ACTISINU * 12CPR 200MG + 30MG
Symptomatic treatment of nasal congestion associated with acute rhinosinusitis of suspected viral origin with headache and / or fever. ACTISINU is indicated in adults and adolescents aged 15 years and over.
Dosage and method of use
Dosage Adults and adolescents aged 15 years and over: 1 tablet (equivalent to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 6 hours as needed. For more intense symptoms, 2 tablets (equivalent to 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride) every 6 hours as needed, up to a maximum total daily dose of 6 tablets (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride ). Do not exceed the maximum total daily dose of 6 tablets (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride). For short term use. In the event of worsening of symptoms, the doctor should be consulted. The maximum duration of treatment is 4 days for adults and 3 days for adolescents from 15 years of age. In situations where the symptoms consist mainly of pain / fever or nasal congestion, the administration of products containing a single active ingredient is preferred. Undesirable effects can be reduced by using the lowest dose for the minimum time needed to control symptoms (see section 4.4). Pediatric population ACTISINU is contraindicated in pediatric patients less than 15 years of age (see section 4.3). Method of administration For oral use. The tablets should be swallowed whole, not chewed, with plenty of water, preferably with meals.
• Hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or to any of the excipients listed in section 6.1; • Patients under the age of 15; • Women in the third trimester of pregnancy (see section 4.6); • Mothers who are breastfeeding (see section 4.6); • Patients who have previously shown hypersensitivity reactions (eg bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); • History of gastrointestinal bleeding or perforation related to previous NSAID therapy; • Active episodes or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of ulceration or bleeding demonstrated); • Cerebrovascular or other bleeding; • Unexplained hematopoietic abnormalities; • Severe hepatic insufficiency; • Severe renal insufficiency; • Severe heart failure; • Severe cardiovascular disorders, coronary artery 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 closed-angle glaucoma; • Risk of urinary retention related to urethroprostatic disorders; • History of myocardial infarction; • History of convulsions; • Systemic lupus erythematosus; • Concomitant use of other vasoconstrictor agents used as nasal decongestants, administered both orally and 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.
The most commonly observed adverse reactions related to ibuprofen are gastrointestinal in nature. Peptic ulcers, GI perforation or bleeding, possibly fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration (see section 4.4 "Special warnings and precautions for use"). Gastritis was observed less frequently. In general, the risk of developing adverse reactions (particularly 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 could consist of: (a) Nonspecific allergic reaction and anaphylaxis (b) Respiratory tract reactivity including asthma, aggravated asthma, bronchospasm or dyspnoea (c) Various skin disorders, including eruptions of various kinds, itching, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme) In patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease), Single cases of aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever or disorientation have been observed during treatment with ibuprofen. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) may be associated with a slightly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) (see section 4.4). The following list of adverse reactions refers to those observed with ibuprofen and pseudoephedrine hydrochloride at doses contained in short-term over-the-counter medications. In the treatment of chronic conditions, under long-term treatment, further adverse reactions may occur. Patients should be advised to stop taking ACTISINU immediately and consult a physician if a serious adverse drug reaction occurs.
