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ZERINOACTIV * 20CPR 200MG + 30MG

SANOFI SpA
041218025
12 Items
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Indicated for nasal congestion, rhinitis and sinusitis.


Indicated in case of cold and headache.


Deductible over-the-counter drug.


Anti-inflammatory and decongestant action.


















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SANOFI SpA
041218025
12 Items

ZERINOACTIV * 20CPR 200MG + 30MG

Therapeutic indications

Symptomatic treatment of nasal / sinus congestion with headache, fever and pain associated with the common cold. ZERINOACTIV is indicated in adults and adolescents over 15 years of age.

Dosage and method of use

Dosage Adults and adolescents over 15 years of age: 1 tablet (corresponding to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 6 hours, if needed. In case of more severe symptoms, 2 tablets (corresponding to 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride) every 6 hours, if necessary, up to a maximum total dose of 6 tablets per day (corresponding to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). The maximum total dose of 6 tablets per day (corresponding to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride) should not be exceeded. Treatment should not last longer than 5 days Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). This combination should be used when both the decongestant action of pseudoephedrine hydrochloride and the analgesic and / or anti-inflammatory action of ibuprofen are required. If only one symptom is prevalent (nasal congestion or headache and / or fever), therapy with a single substance product is preferable. Pediatric population ZERINOACTIV is contraindicated in pediatric patients less than 15 years of age (see section 4.3). If the use of this medicine is necessary for more than 3 days in adolescents, or in the event of worsening of symptoms, the doctor should be consulted. Method of administration For oral use. The tablets should be swallowed, without chewing, with a large glass of water, preferably during meals.

Contraindications

• Known hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or to any of the excipients mentioned in section 6.1; • Patients under the age of 15; • Pregnancy and lactation (see section 4.6); • History of allergy or asthma induced by ibuprofen or substances with similar activity, such as other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid; • History of gastrointestinal bleeding or perforation related to previous anti-inflammatory drug therapy; • History of recurrent or ongoing peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding); • Cerebrovascular haemorrhage or other bleeding episodes; • Disorders of hematopoiesis of unknown origin; • Severe hepatocellular insufficiency; • Severe renal insufficiency; • Severe heart failure (NYHA class IV); • Severe or poorly controlled hypertension; • History of stroke or presence of stroke risk factors (due to the a-sympathomimetic activity of pseudoephedrine hydrochloride); • Severe coronary insufficiency; • Risk of closed-angle glaucoma; • Risk of urinary retention related to urethroprostatic diseases; • History of myocardial infarction; • History of seizures; • Disseminated lupus erythematosus; • Concomitant use of other vasoconstrictors used 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 events related to ibuprofen are gastrointestinal in nature. In general, the risk of developing adverse events (especially the risk of developing serious gastrointestinal complications) increases with increasing dose and duration of treatment. Hypersensitivity reactions have been reported following treatment with ibuprofen, which may include: (a) Nonspecific allergic reactions and anaphylaxis; (b) Respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm or dyspnoea; (c) Various skin conditions, including rashes of various kinds, 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, mixed connective tissue disorders), isolated cases of aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, have been observed during treatment with ibuprofen. fever or disorientation. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). The list of adverse events below refers to events that occurred with ibuprofen and pseudoephedrine hydrochloride at the doses contained in the over-the-counter drugs, for short-term use. In the treatment of chronic conditions, further adverse effects may occur during a long-term treatment. Patients should be advised to stop taking ZERINOACTIV 200 mg / 30 mg film-coated tablets immediately and to consult their physician if a serious adverse drug reaction occurs. Adverse reactions considered, at least possibly, related to treatment are listed below by system organ class and frequency. Frequencies are defined as very common (≥1 / 10), common (≥1 / 100,

Infections and infestations Ibuprofen Very rare Worsening of inflammations of an infectious nature (eg development of necrotizing fasciitis). Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or disorientation) in patients with active autoimmune diseases (les, mixed connective tissue disease).
Disorders of the blood and lymphatic system Ibuprofen Very rare Disorders of hematopoiesis (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, the signs of which may be facial edema, angioedema, dyspnoea, tachycardia, drop in blood pressure, anaphylactic shock.
Psychiatric disorders Ibuprofen Very rare Psychotic reactions, depression.

Pseudoephedrine hydrochloride

Not known Agitation, hallucinations, anxiety, behavioral abnormalities, insomnia.
Nervous system disorders Ibuprofen Uncommon Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.

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.
Gastrointestinal disorders Ibuprofen Common Dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, slight gastrointestinal blood loss which in rare cases leads to anemia.

Ibuprofen

Uncommon

Gastric ulcer with haemorrhage and / or perforation, gastritis, ulcerative stomatitis, worsening of colitis and Crohn's disease (see section 4.4).

Ibuprofen

Very rare

Esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures.

