Aspirin flu and stuffy nose 500 mg + 30 mg 10 sachets granules for oral solution

Aspirin Flu and Stuffy Nose 500 mg + 30 mg 10 sachets granules for oral solution is an over-the-counter medicine specifically formulated for the symptomatic treatment of nasal congestion and sinuses (rhinosinusitis), associated with painful and feverish states typical of flu and colds . Each sachet contains 500 mg of acetylsalicylic acid and 30 mg of pseudoephedrine hydrochloride , a combination that offers a complete action: acetylsalicylic acid acts as a pain reliever, anti-inflammatory and antipyretic , while pseudoephedrine performs an effective nasal decongestant function, promoting breathing and reducing the sensation of a stuffy nose.

The product is indicated for adults and adolescents from 16 years of age who need rapid and targeted relief from flu and cold symptoms, such as headache, muscle pain, fever and nasal congestion . The formulation in granules for oral solution makes taking it simple and pleasant: just dissolve the contents of a sachet in a glass of water to obtain a suspension with a pleasant orange flavor .

Thanks to the presence of acetylsalicylic acid , Aspirin influenza and stuffy nose acts quickly against pain and fever , while pseudoephedrine hydrochloride frees a stuffy nose and paranasal sinuses, improving the quality of breathing. The product is ideal for those looking for a complete and practical symptomatic treatment , in a format of 10 soluble sachets , perfect to always carry with you.

The combination of the two active ingredients makes this medicine an effective solution to deal with the typical ailments of the cold season , offering rapid and lasting relief from the most annoying symptoms. Aspirin influenza and stuffy nose 500 mg + 30 mg is the ideal choice for those who want to quickly return to their daily activities, effectively combating nasal congestion, pain and fever with a single product.

ACTIVE INGREDIENTS

Active ingredients contained in Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - What is the active ingredient of Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution?

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

EXCIPIENTS

Composition of Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - What does Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution contain?

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

DIRECTIONS

Therapeutic indications Aspirin flu and stuffy nose 500 mg + 30 mg 10 sachets granules for oral solution - Why is Aspirin flu and stuffy nose 500 mg + 30 mg 10 sachets granules for oral solution used? What is it for?

Symptomatic treatment of nasal congestion and sinusitis (rhinosinusitis) with painful and feverish conditions associated with flu and/or cold symptoms. Aspirin influenza and stuffy nose is indicated for adults and adolescents from 16 years.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Aspirin flu and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - When should Aspirin flu and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution not be used?

- 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; - Haemorrhagic diathesis; - Pregnancy; - Breast-feeding; - Severe hepatic insufficiency; - Severe renal insufficiency; - Severe cardiac insufficiency; - In combination with methotrexate used in doses of 15 mg/week or more (see section 4.5); - Severe hypertension; - Severe coronary artery disease; - Treatment with monoamine oxidase inhibitor medicinal products in the previous two weeks. - Narrow-angle glaucoma - Urinary retention

DOSAGE

Quantity and method of taking Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - How do you take Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution?

Dosage The contents 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 a single active ingredient is more appropriate. Aspirin influenza and blocked nose should not be taken for more than 3 days without first consulting a doctor. Paediatric population Aspirin influenza and blocked nose should not be taken by children and adolescents under the age of 16 years, without consulting a doctor. Given the limited experience of use of Aspirin influenza and blocked nose in children and adolescents, it is not possible to indicate 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 should be dissolved in a glass of water before taking. The resulting suspension has an orange flavour.

CONSERVATION

Storage Aspirin flu and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - How do you store Aspirin flu and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution?

Do not store above 30°C.

WARNINGS

Warnings Aspirin flu and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - About Aspirin flu and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution it is important to know that:

- Concomitant treatment with anticoagulants (see section 4.5); - 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 haemorrhagic events), as the medicinal product may further increase the risk of renal damage and acute renal failure; - Impaired hepatic function; - Renal tubular acidosis due to accumulation of pseudoephedrine and increased risk of adverse effects; - Hypersensitivity to analgesics / anti-inflammatory or antirheumatic drugs or other allergens; - Hyperthyroidism, mild to moderate hypertension, diabetes mellitus, ischaemic 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. Due to its inhibitory effect on platelet aggregation which continues 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 limited doses, acetylsalicylic acid reduces the excretion of uric acid. This may cause gout in patients who already tend to have limited excretion of uric acid. Regular use of painkillers (especially combinations of several painkillers) may permanently damage the kidneys (analgesic nephropathy). One sachet of Aspirin influenza and stuffy nose 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. Aspirin influenza and stuffy nose 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 haemolysis or haemolytic anaemia. Factors that may increase the risk of haemolysis are, for example, high dosage, influenza or acute infections. Severe skin reactions Severe skin reactions such as acute generalised 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 oedematous erythema and located mainly in 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, Aspirin influenza 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. Pseudoephedrine should be discontinued immediately and medical advice should be sought if abdominal pain, rectal bleeding or other symptoms of ischaemic colitis occur suddenly. Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, such as scotoma. Athletes should be aware that they may test positive in “anti-doping” tests while taking this drug. Paediatric 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, Aspirin influenza e naso chiusa should not be taken by children and adolescents under 16 years of age without consulting a doctor.

