MOMENXSIN 12CPR 200MG+30MG

MOMENXSIN 200 MG/30 MG COMPRESSE RIVESTITE WITH FILM.

active ingredients

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 paragraph 6.1.

Excellent

Compressed core: Microcrystalline cellulose; Hydrogen calcium phosphate anidro; Croscarmellosa Sodica; Corn starch; Anidra colloidal silica; Magnesium stearate. Coating of the tablet: Ipromellosa; Macrogol 400; Talco; Titanium Dioxide (E171); Yellow iron oxide (E172).

Therapeutic indications

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

Contraindications

• Hypersensitivity to ibuprofen, pseudo-ephedrine hydrochloride or any of the excipients listed in paragraph 6.1; • Patients under 15 years of age; • Women in the third quarter of pregnancy (see paragraph 4.6); • nursing women (see paragraph 4.6); • Patients with anamnesis of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); • History of bleeding or gastrointestinal perforation associated with an earlier NSAID-based therapy; • Recurring peptic ulceration; • cerebrovascular bleeding or other nature; • Hemopoietic abnormalities of unknown origin; • Severe liver failure; • Severe kidney failure; • Severe heart failure; • Pregnant cardiovascular disorders, coronary heart disease (cardiopathy, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, feochromocytoma; • History of strokes or presence of risk factors for stroke (due to α-simpaticomimetic activity of pseudoephedrine hydrochloride); • Closed angle glaucoma risk; • Urinary retention risk related to uretroprostatic disorders; • Myocardial infarction history; • Convulsive crisis history; • Systemic erythematous lupus; • Concurrent use of other vasoconstrictors such as nasal decongestants, administered by mouth or nasal (e.g. phenylpropanolamin, phenylphrine and ephedrine), and methylfenidate (see paragraph 4.5); • Concurrent use of non-selective inhibitors of monoamino oxidase (IMAO) (hyproniazide) (see paragraph 4.5) or use of monoamino oxidase inhibitors in the last two weeks.

Population

Posology. Adults and teenagers aged 15 or older: 1 tablet (equivalent to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 6 hours if necessary. In case of more intense symptoms, 2 tablets (equivalent to 400 mg of ibuprofen and 60 mg of pseudoefedrine hydrochloride) every 6 hours if necessary, up to a maximum 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 teenagers aged 15 or older. In cases where symptoms consist mainly of pain or fever or nasal congestion, it is preferable to administer a product containing a single active ingredient. Undesirable effects can be contained with the use of the minimum effective dose for the shortest time necessary to control symptoms (see paragraph 4.4).Pediatric population: Momenxsin is contraindicated in pediatric patients under 15 years of age (see paragraph 4.3). Method of administration: For oral use. The tablets must be swallowed whole and not chewed, with a glass of water, preferably during meals.

Conservation

Do not store at temperature above 30°C.