|Very common (≥1 / 10) |
|Common (≥1 / 100, |
|Uncommon (≥1 / 1,000 to |
|Rare (≥1 / 10,000, |
|Very rare ( |
|Not known (frequency cannot be estimated from the available data) |
| Infections and infestations ||Ibuprofen ||Very rare ||Exacerbation of infectious inflammation (e.g. necrotizing fasciitis), aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or disorientation in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease) |
| Disorders of the blood and lymphatic system ||Ibuprofen ||Very rare ||Haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) |
| Disorders of the immune system ||Ibuprofen ||Uncommon ||Hypersensitivity reactions with hives, itching and asthma attacks (with lowering of blood pressure) |
| ||Ibuprofen and pseudoephedrine hydrochloride ||Very rare ||Severe generalized hypersensitivity reactions, with signs such as facial edema, angioedema, dyspnoea, tachycardia, lowering of blood pressure, anaphylactic shock |
| Psychiatric disorders ||Ibuprofen ||Very rare ||Psychotic reactions, depression |
| ||Pseudoephedrine hydrochloride ||Not known ||Agitation, hallucination, anxiety, abnormal behavior, insomnia |
| Nervous system disorders ||Ibuprofen ||Uncommon ||Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness |
| ||Pseudoephedrine hydrochloride ||Rare ||Insomnia, nervousness, anxiety, restlessness, tremor, hallucinations |
| ||Pseudoephedrine hydrochloride ||Not known ||Hemorrhagic stroke, ischemic stroke, convulsions, headache |
| Eye disorders ||Ibuprofen ||Uncommon ||Visual disturbances |
| Ear and labyrinth disorders ||Ibuprofen ||Rare ||Tinnitus |
| Cardiac pathologies ||Ibuprofen ||Very rare ||Palpitations, heart failure, myocardial infarction |
| ||Pseudoephedrine hydrochloride ||Not known ||Palpitations, tachycardia, chest pain, arrhythmia |
| Vascular pathologies ||Ibuprofen ||Very rare ||Hypertension |
| ||Pseudoephedrine hydrochloride ||Not known ||Hypertension |
| Respiratory, thoracic and mediastinal disorders ||Pseudoephedrine hydrochloride ||Rare ||Exacerbation of asthma or hypersensitivity reaction with bronchospasm |
| Gastrointestinal disorders ||Ibuprofen ||Common ||Gastrointestinal discomfort, dyspepsia, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, minor gastrointestinal bleeding which rarely leads to anemia |
| ||Ibuprofen ||Uncommon ||Gastrointestinal ulcers sometimes with bleeding and / or perforation, gastritis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) |
| ||Ibuprofen ||Very rare ||Esophagitis, pancreatitis, diaphragm-like intestinal stenosis |
| ||Pseudoephedrine hydrochloride ||Not known ||Dry mouth, thirst, nausea, vomiting |
| Hepatobiliary disorders ||Ibuprofen ||Very rare ||Hepatic dysfunction, liver damage, particularly in case of long-term therapy, hepatic failure, acute hepatitis |
| Skin and subcutaneous tissue disorders ||Ibuprofen ||Uncommon ||Various skin rashes |
| ||Ibuprofen ||Very rare ||Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia, severe skin infections and soft tissue complications in case of chickenpox infection |
| ||Pseudoephedrine hydrochloride ||Not known ||Skin rash, hives, itching, 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 ||Increased serum creatinine, edema (particularly in patients with arterial hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal failure |
| ||Pseudoephedrine hydrochloride ||Not known ||Difficulty in urination |
Reporting of suspected adverse reactions The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at "www.agenziafarmaco.gov.it/it/responsabili"
Avoid concomitant use of ACTISINU with other NSAIDs, including selective cyclooxygenase (COX) –2 inhibitors. Undesirable effects can be reduced by using the lowest effective dose for the minimum period of time necessary to control symptoms (see "Gastrointestinal effects" and "Cardiovascular and cerebrovascular effects" below). If symptoms persist beyond the maximum recommended treatment duration with this medicine (4 days for adults and 3 days for adolescents), the measures to be taken should be reassessed, in particular the possible usefulness of an antibiotic treatment. Acute rhinosinusitis, of suspected viral origin, is defined as a series of bilateral rhinological symptoms of moderate intensity, dominated by nasal congestion with serous or purulent rhinorrhea, occurring in an epidemic context. The purulent appearance of rhinorrhea is common and does not systematically correspond to bacterial superinfection. Sinus pains, during the first days of the disease, are associated with congestion of the sinus mucosa (acute congestive rhinosinusitis) and very often resolve spontaneously. In case of acute bacterial sinusitis, antibiotic therapy is justified. Special warnings related to pseudoephedrine hydrochloride: • Strictly adhere to the dosage, the maximum recommended duration of treatment (4 days for adults and 3 days for adolescents) and contraindications (see section 4.8). • Patients should be advised that treatment should be discontinued if hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or other neurological signs such as the onset or worsening of headache occur. Before using this medicine, patients should consult their doctor in case of: • Hypertension, heart disease, hyperthyroidism, psychosis or diabetes. • Concomitant administration of anti-migraine drugs, mainly ergot alkaloid vasoconstrictors (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 after systemic administration of vasoconstrictors, mainly during febrile episodes or in case of overdose. These symptoms were more commonly reported in the pediatric