MOMENT GRANT 12BUST 200MG

MOMENT 200 MG FREE FOR ORAL DEPARTMENT

active ingredients

A bag contains: Active ingredient: ibuprofene mg 200 (as sodium salt dihydrate 256 mg). Excipients with known effects: sucrose, potassium, aspartame (E 951). For the full list of excipients see paragraph 6.1

Excellent

Each bag contains: Sucrose, potassium bicarbonate, orange aroma, potassium acesulfame, aspartame (E 951).

Therapeutic indications

Pain of various origins and natures (menstrual pain, headache, toothache, neuralgia, osteo-articular and muscular pain).

Contraindications

• Hypersensitivity to the active substance, to other antirheumatics (acetylsalicylic acid, etc.) or to any of the excipients listed in paragraph 6.1. • Children under 12 years of age.• Third trimester of pregnancy and breast-feeding (see section 4.6).• 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).• Phenylketonuria (see section 4.4).• Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Dosage

Adults and teenagers over 12 years: 1-2 sachets, 2-3 times a day. Dissolve the contents of the sachet in a glass of water mixing with a teaspoon until dissolution and immediately drink the solution. Do not exceed 1200 mg (6 sachets) per day. In case the use of the medicinal product is necessary for more than 3 days in adolescents aged 12 years or in case of worsening of symptomatology, the doctor must be consulted. Do not exceed the recommended doses. Senior patients must comply with the above minimum dosages (see paragraph 4.4). Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). Renal impairment: in patients with mild to moderate renal impairment, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. Hepatic Comprogation: 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. Moment is contraindicated in patients with severe liver failure (see paragraph 4.3). Pediatric population Moment is contraindicated in children under the age of 12 (see paragraph 4.3). Method of administration Dissolve the contents of the sachet in a glass of water mixing with a teaspoon until dissolution and immediately drink the solution. You can take Moment on an empty stomach. In subjects with problems of gastric tolerability, it is preferable to take the medicine on a full stomach.

Conservation

This medicine does not require any special condition of conservation.

Warnings

• In asthmatic patients the product should be used with caution, following medical evaluation.• The use of Moment, as of any drug inhibiting the synthesis of prostaglandins and cyclooxygenase is not recommended in women intending to become pregnant.• The administration of Moment should be suspended in women who have fertility problems or who are undergoing investigation of fertility.• Undesirable effects may be minimised by using the lowest effective dose for the shortest duration 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 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 (p.es. infarction of myocardial or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with increased 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 fluids, hypertension and edema were found in association with NSAIDs. FANS can reduce the effect of diuretics and other antihypertensive drugs (see paragraph 4.5) • Gastrointestinal bleeding, ulceration and perforation Moment 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 aspirin or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, particularly elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Carefully check patients taking concomitant drugs 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 aspirin (see paragraph 4.5). When bleeding occurs or gastrointestinal ulceration in patients taking Moment treatment should be suspended. I FANS should be administered 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. - Severe skin reactions Serious 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 Moment 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 occur.The same applies to those subjects who have experienced 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 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 a hypersensitivity reaction after administration of ibuprofen, treatment must be discontinued.Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms.• 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). 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. Masking the symptoms of underlying infections Moment can mask the symptoms of infection, which may delay the start of proper treatment and therefore worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Moment 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. Important information about some excipients Moment 200 mg granulate per oral solution contains: • Potassium: this medicine contains 2,25 mm of potassium per bag. To be considered in patients with reduced kidney function or in patients who follow a low potassium diet. • Aspartame: this medicine contains 20 mg of aspartame per sachet equivalent to 20 mg/3000 mg. Aspartame ingested orally is hydrolyzed in the gastrointestinal tract. Fenilalanin is the main product of its hydrolysis, therefore it is contraindicated in subjects suffering from phenylchetonuria. • Sucrose: patients with rare hereditary problems of fructose intolerance, glucose and galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Interactions

