ASPIRIN COLD & FLU C*20

Aspirin flu and blocked nose 500 mg / 30 mg granules for oral suspension
Acetylsalicylic acid, pseudoephedrine hydrochloride

What it is and what it is used for
Aspirin flu and blocked nose contains the active ingredients acetylsalicylic acid and pseudoephedrine hydrochloride.
It has pain-relieving, anti-inflammatory, antipyretic and nasal decongestant properties.
This medicine is used for the symptomatic treatment of nasal and sinus congestion (rhinosinusitis) and painful and febrile conditions associated with flu and/or cold symptoms.
If you only have one of these symptoms, it might be more appropriate to take a medicine containing only one active ingredient.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.
Aspirin flu and blocked 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 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 salicylates or substances with a similar action (i.e. non-steroidal anti-inflammatory drugs)
• if you suffer from stomach ulcers
• if you have a predisposition to bleeding
• if you suffer from liver failure
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure
• if you suffer from severe heart failure
• if you suffer from severe coronary artery disease
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by medicines
• 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 (MAO) inhibitors (or have taken them in the previous two weeks)
• if you suffer from narrow-angle glaucoma (closed-angle glaucoma)
• if you suffer from urinary retention

Warnings and precautions
Consult your doctor or pharmacist before taking ASPIRIN flu and blocked nose:
• if you are allergic (hypersensitive) to other analgesics, anti-rheumatics or anti-inflammatories
• if you suffer from allergies (e.g. with rash, itching, hives), asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or long-term lung diseases
• if you have a history of stomach ulcers or gastrointestinal bleeding
• if you are also taking medicines that thin the blood and prevent it from 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 and 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 prone 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 (hereditary disease affecting red blood cells), as high doses of acetylsalicylic acid could lead to haemolysis (destruction of red blood cells)
• if you habitually take several painkillers together (especially combinations of different analgesics). You are at risk of permanent kidney disease
• if you suffer from hyperthyroidism, mild to moderate hypertension, diabetes mellitus, heart disease, elevated intraocular pressure, prostate enlargement or sensitivity to some of the components present in cough/cold medicines, e.g. phenylephrine and ephedrine (sympathomimetic substances)
• if you suffer from a pathological condition in which the kidneys are unable to properly eliminate acids from the body (renal tubular acidosis). This may lead to an increased risk of undesirable effects due to a higher level of pseudoephedrine in the blood
• if you develop a widespread feverish rash associated with pustules, stop taking Aspirin flu and blocked nose and contact your doctor or seek immediate medical attention. See section 4.
• sudden abdominal pain or rectal bleeding may occur with Aspirin flu and blocked nose due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, immediately stop treatment with Aspirin flu and blocked nose and contact your doctor or seek medical advice. See section 4.
• a reduction in blood flow to the optic nerve may occur with Aspirin flu and blocked nose. If a sudden loss of vision occurs, stop taking Aspirin flu and blocked nose and immediately contact your doctor or a healthcare facility. See section 4.
• cases of reversible posterior 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. Immediately stop using Aspirin flu and blocked nose 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, by taking this medicine, they may test positive in 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 if 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 everyone 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:

Immediately inform your doctor 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 due to taking the medicine)
• Gastric ulcer which, in isolated cases, can lead to perforation
• Intestinal diaphragm disease (especially in long-term treatment)
• Gastrointestinal bleeding which, in isolated cases, can cause iron deficiency anaemia. Signs of gastrointestinal bleeding are the expulsion of black stools or vomiting with blood
• Reduced kidney function, kidney failure
• Haemolysis (destruction of red blood cells), in case of severe forms of G6PD (Glucose-6-phosphate dehydrogenase) deficiency

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

Mild side effects:
• nausea, vomiting, diarrhoea.

Possible side effects due to pseudoephedrine:
- serious conditions affecting the cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Immediately stop treatment with Aspirin flu and blocked nose and urgently consult your doctor if you develop symptoms that could be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision

Immediately inform your doctor if you notice any of the following serious side effects:

• Increased blood pressure, although this 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 suffering from prostatic hyperplasia
• Skin effects such as rash, hives, itching
• The sudden onset of fever, skin redness 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 blocked nose. See section 2.
Stop using Aspirin flu and blocked nose if you develop these symptoms and contact your doctor or seek immediate medical attention.

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

Mild side effects:
- Redness
- Dry mouth

Reporting side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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.