INTERACTIONS

Interactions Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution - Which medicines or foods can modify the effect of Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution?

Contraindicated combinations (see section 4.3): Methotrexate used at doses of 15 mg/week or higher: 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 caused 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 less than 15 mg/week: 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 caused by salicylates). Anticoagulants, thrombolytics or other inhibitors of platelet aggregation/haemostasis: Increased risk of haemorrhage. Other nonsteroidal anti-inflammatory drugs with salicylates: Increased risk of gastrointestinal ulcers and haemorrhage 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 reduced excretion of this agent by the kidneys. Antidiabetics, e.g. insulin, sulfonylureas: Increased hypoglycaemic effect caused by high doses of acetylsalicylic acid via the hypoglycaemic action of the latter and the dislocation of the sulfonylurea 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: Reduction of blood levels of salicylates during treatment with corticosteroids and risk of salicylate overdose after cessation of this treatment due to increased elimination of salicylates by corticosteroids. Angiotensin converting enzyme (ACE) inhibitors in combination with acetylsalicylic acid: Reduction of glomerular filtration caused by inhibition of vasodilatory 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 of renal tubular elimination of uric acid). 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 against hypertension, such as guanethidine, methyldopa, beta-blockers: Decreased effects.

SIDE EFFECTS

Like all medicines, Aspirin influenza e naso chiusa 500 mg + 30 mg 10 sachets granules for oral solution can cause side effects - What are the side effects of Aspirin influenza e naso chiusa 500 mg + 30 mg 10 sachets granules for oral solution?

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, gastrointestinal tract and cardiovascular system, including 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, diarrhoea; Gastrointestinal ulcers, which may 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, haematomas, epistaxis, urogenital haemorrhage and gingival bleeding. Haemolysis and haemolytic anaemia have been reported in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency; Haemorrhage may cause haemorrhagic anaemia/iron deficiency anaemia (e.g. due to occult microbleeding) with associated clinical and laboratory signs and symptoms, such as asthenia, pallor, 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 Effects on the skin (e.g. rash, urticaria, 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 that occur after authorisation of the medicinal product is important. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose Aspirin flu and stuffy nose 500 mg + 30 mg 10 sachets granules for oral solution - What are the risks of Aspirin flu and stuffy nose 500 mg + 30 mg 10 sachets granules for oral solution in case of overdose?

Acetylsalicylic acid: There is a difference between chronic overdose, which predominantly causes central nervous system disorders (“salicylism”), and acute intoxication, which manifests itself essentially through a severe acid-base imbalance. In addition to acid-base and electrolyte imbalance (e.g. potassium loss), hypoglycaemia, 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 fatal intoxications, death occurs due to respiratory failure. Pseudoephedrine: Abnormal sympathomimetic reactions may occur, e.g. tachycardia, chest pain, agitation, hypertension, 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 intoxication. They correspond to the measures usually taken to reduce the absorption of an active ingredient: accelerating excretion, monitoring water and electrolyte balance, disturbances in temperature regulation, breathing and cardiovascular and brain functions. Immediate medical intervention is essential, even in the absence of obvious symptoms.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution

Pregnancy As there are no data on the combination of the two substances, the use of Aspirina influenza e naso chiusa is contraindicated during 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 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-foetal lethality. Furthermore, an increased incidence of various malformations, including cardiovascular, has 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 given unless absolutely necessary. If acetylsalicylic acid is used by a woman planning a pregnancy, or during the first and second trimester of pregnancy, the dose should be as low 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 the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Therefore, the medicinal product 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 (see section 5.3). Breastfeeding Both salicylates and pseudoephedrine pass into breast milk in small amounts. As there are no data available on the combination of the two substances, the use of Aspirina influenza e naso fermora is contraindicated during breastfeeding. Fertility There is some evidence that drugs that inhibit prostaglandin synthesis may cause impairment of female fertility by 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).

DRIVING AND USE OF MACHINERY

Take Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution before driving or using machines - Does Aspirin influenza and blocked nose 500 mg + 30 mg 10 sachets granules for oral solution affect driving or using machines?

Aspirin Flu and Stuffy Nose causes mild to moderate impairment of the ability to drive or use machines. The risk may increase if alcohol is taken concomitantly.