VICKS FLU TRIPLE A 500 MG/200 MG/10 MG POWDER FOR ORAL SOLUTION 10 SACHETS

Name
Vicks Flu Triple Action 500mg/200mg/10mg powder for oral solution
Paracetamol, Guaifenesin, Phenylephrine HCl


What it is and what it is used for
Vicks Flu Triple Action contains three active ingredients:
• paracetamol is a well-known pain reliever (analgesic). It is effective against pain including headache and sore throat, and can also reduce fever (antipyretic);
• guaifenesin (an expectorant) loosens phlegm, helping to relieve chesty coughs;
• phenylephrine hydrochloride (a nasal decongestant) reduces swelling of the nasal mucosa, providing relief from a congested nose.

Vicks Flu Triple Action is indicated for the short-term symptomatic relief of colds, chills and flu (mild-moderate pain, fever, nasal congestion with expectorant effect on productive cough) in adults and adolescents aged 12 years and over.

You should use Vicks Flu Triple Action only if you have a combination of cold and flu symptoms such as pain and/or fever, nasal congestion, productive cough.

Consult a doctor if you do not feel better or if your symptoms worsen after 3 days.


What you need to know before taking the medicine
Do not take Vicks Flu Triple Action
• if you are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from heart disease;
• if you suffer from high blood pressure (hypertension);
• if you have impaired liver function or severe kidney impairment;
• if you suffer from hyperthyroidism;
• if you are already taking other sympathomimetic medicines (such as pseudoephedrine, oxymetazoline, clonidine, salbutamol, and others);
• if you are diabetic;
• if you suffer from closed-angle glaucoma (increased pressure in the eye);
• if you suffer from porphyria (an inherited disorder characterised by an excessive amount of pigment in the urine);
• if you are taking tricyclic antidepressants;
• if you are taking beta-blockers;
• if you are taking monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson's disease – or if you have taken them in the last 14 days.


Warnings and precautions
Important: Contains paracetamol. Do not take at the same time as other products containing paracetamol. In case of overdose, seek medical attention immediately even if you do not feel unwell, as there is a risk of serious and delayed liver damage. Do not take at the same time as other products against colds, flu or decongestants.

Talk to your doctor or pharmacist before taking Vicks Flu Triple Action:
• if you have alcoholic liver disease or regularly drink alcohol. Regular alcohol consumption impairs liver function and may increase the risk of liver toxicity from products containing paracetamol;
• if he is male and has an enlarged prostate gland, with the possibility of greater difficulty in urinating;
• if you have circulatory problems (including Raynaud's syndrome);
• if you have a persistent cough that lasts more than a week, a cough that produces a lot of mucus (phlegm) or a chronic cough, as occurs with smoking, asthma, chronic bronchitis or emphysema;
• if you have severe haemolytic anaemia, glucose-6-dehydrogenase deficiency, chronic malnutrition disorder or if you are dehydrated.

While taking Vicks Flu Triple Action, tell your doctor immediately if:
if you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a long period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.

Children and adolescents
Vicks Flu Triple Action is not intended to be taken by children under 12 years of age.


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

If you experience any of the following serious side effects, stop taking the medicine immediately and seek urgent medical attention:
• Severe allergic reactions (anaphylaxis), for example skin rash, itching, swelling of the lips, tongue, throat, face, wheezing may occur rarely (may affect up to 1 in 1,000 people);
• Very rarely, cases of serious skin reactions have been reported (may affect up to 1 in 10,000 people). If a skin reaction occurs, stop use and seek urgent medical attention.
Stevens-Johnson syndrome and toxic epidermal necrolysis may initially appear as reddish, target-shaped spots or circular patches, often with central blisters on the trunk. In addition, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These serious rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and may cause life-threatening complications;
• Very rarely, some blood cell disorders may occur, e.g. increased number of nosebleeds, bruising or if you bleed more easily (in less than 1 in 10,000 patients).

Other side effects

Frequency	Side effect
Common (may affect up to 1 in 10 people)	Loss of appetite, nausea or vomiting.
Rare (may affect less than 1 in 1,000 people)	Mild allergic reactions (such as skin rash or hives); Stomach pain, diarrhea; Headache, dizziness; Rapid or irregular heartbeat (palpitations); Increased blood pressure; Sleep problems (insomnia), nervousness, tremor, irritability, restlessness, and confusion or anxiety; Abnormal liver function tests, jaundice.
Very rare (may affect up to 1 in 10,000 people)	Severe reduction in the number of blood cells that makes you more susceptible to infections.
Frequency not known (cannot be estimated from the available data)	Serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

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.