MOMENXSIN * 12CPR 200MG + 30MG

  • Angelini Pharma S.p.A
  • 043682020

Symptomatic treatment of nasal congestion associated with acute rhinosinusitis of suspected viral origin with headache and / or fever. Momenxsin is indicated in adults and adolescents aged 15 years and over.

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MOMENXSIN * 12CPR 200MG + 30MG

Therapeutic indications

Symptomatic treatment of nasal congestion associated with acute rhinosinusitis of suspected viral origin with headache and / or fever. Momenxsin is indicated in adults and adolescents aged 15 years and older.

Dosage and method of use

Dosage. Adults and adolescents aged 15 years and over: 1 tablet (equivalent to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 6 hours as needed. In case of more intense symptoms, 2 tablets (equivalent to 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride) every 6 hours if necessary, up to a maximum total daily dose of 6 tablets (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). Do not exceed the maximum total daily dose of 6 tablets (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). For short-term use.If symptoms worsen, consult a doctor. The maximum duration of treatment is 4 days for adults and 3 days for adolescents aged 15 years and over.In cases where the symptoms consist mainly of pain / fever or nasal congestion, administration of a product containing a single active ingredient is preferable.Undesirable effects can be contained by using the lowest effective dose for the shortest time necessary to control symptoms (see section 4.4).Pediatric population: Momenxsin is contraindicated in pediatric patients less than 15 years of age (see section 4.3).Method of administration:For oral use. The tablets should be swallowed whole and not chewed, with a glass of water, preferably with meals.

Contraindications

• Hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or to any of the excipients listed in section 6.1; • Patients under the age of 15; • Women in the third trimester of pregnancy (see section 4.6); • Breastfeeding women (see section 4.6); • Patients with a history of hypersensitivity reactions (eg bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); • History of gastrointestinal bleeding or perforation associated with previous NSAID therapy; • Current or past recurrent peptic ulcer / haemorrhage (at least two distinct episodes of proven ulceration or bleeding); • Cerebrovascular or other bleeding; • Hematopoietic anomalies of unknown origin; • Severe hepatic insufficiency; • Severe renal insufficiency; • Severe heart failure; • Severe cardiovascular disorders, coronary heart disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, pheochromocytoma; • History of stroke or presence of risk factors for stroke (due to α-Â – sympathomimetic activity of pseudoephedrine hydrochloride); • Risk of closed-angle glaucoma; • Risk of urinary retention related to urethroprostatic disorders; • History of myocardial infarction; • History of seizures; • Systemic lupus erythematosus; • Concomitant use of other vasoconstrictors such as nasal decongestants, administered orally or nasally (eg phenylpropanolamine, phenylephrine and ephedrine), and methylphenidate (see section 4.5); • Concomitant use of non-selective monoamine oxidase inhibitors (MAOIs) (iproniazid) (see section 4.5) or use of monoamine oxidase inhibitors within the last two weeks.

Side effects

The most commonly observed adverse reactions related to ibuprofen are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding, including fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following its administration (see section 4.4 Special warnings and precautions for use). . Gastritis was found less frequently. In general, the risk of experiencing adverse reactions (particularly serious gastrointestinal complications) increases with increasing dose and duration of treatment. Hypersensitivity reactions have been reported following treatment with ibuprofen, which may include: (a) non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm or dyspnoea; (c) various skin disorders, including various skin rashes, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). In patients with active autoimmune disorders (such as systemic lupus erythematosus or mixed connective tissue disease), isolated cases of aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever or disorientation have been observed during treatment with ibuprofen. . Edema, hypertension and heart failure have been reported in association with the use of NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). The list of adverse reactions below refers to reactions that occurred with ibuprofen and pseudoephedrine hydrochloride at doses contained in over-the-counter drugs, for short-term use. In the treatment of chronic conditions, further adverse reactions may occur in the course of long-term treatment. Patients should be advised to stop taking Momenxsin immediately and consult a physician in case of a severe adverse drug reaction. very common (≥1 / 10); common (≥1 / 100,