population. As a result, it is advisable: • to avoid the administration of ACTISINU in combination with medicines capable of lowering 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 to the recommended dosage in all cases and inform patients about the risks of overdose if ACTISINU is taken concomitantly with other vasoconstrictor-containing medicines. Patients with urethroprostatic disorders are more prone to develop symptoms such as dysuria or urinary retention. Elderly patients may be more sensitive to central nervous system (CNS) effects. Precautions for use related to pseudoephedrine hydrochloride: • In patients undergoing scheduled surgery where volatile halogenated anesthetics will be used, it is preferable to discontinue treatment with ACTISINU several days before surgery due to the risk of acute hypertension (see section 4.5). Athletes should be advised that treatment with pseudoephedrine hydrochloride can result in positive doping tests. Interference with serological tests Pseudoephedrine may reduce the uptake of iobenguane i-131 in neuroendocrine tumors, thereby interfering with scintigraphy. Special warnings related to ibuprofen : Bronchospasm may occur in patients suffering from bronchial asthma or allergic diseases or with a history of such conditions. Asthmatic patients should only take this medicine after consulting their doctor (see section 4.3). Patients who present with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis have an increased risk of allergic reactions when taking acetylsalicylic acid and / or NSAIDs. Administration of ACTISINU may cause an acute asthma attack, particularly in some patients who are allergic to acetylsalicylic acid or an NSAID (see section 4.3). Prolonged use of any type of pain reliever for headache can make it worse. If this situation occurs or is suspected, consult a doctor and discontinue treatment. The diagnosis of Medication Overuse Headache (MOH) should be suspected in patients who have frequent or daily headache attacks despite (or because of) regular use of headache medications. Patients with bleeding defects should consult their doctor before using this medicine. Gastrointestinal Effects: The possibility of gastrointestinal bleeding, ulceration or perforation, even fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation, even fatal, is greater with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with bleeding or perforation (see section 4.3), and in elderly subjects. Such patients should begin treatment at the lowest available dose. Consider combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) for these patients and also for patients taking concomitant low-dose acetylsalicylic acid or other medicinal products that tend to increase gastrointestinal risk (see below and paragraph 4.5). Patients with a history of gastrointestinal toxicity, mainly elderly patients, should report any unusual abdominal symptoms (mainly gastrointestinal bleeding), particularly in the early stages of treatment. Particular caution is advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as acetylsalicylic acid (see section 4.5). Discontinue treatment with ACTISINU immediately in case of gastrointestinal bleeding or ulceration. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as this condition may be aggravated (see section 4.8). Through concomitant alcohol consumption, undesirable effects related to the active substance, particularly those affecting the gastrointestinal tract or the central nervous system, could increase in case of NSAID use. Cardiovascular and cerebrovascular effects: Due to the presence of pseudoephedrine hydrochloride, the following conditions are contraindicated (see section 4.3): severe cardiovascular disorders, coronary artery disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, pheochromocytoma, history of stroke or the presence of risk for stroke, history of myocardial infarction. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (≤ 1200 mg / day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA 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 per day) should be avoided. Careful consideration should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses of ibuprofen (2400 mg per day) are required. 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 increased risk of such reactions early in therapy: the onset of the reaction occurs in most cases within the first month of treatment. ACTISINU must be suspended at the first appearance of skin rashes, mucosal lesions or any other possible sign of hypersensitivity. Ibuprofen related precautions for use: • Elderly patients: Ibuprofen pharmacokinetics are not changed by age; therefore no dose adjustment is necessary in the elderly. However, elderly patients should be monitored closely as they have a higher frequency of NSAID-related undesirable effects, particularly gastrointestinal bleeding and perforation, including fatal. • Special attention and special monitoring is required when administering ibuprofen to patients with a history of gastrointestinal disease (such as peptic ulcer, hiatal hernia or gastrointestinal bleeding). • In the initial stages of treatment, careful monitoring of urine production and renal function is required in patients with heart failure, in patients with chronic renal or hepatic impairment, in patients taking diuretics, in hypovolaemic patients after surgery important and, in particular, in elderly patients. There is a risk of kidney damage in dehydrated adolescents. • If visual disturbances occur during treatment, perform a complete ophthalmological examination.