Warnings

Concurrent use of Momenxsin and other NSAIDs, including selective cyclo-oxidase inhibitors (COX)-2, should be avoided. Undesirable effects can be reduced by using for as short as possible the effective minimum dose needed to control symptoms (see "Gatrointestinal Effects" and "Cardiovascular and cerebrovascular Effects" below). If symptoms persist over the recommended maximum duration of treatment with this medicine (4 days for adults and 3 days for teenagers), the measures to be taken must be reassessed, in particular the possible use of antibiotic treatment. The acute rhinositis of suspect viral origin is defined as a series of bilateral rhinological symptoms of moderate intensity, dominated by nasal congestion with severe or purulent rhinology, which occurs in an epidemic context. The purulent appearance of rhorrhea is common and does not systematically correspond to a bacterial over infection. Pain to paranasal breasts in the first days of the pathology is associated with the congestion of its mucosa (renoxious acute congestive) and in most cases spontaneously resolves. In case of acute bacterial sinusitis, the use of antibiotic therapy is justified. Special warnings related to pseudoephedrine hydrochloride: • Posology, the recommended maximum duration of treatment (4 days for adults and 3 days for teenagers) and contraindications must be strictly respected (see paragraph 4.8); • Patients should be informed that the treatment should be suspended if hypertension, tachycardia, palpitations, heart arrhythmias, nausea or any neurological sign, such as onset or worsening of cephalea; • Ischemic Colite Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain develops, rectal bleeding or other symptoms of ischemic colitis, pseudoephedrine should be suspended and consult a doctor. Severe skin reactions: Severe skin reactions such as acute and generalized exantematic pustolosis (AGEP) can occur with products containing pseudoephedrine. This acute pustolose eruption may occur within the first 2 days of treatment, with fever and numerous, small pustulas, mostly not follicular, resulting from a widespread and localized edematous erythema mainly on the skin folds, on the trunk and on the upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustulas are observed, the administration of Momenxsin must be interrupted and appropriate measures should be taken if necessary. Before using this medicine, patients should consult the doctor in case of: • hypertension, cardiopathy, hyperthyroidism, psychosis or diabetes; • concomitant intake of anti- migraine drugs, in particular vasoconstrictors based on alkaloids of the horned rye (due to the α-simpaticomimetic activity of the pseudoephedrine); • mixed connective tissue disease: increased risk of aseptic meningitis (see paragraph 4.8); • neurological symptoms such as seizures, hallucinations, behavioral disorders, state of agitation and insomnia were described following the administration of vasoconstrictors by systemic means, especially during fever episodes or in case of overdose. Such symptoms were most commonly reported in the pediatric population. Therefore it is appropriate: • avoid the administration of Momenxsin in association with drugs that can lower the epilepsy threshold, such as terpenic derivatives, chlobulin, atropino-similar substances and local anesthetics, or in the presence of history of seizures;• strictly adhere to the recommended dosage in all cases and inform patients about the risks of overdosage in case Momenxsin. Patients with uretroprostatic disorders are more likely to develop symptoms such as dysuria and urinary retention. Older patients may be more sensitive to the effects on the central nervous system (SNC). Precautions of use relating to the pseudoephedrine hydrochloride: • In patients who need to be subjected to a programmed surgery where anaesthetic halogenated birds are expected to be used, it is preferable to suspend treatment with Momenxs several days before surgery, in view of the risk of acute hypertension (see paragraph 4.5); • Athletes should be informed that the treatment with pseudoephedrine hydrochloride can lead to positive antidoping tests. Interferences with serological tests: Pseudoephedrine can potentially reduce iobenguano i-131 caption in neuroendocrine tumors, thus interfering with scintigraphy. Special warnings related to ibuprofen: In patients suffering from bronchial asthma or allergic diseases or anamnesis of such pathologies, bronchospasm may occur. In case of asthma, the product should not be taken without consulting a doctor (see paragraph 4.3). Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polypoxes are exposed to a greater risk of allergic reactions in the case of acetyllic acid and/or NANS. The administration of Momenxsin can trigger an acute attack of asthma, especially in some allergic patients with acetylsalicylic acid or an NSAID (see paragraph 4.3). Prolonged use of any kind of painkiller for headache can cause its worsening. Where you experience or suspect this situation, you must apply for medical advice and suspend treatment. Diagnosis of cephalea from excessive use of drugs (MOH) must be suspected in patients who manifest frequent or daily headaches despite (or due to) regular use of cephalea medications. Before using this medicine, patients with blood clotting disorders should consult your doctor. Gastrointestinal effects: Hemorrhage, ulceration or gastrointestinal perforation, sometimes fatal, were reported, at any stage of treatment, with the use of all NSAIDs, with or without warning symptoms or gastrointestinal events. The risk of hemorrhage, ulceration or gastrointestinal perforation, sometimes fatal, increases the higher the doses of NSAIDs, in patients with history of ulcer, especially if complicated by bleeding or perforation (see paragraph 4.3) and in the elderly. These patients must begin treatment with the minimum dose available. For these patients and for those who take a concomitant treatment with low doses of acetylicylic acid or other medicines that may increase the risk of gastrointestinal events, an association therapy with gastroprotectors (e.g. misoprostol or protonic pump inhibitors) (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially older ones, must report any unusual abdominal symptoms (especially gastrointestinal hemorrhage), especially in the early stages of treatment. Particular caution is recommended in patients in concomitant treatment with drugs that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-aggregants such as acetylsalicylic acid (see paragraph 4.5). Treatment with Momenxsin must be immediately suspended in case of bleeding or gastrointestinal ulceration. NSAIDs should be given with caution to patients with history of gastrointestinal pathologies ( ulcerative colitis, Crohn's disease), because these conditions may be exacerbated (see paragraph 4.8). In case of concomitant alcohol intake, use of NSAIDs can increase unwanted effects related to the active ingredient, particularly those affecting the gastrointestinal tract or central nervous system. Cardiovascular and cerebrovascular effects: The following conditions are the subject of contraindications due to the presence of pseudoephedrine hydrochloride (see paragraph 4.3): severe cardiovascular disorders, coronary heart disease (cardiopathy, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, feocromocytoma, stroke history or presence of risk factors for stroke, myocardial heart attack history. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/die), may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that ibuprofen at low doses (e.g. ≤ 1200 mg/die) is associated with increased risk of arterial thrombotic events. Patients suffering from uncontrolled hypertension, heart failure (NYHA II-III), proven ischemic cardiopathy, peripheral arteriopathy and/or cerebrovascular disorders must be treated with ibuprofen only after careful evaluation and high dosages (2400 mg/die) must be avoided. It is also necessary to carry out a careful assessment before patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) undertake long-term treatment, especially if high doses of ibuprofen are required (2400 mg/die). Strict skin reactions: Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal 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 for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Strict skin reactions, such as generalized acute acute exantelosis (PEAG), may occur with medicines containing ibuprofen and pseudoephedrine. This acute pustolose eruption may occur within the first 2 days of treatment, with fever and numerous, small pustulas, mostly not follicular, resulting from a widespread and localized edematous erythema mainly on skin folds, on the trunk and on the upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustulas are observed, as well as appearance of rash, mucosa lesions or any other sign of hypersensitivity, the administration of Momenxsin must be interrupted and appropriate measures must be taken if necessary. Masking the symptoms of underlying infections: Momenxsin can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Momenxsin 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. Precautions for use on ibuprofen: • Seniors: the pharmacokinetics of ibuprofen is not modified by age, therefore posologic adjustments are not necessary in the elderly. However, elderly patients must be carefully monitored, as they are more sensitive to unwanted effects related to NSAIDs, particularly bleeding and gastrointestinal perforation, which can be fatal; • Precaution and special monitoring is required when ibuprofen is given to patients with history of gastrointestinal pathologies (such as peptic ulcer, iatal hernia or gastrointestinal hemorrhage); • In the early stages of treatment, careful monitoring of diuresis and kidney function in patients with heart failure, in patients with chronic impairment of kidney or liver function, in patients taking diuretics, in hypovolemic patients due to increased surgery and, in particular, in elderly patients. Dehydrated adolescents are exposed to the risk of kidney damage; • In case of acute vision during treatment, the patient must be subjected to a complete ophthalmological visit. Important information about some excipients. Momenxsin contains: - Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’.