Infections and infestations Ibuprofen Very rare Exacerbation of infectious inflammations (e.g. necrotizing fasciitis), aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or disorientation) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease )
Disorders of the blood and lymphatic system Ibuprofen Very rare Haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis)
Disorders of the immune system Ibuprofen Uncommon Hypersensitivity reactions with hives, itching and asthma attacks (with drop in blood pressure)
Ibuprofen and Pseudoephedrine hydrochloride Very rare Severe generalized hypersensitivity reactions, signs of which may be facial edema, angioedema, dyspnoea, tachycardia, low blood pressure, anaphylactic shock
Psychiatric disorders Ibuprofen Very rare Psychotic reactions, depression
Pseudoephedrine hydrochloride Not known Agitation, hallucinations, anxiety, abnormal behavior, insomnia
Nervous system disorders Ibuprofen Uncommon Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or tiredness
Pseudoephedrine hydrochloride Rare Insomnia, nervousness, anxiety, restlessness, tremors, hallucinations
Pseudoephedrine hydrochloride Not known Hemorrhagic stroke, ischemic stroke, convulsions, headache
Eye disorders Ibuprofen Uncommon Visual disturbances
Ear and labyrinth disorders Ibuprofen Rare Tinnitus
Cardiac pathologies Ibuprofen Very rare Palpitations, heart failure, myocardial infarction
Pseudoephedrine hydrochloride Not known Palpitations, tachycardia, chest pain, arrhythmia
Vascular pathologies Ibuprofen Very rare Hypertension
Pseudoephedrine hydrochloride Not known Hypertension
Respiratory, thoracic and mediastinal disorders Pseudoephedrine hydrochloride Rare Exacerbation of asthma or hypersensitivity reaction with bronchospasm
Gastrointestinal disorders Ibuprofen Common Gastrointestinal discomfort, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, mild gastrointestinal bleeding which in rare cases leads to anemia
Ibuprofen Uncommon Gastrointestinal ulcers in some cases associated with bleeding and / or perforation, gastritis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4)
Ibuprofen Very rare Esophagitis, pancreatitis, diaphragm-like intestinal stricture
Pseudoephedrine hydrochloride Not known Dry mouth, thirst, nausea, vomiting, ischemic colitis
Hepatobiliary disorders Ibuprofen Very rare Hepatic dysfunction, liver damage, especially with prolonged therapy, liver failure, acute hepatitis
Skin and subcutaneous tissue disorders Ibuprofen Uncommon Various skin rashes
Ibuprofen Very rare Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia, severe skin infections and soft tissue complications in case of chickenpox infection
Ibuprofen Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalized exanthematous pustulosis (AGEP)
Pseudoephedrine hydrochloride Not known Rash, urticaria, pruritus, hyperhidrosis, severe skin reactions including acute generalized exanthematous pustulosis (AGEP)
Renal and urinary disorders Ibuprofen Rare Damage to kidney tissue (papillary necrosis) and high concentrations of uric acid in the blood
Ibuprofen Very rare Increased serum creatinine, edema (particularly in patients with arterial hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal failure
Pseudoephedrine hydrochloride Not known Difficulty in urination

Reporting of suspected adverse reactions:

