Aspirina influenza e naso chiuso 20 sachets

Product Description

Drug useful for the symptomatic treatment of flu-like syndromes and/or colds with nasal congestion, sinusitis, pain and fever.

Composition

Active Ingredients

Each sachet contains 500 mg of acetylsalicylic acid and 30 mg of pseudoephedrine hydrochloride.

Excipients

Citric acid, sucrose, hypromellose, saccharin, orange flavoring containing benzyl alcohol, acetic acid, alpha tocopherol, modified starch E1450 and maltodextrin.

Indications

Symptomatic treatment of nasal congestion and sinusitis (re (sinusitis) with painful and feverish conditions associated with flu and/or cold symptoms. This medicine is indicated for adults and adolescents 16 years of age and older.

Contraindications

Hypersensitivity to pseudoephedrine, acetylsalicylic acid or other salicylates, or to any of the excipients; history of asthma induced by the administration of salicylates or substances with a similar action, in particular nonsteroidal anti-inflammatory drugs; acute gastrointestinal ulcers; haemorrhagic diathesis; pregnancy; breastfeeding; severe hepatic insufficiency; severe renal insufficiency; severe cardiac insufficiency; in combination with methotrexate used in doses of 15 mg/week or more; severe hypertension; severe coronary artery disease; treatment with monoamine oxidase inhibitor drugs in the previous two weeks.

Dosage

Dosage. The contents of 1-2 sachets are for adults and adolescents aged 16 years and over. If necessary, the single dose can be repeated at intervals of 4-8 hours. Do not exceed the maximum daily dose of 6 sachets. If one of the symptoms prevails, treatment with a single active ingredient is more appropriate. This medicine should not be taken for more than 3 days without first consulting a doctor.

Paediatric population. This medicine should not be taken by children and adolescents under 16 years of age without consulting a doctor. Given the limited experience of using this medicine in children and adolescents, it is not possible to indicate a specific recommended dose.

Method of administration: This medicine should be dissolved in a glass of water before taking. The resulting suspension has an orange flavor.

Conversation

Do not store above 30 degrees C.

Warnings

Concomitant treatment with anticoagulants; history of gastrointestinal ulcers, including chronic or recurrent ulcer disease, or history of gastrointestinal bleeding; patients with impaired renal function or impaired cardiovascular function (e.g. renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis, or major bleeding events), as acetylsalicylic acid may further increase the risk of renal damage and acute renal failure; impaired hepatic function; hypersensitivity to analgesics / anti-inflammatories
or antirheumatics or other allergens; Hyperthyroidism, mild to moderate hypertension, diabetes mellitus, ischemic heart disease, elevated intraocular pressure (glaucoma), prostatic hypertrophy, or sensitivity to sympathomimetic agents; elderly patients may be particularly sensitive to the central nervous system effects of pseudoephedrine. Acetylsalicylic acid may accelerate bronchospasm and induce asthma attacks or other hypersensitivity reactions. The following existing conditions are risk factors: bronchial asthma, allergic rhinitis (hay fever), nasal polyps, or chronic respiratory disease. This also applies to patients who have allergic reactions (e.g., skin reactions, itching, urticaria) to other substances. Given its inhibitory effect on platelet aggregation, which persists for several days after administration, acetylsalicylic acid may lead to an increased tendency to develop haemorrhages during and after surgical procedures (including minor procedures such as tooth extractions). At low doses, acetylsalicylic acid reduces uric acid excretion. This may cause gout in patients who already have a limited uric acid excretion. Habitual use of analgesics (especially the combination of several analgesic medications) can cause permanent kidney damage (analgesic nephropathy). One sachet of this medicine contains 2 g of sucrose (equivalent to 0.17 units of carbohydrates). This should be taken into consideration in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains 3.78 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should contact their doctor, as large amounts of benzyl alcohol may cause metabolic acidosis. In patients with severe glucose-6-phosphate dehydrogenase (G6DP) deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia. Factors that may increase the risk of hemolysis include high doses, influenza, or acute infections. Severe skin reactions: Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with products containing pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules arising from widespread edematous erythema, primarily located on the skin folds, trunk, and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or numerous small pustules are observed, administration of this drug should be discontinued and appropriate measures taken if necessary. Ischemic colitis: There have been reports of ischemic colitis with the use of pseudoephedrine. Use of pseudoephedrine should be discontinued immediately and medical advice should be sought if sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis occur. Athletes should be aware that taking this drug may result in positive doping tests. Pediatric population. There is a possible association between acetylsalicylic acid and Reye's syndrome when administered to children and adolescents for the treatment of viral infections, with or without influenza. For this reason, this drug should not be taken by children and adolescents under 16 years of age without consulting a doctor.

