PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PARACETAMOL SELLA 500 mg tablets

Paracetamol
Equivalents medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use 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 notice no improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

What PARACETAMOL SELLA is and what it is used for
What you need to know before using PARACETAMOL SELLA
How to use PARACETAMOL SELLA
Possible side effects
How to store PARACETAMOL SELLA
Contents of the pack and other information

1. What PARACETAMOLO SELLA is and what it is used for

PARACETAMOLO SELLA contains the active substance paracetamol, which works by reducing fever (antipyretic) and relieving pain (analgesic).
PARACETAMOLO SELLA is used in adults, adolescents and children weighing 21 kg (approximately 6 years of age) (see section 3 "How to use PARACETAMOLO SELLA") for:

symptomatic treatment of feverish conditions such as influenza, exanthematous diseases (infectious diseases typical in children and adolescents), acute respiratory tract illnesses, etc.;
pain of various origin and nature (headache, neuralgia, muscle pain, and other moderate-intensity painful conditions).

Consult your doctor if you/your child do not feel better or feel worse after 3 days of treatment.

2. What you need to know before using PARACETAMOL SELLA

Do not use PARACETAMOL SELLA:

if the person taking the medicine is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using PARACETAMOL SELLA.
Never exceed the recommended dose.
During treatment with PARACETAMOL SELLA, contact your doctor immediately if:

you suffer from 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 and rapid breathing, drowsiness, nausea, and vomiting.
Use this medicine with caution and consult your doctor:
if you chronically consume alcohol or drink excessively (3 or more alcoholic drinks per day);
if you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite);
if you suffer from bulimia (an eating disorder in which a person consumes excessive amounts of food and then resorts to various methods to eliminate it);
if you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic illness);
if you have been following an inadequate diet for a long time (chronic malnutrition);
if you suffer from dehydration (severe loss of water/fluids from the body);
if you suffer from hypovolemia (reduced blood volume in circulation);
if you have liver diseases that reduce liver function (hepatic insufficiency, hepatitis, Gilbert's syndrome);
if you are receiving concomitant treatment with medicines that affect liver function (see section “Other medicines and PARACETAMOL SELLA”);
if you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency may cause a blood disorder);
if you suffer from haemolytic anaemia (destruction of red blood cells);
if you are taking other medicines to treat pain (analgesics), reduce fever (antipyretics), or treat inflammation (non-steroidal anti-inflammatory drugs) (see section “Other medicines and PARACETAMOL SELLA”).

Stop treatment and contact your doctor immediately if you experience allergic reactions
(see section “Possible side effects”).
Avoid prolonged or frequent use of the medicine without first consulting your doctor, and do not take
other products containing paracetamol simultaneously, as serious adverse reactions may occur if paracetamol is taken in high doses.
Use of high doses and/or prolonged use
Using high doses and/or prolonged use of this medicine may cause even severe adverse effects on the kidneys and blood. In such cases, your doctor will monitor liver and kidney function and blood composition over time through appropriate tests. Before taking this medicine, inform your doctor if the person taking the medicine suffers from kidney or liver disease.
Do not take higher doses than recommended, as higher doses may cause serious liver damage. For this reason, contact your doctor as soon as possible if you have taken more PARACETAMOL SELLA than recommended in this leaflet.
Other medicines and PARACETAMOL SELLA
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 or pharmacist if you are taking the following medicines:

medicines containing paracetamol. During treatment with paracetamol, check before taking or giving any other medicine to a child whether it contains paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses;
medicines that slow gastric emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of PARACETAMOL SELLA;
medicines that accelerate gastric emptying (e.g. prokinetics), as these medicines accelerate the effect of PARACETAMOL SELLA;
cholestyramine (a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
chloramphenicol (an antibiotic), as it may increase the risk of adverse effects;
anticoagulants (medicines used to thin the blood). In case of high-dose paracetamol treatment (4 g daily for at least 4 days), take or give PARACETAMOL SELLA to the child only under strict medical supervision;
rifampicin (an antibiotic);
antiepileptics (medicines used to treat epilepsy), such as carbamazepine, glutethimide, phenobarbital;
cimetidine (a medicine used to reduce gastric acid secretion);
zidovudine (an antiviral medicine used for HIV treatment);
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called high anion gap metabolic acidosis) that require urgent treatment (see section 2). The use of these medicines with PARACETAMOL SELLA requires close medical monitoring.

