Aspirin Flu Blocked Nose 20 Sachets

Aspirin Flu and Stuffy Nose is a medicine indicated for the treatment of cold and flu symptoms, including nasal congestion, headache and fever. Thanks to the combination of acetylsalicylic acid and a nasal decongestant, this product helps reduce inflammation and clear the airways.

ACTIVE INGREDIENTS

Active ingredients contained in Aspirin Flu Blocked Nose 20 Sachets - What is the active ingredient in Aspirin Flu Blocked Nose 20 Sachets?

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 Flu Blocked Nose 20 Sachets - What does Aspirin Flu Blocked Nose 20 Sachets contain?

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

DIRECTIONS

Therapeutic indications Aspirin Flu Blocked Nose 20 Sachets - Why is Aspirin Flu Blocked Nose 20 Sachets used? What is it for?

Symptomatic treatment of nasal congestion and sinuses (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 SIDE EFFECTS

Contraindications Aspirin Flu Blocked Nose 20 Sachets - When should Aspirin Flu Blocked Nose 20 Sachets not be used?

Hypersensitivity to acetylsalicylic acid or other salicylates, pseudoephedrine, 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 nonsteroidal anti-inflammatory drugs; acute gastrointestinal ulcers; haemorrhagic diathesis; severe hepatic insufficiency; severe acute or chronic renal disease/renal failure; severe heart failure; severe uncontrolled hypertension; severe coronary artery disease; in combination with methotrexate used in doses of 15 mg/week or more (see section 4.5); pregnancy; breast-feeding; treatment with monoamine oxidase inhibitor medicinal products in the previous two weeks; narrow-angle glaucoma; urinary retention.

DOSAGE

Quantity and method of taking Aspirin Flu Blocked Nose 20 Sachets - How do you take Aspirin Flu Blocked Nose 20 Sachets?

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 stuffy nose should not be taken for more than 3 days without first consulting a doctor. Paediatric population: Aspirin influenza and stuffy 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 stuffy 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 influenza e naso chiusa should be dissolved in a glass of water before taking. The resulting suspension has an orange flavour.

CONSERVATION

Storage Aspirin Flu Blocked Nose 20 Sachets - How do you store Aspirin Flu Blocked Nose 20 Sachets?

Do not store above 30 degrees C.

WARNINGS

Warnings Aspirin Flu Blocked Nose 20 Sachets - About Aspirin Flu Blocked Nose 20 Sachets it is important to know that:

Hypersensitivity to analgesics/anti-inflammatories or antirheumatics or other allergens. 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, pruritus, urticaria) to other substances. History of gastrointestinal ulcers including chronic or recurrent ulcer disease or history of gastrointestinal bleeding. Concomitant treatment with anticoagulants (see section 4.5). 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). Patients with impaired hepatic function. 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. 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. 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. Habitual use of analgesics (especially the combination of several analgesic medicinal products) may permanently damage the kidneys (analgesic nephropathy). Hyperthyroidism, mild to moderate hypertension, diabetes mellitus, ischaemic heart disease, elevated intraocular pressure (glaucoma), prostatic hypertrophy, or sensitivity to sympathomimetic agents. Renal tubular acidosis due to accumulation of pseudoephedrine and increased risk of side effects. 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 edematous 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. 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, such as scotoma. Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3). Pseudoephedrine should be discontinued and medical attention should be sought immediately if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, convulsions and/or visual disturbances. Most reported cases of PRES and RCVS resolved after discontinuation and appropriate treatment. Doping: Athletes should be aware that taking this drug may result in positive "anti-doping" tests. 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, since large amounts of benzyl alcohol may cause metabolic acidosis. Elderly patients: elderly patients may be particularly sensitive to the effects of pseudoephedrine on the central nervous system. 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 Flu and Stuffy Nose should not be taken by children and adolescents under 16 years of age, without consulting a doctor.

INTERACTIONS

Interactions Aspirin Flu Blocked Nose 20 Sachets - Which medicines or foods can modify the effect of Aspirin Flu Blocked Nose 20 Sachets?'

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. Antidepressants: increased effects. 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 the 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 the 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. In addition, limitation of the antihypertensive effect. Medicines against hypertension, such as guanethidine, methyldopa, beta-blockers: reduction of effects. Valproic acid: increased toxicity of valproic acid due to dislocation from protein binding sites. Uricosurics such as benzbromarone, probenecid: limitation of the uricosuric effect (antagonism with the elimination of uric acid at the renal tubules). Salbutamol tablets: increased effects (worsening of cardiovascular side effects); this does not preclude the judicious use of an adrenergic bronchodilator aerosol. Other sympathomimetic drugs: increased effects. Alcohol: increased damage to the gastrointestinal mucosa and prolonged bleeding time due to the additive effects of acetylsalicylic acid and alcohol.

SIDE EFFECTS

Like all medicines, Aspirin Flu Blocked Nose 20 Sachets can cause side effects - What are the side effects of Aspirin Flu Blocked Nose 20 Sachets?

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 related 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 damage 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). Posterior reversible encephalopathy syndrome (PRES) (See section 4.4.); Reversible cerebral vasoconstriction syndrome (RCVS) (See section 4.4). 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 generalised exanthematous pustulosis (AGEP). Gastrointestinal disorders: ischaemic colitis, dry mouth. Eye disorders: ischaemic optic neuropathy. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorisation 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 Flu Blocked Nose 20 Sachets.

Pregnancy: Since 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 cause an increase in pre- and post-implantation embryonic loss and embryo-foetal lethality. In addition, 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 trimesters 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 newborn, at the end of pregnancy, to: possible prolongation of bleeding time, anti-aggregating effect that can occur even at very low doses; inhibition of uterine contractions that causes delay or prolongation of 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 quantities. Since there are no data available on the combination of the two substances, the use of Aspirina influenza e naso chiusa is contraindicated during breastfeeding. Fertility: There is some evidence that drugs that inhibit prostaglandin synthesis may impair 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).