MOMENTACT 10CPS MOLLI 400MG

MOMENTACT 400 MG CAPSULE MOLLI

active ingredients

Each capsule contains: Active ingredient: ibuprofen 400 mg Excipients with known effects: sorbitol, Ponceau 4R (E124)For the complete list of excipients see paragraph 6.1.

Excellent

Macrogol 600, potassium hydroxide, jelly, sorbitol partially dehydrated liquid, purified water, ponceau 4R (E124), lecithin, crushed coconut oil.

Therapeutic indications

Momentact is indicated in adults and adolescents over the age of 12. Pain from various origins and nature (headache, toothache, neuralgia, osteo-articolar and muscle pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu states.

Contraindications

• Hypersensitivity to the active ingredient, to other antireumatics (acetylsalicylic acid, etc.) or to any of the excipients listed in the paragraph 6.1. • Do not administer children under 12 years of age. • Ibuprofen is contraindicated during the third trimester of pregnancy and during lactation. • 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). • Severe dehydration (caused by vomiting, diarrhea or insufficient liquid supply).

Population

Population Adults and teenagers over 12 years: 1 capsule 2-3 times a day. Do not exceed the dose of 3 capsules per day. 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). In case the use of the medicinal product is necessary for more than 3 days in adolescents, or in case of worsening of symptomatology, the doctor must be consulted. Do not exceed the recommended doses: especially older patients must comply with the above minimum dosages. Seniors: NSAIDs must be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of potentially fatal gastrointestinal hemorrhage, ulceration or perforation (see paragraph 4.4). If the treatment is considered necessary, the lowest dose should be used for the shortest duration necessary for the control of symptoms (see paragraph 4.4). Renal insufficiency: in patients with mild or moderate renal function reduction, the dosage must be kept as low as possible for the shortest duration necessary to control symptoms and renal function must be monitored. Epathetic 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. Momentact is contraindicated in patients with severe liver failure (see paragraph 4.3). Pediatric population Momentact is contraindicated in children under the age of 12 (see paragraph 4.3). Method of administration You can take Momentact on an empty stomach. In subjects with problems of gastric tolerability, it is preferable to take the medicine on a full stomach.

Conservation

Store at a temperature below 25°C.

Warnings

• The use of Momentact, as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to begin a pregnancy. • The administration of Momentact 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). • Senior 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 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. NSAIDs can reduce the effect of diuretics, to other antihypertensive drugs (see paragraph 4.5). 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. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful evaluation. Analogue considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (p.es. hypertension, hyperlipidemia, diabetes mellitus, smoking). • Gastrointestinal bleeding, ulceration and drilling The use of Momentact must be avoided in conjunction with NSAIDs, including selective cycloxygenase-2 inhibitors (COX-2), due to an increase in the risk of ulceration or bleeding (see paragraph 4.5). In particular, 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, particularly 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 (SSRIs) or anti-aggregating agents such as acetilsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking Momentact, treatment must 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). • Dermatory effects Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momentact must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity as well as if visual disturbances or persistent signs of liver dysfunction occur. • 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. • Respiratory disorders Momentact 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, hives 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. • Aseptic 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 central nervous system. • Hybuprofen can mask signs or symptoms of infection (fever, pain and swelling). Important information about some excipients Momentact capsule contains: - Sorbitol (E420)): this medicine contains 23.46 mg of sorbitol per dose, equivalent to 23.46 mg/1180 mg. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medicines co- administered; - Ponceau 4R (E124): can cause allergic reactions.

Interactions

It is advisable to use the doctor's advice in case of any concomitant therapy before the administration of the product. 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. • 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). You should not associate ibuprofen with other NSAIDs, including selective COX-2 inhibitors, for potential additive effect (see section 4.4). • 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). • Anti-aggregating agents and selective serotonin reuptake 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 Momentact 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 prolong and 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 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 their 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 oxypentiphylline (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 Momentact were reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, 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; non-common: hypersensitivity reactions such as rash of various types, hives, itching, porporous, angioedema, esantema, reaction to the respiratory tract including asthma, also severe, bronchospasm or dispnea asthmatic attack (sometimes with hypotension); rare: lupus erythematose syndrome; very rare: severe hypersensitivity reactions. Symptoms may include: edema of the face, edema of the tongue, edema of the larynx edema of the airways with constriction, dispnea, tachycardia, anaphylaxis, exfoliative dermatitis and bollose (including Stevens-Johnson syndrome, toxic epidermal necrolysis and multiform erythema). Heart and vascular disease In association with NSAID treatment, edema, fatigue, hypertension and heart failure were reported. 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, edema, hypertension. Other adverse events reported with less frequency and for which a causality has not necessarily been established include: Emolinfopoietic system pathologies Rares: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia. Psychiatric disorders Not common: insomnia, anxiety. Rares: depression, confusion, hallucinations. Diseases of the nervous system Municipalities: chief. Not common: paresthesia, drowsiness. Rares: optic neuritis. Infections and infestations Not common. Rares: aseptic meningitis Rinite and aseptic meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosis and mixed connecttivitis) with symptoms of nucal 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. Thoracic and mediastinic respiratory 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 reactions, including Stevens-Johnson syndrome and epidermal toxic necrolysis. In exceptional cases, severe skin infections and pathologies of soft tissue may occur during chickenpox infection (see "infections and infestations"). Notable: reaction from drug with eosinophilia and systemic symptoms (DrESS syndrome). Kidney and urinary pathologies Non-common: damage of kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrosic syndrome and kidney failure. Systemic pathologies and conditions for administration Common: malaise, fatigue. Rares: edema. Reporting 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 http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa.

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, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the 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 must be taken into account the gastric lavender. 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 has shown to cause an increase in the loss of pre- and post-planning and embryofetal 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, Momentact should not be administered if not in strictly necessary cases. If Momentact 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 fetus to

: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios;

At the end of pregnancy, all prostaglandin synthesis inhibitors can expose the mother and the newborn, to

:- possible prolongation of bleeding time, and anti-aggregating effect that may also occur at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Therefore Momentact 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