PARACETAMOL SAND "500 MG TABLETS" 20 TABLETS IN PVC/AL BLISTER"

Name
Paracetamol Sandoz 500 mg tablets
Equivalent medicine


What is it and what is it used for?
Paracetamol Sandoz contains the active ingredient paracetamol. It is a medicine used to relieve pain and reduce fever (analgesic and antipyretic).

Paracetamol Sandoz 500 mg is used for mild to moderate pain and fever in adults, adolescents and children over 9 years of age.

Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 5 days for pain treatment or 3 days for fever treatment.


What you need to know before taking the medicine
Do not take Paracetamol Sandoz
- if you are 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 taking Paracetamol Sandoz if you have:
• frequent use of large quantities of alcohol;
• liver problems such as liver inflammation or reduced liver function;
• Gilbert's syndrome (a rare inherited metabolic disorder with possible signs such as yellowing of the skin or whites of the eyes);
• kidney problems (moderate to severe renal insufficiency);
• an inherited deficiency of a certain enzyme called glucose 6-phosphate dehydrogenase;
• abnormal breakdown of red blood cells which can make the skin pale yellow and cause weakness or shortness of breath (hemolytic anemia);
• insufficient total body water (dehydration);
• underweight or chronic malnutrition;
• asthmatic patients sensitive to acetylsalicylic acid.

Consult your doctor if any of the above warnings apply to you or have applied to you in the past. You may need to avoid using this medicine or reduce the dose of Paracetamol Sandoz.

While taking Paracetamol Sandoz, tell your doctor immediately if:
- if you suffer from 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 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.

Warning: Taking higher than recommended doses does not provide better pain relief but carries the risk of serious liver damage. Therefore, the maximum daily dose of paracetamol should not be exceeded. Consult a doctor or pharmacist before using other medicines containing paracetamol at the same time. Symptoms of liver damage usually appear after a couple of days. It is therefore important to consult a doctor immediately if you have taken more than recommended. See also section 3 "If you take more Paracetamol Sandoz than you should".

If you experience high fever, signs of infection, or symptoms that last longer (pain lasting 5 days or fever lasting 3 days), or if your symptoms worsen, you should contact a doctor.

Taking painkillers frequently over a long period of time can cause headaches or make them worse. You should not increase the dose of your painkiller, but contact your doctor for advice.

Effects of paracetamol on diagnostic tests: for example, some tests to check uric acid and blood glucose may be affected.

Children
Paracetamol Sandoz 500 mg is not suitable for children under 9 years of age.


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

Stop treatment and contact your doctor immediately if you experience a serious allergic reaction (hypersensitivity) to paracetamol with possible signs such as: swelling of the face, lips, neck or throat (angioedema), shortness of breath (dyspnoea), sweating (sweating episodes), nausea or low blood pressure, as well as shock (very rare: may affect up to 1 in 10,000 people).
The following other side effects may occur following the use of paracetamol:

Rare (may affect up to 1 in 1,000 people)
- Some blood disorders:
- reduction in platelet count, which increases the risk of bleeding or bruising (thrombocytopenia);
- unexplained formation of hematomas (thrombocytopenic purpura);
- reduction of white blood cells (leukopenia);
- reduction in red blood cells which can make the skin pale yellow and cause weakness or shortness of breath (hemolytic anemia);
- severe reduction in the number of white blood cells which may cause infections, more likely with long-term treatment;
- allergies (excluding angioedema);
- abnormal liver function, increased liver enzymes in the blood, liver failure, liver necrosis, yellowing of the skin and whites of the eyes;
- skin rash, itching, sweating, redness, hives;
- depression, confusion, seeing, feeling or hearing things that are not there (hallucinations);
- tremor, headache;
- blurred vision;
- swelling due to water retention (edema);
- bleeding, abdominal pain, diarrhea, feeling unwell, vomiting;
- dizziness, feeling generally unwell, fever, drowsiness.

Very rare (may affect up to 1 in 10,000 people)
- severe reduction in blood cells that can cause weakness, bruising, or an increased chance of infections (pancytopenia);
- severe skin reactions;
- generalized skin rash (exanthema);
- constriction due to cramps of the airway muscles (bronchospasm) in people who are sensitive to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs, a group of painkillers with anti-inflammatory and antipyretic action);
- decreased blood sugar levels;
- kidney damage: inflammation of the kidneys (interstitial nephritis), cloudy urine (sterile pyuria), blood in the urine, inability to produce urine.

Frequency not known (frequency cannot be estimated from the available data)
- Severe skin reactions: acute generalized exanthematous pustulosis, toxic epidermal necrolysis, drug-induced dermatosis and Stevens-Johnson syndrome;
- Liver intoxication;
- Serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Single daily doses of 6 g of paracetamol (in children above 140 mg/kg body weight), or long-term use of 3-4 g of paracetamol per day, can cause liver damage.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.