ASPIRINA INFLUENCE AND NASO C 20

ASPIRINA FLU AND STUFFED NOSE 500 MG / 30 MG GRANULES FOR ORAL SUSPENSION

active principles

Each sachet contains 500 mg of acetylsalicylic acid and 30 mg of pseudoephedrine hydrochloride Excipients with known effects: Each sachet contains 2g of sucrose. Each sachet contains 3.78 mg of benzyl alcohol. For the complete list of excipients, see section 6.1.

Exceptions

Citric acid Sucrose Hypromellose Saccharin Orange flavor containing benzyl alcohol, acetic acid, alpha tocopherol, modified starch E1450 and maltodextrin

Therapeutic indications

Symptomatic treatment of nasal and sinus congestion (rhinosinusitis) with pain and fever associated with flu and/or cold symptoms. Aspirin flu and stuffy nose is indicated for adults and adolescents from 16 years of age.

Contraindications

- Hypersensitivity to pseudoephedrine, acetylsalicylic acid or other salicylates, or to any of the excipients listed in section 6.1; - History of asthma induced by the administration of salicylates or substances with a similar action, in particular non-steroidal anti-inflammatory drugs; - Acute gastrointestinal ulcers; - bleeding diathesis; - Pregnancy; - Feeding time; - Severe liver failure; - Severe renal insufficiency; - severe heart failure; - In combination with methotrexate used in doses of 15 mg/week or higher (see section 4.5); - Severe hypertension; - Severe coronary artery disease; - Treatment with monoamine oxidase inhibitor medicines in the previous two weeks. - Narrow angle glaucoma - Urinary retention

Posology

Posology The content of 1-2 sachets for adults and adolescents from 16 years. If necessary, the single dose can be repeated after a period of at least 4 hours. Do not exceed the maximum daily dose of 6 sachets. If one of the symptoms prevails, treatment with only one active substance is more appropriate. Aspirin flu and stuffy nose should not be taken for more than 3 days without first consulting a doctor. Pediatric population Aspirin flu and stuffy nose should not be taken by children and adolescents under the age of 16 without consulting their doctor. Given the limited experience of using Aspirin flu and stuffy nose in children and adolescents, it is not possible to give a specific recommended dose. Patients with impaired hepatic function Acetylsalicylic acid should be used with caution in patients with impaired hepatic function (see section 4.4) Patients with impaired renal function Acetylsalicylic acid should be used with caution in patients with impaired renal function or impaired cardiovascular circulation (see section 4.4.) Method of administration Aspirin flu and stuffy nose must be dissolved in a glass of water before taking. The resulting suspension tastes like orange.

Storage

Do not store above 30°C.

Warnings

- Concomitant treatment with anticoagulants (see section 4.5); - History of gastrointestinal ulcers including chronic or relapsing 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 the medicinal product may further increase the risk of renal damage and acute renal; - Impaired liver function; - Renal tubular acidosis due to accumulation of pseudoephedrine and increased risk of side effects - 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 effects of pseudoephedrine on the central nervous system. 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 continues for several days after administration, acetylsalicylic acid may lead to an increased tendency to develop bleeding during and after surgical procedures (including minor procedures such as tooth extractions). In limited doses, acetylsalicylic acid reduces the excretion of uric acid. This can lead to gout in patients who are already prone to limited excretion of uric acid. Habitual use of pain relievers (especially combining several pain relievers) can permanently damage the kidneys (analgesic nephropathy). One sachet of Aspirin flu and stuffy nose contains 2 g of sucrose (the equivalent of 0.17 carbohydrate units). 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. Aspirin flu and stuffy nose contains 3.78 mg of benzyl alcohol in each sachet. Benzyl alcohol can cause allergic reactions. Patients with liver or kidney disease should contact their physician, as large amounts of benzyl alcohol can cause metabolic acidosis. In patients with severe glucose-6-phosphate dehydrogenase (G6DP) deficiency, acetylsalicylic acid may induce haemolysis or haemolytic anemia. Factors that may lead to an increased risk of haemolysis are, for example, high dosage, influenza or acute infections. Severe skin reactions Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP) can 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 resulting from a widespread oedematous erythema and located mainly on skin folds, trunk and upper limbs. Patients should be closely monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, the administration of Aspirin flu and stuffy nose should be discontinued and appropriate measures taken if necessary. Ischemic colitis There have been reports of ischemic colitis with the use of pseudoephedrine. The use of pseudoephedrine should be discontinued immediately and medical advice should be sought if abdominal pain, rectal bleeding or other symptoms of ischemic colitis occur suddenly. Ischemic optic neuropathy Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, e.g. in case of scotoma. Athletes must be aware that, by taking this drug, they may be positive in "anti-doping" tests.Pediatric population There is a possible association between acetylsalicylic acid and Reye's syndrome when given to children and adolescents for the treatment of viral infections, with or without influenza. For this reason, Aspirin flu and stuffy nose should not be taken by children and adolescents under the age of 16 without consulting their doctor.