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Concomitant use of Momenxsin and other NSAIDs, including selective cyclo-oxygenase (COX) -2 inhibitors, should be avoided. Undesirable effects can be reduced by using the lowest effective dose necessary to control symptoms for the shortest time possible (see sections "Gastrointestinal effects" and "Cardiovascular and cerebrovascular effects" below). If symptoms persist beyond the maximum duration treatment with this medicinal product (4 days for adults and 3 days for adolescents), the measures to be taken, in particular the possible usefulness of an antibiotic treatment, should be re-evaluated. Acute rhinosinusitis of suspected viral origin is defined as a series of bilateral rhinological symptoms of moderate intensity, dominated by nasal congestion with severe or purulent rhinorrhea, which occurs in an epidemic setting. The purulent appearance of rhinorrhea is common and does not consistently correspond to bacterial superinfection. Sinus pain in the first days of the pathology it is associated with the congestion of relat mucosal vat (acute congestive rhinosinusitis) and in most cases it resolves spontaneously. In case of acute bacterial sinusitis, the use of antibiotic therapy is justified. Special warnings related to pseudoephedrine hydrochloride:• The posology, the maximum recommended duration of treatment (4 days for adults and 3 days for adolescents) and contraindications must be strictly observed (see section 4.8); • Patients should be advised that treatment should be discontinued if hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs such as the onset or worsening of headache occur; • Ischemic colitis Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain, rectal bleeding or other symptoms of ischemic colitis develop, pseudoephedrine should be discontinued and a physician consulted.Severe skin reactions:Severe skin reactions such as acute and generalized exanthematous pustulosis (AGEP) can occur with products containing pseudoephedrine. This acute pustular rash can occur within the first 2 days of treatment, with fever and numerous, mostly non-follicular, small pustules resulting from a widespread edematous erythema and located mainly on the skin folds, trunk and upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, administration of Momenxsin should be discontinued and appropriate measures taken if necessary. Before using this medicine, patients should consult their doctor in case of: • hypertension, heart disease, hyperthyroidism, psychosis or diabetes; • concomitant intake of anti-migraine drugs, in particular vasoconstrictors based on ergot alkaloids (due to the α-sympathomimetic activity of pseudoephedrine); • mixed connective tissue disease: increased risk of aseptic meningitis (see section 4.8); • Neurological symptoms such as seizures, hallucinations, behavioral disturbances, agitation and insomnia have been described following the administration of systemic vasoconstrictors, especially during febrile episodes or in case of overdose. Such symptoms were reported more commonly in the pediatric population. Therefore it is advisable: • to avoid the administration of Momenxsin in combination with drugs that can lower the epileptogenic threshold, such as terpene derivatives, clobutinol, atropine-like substances and local anesthetics, or in the presence of a history of seizures; cases, at the recommended posology and inform patients about the risks of overdose if Momenxsin is taken concomitantly with other vasoconstrictor containing medicinal products. Patients with urethroprostatic disorders are more prone to developing symptoms such as dysuria and urinary retention. Elderly patients may be more sensitive to central nervous system (CNS) effects. Usage precautions related to pseudoephedrine hydrochloride:• In patients undergoing scheduled surgery where halogenated volatile anesthetics are planned, it is preferable to discontinue treatment with Momenxsin several days prior to surgery, due to the risk of acute hypertension (see section 4.5); • Athletes should be advised that treatment with pseudoephedrine hydrochloride may result in positive doping tests.Interference with serological tests:Pseudoephedrine has the potential to reduce iobenguane I-131 uptake in neuroendocrine tumors, thus interfering with scintigraphy. Special warnings regarding ibuprofen:Bronchospasm may occur in patients suffering from bronchial asthma or allergic diseases or with a history of such conditions. In case of asthma, the product should not be taken without first consulting a doctor (see section 4.3). Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis are at an increased risk of allergic reactions when taking acetylsalicylic acid and / or NSAIDs. Administration of Momenxsin may trigger an acute asthma attack, particularly in some patients allergic to acetylsalicylic acid or an NSAID (see section 4.3). Prolonged use of any type of pain reliever for headache can cause them to worsen. If this situation is found or suspected, medical advice should be sought and treatment discontinued. The diagnosis of drug overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or due to) regular use of headache medications. Before using this medicine, patients suffering from blood clotting disorders should consult their doctor. Gastrointestinal Effects: Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, has been reported at any stage of treatment with the use of all NSAIDs, with or without warning symptoms or previous gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation, sometimes fatal, increases the higher the doses of NSAIDs, in patients with a history of ulcer, particularly if complicated with bleeding or perforation (see section 4.3) and in the elderly. These patients should start treatment with the lowest available dose. For these patients and for those taking concomitant treatment with low dose acetylsalicylic acid or other medicinal products that may increase the risk of gastrointestinal events, combination therapy with gastroprotectors (e.g. misoprostol or proton pump inhibitors) should be considered. (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially in the early stages of treatment. Particular caution is advised in patients on concomitant treatment with drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as acetylsalicylic acid (see section 4.5 ). Treatment with Momenxsin should be discontinued immediately in case of gastrointestinal bleeding or ulceration. 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). In case of concomitant alcohol intake, the use of NSAIDs may increase undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system. Cardiovascular and cerebrovascular effects: The following conditions are subject to contraindications due to the presence of pseudoephedrine hydrochloride (see section 4.3): severe cardiovascular disorders, coronary heart disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, pheochromocytoma, history of stroke or the presence of risk for stroke, history of myocardial infarction. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg / day), may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg / day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, heart failure (NYHA II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disorders should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. Careful consideration should also be made before patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) undertake long-term treatment, particularly if high doses of ibuprofen (2400 mg / day). Severe skin reactions: 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 for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Severe skin reactions, such as acute generalized exanthematous pustulosis (PEAG), can occur with medicines containing ibuprofen and pseudoephedrine. This acute pustular rash can occur within the first 2 days of treatment, with fever and numerous, mostly non-follicular, small pustules resulting from a widespread edematous erythema and located mainly on the skin folds, trunk and upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, as well as the appearance of rash, mucosal lesions or any other signs of hypersensitivity, administration of Momenxsin should be discontinued and appropriate measures taken if necessary.Masking Symptoms of Underlying Infections:Momenxsin can mask the symptoms of infection, which could delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Momenxsin is given for the relief of infection-related fever or pain, monitoring of infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Precautions for use related to ibuprofen: • Elderly: The pharmacokinetics of ibuprofen are not affected by age, therefore no dosage adjustments are required in the elderly. However, elderly patients should be carefully monitored, as they are more sensitive to NSAID-related undesirable effects, in particular gastrointestinal bleeding and perforation, which can be fatal; • Caution and special monitoring are required when administering ibuprofen to patients with a history of gastrointestinal disease (such as peptic ulcer, hiatal hernia or gastrointestinal haemorrhage); • In the initial stages of treatment, careful monitoring of diuresis and renal function is necessary in patients with heart failure, in patients with chronic renal or hepatic impairment, in patients taking diuretics, in patients hypovolaemic due to surgery major surgery and, in particular, in elderly patients. Dehydrated adolescents are at risk of kidney damage; • In case of visual disturbances during treatment, the patient should undergo a complete ophthalmological examination. Important information about some of the ingredients. Momenxsin contains: -Sodium:this medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

