10SUPP 60MG

NUROFENBABY 60 MG SUPPOSEDLY IN EARLY CHILDHOOD

active ingredients

Each suppository contains: ibuprofene 60 mg For full list of excipients, see paragraph 6.1.

Excellent

Solid semisynthetic glycerides

Therapeutic indications

Symptomatic treatment of mild and moderate pain. Syntomatic treatment of fever. Nurofenbaby suppositories are indicated when oral administration is not recommended, e.g. in case of vomiting.

Contraindications

Hypersensitivity to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAID) or any of the excipients. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory drugs. History of hemorrhage or gastrointestinal drilling associated with previous treatments with FANS. In the presence or in the case of history of recurrent peptic ulcer/hemorrhage (two or more episodes ascertained of ulceration or bleeding). Severe kidney failure, severe liver failure or severe heart failure. Patients with history of cerebrovascular bleeding or other active bleeding. Patients with unclear disorders of blood formation. Patients with severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake). In the last trimester of pregnancy (see paragraph 4.6). Children under 6.0 Kg (under 3 months of age).

Population

Rectal use Only for a short period of treatment. Nurofenbaby should be given to children over 3 months of age and a body weight of at least 6.0 kg. The single maximum dose should not exceed 10 mg of ibuprofen per kg of body weight. The interval between one administration and the next should not be less than 6 hours. The maximum daily dose of ibuprofen is 20–30 mg/kg body weight, divided into 3 or 4 administrations. This means: bodyweight children between 6.0 and 8.0 kg (between 3 and 9 months): 1 supposes at the beginning of the treatment, to be repeated if necessary, after at least 6–8 hours. No more than 3 suppositories should be given within 24 hours. Bodyweight children between 8.0 and 12.5 kg (between 9 months and 2 years): 1 supposes at the beginning of the treatment, to be repeated if necessary, only after 6 hours. No more than 4 suppositories should be given within 24 hours. Nurofenbaby 60 mg suppositories are not suitable for children weighing less than 6.0 kg (3 months of age) (see paragraph 4.3). The administration in patients with kidney or liver failure should take place after consulting the doctor. Children between 3 and 5 months must be consulted if symptoms worsen or within 24 hours if symptoms persist. In case this medicine is required for more than 3 days in children from 6 months of age, or in case of worsening of symptoms it must be consulted by the doctor The side effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4).

Conservation

Do not store at temperature above 25°C

Warnings

Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see gastrointestinal and cardiovascular risk below). Seniors: Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal. The elderly have an increased risk of adverse reactions. Caution is required in patients with: • Systemic erythematous lupus or mixed connective tissue disease, due to increased risk of aseptic meningitis (see paragraph 4.8). • Congenital disorders of porphyrin metabolism (e.g., intermittent acute porphyria). • Gastrointestinal disorders and chronic inflammatory bowel diseases ( ulcerative colitis, Crohn's disease) (see paragraph 4.8). • History of hypertension and/or heart failure because in association with therapies with NSAIDs fluid retention and edema have been reported • Renal damage, as kidney function can worsen (see paragraphs 4.3 and 4.8). • Hepatic dysfunction (see paragraphs 4.3 and 4.8) • Immediately after major surgery • Hay fever, nasal polyps or chronic obstructive respiratory disorders, as there is an increased risk of allergic reaction on these patients. These can occur in the form of asthma attacks (called "analgesic asthma"), Quincke edema or hives • In patients who have already manifested allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions following the administration of Nurofenbaby Other: the use of Nurofenbaby in children must be avoided in conjunction with the administration of other NSAIDs including selective cyclooxygenase–2 inhibitors. Undesirable effects can be minimized with the use of the effective minimum dose for the shortest possible duration of treatment needed to control symptoms. Cardiovascular and cerebrovascular effects: Caution is required (a doctor's or pharmacist's advice) before administering Nurofenbaby to patients with history of hypertension and/or heart failure, since fluid retention, hypertension and edema have been reported following therapies with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/die) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with an increase in the risk of myocardial infarction. Gastrointestinal effects (GI): during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, disorders of rectum and anus, gastrointestinal bleeding, ulceration or perforation, which may be fatal. The risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAIDs, in patients with ulcer history, especially if complicated by hemorrhage or perforation (see paragraph 4.3) and in the elderly. These patients should start treatment with the lowest dosage. For these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events should be taken into account the concomitant use of gastroprotective agents (e.g. misoprostol or protonic pump inhibitors) (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially if elderly, must report any unusual abdominal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Cautisus should be lent to patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as acetilsalicylic acid (see paragraph 4.5). When bleeding occurs or gastrointestinal ulceration in patients taking Nurofenbaby treatment should be stopped. NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Respiratory: bronchospasm may worsen in patients suffering from or with history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyposi or allergic disease. Other considerations: Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely.At the first signs of a hypersensitivity reaction after administration/intake of Nurofenbaby, therapy should be discontinued.Medical rescue measures, in line with the symptoms, should be undertaken by specialist personnel.Ibuprofen, the active substance of Nurofenbaby, can temporarily inhibit the function of platelets (thrombocyte aggregation).Therefore, it is recommended to carefully monitor patients with coagulation disorders.In case of prolonged administration of Nurofenbaby, regular monitoring of liver values, kidney function as well as blood count is required.Prolonged use of any type of painkiller for headaches may worsen the symptoms.If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued.The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of the regular use of headache medications.Active substance-related undesirable effects, particularly those affecting the gastrointestinal tract or the central nervous system, may be increased when NSAIDs are taken in combination with alcohol.NSAIDs may mask the symptoms of infections and fever.Monitoring of urine output and renal function should be considered in patients with heart failure, renal or hepatic failure, those taking diuretics or who have undergone major surgery resulting in dehydration. Renal diseases: in general, the usual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney injury, with risk of kidney failure (nephropathy from analgesics). Paediatric population: in dehydrated children there is a risk of kidney damage. Promoted female fertility: see paragraph 4.6. Dermatory effects: Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens–Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk, as the onset of reaction occurs in most cases within the first month of treatment. Nurofenbaby must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. The chickenpox can exceptionally be the origin of serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs cannot be excluded in the worsening of such infections, therefore it is recommended to avoid the use of Nurofenbaby in case of chickenpox.