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that paracetamol administration may interfere with the measurement of uric acid levels (uricemia) and blood glucose levels (glycemia).
PARACETAMOL SELLA and alcohol
Take PARACETAMOL SELLA with caution if you chronically consume alcohol or drink excessively (3 or more alcoholic drinks per day), as there is a risk of toxicity (see sections “Warnings and precautions” and “If you take more PARACETAMOL SELLA than you should”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, PARACETAMOL SELLA 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 time.
Contact your doctor or midwife if pain and/or fever do not decrease or if you need to take the medicine more frequently.
This medicine may be taken during breastfeeding only if strictly necessary and under medical supervision.
Driving and using machines
The use of PARACETAMOL SELLA does not affect the ability to drive or operate machinery.
PARACETAMOL SELLA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use PARACETAMOLO SELLA

Use PARACETAMOLO SELLA exactly as instructed in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablet with a glass of water. If you have difficulty swallowing, you may divide the tablet into two equal parts.

Recommended dose in adults:
One tablet at a time, repeated if necessary after 4 hours, without exceeding 6 doses per day. In case of severe pain or high fever, two 500 mg tablets may be taken, repeated if necessary after no less than 4 hours.
Do not exceed 6 tablets per day (3 g of paracetamol) within 24 hours (see “If you use more PARACETAMOLO SELLA than you should”).

Use in children and adolescents
The dose is calculated based on body weight. Approximate age ranges corresponding to body weight are provided for information only:

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 one 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 one 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 one tablet, repeated if necessary after 4 hours, without exceeding 6 doses per day.

If you/your child suffer from severe renal impairment (severely reduced kidney function)
If your doctor has diagnosed severe renal impairment, the interval between doses must be at least 8 hours.

Duration of treatment
Do not use PARACETAMOLO SELLA for more than 3 consecutive days without consulting your doctor. Your doctor must assess the need for treatment beyond 3 consecutive days.

If you use more PARACETAMOLO SELLA than you should
If you or someone else has taken an excessive dose of PARACETAMOLO SELLA, contact your doctor immediately or go to the nearest hospital.

Symptoms
After taking very high doses of paracetamol, symptoms that you or the child may experience within the first 12–48 hours include:

Anorexia (lack of or reduced appetite), nausea, and vomiting, followed by a marked deterioration in general condition;
Changes in blood laboratory values (increased bilirubin in blood, lactate dehydrogenase, liver transaminase levels, decreased blood protrombin levels);
Liver damage that may lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and may be fatal, especially in the following cases:
If the person taking the medicine has liver disease;
Chronic alcoholism;
Long-term inadequate nutrition (chronic malnutrition);
If the person taking the medicine is also taking other medicines or substances that increase liver activity.

Treatment
Immediate treatment is essential due to the risk of severe and irreversible liver damage, even delayed, and a reduction in protrombin levels (a protein involved in blood clotting).
Recommended treatment for overdose should be started as early as possible and, in addition to standard procedures (e.g. stomach emptying), includes the administration of antidotes (substances able to counteract the drug's toxic effects), such as acetylcysteine, as soon as possible.

If you forget to use PARACETAMOLO SELLA
Do not take a double dose to make up for the missed dose.

If you stop using PARACETAMOLO SELLA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you or the child experience any of the following side effects, STOP taking this medicine immediately
and contact your doctor without delay:

allergic reactions such as:
- skin redness accompanied by itching (urticaria);
- swelling of the throat (laryngeal oedema);
- swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema);
- severe allergic reaction (anaphylactic shock).

Additionally, individuals taking this medicine may experience the following side effects:
Frequency not known (cannot be estimated from available data):

decrease in the number of platelets in the blood (thrombocytopenia);
decrease in the number of white blood cells in the blood (leucopenia, agranulocytosis);
decrease in haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia);
dizziness;
stomach and intestinal disturbances;
abnormal liver function;
inflammation of the liver (hepatitis);
red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
reduced kidney function (acute renal failure);
inflammation of the kidneys (interstitial nephritis);
blood in the urine (haematuria);
cessation or reduction of urine production (anuria);
severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious underlying disease using paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://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 SELLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The
expiry date refers to the last day of that month.
Store in the original container.
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 SELLA contains

The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other ingredients are: lactose, rice starch, hydroxypropylcellulose, polyvinylpyrrolidone, crospovidone, magnesium stearate, talc, colloidal silicon dioxide.

Description of the appearance of PARACETAMOLO SELLA and package contents
Pack containing 30 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)