Interactions

Association of pseudophedrine with:	Possible reaction
Non-Selective IMAO (iproniazide)	Paroxysm hypertension and hyperthermia, which can be fatal. Due to the long duration of IMAO action, this interaction can occur up to 15 days after the suspension of the IMAO.
Other sympathomimetic or vasoconstrictors with indirect action administered by mouth or nasal, α-simpaticomimetic drugs, phenylpropanolamin, phenylphrine, ephedrine, methylfenidate	Vasket risk and/or hypertensive crisis.
Reversible inhibitors of monoamino-oxidase A (RIMA), linezolid, dopaminergic alkaloids of the horned rye, vasoconstrictor alkaloids of the horned rye	Vasket risk and/or hypertensive crisis.
Halogenated volatile anesthetics	Acute perioperative hypertension. In case of planned surgery, suspend taking Momenxsin several days in advance.
Guanetidine, reserpine and methyldopa	The effect of pseudoephedrine could be attenuated.
Antidepressants	The effect of pseudoephedrine could be attenuated or enhanced.
Digital, chinidine or antidepressants	Increased frequency of arrhythmias.

Concurrent use of ibuprofen with:	Possible reaction
Other NSAIDs, including salicylates and selective COX-2 inhibitors	Concurrent administration of several NSAIDs could increase the risk of hemorrhage and gastrointestinal ulcers due to a synergistic effect. Therefore, the concomitant use of ibuprofen with other NSAIDs must be avoided (see paragraph 4.4).
Digoxin	The concurrent use of Momenxsin with digoxsin-based preparations could increase the serum levels of the latter. With correct use (maximum 4 days), there is usually no need to control the serum levels of digoxin.
Courtesy	Corticosteroids may increase the risk of adverse reactions, particularly by gastrointestinal tract (hemorrhage or gastrointestinal ulceration) (see paragraph 4.3).
Anti-aggregation agents	Increased risk of gastrointestinal bleeding (see paragraph 4.4).
Acetylsalicylic acid	Generally, concurrent administration of ibuprofen and acetylsalicylic acid is not recommended due to the potential increase in adverse effects. Experimental data suggests that ibuprofen could determine the competitive inhibition of the effect of acetylsalicylic acid at low dose on platelet aggregation, when the two medicines are taken simultaneously. Despite the doubts regarding the applicability of these data to clinical situations, the possibility that regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low dosage cannot be excluded. No clinically relevant effect is considered likely due to the occasional use of ibuprofen (see paragraph 5.1).
Anticoagulanti (e.g. warfarin, ticlopidine, clopidogrel, thyrofiban, eptifibatide, abciximab, iloprost)	NSAIDs such as ibuprofen can enhance the effects of anticoagulants (see paragraph 4.4).
Fenitoin	The concomitant use of Momenxsin with phenytoin-based preparations could increase the serum levels of the latter. With correct use (maximum 4 days), there is usually no need to control the serum levels of phenytoin.
Selective serotonin reuptake inhibitors (SSRI)	Increased risk of gastrointestinal bleeding (see paragraph 4.4).
Litio	The concomitant use of Momenxsin with lithium-based preparations could increase the serum levels of the latter. With correct use (maximum 4 days), there is usually no need to control the serum levels of lithium.
Probenecid and the Finpirazone	Drugs containing probenecid or finpirazone may delay the excretion of ibuprofen.
Diuretics, ACE inhibitors, betabloccants and antagonists of angiotensin II	NSAIDs could reduce the effect of diuretics and other antihypertensive medicines. In some patients with impairment of kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function), the concomitant administration of ACE inhibitors, betabloccants or antagonists of angiotensin II and agents that inhibit cycle-oxygenase could cause further deterioration of kidney function, including a possible acute kidney failure that is usually reversible. Therefore, this association must be administered with caution, especially in the elderly. Patients should be properly hydrated and should be taken into account the monitoring of kidney function after the start of concomitant therapy and subsequently periodically.
Diuretic potassium savers	Concurrent administration of Momenxsin and potassium-saving diuretics can cause hyperpotassium (it is recommended to control potassium serum levels).
Methodology	The administration of Momenxsin in the 24 hours prior to or after taking metotrexate may increase its concentrations and toxic effects.
Ciclosporin	The risk of kidney damage caused by cyclosporin has increased by the concomitant use of some non-steroidal anti-inflammatory drugs. This effect cannot be excluded even in the case of contemporary intake of cyclosporin and ibuprofen.
Tacrolimus	The risk of nephrotoxicity increases if the two drugs are administered concomitantly.
Zidovudine	There is evidence of an increased risk of haemarthrosis and haematoma in HIV (+) haemophiliac patients receiving concomitant treatment with zidovudine and ibuprofen.
Sulfonylureas	Clinical studies have demonstrated the existence of interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas).Although no interactions between ibuprofen and sulfonylureas have been described so far, when these two drugs are taken at the same time, it is advisable, as a precaution, to monitor blood sugar levels.
Chinolonic Antibiotics	Animal studies indicate that NSAIDs can increase the risk of convulsions associated with the use of kinolonic antibiotics. Patients taking NSAIDs and kinolones can be exposed to a greater risk of convulsions.
Eparine; ginkgo biloba	Increased risk of bleeding.

