Name
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 symptoms, headaches and fever.
- Pseudoephedrine works on the blood vessels in the nose to relieve nasal congestion.
- Diphenhydramine relieves the symptoms of a runny nose, sneezing, eliminates phlegm 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 symptoms of night-time pain that cause difficulty in falling asleep.

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

The pack contains tablets of two different colors to be used at different times of the day. Read the leaflet carefully to take the right tablet at the right time of day.
- "Day tablets": Yellow tablets contain paracetamol and pseudoephedrine - for daytime use.
- "Night tablets": The blue tablets contain paracetamol and diphenhydramine - for night-time use.

You MUST see your 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 section 6);
- if your blood pressure is very high (severe hypertension) or your 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 (a rare tumor that affects the 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 passing urine (urinary retention);
- if your thyroid is working too hard.

DO NOT give Vicks Flu Day Night to children and adolescents under 15 years of age.


Warnings and precautions
Diphenhydramine may cause drowsiness. DO NOT take the blue nighttime 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 inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking Vicks Flu Day Night and contact your doctor or seek medical help immediately. See section 4.

With Vicks Flu Day Night, a reduction in blood flow to the optic nerve may occur. If you experience sudden vision loss, stop taking Vicks Flu Day Night and contact your doctor or healthcare provider immediately. See section 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 a deficiency of the enzyme glucose-6-phosphate dehydrogenase (a condition also known as favism);
- if you have a glutathione deficiency (an antioxidant);
- if you suffer from anemia;
- if he is dehydrated;
- if he is chronically malnourished;
- if you weigh less than 50 kg;
- if he is 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 generalized feverish rash associated with pustules, stop taking Vicks Flu Day Night and contact your doctor or seek medical attention immediately. See section 4 Possible side effects.

Cases of posterior reversible 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 section 4 "Possible side effects" for symptoms).

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


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

Not known: frequency cannot be estimated from the available data

- serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
Stop taking Vicks Flu Day Night immediately and contact 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

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 may 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 to occur in asthmatics sensitive to aspirin or other NSAIDs.
Very rarely, cases of serious skin reactions have been reported.

STOP TAKING Vicks Flu Day Night and contact your doctor if any of the following situations apply to you:
- some people have suffered from hallucinations, but this is a rare occurrence
- 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 those with prostate problems, may experience difficulty urinating.

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 Vicks Flu Day Night. See section 2 Warnings and precautions

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

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.