INFIAMMAZ AND DOL 12BUST

NEO BOROCILLINA INFIAMMATION AND ONLY 400 MG GRANULATE FOR ORAL SOLUTION

active ingredients

Each 400 mg bag contains: Active ingredient: Ibuprofen sodium salt dihydrate 512 mg (corresponding to 400 mg of Ibuprofene). Exciting with known effects: aspartame: 50 mg potassium: 94 mg (2,4 mmol) sucrose: 2088 mg For the complete list of excipients see paragraph 6.1

Excellent

Each 400 mg bag contains: sucrose, potassium bicarbonate, mint aroma, potassium acesulfame, aspartame (E951).

Therapeutic indications

Pain from various origins and nature (gorge disease in progress of pharyngitis, pharynxylitis and post tonsilktomy, headaches, toothache, neuralgia, osteo-articocular and muscle pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu states. Neo Borocillin Inflammation and Pain is indicated in adults and children over 12 years.

Contraindications

• Do not administer children under the age of 12. • Third quarter of pregnancy and nursing (see paragraph 4.6). • Hypersensitivity to the active ingredient (ibuprofen), acetylsalicylic acid, other analgesics, antipyretics, non-steroidal anti-fiammatories (NSAID) or any of the excipients listed in the paragraph 6.1. • Patients who have manifested bronchospasm, asthma, rhinitis or hives resulting in the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. • Active or severe gastroduodenal ulcer or other gastropathies. • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Hepatic or severe kidney failure. • severe heart failure (IV class NYHA). • Granulated envelopes for oral solution contain aspartame; are therefore contraindicated in subjects suffering from phenylchetonuria (see paragraph 4.4). • Severe dehydration (caused by vomiting, diarrhea or insufficient liquid supply).

Population

The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Adults and teenagers (from 12 years of age): 1 sachet 2-3 times a day. Do not exceed 1200 mg (3 sachets) per day. In adolescents (aged between ≥ 12 years old patients should comply with the above minimum dosages.Renal insufficiency: in patients with mild or moderate reduction of kidney 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 insufficiency: in patients with mild or moderate reduction of liver function, the dosage must be kept as low as possible for the shortest duration necessary to control symptoms and liver function must be monitored. Neo Borocillin Inflammation and Pain is contraindicated in patients with severe liver failure (see paragraph 4.3). 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 paragraph 4.4). Pediatric population Neo Borocillin Inflammation and Pain is contraindicated in children under 12 years (see paragraph 4.3). Method of administration Take the product on a full stomach. Dissolve the contents of the sachet in a glass of water mixing with a teaspoon until dissolution and immediately drink the solution.

Conservation

This medicine does not require any special condition of conservation.

