PARACETAMOL ZEN 500 MG TABLET 20 TABLETS IN PVC/AL BLISTER

Name
Paracetamol Zentiva Srl 500 mg tablets
Paracetamol Zentiva Srl 1000 mg tablets
Equivalent medicine


What it is and what it is used for
This product contains paracetamol, an active ingredient that relieves fever and pain.
Paracetamol Zentiva Srl tablets are used for the short-term symptomatic treatment of mild to moderate pain such as headache, toothache, menstrual pain, muscle and joint pain during flu and cold and/or fever.

Paracetamol Zentiva Srl 500 mg is intended for adults, adolescents and children weighing more than 21 kg (aged 6 years and over).
Paracetamol Zentiva Srl 1000 mg is intended for adults and adolescents weighing more than 60 kg (aged 15 years and over).
Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 3 days (in case of fever) or 5 days (in case of pain).
Paracetamol Zentiva Srl 500 mg tablets: do not administer the product to children for more than 3 days without consulting a doctor.


What you need to know before taking the medicine
Do not take Paracetamol Zentiva Srl:
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- has severe liver failure;
- has acute inflammation of the liver.


Warnings and precautions
Do not use Paracetamol Zentiva Srl at the same time as other medicines containing paracetamol.
Using doses higher than recommended may lead to the risk of serious liver damage.

Do not drink alcoholic beverages while taking this medicine.

Talk to your doctor or pharmacist before taking Paracetamol Zentiva Srl if:
- suffers from liver disease;
- suffers from kidney disease;
- abuses alcohol;
- has a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- suffer from a low number of red blood cells caused by their abnormal breakdown (haemolytic anaemia);
- he is old;
- is dehydrated or malnourished.

During treatment with Paracetamol Zentiva Srl, 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) 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.
Do not take this medicine without your doctor's advice if you have problems with alcohol consumption.

Children and adolescents
Due to the amount of active ingredient in the tablet, Paracetamol Zentiva Srl 500 mg is not suitable for children under 6 years of age with a body weight of less than 21 kg.
Due to the amount of active substance in the tablet, Paracetamol Zentiva Srl 1000 mg is not intended for children and adolescents under 15 years of age and weighing less than 60 kg.


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

Stop taking the medicine immediately and seek immediate medical attention if any of the following rare side effects occur:
- Allergic reactions such as skin rash or itching (rare - may affect up to 1 in 1,000 people), sometimes accompanied by breathing problems, swelling of the lips, tongue, throat or cheeks;
- Severe skin reaction including peeling of the skin or blistering of the mouth (very rare - may affect up to 1 in 10,000 people);
- Previous breathing problems after taking acetylsalicylic acid or other painkillers belonging to the group of non-steroidal anti-inflammatory drugs and have similar problems after taking Paracetamol Zentiva Srl (very rare - may affect up to 1 in 10,000 people);
- Unexplained bruising (very rare - may affect up to 1 in 10,000 people).

Other side effects
Very rare (may affect up to 1 in 10,000 people):
- Liver dysfunction.

Frequency not known (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.