ZERINOACTIV 20CPR 200MG+30MG

ZERINOACTIV 200 MG/30 MG COMPRESSE RIVESTITES WITH FILM

active ingredients

Each tablet covered with white film contains 200 mg of ibuprofen and 30 mg of pseudoefedrine hydrochloride. Excipients with known effects: Each tablet contains 84 mg of lactose monohydrate (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.

Excellent

Nucleus : Lactose monohydrate Cellulosa microcrystalline Sodium starchy (type A) Silice colloidal anidra Magnesium stearate Coating : Polyvinyl alcohol Titanium dioxide E 171 Macrogol/PEG 3350 Talco

Therapeutic indications

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

Contraindications

• Hypersensitivity known to ibuprofen, to pseudoephedrine hydrochloride or to any of the excipients listed in paragraph 6.1; • Patients under 15 years of age; • Pregnancy and nursing (see paragraph 4.6); • History of allergy or asthma induced by ibuprofen or by substances with similar activity, such as other non-steroidal anti-inflammatory drugs (NSAID) or acetylsalicylic acid; • History of bleeding or gastrointestinal perforation, related to a previous therapy with anti-inflammatory drugs; • History of peptic ulcer/curring bleeding or in place (two or more separate episodes of proven ulceration or bleeding); • cerebrovascular bleeding or other bleeding episodes; • Disorders of unknown origin; • Severe hepatocellular failure; • Severe kidney failure; • severe heart failure (IV NYHA class); • severe or poorly controlled hypertension; • History of stroke or presence of risk factors of stroke (due to a-simpaticomimetic activity of pseudoephedrine hydrochloride); • Severe coronary failure; • Closed angle glaucoma risk; • Risk of urinary retention related to uretroprostatic diseases; • Myocardial infarction history; • Convulsive crisis history; • Lupus erythematosus disseminated; • Concurrent use of other vasoconstrictors used as nasal decongestants, administered by mouth or nasal (e.g. phenylpropanolamin, phenylphrine and ephedrine), and methylphenylphenidate (see paragraph 4.5); • Concurrent use of non-selective inhibitors of monoamino-oxidase (IMAO) (hyproniazide) (see 4.5) or use of monoamino-oxidase inhibitors in the last two weeks.

Population

Population Adults and teenagers aged 15: 1 tablet (corresponding to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 6 hours, if necessary. In case of more serious symptoms, 2 tablets (corresponding to 400 mg of ibuprofen and 60 mg of pseudoefedrine hydrochloride) every 6 hours, if necessary, up to a total maximum dose of 6 tablets per day (corresponding to 1200 mg of ibuprofen and 180 mg of pseudoefedrine hydrochloride). You should not exceed the total maximum dose of 6 tablets per day (corresponding to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). Treatment should not last for more than 5 days The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). This association must be used when both the decongesting action of the pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofene are necessary. If only one symptom is prevalent ( nasal congestion or cephalea and/or fever), therapy with a monosostance is preferable. Pediatric population ZERINOACTIV is contraindicated in pediatric patients under 15 years of age (see paragraph 4.3). If the use of this medicine is necessary for more than 3 days in adolescents, or in case of a worsening of symptomatology, the doctor must be consulted. Method of administration For oral use. Tablets should be ingested, without chewing, with a glass of water, preferably during meals.

Conservation

Do not store at temperature above 25°C. Store in the original packaging. Keep blister in the outside packaging.

