PARACETAMOL ZEN*20TAB 500MG

Paracetamol Zentiva S.r.l. 500 mg tablets
Paracetamol Zentiva S.r.l. 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 S.r.l. 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 colds, and/or fever.

Paracetamol Zentiva S.r.l. 500 mg is intended for adults, adolescents, and children weighing more than 21 kg (6 years of age or older).
Paracetamol Zentiva S.r.l. 1000 mg is intended for adults and adolescents weighing more than 60 kg (15 years of age or older).
Consult your doctor if you do not notice improvements or if your symptoms worsen after 3 days (in case of fever) or 5 days (in case of pain).
Paracetamol Zentiva S.r.l. 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 S.r.l.:
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver failure;
- if you have acute liver inflammation.

Warnings and precautions
Do not use Paracetamol Zentiva S.r.l. simultaneously with other medicines containing paracetamol.
Using doses higher than those recommended may lead to the risk of severe liver damage.

Do not drink alcoholic beverages while taking this medicine.

Consult your doctor or pharmacist before taking Paracetamol Zentiva S.r.l. if:
- you suffer from liver disease;
- you suffer from kidney disease;
- you abuse alcohol;
- you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- you suffer from a low number of red blood cells caused by their abnormal degradation (hemolytic anemia);
- you are elderly;
- you are dehydrated or malnourished.

During treatment with Paracetamol Zentiva S.r.l., immediately inform your doctor if:

If you suffer from serious illnesses, including severe renal impairment 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). In patients in these situations, a severe condition called metabolic acidosis (an abnormality of blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with rapid deep breathing, drowsiness, nausea, and vomiting.
Do not take this medicine without medical advice if you have problems with alcohol consumption.

Children and adolescents
Due to the amount of active ingredient in the tablet, Paracetamol Zentiva S.r.l. 500 mg is not suitable for children under 6 years of age weighing less than 21 kg.
Due to the amount of active ingredient in the tablet, Paracetamol Zentiva S.r.l. 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 skin peeling or blistering in 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 having similar problems after administering Paracetamol Zentiva S.r.l. (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):
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients suffering from a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.