Vicks Flu Triple Action

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vicks Flu Tripla Azione

500mg/200mg/10mg powder for oral solution
Paracetamol, Guaifenesin, Phenylephrine HCl
Please read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What Vicks Flu Tripla Azione is and what it is used for
2. What you need to know before taking Vicks Flu Tripla Azione
3. How to take Vicks Flu Tripla Azione
4. Possible side effects
5. How to store Vicks Flu Tripla Azione
6. Contents of the pack and other information

1. WHAT VICKS FLU TRIPLA AZIONE IS AND WHAT IT IS USED FOR

Vicks Flu Tripla Azione contains three active substances:

• Paracetamol, 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), which helps loosen mucus, thereby helping to relieve chesty cough;
• Phenylephrine hydrochloride (a nasal decongestant), which reduces swelling of the nasal mucosa, providing relief from nasal congestion.

Vicks Flu Tripla Azione is indicated for short-term symptomatic relief of cold,
chills, and flu (mild to moderate pain, fever, nasal congestion with expectorant effect
on chesty cough) in adults and adolescents aged 12 years and older.
You should use Vicks Flu Tripla Azione only if you have a combination of cold and
flu symptoms such as pain and/or fever, nasal congestion, and chesty cough.
Consult a doctor if you do not feel better or if your symptoms worsen after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VICKS FLU TRIPLE ACTION

Do not take Vicks Flu Tripla Azione

• if you are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have heart disease;
• if you suffer from high blood pressure (hypertension);
• if you have impaired liver function or severe renal impairment;
• if you have hyperthyroidism;
• if you are already taking other sympathomimetic medicines (such as pseudoephedrine, oxymetazoline, clonidine, salbutamol, and others);
• if you are diabetic;
• if you have closed-angle glaucoma (increased eye pressure);
• if you have porphyria (an inherited disorder characterized by excessive pigments 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 within the last 14 days.

Warnings and precautions
Important: contains paracetamol. Do not take simultaneously with other products
containing paracetamol. In case of overdose, consult your doctor immediately even
in the absence of discomfort, as there is a risk of serious and delayed liver damage.
Do not take simultaneously with other cold, flu, or decongestant remedies.
Talk to your doctor or pharmacist before taking Vicks Flu Tripla Azione:

• if you have alcoholic liver disease or regularly consume alcohol. Regular alcohol consumption impairs liver function and may increase the risk of hepatotoxicity from paracetamol-containing products;
• if you are male and have an enlarged prostate gland, which may cause increased difficulty in urinating;
• if you have circulatory problems (including Raynaud's syndrome);
• if you experience a persistent cough lasting more than one week, a cough producing a lot of mucus (phlegm), or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema;
• if you have severe haemolytic anaemia, glucose-6-phosphate dehydrogenase deficiency, chronic malnutrition, or if you are dehydrated.

During treatment with Vicks Flu Tripla Azione, inform your doctor immediately if:
you suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their
toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are
also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called
metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is
used regularly for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin.
Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing,
drowsiness, nausea, and vomiting.
Children and adolescents
Vicks Flu Tripla Azione is not intended for use in children under 12 years of age.
Other medicines and Vicks Flu Tripla Azione
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist before taking Vicks Flu Tripla Azione if you are taking medicines:

• Containing paracetamol or other decongestants for cold and flu. If you are taking these, do not take Vicks Flu Tripla Azione.
• Monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson’s disease. Do not take Vicks Flu Tripla Azione if you have taken MAOIs within the last 14 days.
• Tricyclic antidepressants for the treatment of depression, such as amitriptyline or imipramine.
• Medicines for high blood pressure (antihypertensives), or medicines to improve heart function or correct heart rhythm abnormalities (digoxin, lanoxin, digitoxin).
• Atropine sulfate is commonly used for eye examinations, treatment of bradycardia (low heart rate), and as an antidote for poisoning.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap) requiring urgent treatment (see section 2).
• Medicines for nausea and vomiting (such as metoclopramide or domperidone).
• Medicines to thin the blood (anticoagulants), such as warfarin or other coumarin derivatives.
• Medicines for high cholesterol (such as cholestyramine).
• Sedatives (barbiturates).
• Medicines used to control epilepsy, e.g., lamotrigine and barbiturates.
• Acetylsalicylic acid and other salicylates used to reduce pain, fever, and blood clots.
• Alpha-adrenergic agonists such as medicines for attention deficit/hyperactivity disorder (clonidine, guanfacine), medicines for spastic conditions (tizanidine).
• Medicines for migraine headache (ergotamine, dihydroergotamine).
• Probenecid or AZT (zidovudine).
• Isoniazid or rifampicin (used for the treatment or prevention of tuberculosis).