Warnings

ZERINOACTIV should be avoided in association with other NSAIDs containing cyclooxygenase inhibitors (COX)-2. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment, necessary to obtain control of symptoms (see the below paragraphs regarding “Gatrointestinal Effects” and “Cardiovascular and cerebrovascular Effects”). Severe skin reactions Severe skin reactions such as generalized acute exantelosis (PEAG) can occur with products containing ibuprofen and pseudophedrine. 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 ZERINOACTIV must be interrupted and if necessary appropriate measures must be taken Special warnings related to pseudoephedrine hydrochloride : • Strictly adhere to posology, the maximum recommended treatment duration (5 days) and contraindications (see paragraph 4.8); • Patients should be informed to suspend treatment if they develop hypertension, tachycardia, palpitations, heart arrhythmias, nausea or any neurological sign, such as onset or worsening of a headache. Ischetical 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. Ischemic Optical Neuropatia Cases of ischemic optical neuropathy have been reported with the pseudoephedrine. The pseudoephedrine should be interrupted if sudden loss of sight or reduction of visual acuity should occur, for example in case of scotoma. Before using this product, patients should consult the doctor in case of: • hypertension, cardiopathy, hyperthyroidism, psychosis or diabetes; • concomitant intake of drugs against migraine, in particular vasoconstrictors based on alkaloids of the horned rye (due to the a-simpaticomimetic activity of the pseudophedrine); • systemic erythematous lupus (LES) and mixed pathologies of connective tissue: greater risk of developing aseptic meningitis (see paragraph 4.8); • neurological symptoms such as seizures, hallucinations, behavior disorders, agitation and insomnia. These were described following the administration of systemic vasoconstrictors, especially during fever or overdose. Such symptoms were most commonly reported in the pediatric population. As a result, it is appropriate: • avoid the administration of ZERINOACTIV in association with drugs that can lower the epilepsy threshold, such as terpenic derivatives, chlobutinol, atropino-similar substances and local anesthetics, or in the presence of a history of convulsive crisis; • strictly adhere, in all cases, to the recommended dosage and inform patients about the risks of overdosing if ZERINOACTIV is taken in conjunction with other drugs containing vasoconstrictors. Patients with uretroprostatic disorders are more likely to develop symptoms such as dysuria and urinary retention. Older patients can 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 ZERINOACTIV several days before surgery, considering 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. Interference with serological tests Pseudoephedrine can potentially reduce iobenguano i-131 caption in neuroendocrine tumors, thus interfering with scintigraphy. Special warnings related to ibuprofen : For patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polypoxes, there is a greater risk that allergic reactions occur during the intake of acetyllic acid and/or NSAIDs. The administration of ZERINOACTIV can lead to acute asthma attack, especially in some patients allergic to acetylsalicylic acid or an NSAID (see paragraph 4.3). 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 prodromic symptoms or a history of 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, in particular if complicated by hemorrhage or perforation (see paragraph 4.3), and in patients older than 60 years. These patients must begin treatment with the lowest dose available. A concomitant therapy with protective agents (e.g. misoprostol or protonic pump inhibitors) must be taken into account for these patients and also for patients taking low doses of acetylicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially elderly people, may have unusual abdominal symptoms (especially gastrointestinal hemorrhage) in the early stages of treatment. Particular caution should be used in patients in concomitant treatment with drugs that may increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective inhibitors of serotonin reuptake (SSRI) or anti-aggregants such as acetylsalicylic acid (see paragraph 4.5). Treatment with ZERINOACTIV must be immediately suspended if bleeding or gastrointestinal ulceration occurs. I FANS should be administered with caution to patients with history of gastrointestinal diseases ( ulcerative colitis, Crohn's disease) as their conditions may worsen (see paragraph 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 increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg per day) are associated with increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg per day). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg per day) are required of ibuprofen. Precaution is required in patients with anamnesi of hypertension and/or heart failure, as retention of fluid, hypertension and edema have been observed in conjunction with NSAID therapy; in such circumstances you should consult your physician and/or pharmacist before starting treatment. Skin reactions Very rarely have been reported, in association with the use of NSAIDs (see paragraph 4.8), severe skin reactions, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients are at greater risk for these reactions in the early stages of therapy; in fact, in most cases, the reaction arises in the first month of treatment. The administration of ZERINOACTIV must be suspended at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Masking the symptoms of underlying infections ZERINOACTIV 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 ZERINOACTIV 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 ibuprofene : - Elderly: the pharmacokinetics of ibuprofen is not modified by age, there is no need for posologic adjustments in the elderly. However, older subjects must be carefully monitored, as they are more sensitive to the unwanted effects related to NSAIDs, particularly hemorrhage and gastrointestinal perforation, which can be fatal. - Precaution and special monitoring is required when ibuprofen is given to patients with history of gastrointestinal pathology, 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 as a result of increased surgery and especially in elderly patients. - In dehydrated teenagers there is a risk of kidney damage. - If visual disturbances occur during treatment, a complete ophthalmological visit must be made. If symptoms persist or worsen, the patient must be advised to consult a doctor. Excipients with known effect: ZERINOACTIV tablets contains lactose. This product contains 84 mg of lactose monohydrate per tablet (up to 504 mg per recommended daily maximum dose). Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose mal absorption, should not take this medicine. ZERINOACTIV tablets contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "private of sodium".