Interactions

Contraindicated combinations (see section 4.3): Methotrexate used at doses of 15 mg/week. or greater: Increased haematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory agents in general and dislocation of methotrexate from plasma protein binding sites by salicylates). Monoamine oxidase inhibitors (MAOIs), in the previous 2 weeks, increase the risk of adverse cardiovascular events (e.g. arrhythmia, hypertensive crisis). Combinations requiring precautions for use: Methotrexate, used at doses below 15 mg/week: Increased haematological toxicity of methotrexate (decrease in renal clearance of methotrexate by anti-inflammatory agents in general and dislocation of methotrexate from plasma protein binding sites by salicylates). Anticoagulants, thrombolytics or other inhibitors of platelet aggregation/haemostasis: Increased risk of haemorrhage. Other non-steroidal anti-inflammatory drugs with salicylates: Increased risk of gastrointestinal ulcers and bleeding due to synergistic effect. Selective serotonin reuptake inhibitors (SSRIs): Increased risk of upper gastrointestinal haemorrhage due to possible synergistic effect. Digoxin: Plasma concentrations of digoxin are increased due to decreased excretion of this agent by the kidneys. Antidiabetics, e.g. insulin, sulphonylureas: Enhancement of the hypoglycaemic effect caused by high doses of acetylsalicylic acid via the hypoglycaemic action of the latter and the dislocation of the sulphonylurea from plasma protein binding sites. Diuretics in combination with acetylsalicylic acid: Reduction of glomerular filtration due to limitation of prostaglandin synthesis in the kidneys. Systemic glucocorticoids, except hydrocortisone used as replacement therapy in Addison's disease: Decreased blood levels of salicylates during treatment with corticosteroids and risk of salicylate overdose after discontinuation of this treatment due to increased elimination of salicylates by the corticosteroids. Angiotensin converting enzyme (ACE) inhibitors in combination with acetylsalicylic acid: Reduction of glomerular filtration caused by inhibition of vasodilator prostaglandins. Also, 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 acetylsalicylic acid and alcohol. Uricosurics such as benzbromarone, probenecid: Limitation of the uricosuric effect (antagonism with the elimination of uric acid at the level of the renal tubules). Salbutamol tablets: Increased effects (worsening of cardiovascular side effects); this does not preclude the judicious use of an adrenergic-acting aerosol bronchodilator. Antidepressants: Enhanced effects. Other sympathomimetic medicinal products: Enhanced effects. Medicines against hypertension, such as guanethidine, methyldopa, beta-blockers: Reduction of effects.

