Neo Borocillina Inflammation and Pain 400mg Granules Oral Solution 12 Sachets

Therapeutic indications

Pain of various origins and nature (sore throat during pharyngitis, pharyngitis-tonsillitis and post tonsillectomy, headache, toothache, neuralgia, bone-joint and muscle pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu. Neo Borocillin Inflammation and Pain is indicated in adults and children over 12 years.

Dosage

Adults and adolescents (from 12 years of age): 1 sachet 2–3 times a day. Do not exceed the dose of 1200 mg (3 sachets) per day. In adolescents (aged ≥ 12 to <18 years): if use of the medicinal product is necessary for more than 3 days in adolescents, or if symptoms worsen, a doctor should be consulted. Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above. Renal insufficiency : In patients with mild or moderate decreased 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 liver function impairment, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. Neo Borocillin Inflammation and Pain is contraindicated in patients with severe hepatic impairment (see section 4.3). Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Pediatric population Neo Borocillin Inflammation and Pain is contraindicated in children less than 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 immediately drink the solution.

Overdose

Toxicity Signs and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required 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 4–6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea, and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. Treatment There is no specific antidote for ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage should be considered in adults within one hour of ingesting a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. Depending on the clinical condition of the patient, other supportive measures may be necessary. For more information, contact your local poison control center.

Contraindications

• Do not administer to children under 12 years of age. • Third trimester of pregnancy and lactation (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 heart failure (NYHA class IV). • The sachets of granules for oral solution contain aspartame; they are therefore contraindicated in subjects with phenylketonuria (see section 4.4). • Severe dehydration (caused by vomiting, diarrhea 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 listed below using the following convention: Very common (≥1 / 10) Common (≥1 / 100 to <1/10) Not common (≥ 1 / 1,000 to <1/100) Rare (≥1 / 10,000 to <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, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Gastrointestinal perforation with the use of ibuprofen has been rarely observed. After administration of Neo Borocillin Inflammation and Pain have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhea, 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 skin rash, urticaria, pruritus, purpura, angioedema, rash, respiratory tract reactions including bronchospasm, dyspnoea, asthma attack (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: severe hypersensitivity reactions. Symptoms may include: severe asthma, face edema, tongue edema, larynx edema, airway edema with bronchospasm, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis. Cardiac and vascular disorders Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4 ). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, hypertension. Other adverse events for which causality has not necessarily been established include: Blood and lymphatic system disorders Rare: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia, 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 neck stiffness, headache, nausea, vomiting, fever or disorientation (see section 4.4). Exacerbation of infection-related inflammation (eg development of necrotizing fasciitis) has been described. Respiratory system disorders Uncommon: bronchospasm, dyspnoea, apnea. Eye disorders Uncommon: visual disturbances. Rare: ocular alteration with consequent 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: hepatic failure. Skin and subcutaneous tissue disorders Sometimes allergic skin rashes (erythema, itching, urticaria) may occur. Uncommon: photosensitivity reactions. Very rare: bullous dermatitis, including Stevens – Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. In exceptional cases, severe skin infections and soft tissue disorders can 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: azotemia. General disorders and administration site conditions Common: malaise, fatigue. Rare: edema. Investigations Rare: transaminases increased, alkaline phosphatase increased, hemoglobin decreased, hematocrit decreased, bleeding time prolonged, blood calcium decreased, blood uric acid increased. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and 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% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Neo Borocillin Inflammation and Pain should not be administered except in strictly necessary cases. If Neo Borocillin Inflammation and Pain 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. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently Neo Borocillin Inflammation and Pain is contraindicated during the third trimester of pregnancy. Breastfeeding Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influenza in the newborn seems unlikely. If, on the other hand, the 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 difficulty conceiving or who are being investigated for infertility, discontinuation of ibuprofen treatment should be considered.

Special warnings

• In patients with asthma, ibuprofen should be used with caution, after consulting your doctor. • The use of Neo Borocillin Inflammation and Pain, as well as any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. • Administration of Neo Borocillin Inflammation and Pain should be discontinued in women who have fertility problems or who are undergoing fertility investigations. • Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks). • Elderly : Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). • Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. £ 1200 mg / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic 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 patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses (2400 mg / die) of ibuprofen. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs (see section 4.5). • Gastrointestinal haemorrhage, ulceration and perforation : The use of Neo Borocillin Inflammation and Pain should be avoided in conjunction 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 can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). . Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Carefully monitor patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Neo Borocillin Inflammation and Pain the treatment should be discontinued. 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 When initiating treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Ibuprofen can cause water retention and sodium, potassium retention in patients who have never suffered from kidney disorders due to its effects on renal perfusion. This can cause edema or heart failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other renal pathological changes. In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent renal lesions, with the risk of renal failure (analgesic nephropathy). Renal toxicity has been reported 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 prostaglandin formation and, as a secondary effect, in renal blood flow which can rapidly lead to renal failure. Patients most at risk of these reactions are those with impaired 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 from the pretreatment state. There is a risk of impaired renal function in dehydrated adolescents. In case of prolonged use, monitor renal function particularly in the case of diffuse lupus erythematosus. • Dermatological effects Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens – Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Neo Borocillin Inflammation and Pain should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity as well as if visual disturbances or persistent signs of liver dysfunction occur. • Respiratory disorders Neo Borocillin Inflammation and Pain should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or current or previous allergic diseases because bronchospasm, urticaria and angioedema may arise. The same applies to those subjects who have experienced 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 presented these reactions after the use of other analgesics, antipyretics, NSAIDs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis or chronic respiratory diseases obstructive or previous episodes of angioedema (see sections 4.3 and 4.8). Hypersensitivity reactions can present 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 a hypersensitivity reaction after administration of ibuprofen the treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms. • Reduced cardiac, renal and hepatic function Particular caution should be adopted in the treatment of patients with impaired cardiac, hepatic or renal function since the use of NSAIDs may lead to deterioration of renal function. Habitual concomitant use of several painkillers may further increase this risk. In patients with impaired cardiac, hepatic or renal function, the lowest effective dose should be used for the shortest treatment period and periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. • Haematological Effects Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Therefore, patients with coagulation defects or on anticoagulation 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 disorders, it has also been observed in patients who did not have concomitant chronic diseases (see section 4.8). Since ocular alterations have been detected in animal studies with NSAIDs, it is recommended, in case of prolonged treatments, to carry out periodic ophthalmological checks. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. Ibuprofen can mask the signs or symptoms of infection (fever, pain and swelling). Important information about some of the ingredients: Neo Borocillin Inflammation and Pain 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. - aspartame, a source of phenylalanine. Therefore it is contraindicated in subjects with phenylketonuria. - 45 mg of sodium (1.9 mmol) per sachet. To be taken into consideration in people on a low sodium diet. - 94 mg of potassium (2.4 mmol) per sachet. To be taken into consideration in people on a low potassium diet.

Expiry and Retention

This medicine does not require any special storage conditions.

Active principles

Each 400 mg sachet contains: Active ingredient: Ibuprofen sodium salt dihydrate 512 mg (corresponding to 400 mg of Ibuprofen). Excipients with known effects: 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 flavor, acesulfame potassium, aspartame (E951).