Pregnancy. Pseudoephedrine hydrochloride:Animal studies have shown reproductive toxicity (see section 5.3). The use of pseudoephedrine hydrochloride reduces the uterine blood flow of the mother, but clinical data on the effects on pregnancy are insufficient.Ibuprofen: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryonic / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with dose and duration of therapy. Administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation losses and embryonic / fetal lethality in animals. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. If a woman attempting to conceive or in the first or second trimester of pregnancy is to take ibuprofen, 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 oligohydramnios;the mother and the child, at the end of pregnancy:- possible prolongation of bleeding time, an antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions with consequent delay or prolongation of labor. Consequently this medicinal product is: contraindicated in the third trimester of pregnancy and should only be administered as strictly necessary in the first and second trimester.Feeding time:The need to take measures during breastfeeding stems from the presence of pseudoephedrine hydrochloride in the drug formulation: pseudoephedrine hydrochloride is excreted in breast milk. Taking into account the potential cardiovascular and neurological effects of vasoconstrictors, the use of this medicine is contraindicated during breastfeeding.Fertility:There is evidence that cyclo-oxygenase / prostaglandin synthesis inhibitors can impair female fertility by affecting ovulation. The effect is reversible upon discontinuation of treatment.

Expiration and retention

Do not store above 30 ° C.

Interactions with other drugs

Association of pseudoephedrine with: Possible reaction
Non-selective MAOIs (iproniazid) Paroxysmal hypertension and hyperthermia, which can be fatal. Due to the long duration of action of MAOIs, this interaction can occur up to 15 days after the discontinuation of the IMAO.
Other indirectly acting sympathomimetics or vasoconstrictors administered orally or nasally, α-sympathomimetic drugs, phenylpropanolamine, phenylephrine, ephedrine, methylphenidate Risk of vasoconstriction and / or hypertensive crisis.
Reversible inhibitors of monoamine oxidase A (RIMA), linezolid, dopaminergic ergot alkaloids, vasoconstrictive ergot alkaloids Risk of vasoconstriction and / or hypertensive crisis.
Volatile halogenated anesthetics Acute perioperative hypertension. In case of scheduled surgery, stop taking Momenxsin several days in advance.
Guanethidine, reserpine and methyldopa The effect of pseudoephedrine may be attenuated.
Tricyclic antidepressants The effect of pseudoephedrine may be attenuated or enhanced.
Digitalis, quinidine or tricyclic antidepressants Increased frequency of arrhythmias.
Concomitant use of ibuprofen with: Possible reaction
Other NSAIDs, including salicylates and selective COX-2 inhibitors Concomitant administration of several NSAIDs could increase the risk of gastrointestinal bleeding and ulcers due to a synergistic effect. Therefore, the concomitant use of ibuprofen with other NSAIDs should be avoided (see section 4.4).
Digoxin Concomitant use of Momenxsin with digoxin preparations may increase serum levels of the latter. With proper use (maximum 4 days), a check of serum digoxin levels is generally not necessary.
Corticosteroids Corticosteroids may increase the risk of adverse reactions, particularly affecting the gastrointestinal tract (gastrointestinal bleeding or ulceration) (see section 4.3).
Antiplatelet agents Increased risk of gastrointestinal bleeding (see section 4.4).
Acetylsalicylic acid In general, concomitant administration of ibuprofen and acetylsalicylic acid is not recommended due to the potential for increased adverse effects. Experimental data suggest that ibuprofen could result in competitive inhibition of the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are taken simultaneously. Despite doubts regarding the applicability of these data to clinical situations, the possibility that regular long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be ruled out. No clinically relevant effects are considered likely following the occasional use of ibuprofen (see section 5.1).
Anticoagulants (e.g. warfarin, ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost) NSAIDs such as ibuprofen may potentiate the effects of anticoagulants (see section 4.4).
Phenytoin Concomitant use of Momenxsin with phenytoin preparations may increase the serum levels of the latter. With correct use (maximum 4 days), a control of serum phenytoin levels is generally not necessary.
Selective Serotonin Reuptake Inhibitors (SSRIs) Increased risk of gastrointestinal bleeding (see section 4.4).
Lithium Concomitant use of Momenxsin with lithium-based preparations may increase the serum levels of the latter. With proper use (maximum 4 days), a check of serum lithium levels is generally not necessary.
Probenecid and sulfinpyrazone Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen.
Diuretics, ACE inhibitors, beta blockers and angiotensin II antagonists NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), concomitant administration of ACE inhibitors, beta-blockers or angiotensin II antagonists and agents that inhibit cyclo-oxygenase may induce further deterioration renal function, including any acute renal failure which is usually reversible. Therefore, this combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter.
Potassium-sparing diuretics Concomitant administration of Momenxsin and potassium-sparing diuretics may cause hyperkalaemia (monitoring of serum potassium levels is recommended).
Methotrexate Administration of Momenxsin within 24 hours before or after methotrexate intake may increase its concentrations and toxic effects.
Cyclosporine The risk of cyclosporine-induced kidney damage is increased by the concomitant use of some non-steroidal anti-inflammatory drugs. This effect cannot be excluded even in the case of simultaneous intake of cyclosporine and ibuprofen.
Tacrolimus The risk of nephrotoxicity increases if the two medicines are administered simultaneously.
Zidovudine There is evidence of an increased risk of haemarthrosis and hematoma in HIV (+) haemophilia patients receiving concomitant treatment with zidovudine and ibuprofen.
Sulfonylureas Clinical research has shown the existence of interactions between non-steroidal anti-inflammatory drugs and antidiabetic drugs (sulfonylureas). Although interactions between ibuprofen and sulfonylureas have not been described so far, it is advisable, as a precaution, to check blood glucose values in case of concomitant intake of these two drugs.
Quinolone antibiotics Animal studies indicate that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may be at an increased risk of experiencing seizures.
Heparin;gingko biloba Increased risk of bleeding.

