Paracetamol Sella "500 mg Tablets" 30 Tablets"

Name
PARACETAMOL SELLA 500 mg tablets
Paracetamol
Equivalent medicine


What is it and what is it used for?
PARACETAMOLO SELLA contains the active ingredient paracetamol which works by reducing fever (antipyretic) and relieving pain (analgesic).

PARACETAMOLO SELLA is used in adults, adolescents and children weighing 21 kg or more (approximately 6 years) (see section 3 "How to use PARACETAMOLO SELLA") for:
- the symptomatic treatment of febrile conditions such as influenza, exanthematous diseases (infectious diseases typical of children and adolescents), acute respiratory tract diseases, etc.;
- pain of various origins and natures (headaches, neuralgia, muscle pain and other moderately severe painful symptoms).

Contact your doctor if you/your child does not feel better or if you/your child feels worse after 3 days of treatment.


What you need to know before taking the medicine
Do not use PARACETAMOL SELLA:
- if the person taking the medicine is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions
Talk to your doctor or pharmacist before using PARACETAMOLO SELLA.
Never exceed the recommended dose.

During treatment with PARACETAMOLO SELLA, inform your doctor immediately if :
- if you have serious illnesses, including severe kidney failure 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). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

Use this medicine with caution and consult your doctor :
- if you use alcohol chronically or excessively (3 or more alcoholic drinks a day);
- if you suffer from anorexia (an eating disorder characterised by lack or reduction of appetite);
- if you suffer from bulimia (an eating disorder in which a person eats 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 diseases);
- if you have been following an incorrect diet for a long time (chronic malnutrition);
- if you suffer from dehydration (severe loss of water/fluid from the body);
- if you suffer from hypovolemia (reduced blood volume in circulation);
- if you suffer from liver diseases that reduce its functionality (liver failure, hepatitis, Gilbert's syndrome);
- if you are taking concomitant medicines that alter liver function (see "Other medicines and PARACETAMOL SELLA");
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease);
- if you suffer from haemolytic anaemia (destruction of red blood cells);
- if you are taking other medicines to treat pain (analgesics), to lower fever (antipyretics), or to 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 at the same time because if paracetamol is taken in high doses, serious adverse reactions can occur.

Use of high doses and/or for prolonged periods
The use of high and/or prolonged doses of this medicine can cause serious kidney and blood problems. In these cases, your doctor will monitor liver and kidney function and blood composition over time through appropriate tests. Before taking this medicine, tell your doctor if you have kidney or liver disease.

Do not take higher doses than recommended because a higher dose can cause serious liver damage. Therefore, contact your doctor as soon as possible if you have taken more PARACETAMOL SELLA than recommended in this leaflet.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/your child experiences the following side effects STOP taking this medicine and contact your doctor immediately :
• allergic reactions with :
- redness of the skin accompanied by itching (hives);
- swelling of the throat (laryngeal edema);
- swelling of the hands, feet, ankles, face, lips, tongue and/or throat (angioedema);
- severe allergic reaction (anaphylactic shock).

In addition, those taking the medicine may experience the following side effects:
Frequency not known (cannot be estimated from the available data):
- reduction in the number of platelets in the blood (thrombocytopenia);
- reduction in the number of white blood cells in the blood (leukopenia, agranulocytosis);
- reduction of hemoglobin in the blood, the substance that carries oxygen in the blood (anemia);
- dizziness;
- stomach and intestinal disorders;
- abnormal liver function;
- inflammation of the liver (hepatitis);
- red spots, bullous lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
- reduction in kidney function (acute renal failure);
- inflammation of the kidneys (interstitial nephritis);
- blood in the urine (hematuria);
- cessation or reduction in urine production (anuria);
- a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.