Pseudoephedrine hydrochloride

Not known

Dry mouth, thirst, nausea, vomiting.
Hepatobiliary disorders Ibuprofen Very rare Hepatic dysfunction, liver damage, especially in case of prolonged therapy, liver failure, acute hepatitis.
Skin and subcutaneous tissue disorders Ibuprofen Uncommon Various skin rashes.

Ibuprofen

Very rare

Bullous rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia, severe skin infections, soft tissue complications in chickenpox infection.

Pseudoephedrine hydrochloride

Not known

Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP), rash, urticaria, pruritus, hyperhidrosis.
Renal and urinary disorders Ibuprofen Rare Damage to kidney tissue (papillary necrosis) and high concentrations of uric acid in the blood.

Ibuprofen

Very rare

Formation of edema (especially in patients with arterial hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal failure.

Pseudoephedrine hydrochloride

Not known

Difficulty urinating.
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 at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp etta-adverse-reaction.

Special warnings

The use of ZERINOACTIV in combination with other NSAIDs containing cyclooxygenase (COX) -2 inhibitors should be avoided. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to achieve symptom control (see below on "Gastrointestinal Effects" and "Cardiovascular and Cerebrovascular Effects" below. ). Special warnings related to pseudoephedrine hydrochloride : • The posology, the maximum recommended treatment duration (5 days) and contraindications must be strictly adhered to (see section 4.8); • Patients should be advised to discontinue treatment if they develop hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs such as the onset or worsening of a headache. 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, small, mostly non-follicular 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 ZERINOACTIV should be discontinued and appropriate measures taken if necessary. Before using this product, patients should consult their physician in case of: • hypertension, heart disease, hyperthyroidism, psychosis or diabetes; • concomitant intake of drugs against migraine, in particular vasoconstrictors based on ergot alkaloids (due to the a-sympathomimetic activity of pseudoephedrine); • systemic lupus erythematosus (SLE) and mixed connective tissue disorders: increased risk of developing aseptic meningitis (see section 4.8); • neurological symptoms such as seizures, hallucinations, behavioral disturbances, agitation and insomnia. These have been described following the administration of systemic vasoconstrictors, especially during febrile episodes or in case of overdose. These symptoms were reported more commonly in the pediatric population. Consequently, it is advisable: • to avoid the administration of ZERINOACTIV 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; • strictly adhere, in all cases, to the recommended posology and inform patients about the risks of overdose if ZERINOACTIV is taken concomitantly with other drugs containing vasoconstrictors. Patients with urethroprostatic disorders are more prone to the development of 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 volatile halogenated anesthetics are expected to be used, it is preferable to discontinue treatment with ZERINOACTIV several days prior to surgery, given 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 : For patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis there is an increased risk of allergic reactions occurring when taking acetylsalicylic acid and / or NSAIDs. Administration of ZERINOACTIV may precipitate an acute asthma attack, particularly in some patients allergic to acetylsalicylic acid or an NSAID (see section 4.3). Gastrointestinal effects Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, have been reported at any stage of treatment with the use of all NSAIDs, with or without prodromal symptoms or a previous history of 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 haemorrhage or perforation (see section 4.3), and in older patients. at 60. These patients should start treatment with the lowest available dose. Concomitant therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, may have unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Particular caution should be exercised in patients being treated concomitantly 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 acid. acetylsalicylic (see section 4.5). Treatment with ZERINOACTIV should be discontinued immediately if gastrointestinal bleeding or ulceration occurs. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may worsen (see section 4.8) . Cardiovascular and cerebrovascular effects Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increased 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 per day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg daily ). Careful consideration should also be exercised before initiating long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses (2400 mg per day) of ibuprofen. Caution is required in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with NSAID therapy; in such circumstances you should consult your doctor and / or pharmacist before starting treatment. 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 are at increased risk for these reactions in the early stages of therapy; in fact, in most cases, the reaction occurs in the first month of treatment. Administration of ZERINOACTIV should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Usage precautions related to ibuprofen : - Elderly: Ibuprofen pharmacokinetics are not affected by age, no dosage adjustments are required in the elderly. However, elderly subjects should be closely 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 ibuprofen is administered 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 hypovolaemic patients as a result of surgery. major surgery and especially in elderly patients. - There is a risk of kidney damage in dehydrated adolescents. - If visual disturbances occur during the course of treatment, a complete ophthalmological examination should be carried out. If symptoms persist or worsen, the patient should be advised to consult a physician. This product contains 504 mg of lactose monohydrate when taking the maximum recommended daily dose. Patients with rare hereditary conditions of galactose intolerance, eg. galactosemia, lactase deficiency or glucose-galactose malabsorption, should not take this medicine.

