn:
possible prolongation of bleeding time, anti-aggregation effect, which can occur even at very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, ibuprofen is contraindicated during the third trimester of pregnancy (see Contraindications section).
Breastfeeding. Ibuprofen and its metabolites are excreted in breast milk in low concentrations. There is currently no evidence of adverse effects on the infant, so for short-term treatment of pain and fever at recommended doses, it is usually not necessary to interrupt breastfeeding.
Fertility.
There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in accordance with the recommended doses and duration of treatment, the drug is not expected to affect the reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
For short-term use only. The lowest effective dose should be used for the shortest time necessary to relieve symptoms (see section 4.4).
This medicine should only be used in children aged 3 months and over with a body weight of at least 6 kg. The maximum single dose should not exceed 10 mg/kg body weight. The dosing interval should not be less than 6 hours. The maximum daily dose of ibuprofen is 20-30 mg/kg body weight, divided into 3-4 single doses.
Children weighing 6-8 kg (3-9 months): at the beginning of treatment - 1 suppository. If necessary, another suppository can be used, but not earlier than after 6-8 hours. Do not use more than 3 suppositories within 24 hours.
Children weighing 8-12 kg (9 months-2 years): at the beginning of treatment - 1 suppository. If necessary, another suppository can be used, but not earlier than after 6 hours. Do not use more than 4 suppositories in 24 hours.
This medicine is contraindicated in children weighing less than 6 kg and under 3 months of age.
Patients with kidney or liver failure should consult a doctor before using this medicine.
If symptoms worsen or persist after 24 hours of treatment in children aged 3–5 months, a doctor should be consulted immediately.
If symptoms persist for more than 3 days after the start of treatment or worsen in children aged 6 months and older, a doctor should be consulted.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time necessary to control symptoms.
Children
The drug should be used in children weighing at least 6 kg and aged 3 months to 2 years.
Overdose
The use of doses greater than 200 mg/kg body weight in children may cause intoxication.
Symptoms. Symptoms of overdose may include nausea, vomiting, epigastric pain or, less commonly, diarrhea. Nystagmus, blurred vision, tinnitus, headache and gastrointestinal bleeding may also occur. In more severe poisoning, toxic effects on the central nervous system may occur in the form of vertigo, dizziness, drowsiness, sometimes agitation and disorientation or coma. Sometimes patients develop convulsions. In severe poisoning, hyperkalemia and metabolic acidosis may occur, as well as an increase in prothrombin time/INR (probably due to interaction with circulating blood clotting factors). Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur. In patients with bronchial asthma, exacerbation of asthma is possible.
Treatment. There is no specific antidote. Treatment should be symptomatic and supportive, and include maintaining a patent airway and monitoring cardiac function and vital signs until the patient's condition is normal. Intravenous diazepam or lorazepam should be administered for frequent or prolonged seizures. Bronchodilators should be administered for exacerbations of bronchial asthma.
Side effects
The following list of adverse reactions includes all adverse reactions that have been reported with ibuprofen, including those observed with high doses during long-term therapy in patients with rheumatism. The frequency reported, which is beyond the very rare reports, refers to short-term use of doses (maximum 1200 mg ibuprofen per day) for oral dosage forms and maximum 1800 mg per day for suppositories.
It should be noted that these adverse reactions are mainly dose-dependent and vary individually for each patient.
Adverse reactions that have occurred with ibuprofen are listed below by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The most frequently observed adverse reactions are from the gastrointestinal tract. Most of the adverse reactions are dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Gastrointestinal ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. Nausea, vomiting, diarrhea, abdominal distension, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after the use of ibuprofen. Gastritis has been observed less frequently.
Edema, hypertension, and heart failure have been reported to be associated with NSAID treatment.
Clinical trial data and epidemiological data suggest that the use of ibuprofen, especially at high doses of 2400 mg per day and with long-term treatment, may be associated with a slightly increased risk of arterial thrombotic complications (e.g. myocardial infarction or stroke).
If signs of infection develop or worsen while taking ibuprofen, the patient is advised to seek immediate medical attention. It is important to determine whether antimicrobial/antibiotic therapy is indicated.
With long-term therapy, it is necessary to regularly perform blood tests.
The patient should immediately consult a doctor and stop using ibuprofen if any of the symptoms of hypersensitivity reactions occur, which may develop even after the first administration of the drug. In such cases, immediate medical attention is required.
If severe epigastric pain, melena, or bloody vomiting occurs, discontinue use of the drug and consult a doctor immediately.
Infections and invasions.
Very rare: exacerbation of inflammation associated with infection (e.g. development of necrotizing fasciitis. In exceptional cases, chickenpox can cause severe infectious complications of the skin and soft tissues).
From the blood and lymphatic system.
Very rare: very rare: blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, nasal and skin bleeding, hematomas. In such cases, the patient should stop taking this medicine, avoid self-medication with analgesics or antipyretics and consult a doctor.
From the immune system.
Hypersensitivity reactions1
Uncommon: urticaria and pruritus.
Very rare: severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylactic reaction, angioedema or severe shock). Exacerbation of asthma.
From the psychological side.
Very rare: psychotic reactions, depression.
From the nervous system.
Uncommon: central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue.
Very rare: aseptic meningitis2
From the organs of vision.
Uncommon: visual disturbances.
From the side of the hearing organs.
Rare: tinnitus.
From the side of the cardiovascular system
Very rare: heart failure, palpitations, edema, myocardial infarction.
Frequency unknown: Kounis syndrome.
From the vascular system.
Very rare: arterial hypertension, vasculitis.
From the digestive system
Common: gastrointestinal complaints such as abdominal pain, nausea, dyspepsia, diarrhoea, flatulence, constipation, heartburn, vomiting and minor gastrointestinal bleeding, which in exceptional cases may lead to anaemia.
Uncommon: gastric and duodenal ulcers, perforations or gastrointestinal bleeding, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis, localised rectal irritation.
Very rare: esophagitis, formation of diaphragmatic intestinal strictures, pancreatitis.
From the liver.
Very rare: liver dysfunction, liver damage, especially with long-term therapy, liver failure, acute hepatitis.
On the skin and subcutaneous tissue.
Uncommon: various skin rashes.
Very rare: severe cutaneous adverse reactions (SCARs) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), alopecia.
Frequency unknown: Drug-induced eosinophilia with systemic symptoms (DRESS syndrome); acute generalized exanthematous pustulosis; photosensitivity reactions.
From the respiratory tract and mediastinal organs.
Frequency unknown: airway reactivity including asthma, bronchospasm or dyspnea.
On the part of the kidneys and urinary system.
Rare: kidney tissue damage (papillary necrosis) and increased blood urea concentration may occur.
Very rare: edema, especially in patients with hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure.
Laboratory studies.
Rare: decreased hemoglobin level.
Description of selected adverse reactions
2 The mechanism of pathogenesis of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis associated with NSAIDs suggest an immune-mediated reaction (due to temporal relationship to drug intake and resolution of symptoms after drug withdrawal). In particular, isolated cases of symptoms of aseptic meningitis (such as neck stiffness, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
2 blisters of 5 suppositories in a cardboard box.
Vacation category
Without a prescription.
Producer
Famar A.V.E. Avlon plant
Location of the manufacturer and its business address.
49th km National Road Athens-Lamia Avlona Attica, 19011, Greece.