Pregnancy and breastfeeding
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 are insufficient regarding the effects on pregnancy.Ibuprofen: Inhibition of prostaglandin synthesis could adversely affect pregnancy and / or embryo-fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformation and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with dose and duration of therapy. Administration of a prostaglandin synthesis inhibitor has been shown to increase pre- and post-implantation loss and embryo-fetal lethality in animals. Furthermore, the increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given a prostaglandin synthesis inhibitor during the period of organogenesis. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors could expose the fetus a: –cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal function, which could lead to renal failure with oligohydroamnios; the mother and the child at the end of pregnancy, to: –possible prolongation of bleeding time, an anti-aggregating effect which could occur even at very low doses; –Inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, the use of this medicine is: Contraindicated during the third trimester of pregnancy and should only be administered if clearly needed during the first and second trimester. Breastfeeding The measures to be taken during breastfeeding derive from the presence of pseudoephedrine hydrochloride in the drug formulation: pseudoephedrine hydrochloride is excreted in breast milk. Considering the potential cardiovascular and neurological effects of vasoconstrictors, the ingestion of this medicinal product is contraindicated during breastfeeding. . This alteration is reversible upon discontinuation of treatment.
Expiration and retention
Do not store above 30 ° C.
Interactions with other drugs
| Combination of pseudoephedrine with: || Possible reaction |
|Non-selective MAOIs (iproniazid): ||Paroxysmal hypertension and hyperthermia, even 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 sympathomimetic or vasoconstrictive drugs administered orally or nasally with indirect action, α-sympathomimetic drugs, phenylpropanolamine, phenylephrine, ephedrine, methylphenidate: ||Risk of vasoconstriction and / or hypertensive crisis. |
|Reversible monoamine oxidase inhibitors (RIMA), linezolid, dopaminergic ergot alkaloids, vasoconstrictor ergot alkaloids: ||Risk of vasoconstriction and / or hypertensive crisis. |
|Volatile halogenated anesthetics: ||Acute perioperative hypertension. In case of planned surgery, stop ACTISINU treatment several days before. |
|Guanethidine, reserpine and methyldopa: ||The effect of pseudoephedrine could be reduced. |
|Tricyclic antidepressants: ||The effect of pseudoephedrine could be reduced or increased. |
|Digitalis, quinidine or tricyclic antidepressants: ||Increased frequency of arrhythmia. |
| Concomitant use of ibuprofen with: || Possible reaction |
|Other NSAIDs, including salicylates and selective COX-2 inhibitors: ||Concomitant administration of some NSAIDs may increase the risk of gastrointestinal ulcers or bleeding due to the synergistic effect. Therefore, the concomitant use of ibuprofen with other NSAIDs should be avoided (see section 4.4). |
|Digoxin: ||Concomitant use of ACTISINU with digoxin preparations could increase the serum levels of these medicinal products. A check of serum digoxin is generally not required in case of correct use (maximum for 4 days). |
|Corticosteroids: ||Corticosteroids may increase the risk of adverse reactions, mainly of the gastrointestinal tract (gastrointestinal ulceration or bleeding) (see section 4.3). |
|Anti-platelet agents: ||Increased risk of gastrointestinal bleeding (see section 4.4). |
|Acetylsalicylic acid: ||Administration of ibuprofen concomitantly with acetylsalicylic acid is generally not recommended due to the potential for increased adverse events. Experimental data suggest that ibuprofen, when administered concomitantly with acetylsalicylic acid, can competitively inhibit the effect of low doses of the latter on platelet aggregation. Despite the uncertainties regarding extrapolation of these data to the clinical situation, it cannot be excluded that long-term regular use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid. No clinically relevant effects are considered likely following the occasional use of ibuprofen (see section 5.1). |
