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.
Active Ingredients
Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride. Excipient with known effect: sodium. For the full list of excipients, see section 6.1.
Excipients
Tablet core: Microcrystalline cellulose; Calcium hydrogen phosphate anhydrous; Croscarmellose sodium ; Maize starch; Colloidal anhydrous silica; Magnesium stearate. Tablet coating: Hypromellose; Macrogol 400; Talc; Titanium dioxide (E171); Yellow iron oxide (E172).
Dosage
Dosage. Adults and adolescents aged 15 years and over : 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 6 hours if necessary. In case of more severe symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride) every 6 hours if necessary, up to a maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride). Do not exceed the maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg 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 predominantly of pain/fever or nasal congestion, the administration of a product containing a single active ingredient is preferable. Undesirable effects can be limited by using the lowest effective dose for the shortest time necessary to control the symptoms (see section 4.4). Paediatric population : Momenxsin is contraindicated in paediatric patients under 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 during meals.
Warnings
Concomitant use of Momenxsin and other NSAIDs, including selective cyclooxygenase (COX)-2 inhibitors, should be avoided. Undesirable effects may be minimised by using the lowest effective dose necessary to control symptoms for the shortest duration possible (see sections "Gastrointestinal effects" and "Cardiovascular and cerebrovascular effects" below). If symptoms persist beyond the maximum recommended duration of treatment with this medicinal product (4 days for adults and 3 days for adolescents), the measures to be implemented, in particular the possible usefulness of 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 rhinorrhoea, occurring in an epidemic context. The purulent aspect of rhinorrhoea is common and does not systematically correspond to bacterial superinfection. Sinus pain in the first few days of the disease is associated with congestion of the sinus mucosa (acute congestive rhinosinusitis) and resolves spontaneously in most cases. In case of acute bacterial sinusitis, antibiotic therapy is justified. Special warnings related to pseudoephedrine hydrochloride : • The dosage, the maximum recommended duration of treatment (4 days for adults and 3 days for adolescents) and the contraindications must be strictly respected (see section 4.8); • Patients should be informed that treatment must be discontinued if hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs, such as the onset or worsening of headache, appear; • 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 doctor should be consulted. Serious skin reactions: Serious skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with products containing pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules arising from a widespread edematous erythema and located mainly on the skin folds, trunk and upper limbs. Patients should 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 use of antimigraine 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. These symptoms have been reported more commonly in the pediatric population. Therefore, it is advisable to: • avoid the administration of Momenxsin in association with drugs that can lower the epileptogenic threshold, such as terpene derivatives, clobutinol, atropine-like substances and local anaesthetics, or in the presence of a history of seizures; • strictly adhere, in all cases, to the recommended dosage and inform patients about the risks of overdose if Momenxsin is taken concomitantly with other medicinal products containing vasoconstrictors. Patients with urethroprostatic disorders are more likely to develop symptoms such as dysuria and urinary retention. Elderly patients may be more sensitive to the effects on the central nervous system (CNS). Precautions for use relating to pseudoephedrine hydrochloride : • In patients who are scheduled to undergo surgery in which volatile halogenated anaesthetics are to be used, it is preferable to discontinue treatment with Momenxsin several days before the operation, in view of the risk of acute hypertension (see section 4.5); • Athletes should be informed that treatment with pseudoephedrine hydrochloride may result in positive anti-doping tests. Interference with serological tests: Pseudoephedrine may potentially reduce the uptake of iobenguane i-131 in neuroendocrine tumors, thereby interfering with scintigraphy. Special warnings related to ibuprofen : In patients suffering from bronchial asthma or allergic diseases or with a history of these diseases, bronchospasm may occur. In case of asthma, the product should not be taken without first consulting a doctor (see section 4.3). Patients suffering from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are exposed to a greater risk of allergic reactions in case of intake of acetylsalicylic acid and/or NSAIDs. The 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 painkiller for headache may cause it to worsen. If this situation is observed or suspected, medical advice should be sought and treatment should be discontinued. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) the regular use of headache medications. Patients with blood clotting disorders should consult their doctor before using this medicine. Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of GI events. The risk of gastrointestinal bleeding, ulceration or perforation, sometimes fatal, is increased with increasing NSAID doses, 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 on the lowest available dose. Combination therapy with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for those taking concomitant low dose acetylsalicylic acid or other medicinal products likely to increase GI risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (in particular GI bleeding), particularly in the initial stages of treatment. Particular caution is advised in patients receiving concomitant treatment with drugs which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as acetylsalicylic acid (see section 4.5). Treatment with Momenxsin should be discontinued immediately in the event 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 intake of alcohol, the use of NSAIDs may increase the undesirable effects related to the active substance, in particular those affecting the gastrointestinal tract or the central nervous system. Cardiovascular and cerebrovascular effects: The following conditions are contraindicated 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 presence of risk factors for stroke, history of myocardial infarction. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example 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 ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be given 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) are required. 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). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), may occur with medicinal products containing ibuprofen and pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous small, mostly non-follicular pustules arising from a widespread oedematous erythema and located mainly in the skin folds, trunk and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules, as well as the appearance of a skin rash, mucosal lesions or any other sign of hypersensitivity are observed, administration of Momenxsin should be discontinued and appropriate measures taken if necessary. Masking of symptoms of underlying infections: Momenxsin may mask the symptoms of infection, which may delay 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 varicella. When Momenxsin is administered for the relief of infection-related fever or pain, monitoring for 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 adjustment is necessary in the elderly. However, elderly patients should be carefully monitored, as they are more sensitive to adverse reactions related to NSAIDs, in particular gastrointestinal bleeding and perforation, which may be fatal; • Caution and special monitoring are required when ibuprofen is administered to patients with a history of gastrointestinal disease (such as peptic ulcer, hiatus 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 who are hypovolaemic due to major surgery and, in particular, in elderly patients. Dehydrated adolescents are at risk of renal damage; • If vision changes during treatment, the patient should undergo a complete ophthalmological examination. Important information about some of the excipients. Momenxsin contains: - Sodium: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Conservation
Do not store above 30°C.