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 respiratory disease exacerbated by acetylsalicylic acid, mild to moderate reactions potentially affecting the skin, respiratory tract, of the gastrointestinal tract and cardiovascular system, which include symptoms such as rash, urticaria, oedema, pruritus, rhinitis, nasal congestion, cardiorespiratory distress and, very rarely, severe reactions, including anaphylactic shock. Gastrointestinal disorders Gastroduodenal disorders (gastralgia, dyspepsia, gastritis); Nausea, vomiting, diarrhea; Gastrointestinal ulcers, which can lead to perforation in isolated cases. Disease of the intestinal diaphragms (especially in long-term treatment). Hepatobiliary disorders Transient hepatic impairment with increased transaminases. Blood and lymphatic system disorders Increased risk of bleeding, haemorrhage such as procedural haemorrhage, haematoma, epistaxis, urogenital haemorrhage and gingival bleeding. Haemolysis and haemolytic anemia have been reported in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency; Bleeding may cause haemorrhagic anaemia/iron deficiency anemia (e.g. occult microbleeds) with related clinical and laboratory signs and symptoms, such as asthenia, pallor, hypoperfusion. Nervous system disorders Overdose may cause dizziness. Ear and labyrinth disorders Overdose may cause tinnitus. Renal and urinary 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 Stimulation of the central nervous system (eg insomnia, rarely hallucinations). Renal and urinary tract disorders Urinary retention, especially in patients with prostatic hyperplasia. Skin and subcutaneous tissue disorders Effects on the skin (e.g. rash, hives, pruritus). Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP). Gastrointestinal disorders Ischemic colitis. Dry mouth Eye disorders Ischemic optic neuropathy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdose

Acetylsalicylic acid: There is a difference between chronic overdose, which predominantly causes disturbances of the central nervous system ("salicylism"), and acute intoxication, which manifests itself mainly through a severe imbalance of the acid-base balance. In addition to acid-base and electrolyte imbalances (e.g. loss of potassium), hypoglycemia, skin rashes and gastrointestinal bleeding, symptoms may include hyperventilation, tinnitus, nausea, vomiting, decreased vision and hearing, headache, dizziness and confusion. In severe intoxications, delirium, tremor, dyspnoea, sweating, dehydration, hyperthermia and coma may occur. In intoxications with lethal consequences, death occurs due to respiratory failure. Pseudoephedrine: Abnormal sympathomimetic reactions may occur, e.g. tachycardia, chest pain, agitation, hypertension, wheezing, shortness of breath, convulsions, hallucinations, following intoxication. The methods used to treat Aspirin intoxication flu and stuffy nose depend on the extent, stage and clinical symptoms of the intoxication. They correspond to the measures usually taken to reduce the absorption of an active substance: accelerate excretion, monitor water and electrolyte balance, disturbances in temperature regulation, respiration, cardiovascular and brain functions. Immediate medical intervention is essential, even in the absence of manifest symptoms.

Pregnancy

Since no data are available on the combination of the two substances, the use of Aspirin flu and stuffy nose is contraindicated in pregnancy. Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryo-foetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion and of cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. This risk is thought 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-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless absolutely necessary. When acetylsalicylic acid is used by a woman planning to become pregnant, or during the first and second trimester of pregnancy, the dose should be 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 can evolve into renal failure with oligohydramniosis. The mother and the newborn, at the end of the pregnancy, to: - possible protraction of the bleeding time, antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions which causes the delay or prolongation of labour. Therefore, the medicine is contraindicated in the third trimester of pregnancy. The limited data available on the use of pseudoephedrine in pregnancy do not show an increased risk of malformations. However, the use of pseudoephedrine in pregnancy is not recommended. In animal studies both active substances have shown reproductive toxicity (see section 5.3).

Feeding time

Both salicylates and pseudoephedrine pass into breast milk in small amounts. Since there is no data available on the combination of the two substances, the use of Aspirin flu and stuffy nose is contraindicated during breastfeeding.

Fertility

There is some evidence that drugs that inhibit prostaglandin synthesis may cause impairment of female fertility through an effect on ovulation. This is reversible upon discontinuation of treatment. Animal studies have shown adverse effects on male and female fertility (see section 5.3)

Source: Farmadati