Paracetamol Eurospital

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PARACETAMOL EUROSPITAL 500 mg tablets

Paracetamol
Please 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 effects, 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:

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

1. What PARACETAMOL EUROSPITAL is and what it is used for

PARACETAMOL EUROSPITAL 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 EUROSPITAL is used to reduce fever in the treatment of influenza or respiratory tract infections and to provide relief from mild to moderate pain of various types, 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 EUROSPITAL

Do not take PARACETAMOL EUROSPITAL:

• 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 EUROSPITAL. Never exceed the recommended dose. Take this medicine with caution:

• if you have liver problems such as mild to moderate hepatic insufficiency, or Gilbert's syndrome (an inherited condition causing yellowish skin discoloration)
• if you have severe kidney problems (renal failure)
• 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 this medicine without first consulting your doctor, and do not take other products containing paracetamol at the same time.
Do not take higher doses than those 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 EUROSPITAL than recommended in this leaflet.
Taking this medicine may alter the results of certain laboratory tests, such as measurements of uric acid levels (uricemia) or blood sugar (glycemia).
During treatment with PARACETAMOL EUROSPITAL, inform your doctor immediately if:

• you suffer from serious illnesses, including severe kidney 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 imbalance 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.

Other medicines and PARACETAMOL EUROSPITAL

Tell 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 imbalances (known as metabolic acidosis with high anion gap), which requires urgent treatment.

PARACETAMOL EUROSPITAL and alcohol

Avoid consuming alcohol during treatment with PARACETAMOL EUROSPITAL.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only when absolutely necessary and under strict medical supervision. If needed, PARACETAMOL EUROSPITAL may be used during pregnancy. It is advisable to use the lowest possible 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 EUROSPITAL does not affect the ability to drive or operate machinery.

Paracetamol EUROSPITAL contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take PARACETAMOL EUROSPITAL

Take PARACETAMOL EUROSPITAL exactly as instructed 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 should be calculated according to body weight:

• Children weighing between 21 and 25 kg (approximately 6 to 10 years of age): 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 8 to 13 years of age): 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 12 to 15 years of age): the recommended dose is 1 tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.
• Adolescents weighing more than 50 kg (approximately over 15 years of age): the recommended dose is 1 tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.

If you take more PARACETAMOL EUROSPITAL than you should
In case of overdose with PARACETAMOL EUROSPITAL, 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 PARACETAMOL EUROSPITAL
Do not take a double dose to make up for the missed dose. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 changes 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 cause the blood to become more acidic (called metabolic acidosis), in patients with severe illness 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 EUROSPITAL

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 packaging, 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. Contents of the pack and other information

What PARACETAMOLO EUROSPITAL 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 EUROSPITAL and pack contents
Pack of 20 tablets in blister packs.

Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 - Gorgonzola (MI)

Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via G. Pascoli, 1 - Gorgonzola - Milano.

Sales Licensee:
Eurospital S.p.A. Via Flavia, 122 - 34147 Trieste www.eurospital.com