Vicks Flu Tripla Azione with food, drinks, and alcohol
Do not take this product with alcoholic beverages.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your
doctor or pharmacist before taking this medicine. Vicks Flu Tripla Azione may be used during pregnancy only
if necessary and only after medical advice. Vicks Flu Tripla Azione may be used during breastfeeding only
under medical supervision. To relieve pain and/or fever, this medicine should be used at the lowest possible
dose and for the shortest possible duration. Consult your doctor or midwife if pain and/or fever do not improve
or if you need to take this medicine more frequently.
Driving and using machines
This medicine may cause confusion and dizziness. If you experience these symptoms, do not drive or
operate machinery.
Vicks Flu Tripla Azione contains Aspartame, Sucrose, and Sodium:

• Aspartame (E951): this medicine contains 6 mg of aspartame per sachet. Aspartamе is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
• Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
• Sodium: this medicine contains 157 mg of sodium per sachet (sodium is the main component of common table salt). This amount corresponds to 7.85% of the recommended daily intake of sodium for an adult. Consult your doctor or pharmacist if you need to take 3 or more sachets per day over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. HOW TO TAKE VICKS FLU TRIPLE ACTION

Take this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age:
The recommended dose is 1 sachet, which can be taken up to 4 times daily as needed, with at least 4 hours between doses. Do not take more than 4 sachets within 24 hours.
Do not exceed the stated dose.
Use in children and adolescents
This medicine is not intended for use in children under 12 years of age.
Method of administration
This medicine is a powder to be dissolved in water and taken as a warm drink.
Pour the contents of one sachet into a standard-sized cup and add warm, but not boiling, water (approximately 250 ml). Allow it to cool to a drinkable temperature and then drink the yellow, milky solution with a citrus/menthol smell and taste.
Duration of treatment
If symptoms persist for more than 3 days or worsen, consult your doctor.
If you take more Vicks Flu Triple Action than you should
Seek immediate medical attention if you accidentally take more than the recommended dose, or if the medicine is accidentally taken by a child, even in the absence of symptoms, as there is a risk of serious and delayed liver damage.
If you forget to take a dose of Vicks Flu Triple Action
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If you experience any of the following serious adverse reactions, 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, which may occur rarely (may affect up to 1 in 1,000 patients).

• Very rarely, severe skin reactions have been reported (may affect up to 1 in 10,000 patients). If a skin reaction occurs, discontinue use and seek urgent medical attention. Stevens-Johnson syndrome and toxic epidermal necrolysis may initially present as red spots shaped like targets or circular patches, often with central blisters on the trunk. In addition, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These serious skin rashes are often preceded by fever and/or flu-like symptoms. The skin rashes may progress to widespread skin peeling and may lead to potentially life-threatening complications.

• Very rarely, certain blood cell disorders may occur, e.g. increased frequency of nosebleeds, bruising, or bleeding more easily (in fewer than 1 in 10,000 patients).

Other adverse reactions

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE VICKS FLU TRIPLE ACTION

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the sachet or carton after the word “EXP”. The expiry date refers to the last day of that month.
Duration after reconstitution: the reconstituted solution is stable for 90 minutes.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Vicks Flu Tripla Azione contains
The active substances are paracetamol, guaifenesin and phenylephrine hydrochloride. Each sachet of
this medicinal product provides a single dose containing the following active substances: paracetamol
500 mg, guaifenesin 200 mg, phenylephrine hydrochloride 10 mg.
The excipients are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate,
aspartame (E951), potassium acesulfame (E950), powdered menthol, lemon flavour, lemon juice
flavour, quinoline yellow (E104). See the end of section 2.
Description of the appearance of Vicks Flu Tripla Azione and contents of the pack
Vicks Flu Tripla Azione is presented as an ivory-coloured powder contained in laminated sachets
placed inside a cardboard box. The product is available in packs of 5 and 10 sachets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PROCTER & GAMBLE S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Rome, Italy.
Procter & Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
64521 Gross-Gerau, Hessen, Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Influbene Erkältungsgetränk Pulver zur Herstellung einer Lösung zum
Einnehmen
Bulgaria Vicks AntiGrip Complex
Czech Republic Vicks SymptoMed Complete citrón
United Kingdom Vicks Cold, Flu & Cough All In One 500mg/200mg/10mg powder for oral
solution
Estonia TriFlunex
Ireland Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephedrine Hydrochloride 10 mg
Poland Vicks AntiGrip Complex
Latvia TriFlunex 500 mg/200 mg/10 mg Pulveris iekšīgi lietojama Šķīduma Pagatavošanai
Lithuania Paracetamol/Guaifenesin/Phenylephrine Wick 500 mg/200 mg/10 mg Milteliai
geriamajam tirpalui
Hungary GrippoMed Wick Citrom ízű por belsőleges oldathoz
Germany WICK DayMed Kombi Erkältungsgetränk
Italy VicksFlu-TriplaAzione
Romania Vicks AntiGrip Complex
Spain IlviGrip Expertorante polvo para solución oral
This summary of product characteristics was last approved in: March 2026