Effects

The most commonly observed adverse reactions related to ibuprofen are gastrointestinal in nature.Peptic ulcers, perforation or gastrointestinal bleeding, even fatal, may occur, particularly in the elderly (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 consult a doctor in the event of a serious adverse drug reaction.very common (≥1/10);common (≥1/100, Infections and infestations Ibuprofen Very rare Exacerbation of infectious inflammation (e.g. necrotizing fasciitis), aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease) Emolinfopoietic system pathologies Ibuprofen Very rare Hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis) Immune system disorders Ibuprofen Not common Hypersensitivity reactions with urticaria, itching and asthma attacks (with drop in blood pressure) Ibuprofen and Pseudoephedrine hydrochloride Very rare Severe generalized hypersensitivity reactions, signs of which may include facial edema, angioedema, dyspnoea, tachycardia, reduction in blood pressure, anaphylactic shock Psychiatric disorders Ibuprofen Very rare Psychotic reactions, depression Pseudoephedrine hydrochloride Notable Agitation, hallucinations, anxiety, abnormal behavior, insomnia Nervous system disorders Ibuprofen Not common Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability or tiredness Pseudoephedrine hydrochloride Rare Insomnia, nervousness, anxiety, restlessness, tremors, hallucinations Pseudoephedrine hydrochloride Notable Hemorrhagic stroke, ischemic stroke, seizures, headache Eye pathologies Ibuprofen Not common View disturbances Ear and labyrinth pathologies Ibuprofen Rare Tinnitus Heart disease Ibuprofen Very rare Palpitations, heart failure, myocardial infarction Pseudoephedrine hydrochloride Notable Palpitations, tachycardia, chest pain, arrhythmia Vascular diseases Ibuprofen Very rare Arterial hypertension Pseudoephedrine hydrochloride Notable Hypertension Respiratory, chest and mediastinic pathologies Pseudoephedrine hydrochloride Rare Asthma exacerbation or hypersensitivity reaction with bronchospasm Gastrointestinal diseases Ibuprofen Town Gastrointestinal fastidium, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, stipsi, mild gastrointestinal bleeding that in rare cases leads to anemia Ibuprofen Not common Gastrointestinal ulcers in some cases associated with bleeding and/or perforation, gastritis, ulcerative stomatitis, exacerbation of choleitis and Crohn's disease (see paragraph 4.4) Ibuprofen Very rare Esophagitis, pancreatis, intestinal stenosis diaphragm-like Pseudoephedrine hydrochloride Notable Dry mouth, thirst, nausea, vomiting, ischemic colitis Hepatobiliary diseases Ibuprofen Very rare Hepatic dysfunction, liver damage, especially in case of prolonged therapy, liver failure, acute hepatitis Pathologies of skin and subcutaneous tissue Ibuprofen Not common Various skin rashes Ibuprofen Very rare Bollose reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), alopecia, severe skin infections and soft tissue complications in case of chickenpox infection Ibuprofen Notable Reaction from drug with heosinophilia and systemic symptoms (DrESS syndrome) General acute acute acute acute (AGEP) Pseudoephedrine hydrochloride Notable Skin rash, hives, itching, hyperhidrosis, severe skin reactions including generalized acute pulstolosis (AGEP) Kidney and urinary pathologies Ibuprofen Rare Damage to renal tissue (paint necrosis) and high concentrations of uric acid in the blood Ibuprofen Very rare Increase in serum creatinine, hedemi (especially in patients with arterial hypertension or kidney failure), nephrosic syndrome, interstitial nephritis, acute kidney failure Pseudoephedrine hydrochloride Notable Difficulty in urination 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The clinical effects of overdose are most likely due to the presence in this product of the pseudoephedrine hydrochloride, rather than ibuprofen. The effects are not clearly related to the dose taken due to the different sensitivity of the various individuals to the sympathomimetic properties. Symptoms due to the sympathomimetic effect SNC Depression: for example sedation, apnea, cyanosis, coma.Stimolazione of the SNC (most likely in children): for example insomnia, hallucinations, seizures, tremors. In addition to the symptoms already mentioned as side effects, the following symptoms may occur: hypertensive crisis, heart arrhythmias, weakness and muscle tension, euphoria, excitement, thirst, chest pain, dizziness, tinnitus, ataxia, blurred vision, hypotension. Symptoms related to ibuprofen (which are added to gastrointestinal and neurological ones already mentioned as unwanted effects) Sleep, nistagm, tinnitus, hypotension, loss of consciousness. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Therapeutic measures Specific antidotes are not available. If the patient is present within an hour of taking a potentially toxic quantity of medicinal products, it may be considered the administration of activated charcoal by mouth. An electrolyte control and the execution of an ECG are also required. In case of cardiovascular instability and/or symptomatic electrolytic imbalance, a symptomatic treatment must begin.

Pregnancy.

Pseudoefedrine Hydrochloride: Animal studies have shown reproductive toxicity (see paragraph 5.3). The use of pseudoephedrine hydrochloride reduces the uterine blood flow of the mother, but clinical data concerning the effects on pregnancy are insufficient. Ibuprofen: Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Epidemiological studies suggest an increase in the risk of abortion, heart malformation and gastroschisis as a result of the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. It is believed that the risk increases proportionally to the dose and duration of therapy. It has been shown that in animals the administration of an inhibitor of the synthesis of prostaglandine causes an increase in pre- and post-system losses and embryo/fetal lethal. In addition, there was an increase in the incidence of various malformations, including cardiovascular malformations, in animals which had been given an inhibitor of the synthesis of prostaglandins during the organogenetic period. During the first and second quarter of pregnancy, ibuprofen should not be administered unless strictly necessary. If a woman who is trying to conceive or who is at the first or second trimester of pregnancy should take ibuprofen, 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 oligoidramnios;

mother and child, at the end of pregnancy:

- possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, this medicine is contraindicated in the third quarter of pregnancy and should only be administered where strictly necessary in the first and second quarter.

Nursing:

The need to take measures during breastfeeding comes 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, taking this medicine is contraindicated during breastfeeding.

Fertility:

There are evidence that the inhibitors of the cycle-oxygenase/prostaglandin synthesis can affect female fertility by acting on ovulation. The effect is reversible with the interruption of treatment.

Source: Farmadati