Overdose

The clinical effects of overdose are more likely due to the presence of pseudoephedrine hydrochloride in this product rather than ibuprofen. The effects are not clearly related to the dose taken due to the different sensitivity of the various individuals to sympathomimetic properties.Symptoms due to the sympathomimetic effectCNS depression: e.g. sedation, apnea, cyanosis, coma CNS stimulation (more likely in children): e.g. insomnia, hallucinations, convulsions, tremors. In addition to the symptoms already mentioned as side effects, the following symptoms may occur: hypertensive crisis, cardiac arrhythmias, muscle weakness and tension, euphoria, excitement, thirst, chest pain, dizziness, tinnitus, ataxia, blurred vision, hypotension.Symptoms related to ibuprofen (in addition to the gastrointestinal and neurological ones already mentioned as side effects)Somnolence, nystagmus, tinnitus, hypotension, loss of consciousness. In cases of severe poisoning, metabolic acidosis may occur.Therapeutic measuresThere are no specific antidotes available. If the patient presents within one hour of taking a potentially toxic amount of drug, oral activated charcoal may be considered. An electrolyte check and an ECG are also required. In the event of cardiovascular instability and / or symptomatic electrolyte imbalance, symptomatic treatment should be initiated.

Active principles

Each film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.Excipient with known effects:sodium. For the full list of excipients, see section 6.1.

Excipients

Tablet core:Microcrystalline cellulose; Calcium hydrogen phosphate anhydrous; Croscarmellose sodium;Cornstarch; Anhydrous colloidal silica; Magnesium stearate.Tablet coating:Hypromellose; Macrogol 400; Talc; Titanium dioxide (E171); Yellow iron oxide (E172).

043682020

Data sheet

Packaging
200 mg / 30 mg 12 film-coated tablets
Product Type
HUMAN DRUG
ATC code
R05X
ATC description
Other preparations for colds
Therapeutic Group
Antipyretics, NSAID analgesics
Active principle
ibuprofen + pseudoephedrine
Class
C.
Pharmaceutical form
coated tablets
Type of Administration
oral
Container
cpr / cps / pills / confetti in blister packs
Quantity
12 tablet
Quantity of the Active Ingredient
200MG (ibuprofen) + 30MG (pseudoephedrine hydrochloride)
Recipe required
OTC - self-medication medicine
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