PARACETAMOL DOC 500 MG TABLET 30 TABLETS IN PVC BLISTER

Name
PARACETAMOL DOC Generics 500 mg tablets


What it is and what it is used for
PARACETAMOLO DOC Generici contains the active ingredient paracetamol belonging to a group of medicines known as analgesics and antipyretics, as they act by relieving pain (analgesic action) and lowering body temperature in case of fever (antipyretic action).
PARACETAMOL DOC Generics is used to lower fever and provide relief from mild to moderate pain.
Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment.


What you need to know before taking the medicine
Do not take PARACETAMOL DOC Generics:
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from severe kidney problems (severe renal insufficiency);
- if you abuse alcohol.


Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOLO DOC Generici. Never exceed the recommended dose.

Take this medicine with caution :
- if you suffer from liver problems such as liver failure, Gilbert's syndrome (a hereditary disease that causes yellowing of the skin) or acute hepatitis and if you are taking other medicines that alter the function of the liver;
- if you suffer from haemolytic anaemia, characterised by a low number of red blood cells in the blood;
- if you abuse alcohol, in this case the dose must be reduced (see paragraph 3 - Use in people suffering from chronic alcoholism);
- if you have severe kidney problems (severe renal failure);
- if you have a rare hereditary disease characterised by low levels of an enzyme known as glucose-6-phosphate dehydrogenase;
- if you weigh less than 50 kg;
- if you suffer from malnutrition and dehydration.

During treatment with PARACETAMOLO DOC Generici, inform your doctor immediately if:
- have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or 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 in these situations when paracetamol is used at regular doses over a long 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.

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 because a higher dose does not increase the pain-relieving action, but may instead cause serious damage to the liver or kidneys (analgesic nephropathy). For this reason, contact your doctor as soon as possible if you have taken more PARACETAMOLO DOC Generici than recommended in this leaflet.
Suddenly stopping taking painkillers after a long period of incorrect use at high doses can cause headaches, fatigue, muscle pain, nervousness, and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not start taking them again without consulting your doctor.

Taking this medicine may alter the results of some laboratory tests such as measuring the levels of uric acid (uricemia) or sugar (glycemia) in the blood.


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

The following side effects may occur, classified below according to frequency:

Rare (may affect up to 1 in 1,000 people):
- alterations in the production of blood components (bone marrow depression): alterations in platelet levels, stem cell disorders, reduction in red blood cells (non-hemolytic anemia);
- allergies (excluding angioedema), bronchospasm (more likely in asthmatics sensitive to aspirin or NSAIDs);
- depression, confusion, hallucinations;
- tremor, headache (cephalea);
- impaired vision;
- accumulation of fluids and swelling (edema);
- bleeding (hemorrhage);
- abdominal pain, diarrhea, nausea, vomiting;
- pancreatic diseases (acute and chronic pancreatitis, exocrine pancreas diseases);
- liver problems (impaired liver function, liver failure, liver necrosis), yellowing of the skin and whites of the eyes (jaundice);
- itching, skin rashes, sweating, bruising (purpura);
- swelling of the face, tongue and throat (angioedema), hives;
- dizziness, malaise, fever, sedation;
- overdose and poisoning;
- renal alterations (severe renal failure, interstitial nephritis, hematuria, anuresis).

Very rare (may affect up to 1 in 10,000 people):
- liver damage (hepatotoxicity);
- allergic reactions;
- reduction of platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia) and red blood cells (haemolytic anaemia) in the blood;
- reduction in blood sugar levels (hypoglycemia);
- sterile pyuria (cloudy urine) and kidney problems;
- severe skin reactions (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).

Not known (frequency cannot be estimated from the available data):
- a serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.