Hybuprofen (like 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 heparin (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 cannot be excluded the possibility that 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 inhibitors-2 (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 inhibiting 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 Moment in conjunction with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring of renal function should be taken into account after the start of concurrent therapy and later. • Fenitoin and lithium: the concomitant administration of ibuprofen and phenytoin or lithium preparations may lead to a reduced elimination of these medicines resulting in increased plasma levels with 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 reduction of 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 the rate of glomerular filtration and increase the plasma levels of cardiac glycosides. Monitoring of serum glycoside levels is recommended. • Colestiramine: the concomitant administration of ibuprofen and choleramine can reduce the absorption of ibuprofen at the gastrointestinal tract level. However, the clinical relevance of this interaction is not known.• Cyclosporin: concomitant administration of cyclosporin and some NSAIDs causes an increased risk of kidney damage. This effect cannot be excluded for the combination of cyclosporin and ibuprofen. • Plant extracts: Ginkgo Biloba can increase the risk of bleeding in association with NSAIDs. • Mifepristone: due to the anti-prostaglandiniche properties of NSAIDs, their use after mifepristone administration may result in 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 lead to 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 its plasma concentrations. • CYP2C9 inhibitors: the concurrent administration of ibuprofen and inhibitors of CYP2C9 can slow the elimination of ibuprofen (substrate of CYP2C9) by determining an increase in exposure to ibuprofen. In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was observed. The reduction of the dose of ibuprofen should be taken into account in cases of co-administration with strong inhibitors of CYP2C9, especially when high doses of ibuprofen are administered with voriconazole or fluconazole. • Alcohol, biphosphonate and oxpentifilline (pentoxyphylline): can enhance gastrointestinal side effects and the risk of bleeding and ulcer. • Baclofene: high toxicity of baclofene.

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, gastrointestinal pathologies: Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). Gastrointestinal drilling with the use of ibuprofen has rarely been observed. After administration of Moment were reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, gastric pyrosis, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Not common: gastriti; Very rare: pancreatititi. Immune system disorders. Following treatment with NSAIDs, the following side effects were reported: non-specific allergic reaction and anaphylaxis. Not common: hypersensitivity reactions such as skin rash of various types, hives, itching, porpora, angioedema, esantema, reaction to the respiratory tract including bronchospasm, dispnea, asthmatic attack (sometimes with hypotension); Rares: lupus erythematose syndrome; Very rare: severe hypersensitivity reactions. Symptoms may include: severe asthma, edema of the face, edema of the tongue, edema of the larynx, edema of the airways with bronchospasm, dispnea, tachycardia, anaphylaxis, exfoliative and bollose dermatitis. Heart and vascular disease: 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) (see paragraph 4.4). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, hypertension. Other adverse events for which a causality has not necessarily been established include: Diseases of the emolinfopoietic system. Rares: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia, inhibition of piastrinic aggregation. Psychiatric disorders. Not common: insomnia, anxiety; Rares: depression, confusion, hallucinations. Nervous system pathologies. Municipalities: chief; Not common: paresthesia, drowsiness; Rares: optic neuritis. Infections and infestations. Not common: rhinitis; Rares: aseptic meningitis. Synthetic rhinitis and meningitis have been observed especially in patients with pre-existing autoimmune disorders (such as systemic erythematic lupus and mixed connectivity) with symptoms of nucan stiffness, headache, nausea, vomiting, fever or disorientation (see paragraph 4.4). The exacerbation of infection-related inflammations (e.g. development of necrotizing fascites) has been described. Respiratory, thoracic and mediastinic pathologies. Not common: bronchospasmo, dispnea, apnea. Pathologies of the eye. Not common: visual disturbances; Rares: Ocular alteration with consequent visual disorders, toxic optic neuropathy. Ear and labyrinth pathologies. Not common: hearing compromise, tinnitus, vertigo. Hepatobiliary diseases. Not common: abnormal liver function, hepatitis and jaundice; Very rare: liver failure. Pathologies of skin and subcutaneous tissue. Sometimes skin rashes can occur on an allergic basis (hermith, itching, hives). Not common: photosensitivity reactions; Very rare: Bollose dermatitis, including Stevens-Johnson syndrome, tossicaed erythema multiform epidermal necrolysis. In exceptional cases, severe skin infections and pathologies of soft tissues may occur during chickenpox infection (see “infections and infestations”). Notable: reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome), generalized acute hexantholysis (PEAG). Kidney and urinary pathologies. Not common: altered kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrosic syndrome and kidney failure; Rares: hyperazotemia. Systemic pathologies and conditions for administration. Common: malaise, fatigue; Rares: edema. Diagnostic examinations. Rares: increased transaminasis, increased alkaline phosphates, reduced hemoglobin, reduced hematocrite, prolonged bleeding time, decreased blood calcium, increased blood uric acid. Reports of suspicious adverse reactions The reporting of suspicious adverse reactions that occur 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 quarter of pregnancy, Moment should not be administered if not in strictly necessary cases. If Moment 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-idroamnios;

the mother and the newborn, at the end of pregnancy, to

: - possible prolongation of bleeding time, and anti-aggregating effect that may also take place at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently Moment 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, premature 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