|Anticoagulants: (e.g. warfarin, ticlopidine, clopidogrel, tirofiban, eptifibatide, abciximab, iloprost) ||NSAIDs such as ibuprofen may potentiate the effect of anticoagulants (see section 4.4). |
|Phenytoin: ||Concomitant use of ACTISINU with phenytoin preparations could increase the serum levels of these medicinal products. A check of serum phenytoin levels is generally not required with correct use (maximum for 4 days). |
|Selective Serotonin Reuptake Inhibitors (SSRIs): ||Increased risk of gastrointestinal bleeding (see section 4.4). |
|Lithium: ||Concomitant use of ACTISINU with lithium-based preparations may increase the serum levels of these medicinal products. A check of serum lithium is generally not required in case of correct use (maximum for 4 days). |
|Probenecid and sulfinpyrazone: ||Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. |
|Diuretics, ACE inhibitors, beta-blockers and angiotensin-II antagonists: ||NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor, beta-blocker or angiotensin-II antagonist and cyclooxygenase inhibiting agents could lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly subjects. Patients should be adequately hydrated and careful monitoring of renal function considered after initiation of concomitant therapy, and then periodically. |
|Potassium-sparing diuretics: ||Concomitant administration of ACTISINU and potassium-sparing diuretics could lead to hyperkalaemia (monitoring of serum potassium is recommended). |
|Methotrexate: ||Administration of ACTISINU within 24 hours before or after methotrexate administration could lead to elevated concentrations of methotrexate and an increase in its toxic effect. |
|Ciclosporin: ||The risk of cyclosporine-induced kidney damage is increased through concomitant administration of some non-steroidal anti-inflammatory drugs. Furthermore, a similar effect cannot be excluded for a combination of cyclosporine and ibuprofen. |
|Tacrolimus: ||The risk of nephrotoxicity is increased if the two drugs are administered simultaneously. |
|Zidovudine: ||There is evidence of an increased risk of haemarthrosis and hematoma in HIV (+) haemophiliacs receiving concomitant treatment with zidovudine and ibuprofen. |
|Sulfonylureas: ||Clinical investigations have shown interactions between non-steroidal anti-inflammatory drugs and antidiabetic drugs (sulfonylureas). Although no interactions between ibuprofen and sulfonylureas have been described to date, a check of blood glucose values is recommended as a precaution during concomitant intake. |
|Quinolones: ||Animal data indicate that NSAIDs may increase the risk of quinolone-associated seizures. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. |
|Heparin; Gingko biloba: ||Increased risk of bleeding. |
The clinical effects of overdose are more likely due to the pseudoephedrine hydrochloride than the ibuprofen in this medicinal product. The effects are not clearly correlated with the dose taken due to inter-individual 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, heart arrhythmias, muscle weakness and stiffness, 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 ingesting a potentially toxic amount, administration of activated charcoal may be considered. Check electrolytes and perform an ECG. In the event of cardiovascular instability and / or symptomatic electrolyte imbalance, symptomatic treatment should be initiated.
Each film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride. For the full list of excipients, see section 6.1.
Tablet core Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Corn starch Silica colloidal anhydrous Magnesium stearate Tablet coating Hypromellose Macrogol 400 Talc Titanium dioxide (E171) Iron oxide yellow (E172)