Interactions

Association of pseudophedrine with:	Possible reactions
Non-Selective IMAO (hyproniazide):	paroxysmal 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:	risk of vasoconstriction and/or hypertensive crisis.
Reversible inhibitors of monoamino-oxidase A (RIMA), linezolid, dopaminergic alkaloids of the horned rye, vasoconstrictor alkaloids of the horned rye:	risk of vasoconstriction and/or hypertensive crisis.
Halogenated volatile anesthetics:	acute hypertension perioperative. In case of planned surgery, suspend treatment with ZERINOACTIV several days before.
Guanetidine, reserpine and methyldopa:	the effect of the pseudoephedrine may be attenuated.
Antidepressants:	the effect of pseudoephedrine may be attenuated or enhanced.
Digital, chinidine or antidepressants:	Increased frequency of arrhythmias.
Beta-blockers:	Reduction of antihypertensive effects of beta blockers
Other NSAs, including salicylates:	concurrent administration of several NSAIDs can 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 concomitant use of ZERINOACTIV with drugs containing digoxin can increase the serum levels of the latter. Usually, if used correctly (for a maximum of 5 days), it is not necessary to check the serum levels of digoxin.
Corticosteroids:	corticosteroids may increase the risk of adverse reactions, particularly gastrointestinal tract (blood or gastrointestinal ulceration) (see paragraph 4.3).
Anti-platelet agents:	increased risk of gastrointestinal hemorrhage (see paragraph 4.4).
Acetylsalicylic acid (low dose):	concurrent administration of ibuprofen and acetylicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two medicines are administered simultaneously. Although there are uncertainties regarding the extrapolation of this data to the clinical situation, the possibility that regular use, long-term of ibuprofen, can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1).
Anticoagulanti (e.g. warfarin, ticlopidine, clopidogrel, thyrofiban, eptifibatide, abciximab, iloprost):	nSAIDs such as ibuprofen can increase the effects of anticoagulants (see paragraph 4.4).
Fenitoine:	the concomitant use of ZERINOACTIV with drugs containing phenytoin can increase the serum levels of the latter. Usually, if used correctly (for a maximum of 5 days), it is not necessary to check the serum levels of phenytoin.
Selective serotonin reuptake inhibitors (SSRI):	increased risk of gastrointestinal hemorrhage (see paragraph 4.4).
Litio:	the concomitant use of ZERINOACTIV with drugs containing lithium can increase the serum levels of the latter. Usually, if used correctly (for a maximum of 5 days), it is not necessary to control the serum levels of lithium.
Probenecid e sulfinpirazone:	drugs containing probenecid or sulfinpirazone may delay the excretion of ibuprofen.
Diuretics, ACE inhibitors, beta-blockers and antagonists of angiotensin II:	nSAIDs can reduce the effect of diuretics and other antihypertensive medicines. In some patients with compromised kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE, beta-blocker or angiotensin II antagonists along with agents inhibiting cyclooxygenase can cause further worsening of kidney function, including a possible acute kidney failure, usually reversible. Therefore, these associations must be administered with caution especially in elderly patients. Patients should be properly hydrated and renal function monitoring should be taken into account at the beginning of concomitant therapy and subsequently on a periodic basis.
Potassium spare diuretics:	the concomitant intake of ZERINOACTIV and potassium-saving diuretics can lead to hyperkaliemia (it is recommended a control of the serum level of potassium).
Methodology:	ZERINOACTIV administered in 24 hours before or after taking metotrexate may increase its concentrations and therefore toxicity.
Ciclosporin:	the risk of kidney damage caused by cyclosporins has increased by the concomitant use of some non-steroidal anti-inflammatory drugs. This effect cannot be excluded in the event of a contemporary intake of cyclosporins and ibuprofene.
Tacrolimus:	the risk of nephrotoxicity increases in case of concurrent administration of ibuprofene and tacrolimus.
Zidovudina:	in case of concurrent administration of ibuprofen and zidovudine, there is evidence of an increase in the risk of hematomas and hematomas in positive HIV hemophiliacs.
Sulfaniluree:	clinical researches have shown that there are interactions between non-steroidal anti-inflammatory drugs and anti-diabetic drugs (sulfaniluree). Although interactions between ibuprofen and sulfaniluree have not been described so far, in case of concomitant use of these two drugs, it is recommended, precautionally, to control blood sugar.
Chinolonic Antibiotics:	Animal studies indicate that NSAIDs can increase the risk of convulsions associated with the use of kinolonic antibiotics. Patients taking NSAIDs and kinolonics may have an increased risk of developing seizures.
Eparina, Ginkgo biloba:	increased risk of bleeding.

