Name
Aspirin Flu and Stuffy Nose 500mg / 30mg Granules for Oral Suspension
Acetylsalicylic acid, pseudoephedrine hydrochloride


What it is and what it is used for
Aspirin Flu and Stuffy Nose contains the active ingredients acetylsalicylic acid and pseudoephedrine hydrochloride.
It has analgesic, anti-inflammatory, antipyretic and nasal decongestant properties.
This medicine is used in the symptomatic treatment of nasal and sinus congestion (rhinosinusitis) and painful and feverish conditions associated with flu and/or cold symptoms.
If you have only one of these symptoms, it may be more appropriate to take a medicine containing only one active ingredient.
Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 3 days.
Aspirin Flu and Stuffy Nose is indicated for use in adults and adolescents aged 16 years and over.


What you need to know before taking the medicine
Do not take Aspirin for flu and blocked nose:
• if you are allergic (hypersensitive) to acetylsalicylic acid, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6)
• if you have a history of asthma induced by administration of salicylates or substances with a similar action (i.e. non-steroidal anti-inflammatory drugs)
• if you suffer from gastric (stomach) ulcers
• if you have a predisposition to bleeding
• if you suffer from liver failure
• if you suffer from acute (sudden) or chronic (long-term) severe kidney disease or kidney failure
• if you suffer from severe heart failure
• if you suffer from severe coronary heart disease
• if you have very high blood pressure (severe hypertension) or hypertension that is not controlled by drugs
• if you are also taking 15 mg (or more) of methotrexate per week
• if you are pregnant
• if you are breastfeeding
• if you are also taking antidepressants containing monoamine oxidase inhibitors (MAOIs) (or have taken them in the previous two weeks)
• if you suffer from narrow-angle glaucoma (angle-closure glaucoma)
• if you suffer from urinary retention


Warnings and precautions
Talk to your doctor or pharmacist before taking ASPIRIN flu and blocked nose:
• if you are allergic (hypersensitive) to other analgesics, antirheumatics or anti-inflammatories
• if you suffer from allergies (e.g. with rash, itching, hives), asthma, hay flu, swelling of the nasal mucosa (nasal polyps) or long-term lung disease
• if you have a history of stomach ulcers or gastrointestinal bleeding
• if you are also taking medicines that thin the blood and prevent clotting (anticoagulants)
• if you are about to undergo surgery (even minor, such as tooth extraction) as acetylsalicylic acid increases the risk of bleeding even at low doses
• if your liver function is impaired
• if you have impaired kidney or cardiovascular function (for example when the heart does not pump blood adequately through the body, volume depletion, major surgery, blood infection or severe bleeding)
• if you are predisposed to gout. At low doses, acetylsalicylic acid reduces the excretion of uric acid through the urine, which can induce a gout attack
• if you have a G6PD (glucose-6-phosphate dehydrogenase) deficiency (an inherited disease affecting red blood cells), since high doses of acetylsalicylic acid could lead to haemolysis (destruction of red blood cells)
• if you usually take several painkillers together (especially combinations of different painkillers). You are at risk of permanent kidney disease
• if you suffer from hyperthyroidism, mild to moderate hypertension, diabetes mellitus, heart disease, high pressure inside the eye, enlarged prostate or sensitivity to some of the ingredients in cough/cold medicines, e.g. phenylephrine and ephedrine (sympathomimetic substances)
• if you suffer from a condition where your kidneys cannot remove acid from your body properly (renal tubular acidosis). This may lead to an increased risk of side effects due to a higher level of pseudoephedrine in your blood
• if you develop a generalized feverish rash associated with pustules, stop taking Aspirin Flu and Stuffy Nose and contact your doctor or seek medical help immediately. See section 4.
• with Aspirin flu and stuffy nose you may experience sudden abdominal pain or rectal bleeding, due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Aspirin flu and stuffy nose immediately and contact your doctor or seek medical advice. See section 4.
• with Aspirin flu and stuffy nose you may experience a reduction in blood flow to the optic nerve. If you experience sudden loss of vision, stop taking Aspirin flu and stuffy nose and contact your doctor or a health care facility immediately. See section 4.
• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood supply to the brain. Stop using Aspirin Flu and Stuffy Nose immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).

Doping
Athletes should be aware that taking this drug may result in positive "anti-doping" tests.

Elderly people
Elderly patients may be particularly sensitive to pseudoephedrine and experience insomnia or perceive things that are not real (hallucinations).

Children and adolescents
There is a possible association between acetylsalicylic acid and Reye's syndrome when administered to children and adolescents. This is a very rare disease, which can be fatal. For this reason, acetylsalicylic acid should not be taken by children and adolescents under 16 years of age, without medical advice.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of these effects cannot be estimated from the available data and is therefore defined as "not known".

Possible side effects due to acetylsalicylic acid:

Tell your doctor immediately or go to the nearest hospital if you notice any of the following very serious side effects:
• Allergic reactions (such as difficulty breathing, rash with possible decrease in blood pressure), particularly in asthmatic patients
• Respiratory disease exacerbated by acetylsalicylic acid (symptoms of existing respiratory disease worsen by taking the medicine)
• Gastric ulcer which, in isolated cases, can lead to perforation
• Disease of the intestinal diaphragms (especially in long-term treatment)
• Gastrointestinal bleeding, which in isolated cases can cause iron deficiency anemia. Signs of gastrointestinal bleeding are the expulsion of black stools or vomiting with blood
• Reduction of renal function, renal failure
• Hemolysis (destruction of red blood cells), in case of severe forms of G6DP (Glucose-6-phosphate dehydrogenase) deficiency

Tell your doctor immediately if you notice any of the following serious side effects:
• Increased risk of bleeding such as oral, vaginal or anal bleeding
• gastric or intestinal disorders such as stomach pain, indigestion and inflammation of the inner lining of the stomach
• temporary reduction in liver function with increase in liver enzymes called transaminases
• dizziness
• ringing in the ears (tinnitus)

Mild side effects:
• nausea, vomiting, diarrhea.

Possible side effects due to pseudoephedrine:
- serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Stop taking Aspirin Flu and Stuffy Nose immediately and see your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset
• nausea
• vomit
• confusion
• convulsions
• changes in vision

Tell your doctor immediately if you notice any of the following serious side effects:

• Increased blood pressure, although it does not affect individuals with controlled hypertension
• Cardiac effects (e.g. arrhythmia or tachycardia)
• Insomnia, rarely hallucinations and other central nervous system stimulation
• Urinary retention, especially in patients with prostatic hyperplasia
• Skin effects such as rash, hives, itching
• Sudden onset of fever, redness of the skin or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with Aspirin Flu and Stuffy Nose. See section 2.
Stop using Aspirin Flu & Stuffy Nose if you develop these symptoms and contact your doctor or seek medical help immediately.

• Inflammation of the colon due to insufficient blood supply (ischemic colitis)
• Reduction of blood flow to the optic nerve (ischemic optic neuropathy)

Mild side effects:
- Redness
- Dry mouth

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.