Contraindications
• Hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or to any of the excipients listed in section 6.1; • Patients under 15 years of age; • Women in the third trimester of pregnancy (see section 4.6); • Breast-feeding women (see section 4.6); • Patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); • History of gastrointestinal bleeding or perforation associated with previous NSAID therapy; • Current or history of recurrent peptic ulcer/haemorrhage (at least two distinct episodes of proven ulceration or bleeding); • Cerebrovascular or other bleeding; • Haematopoietic abnormalities of unknown origin; • Severe hepatic insufficiency; • Severe renal insufficiency; • Severe cardiac insufficiency; • 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 the α-–sympathomimetic activity of pseudoephedrine hydrochloride); • Risk of narrow-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 (e.g. 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, perforation or gastrointestinal bleeding, even fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, 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 has been observed 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 rashes of various types, 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 symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation, have been observed during treatment with ibuprofen. Oedema, hypertension and cardiac failure have been reported in association with the use of NSAIDs. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). The list of adverse reactions reported below refers to reactions seen with over-the-counter doses of ibuprofen and pseudoephedrine hydrochloride for short-term use. In the treatment of chronic conditions, additional adverse reactions may occur during long-term treatment. Patients should be advised to stop taking Momenxsin immediately and seek medical advice in the event of a serious adverse drug reaction. very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Overdose
The clinical effects of overdose are most likely due to the presence of pseudoephedrine hydrochloride in this product, rather than ibuprofen. The effects are not clearly related to the dose taken because of the different sensitivity of different individuals to the sympathomimetic properties. Symptoms due to the sympathomimetic effect CNS 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 adverse 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 symptoms already mentioned as adverse effects) Drowsiness, nystagmus, tinnitus, hypotension, loss of consciousness. In severe poisoning, metabolic acidosis may occur. Therapeutic measures There are no specific antidotes. If the patient presents within one hour of ingestion of a potentially toxic amount of the drug, oral activated charcoal may be considered. Monitoring of electrolytes and performing an ECG are also necessary. In case of cardiovascular instability and/or symptomatic electrolyte imbalance, symptomatic treatment should be initiated.
Pregnancy
Pregnancy. Pseudoephedrine hydrochloride: Animal studies have shown reproductive toxicity (see section 5.3). The use of pseudoephedrine hydrochloride reduces maternal uterine blood flow, but clinical data on the effects on pregnancy are insufficient. Ibuprofen : Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryonic/foetal 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 proportionally with the dose and duration of therapy. Administration of a prostaglandin synthesis inhibitor to animals has been shown to result in increased pre- and post-implantation loss and embryonic/foetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If a woman attempting to conceive or who is in the first or second trimester of pregnancy must 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 may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligohydramnios; the mother and child, at the end of pregnancy: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, this medicinal product is: contraindicated in the third trimester of pregnancy and should be administered only when strictly necessary in the first and second trimester. Breastfeeding: The need to take measures during breastfeeding arises from the presence of pseudoephedrine hydrochloride in the formulation of the medicinal product: pseudoephedrine hydrochloride is excreted in breast milk. Taking into account the potential cardiovascular and neurological effects of vasoconstrictors, the use of this medicinal product is contraindicated during breastfeeding. Fertility: There is evidence that cyclooxygenase/prostaglandin synthesis inhibitors may impair female fertility by affecting ovulation. The effect is reversible upon discontinuation of treatment.
