VICKS FLU JIORNO NOTTE Film-coated tablets

Зміст інструкції

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

Vicks Flu Giorno Notte film-coated tablets

Paracetamol, pseudoephedrine hydrochloride and diphenhydramine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 4 days. Read this leaflet carefully before taking this medicine as it contains importantinformation for you.
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

This medicine is called Vicks Flu Giorno Notte film-coated tablets but will be referred to as

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 aches and other painful manifestations, headache and fever.
• Pseudoephedrine acts on the blood vessels in the nose to relieve nasal congestion.
• Diphenhydramine relieves symptoms of runny nose, sneezing, eliminates mucus and is suitable for nighttime use.

Vicks Flu Day Night is used for the short-term treatment of symptoms associated with the common cold and
fever such as nasal and sinus congestion, pain, headache and/or fever.
Vicks Flu Day Night is indicated for adults and adolescents starting from 15 years of age.
The package contains tablets of two different colors to be used at different times of the day.
day.

• “Day tablets”: The yellow tablets contain paracetamol and pseudoephedrine - for daytime use.
• “Night tablets”: The blue tablets contain paracetamol and diphenhydramine - for nighttime use. YOU MUST consult your doctor if you do not feel better or if you 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 your blood pressure is very high or 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 heart rate or blood pressure)
• if you suffer from glaucoma (increased intraocular pressure)
• if you suffer from severe kidney disease
• and your thyroid is overactive. Do NOT administer Vicks Flu Day & Night to children and adolescents under 15 years of age. Warnings and precautionsDiphenhydramine can 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.
Consult your doctor or pharmacist beforetaking 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 adolescentsVicks Flu Day & Night MUST NOT be given to children under 15 years of age. Other medicines and Vicks Flu Day & NightTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

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

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

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Fertility
The effects of this product on fertility have not been specifically investigated.

Driving and using machines
Nighttime tablets:
The nighttime tablets contain diphenhydramine and can cause drowsiness or sedation. They can also
cause dizziness, blurred vision, psychomotor and cognitive impairment. These are effects that can
seriously impair the ability to drive vehicles and operate machinery. Do NOT drive or use
machinery if you experience these manifestations.
Daytime tablets:
The daytime tablets do not have known effects on the ability to drive vehicles and use machinery
In exceptional cases, dizziness or hallucinations may occur and this possibility should be taken
into account.

3. How to take Vicks Flu Giorno Notte

Use Vicks Flu Giorno Notte following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Use Vicks Flu Giorno Notte following exactly as stated in this leaflet or the instructions of your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents 15 years of age and over:
Four tablets to be taken during the day as specified below.
Take only one tablet at a time and only at the times indicated on the package.
DO NOT take more than 3 yellow tablets a day.
DO NOT take the blue tablet at night during the day.

Use in children and adolescents
DO NOT administer to children under 15 years of age.

Route of administration and method of administration
For oral use only.
The tablets are swallowed whole (they must not be chewed) with sufficient liquid.

Duration of treatment

This product is intended for short-term treatment only. Treatment should not
continue for more than 4 days.

If you take more Vicks Flu Giorno Notte than you should
If you or someone else accidentally takes more Vicks Flu Giorno Notte than recommended you should
seek immediate medical attention.
You should consult a doctor immediately even if you feel well. This is because too much paracetamol can
cause delayed and serious liver damage.

If you forget to take Vicks Flu Giorno Notte
You must 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 using this medicine, ask your pharmacist or doctor.

4. Possible side effects

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

STOP TAKING Vicks Flu Day Night and see your doctor immediatelyif 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
in asthmatics sensitive to aspirin or other NSAIDs.

STOP TAKING Vicks Flu Day Night and see your doctorif any of the following situations
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 related to paracetamol
• liver problems
• effects on heart rate such as acceleration (tachycardia)
• increased blood pressure
• some men, especially if they have prostate problems, may experience difficulty urinating.

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
• convulsions, paresthesia, dyskinesia
• muscle contractions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system 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 Giorno Notte

Keep this medicine out of the sight and reach of children.
The medicine does not require any special storage conditions.
Do not use Vicks Flu Giorno Notte after the expiry date which is stated on the blister/pack after the
wording “Scad”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 pack and other information

What Vicks Flu Day Night contains

• The active ingredientsin the daytime tablet are paracetamol (500 mg per tablet) and pseudoephedrine hydrochloride (60 mg per tablet)
• The active ingredientsin the nighttime tablet are paracetamol (500 mg per tablet) and diphenhydramine hydrochloride (25 mg per tablet)
• The other ingredientsare microcrystalline cellulose, sodium croscarmellose, copovidone, colloidal silica, magnesium stearate, hypromellose, talc (E553b), triacetin (E1518), pearlescent pigment based on mica (mixture of: potassium aluminium silicate (E555)-[mica] and titanium dioxide (E171)). Additionally, yellow iron oxide (E172) in the daytime tablet and indigo carmine (E132) only in the nighttime tablets.

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

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

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

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