Interactions

Contraindicated combinations. Methotrexate used at doses of 15 mg/week or higher: increased hematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory agents in general and dislocation of methotrexate from plasma protein binding sites caused by salicylates). Monoamine oxidase inhibitors (MAOIs) in the preceding 2 weeks increase the risk of adverse cardiovascular events (e.g., arrhythmia, hypertensive crisis). Combinations requiring precautions for use. Methotrexate, used at doses less than 15 mg/week: Increased hematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory agents in general and dislodgement of methotrexate from plasma protein binding sites by salicylates). Anticoagulants, thrombolytics, or other inhibitors of platelet aggregation/hemostasis: Increased risk of hemorrhage. Other nonsteroidal anti-inflammatory drugs with salicylates in higher doses: Increased risk of gastrointestinal ulcers and hemorrhage due to the synergistic effect. Selective serotonin reuptake inhibitors (SSRIs): Increased risk of upper gastrointestinal hemorrhage due to the possible synergistic effect. Digoxin: Plasma digoxin concentrations are increased due to reduced excretion of this agent by the kidneys. Antidiabetics, e.g., Insulin, sulfonylureas: Increased hypoglycemic effect of high doses of acetylsalicylic acid due to the hypoglycemic action of the latter and the dislocation of the sulfonylurea from plasma protein binding sites. Diuretics in combination with acetylsalicylic acid in higher doses: Reduction of glomerular filtration due to the limitation of prostaglandin synthesis in the kidneys. Systemic glucocorticoids, except hydrocortisone used as replacement therapy in Addison's disease: Reduction of blood salicylate levels during corticosteroid treatment and risk of salicylate overdose after discontinuation of this treatment due to increased salicylate elimination by corticosteroids. Angiotensin-converting enzyme (ACE) inhibitors in combination with acetylsalicylic acid in higher doses: Reduction of glomerular filtration caused by inhibition of vasodilatory prostaglandins. Additionally, limitation of the antihypertensive effect. Valproic acid: Increased toxicity of valproic acid due to dislocation from protein binding sites. Alcohol: Increased damage to the gastrointestinal mucosa and prolonged bleeding time due to the additive effects of aspirin and alcohol. Uricosurics such as benzbromarone, probenecid: Limitation of the uricosuric effect (antagonistic effect on uric acid elimination in the renal tubules). Salbutamol tablets: Increased effects (worsening of cardiovascular side effects); this does not preclude the judicious use of an adrenergic bronchodilator aerosol. Antidepressants: Increased effects. Other sympathomimetic drugs: Increased effects. Medicines for hypertension, such as guanethidine, methyl
dopa, beta-blockers: reduced effects.

Side effects

Frequencies: not known (cannot be estimated from the available data). Possible side effects of acetylsalicylic acid. Immune system disorders: hypersensitivity reactions, with their respective clinical and laboratory manifestations, include asthma syndrome, mild to moderate reactions potentially affecting the skin, respiratory tract, gastrointestinal tract and cardiovascular system, which include symptoms such as rash, urticaria, edema, pruritus, rhinitis, nasal congestion, cardiorespiratory distress and, very rarely, serious reactions, including anaphylactic shock. Gastrointestinal disorders: gastroduodenal disorders (gastralgia, dyspepsia, gastritis); nausea, vomiting, diarrhea; gastrointestinal ulcers, which may lead to perforation in isolated cases. Hepatobiliary disorders: Transient hepatic impairment with increased transaminases. Blood and lymphatic system disorders: Increased risk of bleeding, such as perioperative hemorrhage, hematomas, epistaxis, urogenital bleeding, and gingival bleeding. Hemolysis and hemolytic anemia have been reported in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency; hemorrhage can cause posthemorrhagic anemia/chronic and acute iron deficiency anemia (e.g., due to occult microbleeds) with related clinical and laboratory signs and symptoms, such as asthenia, pallor, and hypoperfusion. Nervous system disorders: Overdose may cause vertigo. Ear and labyrinth disorders: Overdose may cause tinnitus. Renal and urinary tract disorders: Renal impairment and acute renal failure have been reported. Possible side effects of pseudoephedrine. Vascular disorders: Flushing; increased blood pressure, although not affecting controlled hypertension. Cardiac disorders: Cardiac effects (e.g., tachycardia, palpitations, arrhythmias). Nervous system disorders: Central nervous system stimulation (e.g., insomnia, rarely hallucinations). Renal and urinary tract disorders: Urinary retention, especially in patients with prostatic hyperplasia. Skin and subcutaneous tissue disorders: Skin effects (e.g., rash, urticaria, pruritus). Serious skin reactions, including acute generalized exanthematous pustulosis (AGEP). Gastrointestinal disorders: Ischemic colitis. Reporting of suspected adverse reactions: Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system www.agenziafarmaco.gov.it/content/c ome-segnalare-una-sospetta-reazione-avversa.

Pregnancy and breastfeeding

Pregnancy: Since no data are available on the combination of the two substances, the use of this drug is contraindicated during pregnancy. Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryo-fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. This risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation embryonic loss and embryo-fetal lethality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimesters of pregnancy, acetylsalicylic acid should not be administered unless absolutely necessary. If acetylsalicylic acid is used by a woman planning a pregnancy, or during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); Renal dysfunction, which may progress to renal failure with oligohydramnios; The mother and newborn, at the end of pregnancy, may experience: possible prolongation of bleeding time; antiplatelet effect that may occur even at very low doses; inhibition of uterine contractions, which causes delayed or prolonged labor. Therefore, acetylsalicylic acid is contraindicated in the third trimester of pregnancy. The limited data available on the use of pseudoephedrine during pregnancy do not show an increased risk of malformations. However, the use of pseudoephedrine during pregnancy is not recommended. In animal studies, both active substances have shown reproductive toxicity. Breastfeeding: Both salicylates and pseudoephedrine pass into breast milk in small amounts. Since no data are available on the combination of the two substances, the use of this drug is contraindicated during breastfeeding. Fertility: There is some evidence that drugs that inhibit prostaglandin synthesis may impair female fertility by affecting ovulation. This is reversible upon discontinuation of treatment.

Format

20 sachets