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

Name
Paracetamol Sandoz 500 mg tablets
Equivalent medicine


What it is and what it is used for
Paracetamol Sandoz contains the active substance 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 (haemolytic anaemia);
• 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. It may be necessary to avoid using this medicine or reduce the dose of Paracetamol Sandoz.

During treatment with Paracetamol Sandoz, tell 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) 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.

Warning: Taking higher doses than recommended does not provide better pain relief, but carries a risk of serious liver damage. Therefore, the maximum daily dose of paracetamol should not be exceeded. Ask a doctor or pharmacist before using other medicines that also contain paracetamol at the same time. Symptoms of liver damage usually occur 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 (persistent for 5 days for pain or 3 days for fever) or if your symptoms get worse, 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 serious allergic reactions (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 1000 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 may make the skin pale yellow and cause weakness or shortness of breath (haemolytic anaemia);
- severe reduction in the number of white blood cells which may cause infections, more likely in 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 sick, vomiting;
- dizziness, feeling of general malaise, fever, drowsiness.

Very rare (may affect up to 1 in 10,000 people)
- severe reduction in blood cells which may 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 which 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 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.