Warnings

• In asthmatic patients, ibuprofen should be used with caution after consulting the doctor. • The use of Neo Borocillin Inflammation and Pain, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase is not recommended in women who intend to start a pregnancy. • The administration of Neo Borocillin Inflammation and Pain should be suspended in women who have fertility problems or who are subject to fertility surveys. • Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). • Seniors : elderly patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). • Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), 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 suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with an increase in the risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. Caution is required before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure since retention of fluid, hypertension and edema were found in association with NSAIDs. NSAIDs can reduce the effect of diuretics and other antihypertensive drugs (see paragraph 4.5). • Gastrointestinal bleeding, ulceration and drilling: The use of Neo Borocillin Inflammation and Pain should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors due to an increase in the risk of ulceration or bleeding (see paragraph 4.5). During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of acetyllic acid or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Carefully check patients taking concomitant medications that could increase the risk of ulceration or hemorrhage, 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 you experience bleeding or gastrointestinal ulceration in patients taking Neo Borocillin Inflammation and Pain treatment should be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). • Renal effects When treatment with ibuprofen begins, care should be given to patients with considerable dehydration. Ibuprofen can cause water and sodium retention, potassium in patients who have never suffered kidney disorders due to its effects on kidney 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 kidney papillar necrosis and other kidney pathological alterations. In general, the habitual use of analgesics, especially of the associations of different active analgesics, can lead to permanent kidney injuries, with the risk of kidney failure (nephropathy from analgesics). Renal toxicity has been found in patients where kidney prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients may result in a dose-dependent reduction in prostaglandin formation and, as a secondary effect, kidney blood flow that can lead quickly to kidney failure. Patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, elderly and all those patients taking diuretics and ACE inhibitors. The suspension of treatment with NSAIDs is usually followed by the recovery of pretreatment. In dehydrated adolescents there is a risk of alteration of kidney function. In case of prolonged use, watch the kidney function particularly in case of widespread erythematosum lupus. • Strict skin reactions Severely serious skin reactions have been reported, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute (AGEP) esantelosis was reported in relation to medicines containing ibuprofen. Ibuprofen should be suspended at the first appearance of severe signs and symptoms of skin reactions, such as rash, mucosa lesions or any other sign 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 allergic diseases in place or pregress because it may arise bronchospasm, urticaria and angioedema. The same applies to those who have manifested bronchospasm after the use of acetylsalicylic acid or other NSAIDs. • Reactions of hypersensitivity Analgesics, antipyretics, NSAIDs, can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of medication. The risk of hypersensitivity reactions after hiring ibuprofen is greater in individuals who have presented such reactions after the use of other analgesics, antipyretics, NSAIDs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposi or chronic obstructive respiratory diseases or previous episodes of angioedema (see paragraphs 4.3 and 4.8). Hypersensitivity reactions can occur in the form of asthma attacks (the so-called analgesic asthma), Quincke edema or hives. Reactions of severe hypersensitivity (e.g. anaphylactic shock) have rarely been observed. To the first signs of reaction of hypersensitivity after administration of ibuprofen the treatment must be stopped. Medically assisted measures must be initiated by specialized medical personnel, in line with symptomatology. • Reduced heart, kidney and liver function Particular caution should be taken in the treatment of patients with reduced heart, hepatic or kidney function as the use of NSAIDs can lead to a deterioration of kidney function. Concurrent use of different painkillers can further increase this risk. In patients with reduced heart, liver or kidney function, it is appropriate to use the lowest effective dose for the shortest period of treatment and periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. • Ematologic effects Ibuprofen, like other NSAIDs, can inhibit piastrinic aggregation and has given evidence to prolong bleeding time in healthy subjects. Therefore, patients with clotting defects or anticoagulant therapy should be carefully observed. • Synthetic Meningitis Symptoms of aseptic meningitis have been observed on rare occasions in patients with ibuprofen. Although it is more likely that this occurs in patients with systemic erythematous lupus and related connective tissue pathologies, it was also observed in patients who did not manifest concomitant chronic pathologies (see paragraph 4.8). • Masking the symptoms of underlying infections Neo Borocillin Inflammation and Pain can mask the symptoms of infection, which could delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Neo Borocillin Inflammation and Pain is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Ocular alterations are detected during animal studies with NSAIDs, it is recommended, in case of prolonged treatment, to carry out periodic ophthalmologic checks. Alcohol consumption must be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system. Important information about some excipients: Neo Borocillin Inflammation and Pain 400 mg granulated per oral solution contains: - sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure should not take this medicine. This medicine contains 2.1 g sucrose (sugar) per bag: to be considered in people with diabetes mellitus. - aspartame, is a source of phenylalanine, therefore it is contraindicated in subjects with phenylchetonuria. - sodium: This medicine contains 45 mg (1.9 mmol) of sodium per sachet equivalent to 2.25% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. - potassium: this medicine contains 94 mg (2.4 mmol) of potassium per bag. To be considered in patients with reduced kidney function or in patients who follow a low potassium diet.