Effects

The most commonly observed adverse events of ibuprofen are gastrointestinal. In general, the risk of developing adverse events (especially the risk of developing serious gastrointestinal complications) increases when the dose and duration of treatment is increased. After treatment with ibuprofen, hypersensitivity reactions have been reported, which may include: (a) Specific allergic reactions and anaphylaxis; (b) Reactivity of the respiratory tract, which includes asthma, aggravated asthma, bronchospasm or dispnea; (c) Various skin diseases, including eruptions of various types, itching, hives, porpora, angioedema and, more rarely, exfoliative and bollose dermatosis (including epidermal necrolysis and multiform erythema). In patients with autoimmune disorders in place (such as systemic erythematous lupus, mixed pathologies of connective tissue), during treatment with ibuprofen, isolated cases of aseptic meningitis symptoms were observed, such as cloud stiffness, headache, nausea, vomiting, fever or disorientation. In association with the treatment with NSAIDs were reported edema, hypertension and heart failure. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). The list of adverse events listed below refers to events manifested with ibuprofen and pseudoefedrin hydrochloride at the doses contained in the counter drugs, for short-term use. In the treatment of chronic affections, during a long-term treatment, additional adverse effects may occur. Patients should be advised to immediately discontinue the intake of ZERINOACTIV 200 mg/30 mg tablets coated with movies and to consult the doctor if a severe adverse reaction occurs to the drug. The adverse reactions considered, at least possibly, related to the treatment are listed below for organic systemic classification and frequency. The frequencies are defined as very common (≥1/10), common (≥1/100, Infections and infestations Ibuprofen Very rare Improvement of infectious inflammations (e.g. development of necrotizing fascites). Aseptic meningitis (nakedness, headache, nausea, vomiting, fever or disorientation) in patients with autoimmune diseases (LES, mixed connective tissue disease). Emolinfopoietic system pathologies Ibuprofen Very rare Hematopoiesi disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). Immune system disorders Ibuprofen Not common Reactions of hypersensitivity with hives, itching and asthma attacks (with decrease in blood pressure). Ibuprofen and pseudoephedrine hydrochloride Very rare Severe generalized reactions of hypersensitivity, whose signs can be facial edema, angioedema, dispnea, tachycardia, decrease in blood pressure, anaphylactic shock. Psychiatric disorders Ibuprofen Very rare Psychic reactions, depression. Pseudoefedrine Hydrochloride Notable Agitation, hallucinations, anxiety, abnormal behavior, insomnia. Diseases of the nervous system Ibuprofen Not common Central nervous system disorders, such as headaches, dizziness, insomnia, agitation, irritability or fatigue. Pseudoefedrine Hydrochloride Notable Hemorrhagic stroke, ischemic stroke, seizures, headache. Pathologies of the eye Ibuprofen Not common Visual disturbances. Pseudoefedrine Hydrochloride Notable Ischemic Optical Neuropatia Ear and labyrinth pathologies Ibuprofen Rare Tinnitus Heart disease Ibuprofen Very rare Palpitations, heart failure, myocardial infarction. Pseudoefedrine Hydrochloride Notable Palpitations, tachycardia, chest pain, arrhythmia. Vascular diseases Ibuprofen Very rare Arterial hypertension. Pseudoefedrine Hydrochloride Notable Hypertension. Gastrointestinal