Pregnancy and breastfeeding

Pregnancy Pseudoephedrine hydrochloride: Although there are no reproductive toxicity, fertility and postnatal development studies conducted with pseudoephedrine hydrochloride and although pseudoephedrine hydrochloride has been widely used for many years with no apparent deleterious effects, there may be an increased risk regarding the use of pseudoephedrine hydrochloride in the early stages of pregnancy, due to its vasoconstrictive effects. Ibuprofen: During the third trimester of pregnancy, ibuprofen is contraindicated as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. Ibuprofen can delay the onset of labor and increase its duration, with an increased tendency to bleed in both mother and baby. In conclusion, the use of ZERINOACTIV is contraindicated during pregnancy and not recommended in women of childbearing potential who do not use a contraceptive method. Feeding time Pseudoephedrine hydrochloride passes into breast milk. Ibuprofen and its metabolites are excreted in very low concentrations in human breast milk and are unlikely to have adverse effects on infants. In view of the potential cardiovascular and neurological effects of vasoconstrictors, the use of ZERINOACTIV is contraindicated during breastfeeding. Fertility There is limited evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis can impair female fertility by affecting ovulation. Once the treatment has ended, the effect is reversible.

Expiration and retention

Do not store above 25 ° C. Store in the original packaging. Keep the blister in the outer carton.

Interactions with other drugs

Combination of pseudoephedrine with: Possible reactions
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 planned surgery, stop treatment with ZERINOACTIV several days before.
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 reactions
Other NSAIDs, including salicylates: concomitant administration of several NSAIDs may 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 ZERINOACTIV with digoxin-containing drugs may increase serum levels of the latter. Usually, when used correctly (for up to 5 days), it is not necessary to check serum digoxin levels.
Corticosteroids: corticosteroids may increase the risk of adverse reactions, particularly of the gastrointestinal tract (gastrointestinal bleeding or ulceration) (see section 4.3).
Antiplatelet agents: increased risk of gastrointestinal haemorrhage (see section 4.4).
Acetylsalicylic acid (low dose): concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1).
Anticoagulants (e.g. warfarin, ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost): NSAIDs such as ibuprofen may enhance the effects of anticoagulants (see section 4.4).
Phenytoin: concomitant use of ZERINOACTIV with drugs containing phenytoin may increase serum levels of the latter. Usually, when used correctly (for up to 5 days), it is not necessary to check serum phenytoin levels.
Selective Serotonin Reuptake Inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4).
Lithium: concomitant use of ZERINOACTIV with lithium-containing drugs may increase serum levels of the latter. Usually, if used correctly (for up to 5 days), it is not necessary to check serum lithium levels.
Probenecid and sulfinpyrazone: drugs 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) the co-administration of an ACE inhibitor, a beta-blocker or angiotensin II antagonists together with agents that inhibit cyclooxygenase may result in further worsening of renal function, including possible acute renal failure, usually reversible. Therefore, these combinations should be administered with caution especially in elderly patients. Patients should be adequately hydrated and renal function monitoring should be considered at the initiation of concomitant therapy and on a periodic basis thereafter.
Potassium-sparing diuretics: the concomitant intake of ZERINOACTIV and potassium-sparing diuretics may lead to hyperkalaemia (monitoring of serum potassium is recommended).
Methotrexate: ZERINOACTIV administered in the 24 hours before or after taking methotrexate can increase its concentrations and therefore its toxicity.
Cyclosporins: 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 if cyclosporine and ibuprofen are taken simultaneously.
Tacrolimus: the risk of nephrotoxicity increases with concomitant administration of ibuprofen and tacrolimus.
Zidovudine: in case of concomitant administration of ibuprofen and zidovudine, there is evidence of an increased risk of haemarthroses and hematomas in HIV positive haemophiliacs.
Sulfonylureas: clinical research has shown that there are interactions between non-steroidal anti-inflammatory drugs and antidiabetic drugs (sulfonylureas). Although interactions between ibuprofen and sulfonylureas have not been described so far, in case of concomitant use of these two drugs it is recommended, as a precaution, to monitor blood glucose.
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 have an increased risk of developing seizures.
Heparin, Ginkgo 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 do not correlate well with the dose taken due to the different interindividual sensitivity to sympathomimetic properties. Symptoms due to the sympathomimetic effect: CNS depression: eg. sedation, apnea, cyanosis, coma. CNS stimulation (more likely in children): eg. insomnia, hallucinations, convulsions, tremor. 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 symptoms already mentioned as side effects): Somnolence, nystagmus, tinnitus, hypotension, metabolic acidosis, loss of consciousness. Therapeutic measures: There is no specific antidote available. If the patient presents within one hour of ingestion, administration of activated charcoal is recommended. In severe cases, gastric lavage may also be considered. Electrolytes should be checked and an ECG performed. In case of cardiovascular instability and / or symptomatic electrolyte imbalance, symptomatic treatment should be initiated.

Active principles

Each white film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride. Excipients with known effects: Contains 84 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Excipients

Nucleus : Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica, colloidal anhydrous Magnesium stearate Coating : Polyvinyl alcohol Titanium dioxide E 171 Macrogol / PEG 3350 Talc

SANOFI SpA
041218025
12 Items

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