Vicks Flu Day Night

Package leaflet: Information for the user

Vicks Flu Day Night film-coated tablets

Paracetamol, pseudoephedrine hydrochloride and diphenhydramine hydrochloride
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• 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, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms after 4 days. Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

This medicine is called Vicks Flu Day Night film-coated tablets but will be referred to as Vicks Flu Day Night in this package leaflet.

1. What Vicks Flu Day Night 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 pain and other painful symptoms, headache, and fever.
• Pseudoephedrine acts on the blood vessels in the nose to relieve nasal congestion.
• Diphenhydramine relieves runny nose, sneezing, and mucus production, and is suitable for nighttime use.

Vicks Flu Day Night is used for the short-term treatment of symptoms associated with cold and fever, such as nasal and sinus congestion, pain, headache, and/or fever.
Vicks Flu Day Night is indicated for adults and adolescents aged 15 years and older.
The pack contains tablets of two different colours to be taken at different times of the day.
Read the package leaflet carefully 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 feel worse after 4 days.

2. What you need to know before taking Vicks Flu Day Night

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 you have very high blood pressure or suffer from heart disease and are taking beta-blockers
• if you are taking monoamine oxidase inhibitors (known as MAOIs, used to treat Parkinson's disease or depression) or have taken them within the last 14 days
• if you are using other sympathomimetic decongestants (such as nasal decongestants)
• if you suffer from diabetes
• if you have phaeochromocytoma (a rare tumour affecting heart rate or blood pressure)
• if you have glaucoma (increased intraocular pressure)
• if you suffer from severe kidney disease
• if your thyroid gland is overactive.

DO NOT administer 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 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.

Consult 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 suffer from asthma, chronic cough or emphysema (lung disease)
• if you have prostate problems
• if you suffer from alcoholism
• if your arteries or veins are blocked (occlusive vascular disease).

Children and adolescents

Vicks Flu Day Night MUST NOT be administered to children under 15 years of age.

Other medicines and Vicks Flu Day Night

Inform your doctor or pharmacist if you are currently taking, have recently taken or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking the following medicines, as their effects may be altered:

• antidepressants (e.g. MAOIs, including moclobemide and brofaromine, tricyclic antidepressants such as amitriptyline)
• medicines for treating congestion or asthma, stimulants or appetite suppressants
• medicines for treating high blood pressure, including bretylium, betanidine, guanethidine, debrisoquin, methyldopa, reserpine, alpha- and beta-blockers
• medicines that may damage the liver, such as anticonvulsant drugs used for epilepsy (phenytoin, carbamazepine, lamotrigine), hypnotics (barbiturates)
• oral contraceptives ("the pill")
• metoclopramide or domperidone (for treatment of nausea and vomiting)
• cholestyramine (a medicine to lower cholesterol levels)
• anticoagulants (medicines to thin the blood) such as warfarin
• alcohol and other central nervous system (CNS) depressants (e.g. tranquilizers, hypnotics, opioid analgesics, anxiolytics and antipsychotics)
• anticholinergics (medicines acting on the nervous system) such as atropine
• medicines for migraine treatment such as ergotamine, methysergide and bromocriptine
• cardiac glycosides (e.g. digoxin) for treatment of certain heart conditions
• halogenated anaesthetics such as chloroform, cyclopropane, halothane, enflurane, isoflurane
• oxytocin (a drug used to facilitate contractions during childbirth)

Pregnancy, breastfeeding and fertility

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Fertility

The effects of this product on fertility have not been specifically investigated.

Driving and use of machinery

Night tablets:

The night tablets contain diphenhydramine and may cause drowsiness or sedation. They may also cause dizziness, blurred vision, psychomotor and cognitive disturbances. These effects may seriously impair your ability to drive vehicles or operate machinery. DO NOT drive or operate machinery if you experience these symptoms.

Day tablets:

The day tablets do not cause known effects on the ability to drive vehicles or use machinery. However, in exceptional cases, dizziness or hallucinations may occur, and this possibility should be taken into account.

3. How to take Vicks Flu Day Night

Take Vicks Flu Day Night exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take Vicks Flu Day Night exactly as described in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 15 years and over:
Four tablets to be taken throughout the day, as specified in the instructions below.

Take only one tablet at a time and only at the times indicated on the packaging.
DO NOT take more than 3 yellow tablets per day.
DO NOT take the blue evening tablet during the day.
Use in children and adolescents
DO NOT administer to children under 15 years of age.
Route and method of administration
For oral use only.
The tablets must be swallowed whole (not chewed) with sufficient liquid.
Duration of treatment
This product is intended for short-term treatment only. Treatment must not exceed 4 days.
If you take more Vicks Flu Day Night than you should
If you or someone else accidentally takes more Vicks Flu Day Night than recommended, you must
seek immediate medical advice.
You should consult a doctor immediately even if you feel well. This is because excessive paracetamol can cause delayed but severe liver damage.
If you forget to take Vicks Flu Day Night
You should take this medicine exactly as directed, following the instructions above. DO NOT take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your pharmacist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP TAKING Vicks Flu Day Night and contact your doctor immediately if you experience any of the following reactions:
allergic reactions including anaphylactic reactions, angioedema, Stevens-Johnson syndrome, and bronchospasm*
skin rashes (which may be severe and include blistering or skin peeling) and itching*. Cases of bronchospasm have been reported with paracetamol, but these are more likely in aspirin-sensitive or NSAID-sensitive asthmatics.

STOP TAKING Vicks Flu Day Night and contact your doctor if any of the following apply to you:

• some people have experienced hallucinations, but this is a rare event
• restlessness or sleep disturbances
• there have been rare reports of blood disorders, although not necessarily linked to paracetamol
• liver problems
• effects on heart rhythm such as increased heart rate (tachycardia)
• increased blood pressure
• some men, especially those with prostate problems, may experience difficulty urinating.

Other possible side effects:

• trouble falling asleep
• drowsiness, dizziness, blurred vision, headache
• dry mouth, nose, and throat
• stomach discomfort, diarrhoea, nausea, and vomiting
• feeling of tiredness
• confusion, especially in the elderly, restlessness, nervousness
• seizures, paresthesia, dyskinesia
• muscle spasms.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vicks Flu Day Night

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Vicks Flu Day Night after the expiry date stated on the blister pack/box after the word “Exp”. The expiry date refers to the last day of that month.
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. Package contents and other information

What Vicks Flu Giorno Notte contains

• The active substances in the day tablet are paracetamol (500 mg per tablet) and hydrochloride pseudoephedrine (60 mg per tablet).
• The active substances in the night tablet are paracetamol (500 mg per tablet) and hydrochloride diphenhydramine (25 mg per tablet).
• The other components are microcrystalline cellulose, croscarmellose sodium, copovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, talc (E553b), triacetin (E1518), pearly pigment based on mica (mixture of: potassium aluminium silicate (E555) - [mica] and titanium dioxide (E171)). In addition, yellow iron oxide (E172) is included in the day tablet and indigo carmine (E132) only in the night tablets.

Description of the appearance of Vicks Flu Giorno Notte and pack sizes
Day tablets: Film-coated yellow tablets, oblong-shaped, biconvex (dimensions: approximately 17.0 mm x 7.5 mm x 6.5 mm).
Night tablets: Film-coated blue tablets, oval-shaped, biconvex (dimensions: approximately 13.0 mm x 5.4 mm).
The tablets are available in:

• a blister pack containing 12 yellow day tablets and 4 blue night tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
PROCTER & GAMBLE S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Roma
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