VICKS FLU DAY NIGHT*12+4TAB

Vicks Flu Day Night film-coated tablets
Paracetamol, pseudoephedrine hydrochloride and diphenhydramine hydrochloride

What it is and what it is used for
Vicks Flu Day Night contains paracetamol, an analgesic and antipyretic; pseudoephedrine, a nasal decongestant, and diphenhydramine, an antihistamine that causes drowsiness.
- Paracetamol relieves muscle aches and other painful manifestations, headaches, and fever.
- Pseudoephedrine acts on blood vessels in the nose to relieve nasal congestion.
- Diphenhydramine relieves symptoms of runny nose, sneezing, clears mucus, and is suitable for nighttime use.

Vicks Flu Day Night is indicated for the short-term symptomatic treatment of nasal and sinus congestion associated with cold and flu symptoms such as pain, headache and/or fever, and only in combination with nighttime pain symptoms that cause difficulty falling asleep.

Vicks Flu Day Night is indicated for adults and adolescents aged 15 years and over.

The package contains tablets of two different colors to be used at different times of the day. Carefully read the leaflet to take the correct tablet at the right time of day.
- Day tablets: Yellow tablets contain paracetamol and pseudoephedrine - for daytime use.
- Night tablets: Blue tablets contain paracetamol and diphenhydramine - for nighttime use.

You MUST consult a doctor if you do not feel better or if you feel worse after 4 days.

What you need to know before taking the medicine
Do not take Vicks Flu Day Night:
- if you are allergic to paracetamol, pseudoephedrine, diphenhydramine or any of the other ingredients of this medicine (listed in paragraph 6);
- if your blood pressure is very high (severe hypertension) or hypertension is not controlled by medicines;
- if you suffer from heart disease and are taking beta-blockers;
- if you are taking monoamine oxidase inhibitors (known as MAOIs, which are used to treat Parkinson's disease or depression) or if you have taken them in the last 14 days;
- if you are using other sympathomimetic decongestants (such as nasal decongestants);
- if you suffer from diabetes;
- if you suffer from pheochromocytoma (rare tumor that affects heart rhythm or blood pressure);
- if you suffer from glaucoma (increased intraocular pressure);
- if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
- if you have difficulty urinating (urinary retention);
- if your thyroid is overactive.

Do NOT administer Vicks Flu Day Night to children and adolescents under 15 years of age.

Warnings and precautions
Diphenhydramine can cause drowsiness. Do NOT take the blue night tablet during the day!

To avoid overdose, do NOT take other products containing paracetamol, decongestants or antihistamines, including topical antihistamines and other cough and cold medicines.

Sudden abdominal pain or rectal bleeding may occur with Vicks Flu Day Night due to colon inflammation (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Vicks Flu Day Night and contact your doctor or seek immediate medical attention. See section 4.

A reduction in blood flow to the optic nerve may occur with Vicks Flu Day Night. If sudden loss of vision occurs, stop taking Vicks Flu Day Night and consult your doctor or a healthcare facility immediately. See paragraph 4.

Talk to your doctor or pharmacist before taking Vicks Flu Day Night:
- if you are taking antidepressants (sedatives, opioid analgesics, antipsychotics and tranquilizers);
- if you have kidney or liver disease (e.g., Gilbert's syndrome);
- if you are taking medicines that affect liver function;
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (a condition also known as favism);
- if you have a glutathione deficiency (an antioxidant);
- if you suffer from anemia;
- if you are dehydrated;
- if you are chronically malnourished;
- if you weigh less than 50 kg;
- if you are an elderly person;
- if you suffer from diabetes;
- if you suffer from asthma, chronic cough or emphysema (lung disease);
- if you have prostate problems;
- if you suffer from alcoholism;
- if you suffer from psychosis;
- if your arteries or veins are blocked (occlusive vascular disease).

If you develop a widespread feverish rash associated with pustules, stop taking Vicks Flu Day Night and contact your doctor or seek immediate medical attention. See paragraph 4 Possible side effects.

Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of pseudoephedrine-containing medicines. PRES and RCVS are rare conditions that can lead to reduced blood supply to the brain. Stop using Vicks Flu Day Night immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see paragraph 4 Possible side effects for symptoms).

Children and adolescents
Vicks Flu Day Night SHOULD NOT be given to children under 15 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Not known: frequency cannot be estimated from the available data

- serious conditions affecting the cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
Stop treatment with Vicks Flu Day Night immediately and contact your doctor urgently 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

STOP TAKING Vicks Flu Day Night and contact your doctor immediately if any of the following reactions occur:
allergic reactions including anaphylactic reactions, angioedema, Stevens-Johnson syndrome and bronchospasm*
skin rashes (which can be severe and include blistering or peeling of the skin) and itching.
*Cases of bronchospasm have been reported with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Very rarely, cases of severe skin reactions have been reported.

STOP TAKING Vicks Flu Day Night and contact your doctor if any of the following apply to you:
- some people have suffered from hallucinations, but this is a rare event
- restlessness or sleep disturbances
- there have been rare reports of blood disorders, although not necessarily related to paracetamol
- liver problems
- effects on heart rhythm such as acceleration (tachycardia)
- increased blood pressure
- some men, especially in cases of prostate problems, may experience difficulty urinating.

Sudden onset of fever, reddening 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 Vicks Flu Day Night. See section 2 Warnings and precautions

Other possible side effects:
- difficulty falling asleep
- drowsiness, dizziness, blurred vision, headache
- dry mouth, nose and throat
- stomach discomfort, diarrhea, nausea and vomiting
- feeling tired
- feeling confused, especially in the elderly, restlessness, nervousness
- seizures, paresthesia, dyskinesia
- muscle contractions
- Inflammation of the colon due to insufficient blood supply (ischemic colitis)
- Reduced blood flow to the optic nerve (ischemic optic neuropathy), frequency not known

Reporting of 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.