Interactions

Ibuprofen should not be used in association with: Acetylsalicylic acid (aspirin): Unless low dose acetylsalicylic acid, as is common clinical practice, has been advised by your doctor, as it may increase the risk of adverse reactions (see section 4.4).Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse reactions (see section 4.4). Experimental data suggest that ibuprofen may inhibit the effects of low dose aspirin on platelet aggregation when the drugs are administered concomitantly.However, the limited data and the uncertainties regarding the application of ex vivo data to the clinical situation do not allow firm conclusions to be drawn for regular ibuprofen use and no clinically relevant effect is considered likely for occasional ibuprofen use (see section 5.1). Ibuprofen (like other NSAIDs) must be used with caution in association with: • Corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4) • Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4) • Fenitoin: Concurrent use of Nurofenbaby with phenytoin can increase the serum levels of these medicines. The correct use of drugs (administrated for a maximum period of 3 days) usually does not require control of serum levels of phenytoin. • Anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal hemorrhage (see paragraph 4.4). • Anti-hypertensives (ACE inhibitors, beta-blockers and antagonists of angiotensin II) and diuretics: NSAIDs can decrease the effectiveness of these medicines. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE, beta-blocker or an angiotensin II antagonist and agents inhibiting cyclooxygenase may lead to further deterioration of kidney function, including a possible acute kidney failure, generally reversible. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently at regular intervals. Diuretics can increase the risk of NSAID nephrotoxicity. • Litio. There are evidence to support a potential increase in plasma levels of lithium. The correct use of drugs (administrated for a maximum period of 3 days) does not normally require control of the serum levels of lithium. • Probenecid e sulfinpirazone: Medicines containing probenecid or sulfinpirazone may delay the excretion of ibuprofen. • Potassium spare diuretics: Concurrent administration of Nurofenbaby and potassium-saving diuretics can lead to hyperpotassiemia (should be sieric potassium control). • Heart Glucosides (Digoxin): NSAIDs can worsen heart failure, reduce GFR and increase plasma levels of glucosides. Concurrent use of Nurofenbaby with digoxin based preparations can increase the serum levels of these medicines. The correct use of drugs (administrated for a maximum period of 3 days) does not normally require control of the serum levels of digoxin. • Metotrexato. There are evidence to support a potential increase in plasma levels of metotrexate. The administration of Nurofenbaby in the 24 hours prior to or after the administration of metotrexate may lead to high concentrations of metotrexate to an increase in its toxic effects. • Tacrolimus. The risk of nephrotoxicity increases if the two medicines are administered simultaneously. • Ciclosporin: there are limited evidence to support possible interaction between the two medicines resulting in increased risk of nephrotoxicity. • Zidovudina. There is evidence of an increased risk of hematoma and hematoma in seropositive hemophilic patients for HIV treated simultaneously with zidovudine and ibuprofen. • Sulfaniluree: Clinical studies have shown interactions between non-steroidal and anti-diabetic anti-inflammatory drugs (sulfoniluree). Although interactions between ibuprofen and sulfaniluree have not been described so far, it is recommended to control blood glucose values as a precautionary measure during concurrent intake. • Chinolonic Antibiotics: Data from animal studies indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may have an increased risk of developing seizures. • CYP2C9 inhibitors: Concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)–ibuprofen from approximately 80% to 100% was demonstrated. You should consider reducing the dose of ibuprofen when administering strong CYP2C9 inhibitors simultaneously, especially when high doses of ibuprofen are administered with voriconazole or fluconazole.

