Description
Pain of various origins and nature (sore throat during pharyngitis, pharyngotonsillitis and post tonsillectomy, headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of feverish and flu states. Neo Borocillina Inflammation and Pain is indicated in adults and children over 12 years of age.
Active Ingredients
Each 400 mg sachet contains: Active ingredient: Ibuprofen sodium salt dihydrate 512 mg (corresponding to 400 mg of Ibuprofen). Excipients with known effect: aspartame: 50 mg; potassium: 94 mg (2.4 mmol); sucrose: 2088 mg. For the full list of excipients, see section 6.1
Excipients
Each 400 mg sachet contains: sucrose, potassium bicarbonate, mint flavouring, acesulfame potassium, aspartame (E951).
Dosage
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). Adults and adolescents (from 12 years of age): 1 sachet 2-3 times a day. Do not exceed 1200 mg (3 sachets) per day. In adolescents (aged ≥ 12 years to < 18 years): if the use of the medicinal product is necessary for more than 3 days in adolescents, or in case of worsening of symptoms, a doctor should be consulted. Do not exceed the recommended doses; in particular, elderly patients should adhere to the minimum dosages indicated above. Renal impairment: in patients with mild or moderate reduction of renal function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. Hepatic impairment: in patients with mild or moderate reduction of liver function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. Neo Borocillina Inflammation and Pain is contraindicated in patients with severe hepatic impairment (see section 4.3). Undesirable effects can be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see section 4.4). Paediatric population Neo Borocillina Inflammation and Pain is contraindicated in children under 12 years of age (see section 4.3). Method of administration Take the product on a full stomach. Dissolve the contents of the sachet in a glass of water, stirring with a teaspoon until dissolved and drink the solution immediately.
Warnings
• In asthmatic patients, ibuprofen should be used with caution, after consulting your doctor. • The use of Neo Borocillina Inflammation and Pain, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. • The administration of Neo Borocillina Inflammation and Pain should be suspended in women who have fertility problems or who are undergoing investigations into fertility. • Undesirable effects can be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). • Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). • Cardiovascular and cerebrovascular effects: Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses (2400 mg/day) of ibuprofen are required. Caution is advised before initiating treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and oedema have been reported in association with NSAID therapy. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs (see section 4.5). • Gastrointestinal bleeding, ulceration and perforation: The use of Neo Borocillina Infiammazione e Dolore should be avoided in combination with NSAIDs, including selective COX-2 inhibitors due to an increased risk of ulceration or bleeding (see section 4.5). Gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest dose available. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant acetylsalicylic acid or other drugs likely to increase GI risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. Carefully monitor patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving Neo Borocillina Inflammation and Pain, the treatment should be withdrawn. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). • Renal effects Caution should be exercised when initiating treatment with ibuprofen in patients with considerable dehydration. Ibuprofen may cause water, sodium and potassium retention in patients with no history of renal disease due to its effects on renal perfusion. This may cause oedema or cardiac failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other pathological renal changes. In general, habitual use of analgesics, especially combinations of several analgesic active ingredients, may lead to permanent renal damage, with risk of renal failure (analgesic nephropathy). Renal toxicity has been observed in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. Administration of NSAIDs in these patients may result in a dose-dependent reduction in the formation of prostaglandins and, as a secondary effect, in renal blood flow which can quickly lead to renal failure. Patients most at risk of these reactions are those with reduced renal function, heart failure, liver dysfunction, the elderly and all those patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery of the pre-treatment state. In dehydrated adolescents there is a risk of alteration of renal function. In case of prolonged use, monitor renal function particularly in case of diffuse lupus erythematosus. • Severe skin reactions Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in association with medicinal products containing ibuprofen. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity, as well as if visual disturbances or persistent signs of liver dysfunction occur. • Respiratory disorders Neo Borocillina Inflammation and Pain should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or allergic diseases in progress or in the past because bronchospasm, urticaria and angioedema could arise. The same applies to those subjects who have manifested bronchospasm after the use of acetylsalicylic acid or other NSAIDs. • Hypersensitivity reactions Analgesics, antipyretics, NSAIDs, can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have shown such reactions after the use of other analgesics, antipyretics, NSAIDs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis or chronic obstructive respiratory diseases or previous episodes of angioedema (see sections 4.3 and 4.8). Hypersensitivity reactions may present themselves in the form of asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Serious hypersensitivity reactions (e.g. anaphylactic shock) have been observed rarely. At the first signs of hypersensitivity reaction after administration of ibuprofen, treatment must be discontinued. Medically assisted measures should be initiated by specialized medical personnel, in line with the symptoms. • Reduced cardiac, renal and hepatic function Particular caution should be exercised when treating patients with impaired cardiac, hepatic or renal function since the use of NSAIDs may cause deterioration of renal function. The habitual concomitant use of several painkillers may further increase this risk. In patients with impaired cardiac, hepatic or renal function, it is advisable to use the lowest effective dose for the shortest period of treatment and to periodically monitor clinical and laboratory parameters, especially in case of prolonged treatment. • Haematological effects Ibuprofen, like other NSAIDs, may inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Therefore, patients with coagulation defects or on anticoagulant therapy should be carefully observed. • Aseptic meningitis On rare occasions, symptoms of aseptic meningitis have been observed in patients receiving ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients without underlying chronic disease (see section 4.8). • Masking of symptoms of underlying infections Neo Borocillina Inflammation and Pain may mask the symptoms of infection, which may delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox. When Neo Borocillina Infiammazione e Dolore is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should contact a doctor if symptoms persist or worsen. Since ocular alterations have been observed in animal studies with NSAIDs, periodic ophthalmological checks are recommended in case of prolonged treatment. Alcohol consumption should be avoided as it may intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system. Important information about some of the excipients: Neo Borocillina Infiammazione e Dolore 400 mg granules for oral solution contains: - sucrose : patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicinal product contains 2.1 g of sucrose (sugar) per sachet: to be taken into consideration by people with diabetes mellitus. - aspartame , is a source of phenylalanine, therefore it is contraindicated in subjects with phenylketonuria. - sodium : this medicinal product contains 45 mg (1.9 mmol) of sodium per sachet equivalent to 2.25% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. - potassium : this medicinal product contains 94 mg (2.4 mmol) of potassium per sachet. To be taken into consideration by patients with reduced kidney function or in patients on a low potassium diet.