diseases Ibuprofen Town Dispepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, slight blood losses at gastrointestinal level that in rare cases involve anemia. Ibuprofen Not common Gastric ulcer with hemorrhage and/or perforation, gastritis, ulcerative stomatitis, worsening of the colitis and Crohn's disease (see paragraph 4.4). Ibuprofen Very rare Esophagitis, pancreatis, formation of diaphragm-tic intestinal stenosis. Pseudoefedrine 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 rashes. Ibuprofen Ibuprofen Very rare Not known Bollosis blood cells such as Stevens-Johnson syndrome and toxic epidermal necrolysis ( Lyell syndrome), alopecia, severe skin infections, soft tissue complications during chickenpox infection. Reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome), photosensitivity reaction, generalized acute exantematic pustolosis (PEAG) Pseudoefedrine Hydrochloride Notable Severe skin reactions, including generalized acute exantelosis (PEAG), rash, hives, itching, hyperhydrosis. Kidney and urinary pathologies Ibuprofen Rare Damage to renal tissue (paint necrosis) and high concentrations of uric acid in the blood. Ibuprofen Very rare Formation of edema (especially in patients with arterial hypertension or kidney failure), nephrotic syndrome, interstitial nephritis, acute kidney failure. Pseudoefedrine Hydrochloride Notable Difficulty of 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 do not correlate well with the dose taken due to the different interindividual sensitivity to the sympathomimetic properties. Symptoms due to the sympathomimetic effect: Depression of the SNC: for example, sedation, apnea, cyanosis, coma. SNC stimulation (more likely in children): for example insomnia, hallucinations, seizures, tremor. 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, vision blur, hypotension. Symptoms related to ibuprofen (in addition to gastrointestinal and neurological symptoms 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: A specific antidote is not available. If the patient is present within an hour of ingestion, it is recommended to administer activated carbon. In serious cases, the use of gastric lavender can also be considered. You need to control the electrolytes and run an ECG. In case of cardiovascular instability and/or symptomatic electrolytic imbalance, a symptomatic treatment must begin.

Pregnancy

Pseudoefedrine 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 without apparent deleterious effects, there may be an increase in risk regarding the use of pseudoephedrine hydrochloride in the early stages of pregnancy, due to its vasoconstrictoral effects. Ibuprofen: During the third trimester of pregnancy, ibuprofen is contraindicated as there is the risk of premature closure of fetal arterial duct with possible persistent pulmonary hypertension. Hybuprofen can delay the beginning of labor and increase its duration, with an increase in the tendency to bleeding both in the mother and in the child. In conclusion, the use of ZERINOACTIV is contraindicated during pregnancy and not recommended in potentially fertile women who do not use a contraceptive method.

Food

The pseudoephedrine hydrochloride passes into breast milk. Hybuprofen and its metabolites are excreted in very low concentrations in human breast milk and is 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 are limited evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis can affect female fertility by acting on ovulation. Once the treatment is completed, the effect is reversible.

Source: Farmadati