Effects

The list of the following side effects includes all the side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond the indications of very rare unwanted effects, refer to short periods of treatment for daily doses up to a maximum of 1,200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1,800 mg for the supposed. You should consider that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the administration of ibuprofen are listed below, according to the classification for systems and organs and frequency. The frequencies are defined as: very common (≥1/10), common (≥1/100, Classification for systems and organs Frequency Action against Infections and infestations Very rare Increased inflammations related to infections (eg development of necrotizing bundles), in exceptional cases severe skin infections and complications to soft tissues were found during a chickenpox infection. Emolinfopoietic system pathologies Very rare Hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first signs are: fever, throat, superficial ulcers of the mouth, simil symptoms – flu, severe fatigue, bleeding and nasal and skin bruises. In these cases, the patient should immediately stop the medicine, avoid any automedication medication containing analgesics or antipyretics and consult the doctor. Psychiatric disorders Very rare Psychic reactions, depression Immune system disorders Reactions of hypersensitivity constituted by:1 Not common Orticaria and itching Very rare Severe hypersensitivity reactions. The symptoms may be: swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma. Notable Reactivity of the respiratory tract that includes asthma, bronchospasm or dispnea. Diseases of the nervous system Not common Central nervous system disorders such as headaches, dizziness, insomnia, agitation, irritability or fatigue. Very rare Meningitis asettica2 Pathologies of the eye Not common Visual disturbances Ear and labyrinth pathologies Rare Tinnitus Heart disease Very rare Heart failure, palpitations and edema, myocardial infarction Vascular diseases Very rare Hypertension, vasculitis Gastrointestinal diseases Town Gastrointestinal problems, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting and slight blood loss in the stomach and/or in the intestine that in exceptional cases may cause anemia. Not common Gastrointestinal ulcer, perforation or gastrointestinal bleeding. Ulcerative symptoms, worsening of colitis or Crohn's disease (see paragraph 4.4), gastritis, irritation of the localized rectum. Very rare Esophagitis and formation of symil–diaphragmtic intestinal structures, pancreatititis. Hepatobiliary diseases Very rare Hepatic dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis. Pathologies of skin and subcutaneous tissue Not common Various skin rashes Very rare Severe forms of skin reactions such as stamping reactions including Stevens–Johnson syndrome, multiform erythema and toxic epidermal necrolysis, alopecia. Kidney and urinary pathologies rare Rarely, renal tissue damage (paint necrosis) and high concentrations of urea in the blood can occur. Very rare Edema formation particularly in patients with arterial hypertension or kidney failure, nephrosic syndrome, interstitial nephritis that can be accompanied by acute kidney failure. Diagnostic examinations Very rare Decrease in blood haemoglobin levels Description of selected adverse reactions ¹ Hypersensitivity reactions were reported following treatment with ibuprofen. These reactions may include a) non-specific and anaphylaxis allergic reactions, b) respiratory tract reactivity that includes asthma, asthma worsening, bronchospasm or dispnea, or c) different skin pathologies that include various skin rashes, itching, hives, porpora, angioedema and very rarely dermatitis bollose and esfoliative (which include necromy. However, the data available on aseptic meningitis related to NSAIDs induce to think of an immune reaction (due to a temporary relationship with the intake of the drug and the disappearance of symptoms after the suspension of treatment). Note, individual cases of aseptic meningitis symptoms (such as numb neck, headache, nausea, vomiting, fever and disorientation) were observed during treatment with ibuprofen in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

The risk of toxicity can occur in doses greater than 200 mg/kg. a) Symptoms of overdose: Overdose symptoms may include nausea, vomiting, abdominal pain or more rarely diarrhea. They are also possible nistagm, blurred vision, tinnitus, headaches and gastrointestinal bleeding. In cases of more severe poisoning, toxicity is observed at the expense of the central nervous system that manifests itself with dizziness, dizziness, drowsiness, occasional excitement and disorientation or coma. Occasionally patients develop seizures. In severe cases of poisoning you can experience hyperkaliemia and metabolic acidosis and protrombine/ INR can be prolonged, probably due to interference with the action of the factors of the coagulation present in the circle. Acute kidney failure, liver damage, hypotension, respiratory depression and cyanosis can also be found. Asthmatic subjects can be exacerbated. b) Treatment of overdose: There is no specific antidote. Treatment should be symptomatic and. must include the maintenance of airway pervity and the monitoring of heart function and vital signs to the patient's stabilization. If frequent or prolonged, convulsions must be treated with diazepam or lorazepam intravenously. Administer bronchodilators in case of asthma. The local poison center should be contacted for a medical opinion.

Pregnancy

Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and heart and gastroschisis malformations after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre and post-plant and embryo-fetal mortality. In addition, there was an increase in the incidence of various malformations, including cardiovascular disease, in animals that had been given inhibitors of prostaglandin synthesis during the organogenetic period. During the first and second quarter of pregnancy, ibuprofen should not be administered if not in strictly necessary cases. If ibuprofen is used by a woman who tries to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment must be maintained as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction that can progress to kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, an anti-aggregating effect that can also be necessary at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Breastfeeding

Hybuprofen and metabolites pass into breast milk only in small amounts. Since there are no known side effects in the infant, breastfeeding is usually not required if the medicine is taken at recommended doses for fever and pain for short-term treatments.

Fertility

There are some evidence that medicines that inhibit cycloxygenase/prostaglandine synthesis can cause a female fertility impairment due to ovulation. This effect is reversible after termination of treatment.

Source: Farmadati