Conservation
This medicinal product does not require any special storage conditions.
Contraindications
• Do not administer to children under 12 years of age. • Third trimester of pregnancy and breastfeeding (see section 4.6). • Hypersensitivity to the active substance (ibuprofen), to acetylsalicylic acid, to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1. • Patients who have experienced bronchospasm, asthma, rhinitis or urticaria following the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. • Active or severe gastroduodenal ulcer or other gastropathies. • History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Severe hepatic or renal insufficiency. • Severe cardiac insufficiency (NYHA class IV). • The sachets of granules for oral solution contain aspartame; they are therefore contraindicated in subjects suffering from phenylketonuria (see paragraph 4.4). • Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
Side effects
The undesirable effects observed with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and are reported below using the following convention: Very common (≥1/10); Common (≥1/100, < 1/10); Uncommon (≥ 1/ 1,000, < 1/100); Rare (≥1/10,000, < 1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). The most commonly observed adverse events are gastrointestinal in nature. Gastrointestinal disorders: Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Gastrointestinal perforation with the use of ibuprofen has been observed rarely. After administration of Neo Borocillina Inflammazione e Dolore the following have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, epigastric pain, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Uncommon: gastritis; Very rare: pancreatitis. Immune system disorders: The following undesirable effects have been reported following treatment with NSAIDs: non-specific allergic reaction and anaphylaxis; uncommon: hypersensitivity reactions such as various types of skin rash, urticaria, pruritus, purpura, angioedema, exanthema, respiratory tract reactions including bronchospasm, dyspnoea, asthmatic attack (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: severe hypersensitivity reactions. Symptoms may include: severe asthma, facial oedema, tongue oedema, laryngeal oedema, airway oedema with bronchospasm, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis. Cardiac and vascular disorders: Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary oedema, hypertension. Other adverse events for which causality has not necessarily been established include: Blood and lymphatic system disorders: Rare: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia, inhibition of platelet aggregation. Psychiatric disorders. Uncommon: insomnia, anxiety; Rare: depression, confusional state, hallucinations. Nervous system disorders. Common: dizziness; Uncommon: paraesthesia, somnolence; Rare: optic neuritis. Infections and infestations. Uncommon: rhinitis; Rare: aseptic meningitis. Rhinitis and aseptic meningitis have been observed especially in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4). Exacerbation of infection-related inflammation (e.g. development of necrotising fasciitis) has been described. Respiratory system disorders. Uncommon: bronchospasm, dyspnoea, apnoea. Eye disorders. Uncommon: visual disturbances; Rare: ocular impairment resulting in visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders. Uncommon: impaired hearing, tinnitus, vertigo. Hepatobiliary disorders. Uncommon: abnormal liver function, hepatitis and jaundice; Very rare: liver failure. Skin and subcutaneous tissue disorders. Uncommon: photosensitivity reactions; Very rare: bullous dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme; Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous postulanthopathy (AGEP). Allergic skin rashes (erythema, pruritus, urticaria) may occasionally occur. In exceptional cases, serious skin infections and soft tissue disorders may occur during chickenpox infection (see “infections and infestations”). Renal and urinary disorders. Uncommon: impaired renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure; Rare: azotaemia. General disorders and administration site conditions. Common: malaise, fatigue; Rare: oedema. Investigations. Rare: increased transaminases, increased alkaline phosphatase, decreased haemoglobin, decreased haematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Overdose
Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults. However, supportive treatment may be necessary in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions, and loss of consciousness. Nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, excitement, fainting, and cardiovascular toxicity including hypotension, bradycardia, and tachycardia have been reported. Renal failure and liver damage are possible in cases of significant overdose. In cases of severe poisoning, metabolic acidosis may occur. Treatment There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is indicated. Particular attention should be paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount. Alternatively, gastric lavage should be considered in adults within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis should be ensured and renal and hepatic function should be closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. For more information, contact your local poison control center.
Pregnancy
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. From the 20th week of pregnancy onwards, the use of Neo Borocillina Infiammazione e Dolore may cause oligohydramnios resulting from fetal renal dysfunction. This condition may be observed shortly after the start of treatment and is usually reversible with treatment interruption. In addition, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after cessation of treatment. Therefore, during the first and second trimester of pregnancy, Neo Borocillina Infiammazione e Dolore should not be administered unless clearly necessary. If Neo Borocillina Infiammazione e Dolore is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. Following exposure to Neo Borocillina Inflammazione e Dolore for several days from the 20th week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with Neo Borocillina Inflammazione e Dolore should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Neo Borocillina Inflammation and Pain is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breastfeeding Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influence on the newborn seems unlikely. If, however, treatment is longer term, early weaning should be considered. NSAIDs should be avoided during breastfeeding. Fertility The use of Ibuprofen may impair female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who have difficulties conceiving or who are undergoing investigation of infertility, discontinuation of ibuprofen should be considered.