Interactions

It is advisable to use the doctor's advice in case of any concomitant therapy before the administration of the product. Hybuprofen (such as other NSAIDs) must be taken with caution in combination with the substances listed below. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin or heparine (see paragraph 4.4). In case of concomitant treatment, monitoring of the coagulation status is recommended. Acetylsalicylic acid: concurrent administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it is not possible to exclude the possibility that the regular, long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Cycloxygenase-2 inhibitors (COX-2) and other NSAIDs: these substances may increase the risk of adverse reactions to the gastrointestinal tract (see paragraph 4.4). However, it should not associate ibuprofen with acetylsalicylic acid or other NSAIDs, including selective COX-2 inhibitors, for potential additive effect (see paragraph 4.4). Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Diuretics, ACE inhibitors (such as captopril), beta blockers and antagonists of angiotensin II: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of nephrotoxicity associated with NSAIDs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents that inhibit the cyclo-oxidase system can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Neo Borocillin Inflammation and Pain in conjunction with ACE inhibitors or antagonists of angiotensin II. 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 in subsequent periods. Fenitoin and lithium: the concomitant administration of ibuprofen and phenytoin or lithium preparations can determine a reduced elimination of these medicines resulting in increased plasma levels and the possibility of reaching the toxic threshold. If this association is considered necessary, it is recommended to monitor plasma levels of phenytoin and lithium in order to adapt the appropriate posology during the contemporary treatment with ibuprofen. Metotrexate: NSAIDs can inhibit the tubular secretion of metotrexate and some metabolic interactions can occur resulting in reduced metotrexate clearance and increased risk of toxicity. Moclobemide: increases the effect of ibuprofen. Aminoglycosides: NSAIDs can decrease aminoglycoside excretion by increasing toxicity. Heart glycosides: NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Monitoring of serum glycoside levels is recommended. Colestiramine: the concomitant administration of ibuprofen and cholestiramine can reduce the absorption of ibuprofen at the gastrointestinal tract level. However, the clinical relevance of this interaction is not known. Ciclosporine: Concurrent administration of cyclosporin and some NSAIDs causes an increased risk of kidney damage. This effect cannot be excluded from the combination of cyclosporin and ibuprofen. Plant extracts: Ginkgo Biloba can increase the risk of bleeding if taken in association with NSAIDs. Mifepristone: due to the anti-prostaglandiniche properties of the NSAIDs, their use after mifepristone administration can determine a reduction in the effect of mifepristone. The limited evidence suggests that co-administration of NSAIDs and prostaglandins on the same day does not negatively affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the drug on the interruption of pregnancy. Chinolonic antibiotics: patients taking NSAIDs and kinolones can have an increased risk of developing seizures. Sulfaniluree: NSAIDs can increase the hypoglycemic effect of sulfaniluree. In the case of simultaneous treatment, it is recommended to monitor blood glucose levels. Tacrolimus: co-administration of NSAIDs and tacrolimus can cause an increase in the risk of nephrotoxicity. Zidovudine: there are evidence of an increased risk of hematoma and hematoma in positive HIV hemophiliacs in contemporary treatment with Zidovudine and other NSAIDs. Hematological examination is recommended 1-2 weeks after the start of treatment. Ritonavir: can determine an increase in plasma concentrations of NSAIDs. Probenecid: slows the excretion of ibuprofen, with possible increase of plasma concentrations of ibuprofen. CYP2C9 inhibitors: the concurrent administration of ibuprofen and inhibitors of CYP2C9 can slow down the elimination of ibuprofen (substrate of CYP2C9) by causing an increase in exposure to ibuprofen. In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to the S (+)-ibuprofen from approximately 80% to 100%. The reduction of the dose of ibuprofen should be considered in cases of co-administration with strong inhibitors of CYP2C9, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.

Effects

The undesirable effects observed with ibuprofen are generally common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs and are listed below using the following convention: Very common (≥1/10) Common (≥1/100, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. Rarely, nistagm, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life, the gastric lavender must be taken into account. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered 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, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been 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 if not in strictly necessary cases. If Neo Borocillin Inflammation and Pain is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must 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 arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-hydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently Neo Borocillin Inflammation and Pain is contraindicated during the third trimester of pregnancy.

Food

Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influence on the newborn seems unlikely. If, instead, treatment is longer term, early weaning should be considered. NSAIDs must be avoided during breastfeeding.

Fertility

The use of Ibuprofen can compromise female fertility and is not recommended in women waiting for conception. This effect is reversible with the suspension of treatment. In women who have difficulty in conceiving or who are being investigated on infertility, it should be considered the interruption of treatment with ibuprofen.

Source: Farmadati