PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PARACETAMOL NOVA ARGENTIA 500 mg tablets

Paracetamol
Read this leaflet carefully before 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 instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. 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:

What PARACETAMOL NOVA ARGENTIA is and what it is used for
What you need to know before taking PARACETAMOL NOVA ARGENTIA
How to take PARACETAMOL NOVA ARGENTIA
Possible side effects
How to store PARACETAMOL NOVA ARGENTIA
Contents of the pack and other information

1. What PARACETAMOL NOVA ARGENTIA is and what it is used for

PARACETAMOL NOVA ARGENTIA contains the active substance paracetamol, which belongs to a group
of medicines known as analgesics and antipyretics, as they work by relieving pain (analgesic action) and
reducing body temperature in case of fever (antipyretic action).
PARACETAMOL NOVA ARGENTIA is used to reduce fever in the treatment of influenza-like illnesses
or respiratory tract disorders, and to relieve mild to moderate pain of various kinds, such as headache (cephalalgia),
nerve pain (neuralgia) and muscle pain (myalgia).
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking PARACETAMOL NOVA ARGENTIA

Do not take PARACETAMOL NOVA ARGENTIA:

if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
if you have severe liver problems (severe hepatic insufficiency)
if you have severe haemolytic anaemia, characterised by a low number of red blood cells in the blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOL NOVA ARGENTIA.
Never exceed the recommended dose.
Take this medicine with caution:

if you have liver problems such as mild to moderate liver insufficiency, Gilbert's syndrome (an inherited condition causing yellowish skin discoloration)
if you have severe kidney problems (renal insufficiency)
if you have a rare inherited disorder characterised by low levels of an enzyme known as glucose-6-phosphate dehydrogenase.

Avoid prolonged or frequent use of the medicine without first consulting your doctor, and do not take
other products containing paracetamol at the same time.
Do not take higher doses than recommended, as higher doses do not increase pain relief but may instead
cause serious liver or kidney damage. For this reason, contact your doctor as soon as possible if you have taken
more PARACETAMOL NOVA ARGENTIA than recommended in this leaflet.
Taking this medicine may alter the results of certain laboratory tests such as measurements of uric acid levels
(uraemia) or blood sugar (glycaemia).
Other medicines and PARACETAMOL NOVA ARGENTIA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

rifampicin, a medicine used to treat tuberculosis
cimetidine, a medicine used for stomach acidity
medicines used to treat epilepsy (carbamazepine, phenobarbital, glutethimide)
zidovudine, a medicine used to treat AIDS
medicines that affect stomach emptying (anticholinergics, opioids, prokinetics)
chloramphenicol, a medicine used against bacterial infections
colestyramine, a medicine used to lower cholesterol levels in the blood. If you need to take this medicine, take it at least one hour after taking paracetamol.
medicines used to thin the blood (oral anticoagulants)
flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called high anion gap metabolic acidosis) which requires urgent treatment.

During treatment with PARACETAMOL NOVA ARGENTIA, inform your doctor immediately if:

You have 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 at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea and vomiting.

PARACETAMOL NOVA ARGENTIA and alcohol
Avoid consuming alcohol during treatment with PARACETAMOL NOVA ARGENTIA.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only when strictly necessary and
under close medical supervision.
If needed, PARACETAMOL NOVA ARGENTIA may be used during pregnancy. It is advisable to use the
lowest effective dose that relieves pain and/or fever, and to take it for the shortest possible duration. Contact
your doctor/midwife if pain and/or fever do not improve or if you need to take the medicine more frequently.
Driving and using machines
The use of PARACETAMOL NOVA ARGENTIA does not affect the ability to drive or operate machinery.
Paracetamol NOVA ARGENTIA contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take PARACETAMOLO NOVA ARGENTIA

Take PARACETAMOLO NOVA ARGENTIA exactly as directed in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses. If symptoms persist for more than 3 days, consult your doctor.
Swallow the tablet with a little water.
The recommended dose for adults is 1 tablet at a time, repeated if necessary after 4 hours, without exceeding 6 doses per day (3 g of paracetamol).
In case of severe pain or high fever, 2 tablets of 500 mg may be taken, repeated if necessary after no less than 4 hours.

Use in children and adolescents
The dose is calculated according to body weight:

Children weighing between 21 and 25 kg (approximately aged 6 to 10 years): the recommended dose is half a tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day (3 tablets).
Children weighing between 26 and 40 kg (approximately aged 8 to 13 years): the recommended dose is 1 tablet, repeated if necessary after 6 hours, without exceeding 4 doses per day.
Adolescents weighing between 41 and 50 kg (approximately aged 12 to 15 years): the recommended dose is 1 tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.
Adolescents weighing over 50 kg (approximately over 15 years): the recommended dose is 1 tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.

If you take more PARACETAMOLO NOVA ARGENTIA than you should
In case of overdose with PARACETAMOLO NOVA ARGENTIA, inform your doctor or go to the emergency department immediately.
Overdose can have very serious consequences and may even lead to death. Immediate treatment is essential due to the risk of severe liver damage, which may be delayed.
Symptoms may be limited to nausea, vomiting, loss of appetite, pallor, and abdominal pain, and may not reflect the severity of the overdose or the risk of organ damage.

If you forget to take PARACETAMOLO NOVA ARGENTIA
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:

Frequency not known (cannot be estimated from the available data)

changes in platelet levels (thrombocytopenia), reduction in red blood cells (anemia), and abnormalities in white blood cells (leucopenia and agranulocytosis) in the blood
allergic reactions, ranging from mild forms such as skin rash, erythema, urticaria, to severe forms such as swelling of the face, tongue and throat (angioedema and laryngeal edema), up to anaphylactic shock
dizziness
abdominal pain, diarrhoea, nausea, vomiting (gastrointestinal reactions)
liver problems (impaired liver function, hepatitis)
severe skin reactions (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
kidney problems, even severe (acute renal failure, interstitial nephritis)
presence of blood in the urine (haematuria), or failure to produce urine (anuria)
a serious condition that may make the blood more acidic (called metabolic acidosis), in patients affected by a severe illness who are using paracetamol (see section 2).

Very rare cases of severe skin reactions have been reported.

Reporting of side effects

If you experience any side effect, including those 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PARACETAMOLO NOVA ARGENTIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
Store in the original container, tightly closed, protected from light.
Do not dispose of any medicine 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 PARACETAMOLO NOVA ARGENTIA contains

The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other components are: polyvinylpyrrolidone, sodium starch glycolate, talc, magnesium stearate, hydrated colloidal silica, microcrystalline cellulose.

Description of the appearance of PARACETAMOLO NOVA ARGENTIA and pack contents
Pack of 30 tablets in blister.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 – Gorgonzola (MI)
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via G. Pascoli, 1 – Gorgonzola - Milano.