Paracetamol Zentiva S.R.L.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamolo Zentiva S.r.l. 500 mg tablets, 1000 mg tablets

Equivalent medicine
Paracetamolo Zentiva S.r.l. 1000 mg tablets:
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Paracetamolo Zentiva S.r.l. 500 mg tablets:
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days (in case of fever) or 5 days (in case of pain).
• Do not administer this product to children for more than 3 days without consulting a doctor.

Contents of this leaflet:

1. What Paracetamolo Zentiva S.r.l. is and what it is used for
2. What you need to know before taking Paracetamolo Zentiva S.r.l.
3. How to take Paracetamolo Zentiva S.r.l.
4. Possible side effects
5. How to store Paracetamolo Zentiva S.r.l.
6. Contents of the pack and other information

1. What Paracetamolo Zentiva S.r.l. is and what it is used for

This product contains paracetamol, an active substance that relieves fever and pain.
Paracetamolo Zentiva S.r.l. tablets are used for the short-term symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, and muscle and joint pain occurring during influenza, colds and/or fever.
Paracetamolo Zentiva S.r.l. 500 mg is intended for adults, adolescents and children weighing more than 21 kg (aged 6 years and older).
Paracetamolo Zentiva S.r.l. 1000 mg is intended for adults and adolescents weighing more than 60 kg (aged 15 years and older).
Consult a doctor if you do not notice any improvement or if you notice a worsening of symptoms after 3 days (in case of fever) or 5 days (in case of pain).
Paracetamolo Zentiva S.r.l. 500 mg tablets: do not administer this product to children for more than 3 days without consulting a doctor.

2. What you need to know before taking Paracetamol Zentiva S.r.l.

Do not take Paracetamol Zentiva S.r.l.

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver failure.
• if you have acute inflammation of the liver.

Warnings and precautions
Do not use Paracetamol Zentiva S.r.l. simultaneously with other medicines containing
paracetamol.
Taking doses higher than those recommended may lead to a risk of serious liver damage.
Do not drink alcoholic beverages while taking this medicine.
Talk to your doctor or pharmacist before taking Paracetamol Zentiva S.r.l. if:

• you suffer from liver disease.
• you suffer from kidney disease.
• you are an alcohol abuser.
• you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase.
• you suffer from a low red blood cell count due to their abnormal breakdown (hemolytic anemia).
• you are elderly.
• you are dehydrated or malnourished.

Caution is necessary if

• you have a severe infection, which may lead to metabolic acidosis. Signs of metabolic acidosis are:
• Deep, rapid, difficult breathing.
• Nausea (feeling unwell), vomiting.
• Loss of appetite. If a combination of these symptoms occurs, contact your doctor immediately. 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.
Other medicines and Paracetamol Zentiva S.r.l.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Do not use Paracetamol Zentiva S.r.l. simultaneously with other medicines containing paracetamol.
The effects of paracetamol and the effects of other medicines you are taking concurrently may
interact.
Ask your doctor or pharmacist for advice before taking Paracetamol Zentiva S.r.l. if you are taking
one of the following medicines:

• Certain medicines that reduce blood clotting (e.g. warfarin).
• Medicines for nausea and vomiting (e.g. metoclopramide or domperidone) or medicines that lower cholesterol levels (cholestyramine).
• Acetylsalicylic acid, other painkillers and antipyretics belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
• Certain antibiotics (rifampicin, chloramphenicol).
• Certain medicines used to treat gout (probenecid).
• Certain medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine).
• Herbal remedies containing St. John’s wort.
• Zidovudine (used to treat HIV infection).
• Isoniazid (used to treat tuberculosis).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used.

Paracetamol Zentiva S.r.l. with food, drinks and alcohol
Do not drink alcoholic beverages while taking this medicine. Long-term alcohol consumption
significantly increases the risk of liver damage. If you have problems with alcohol consumption, talk to your
doctor before starting treatment with Paracetamol Zentiva S.r.l.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
If necessary, Paracetamol Zentiva S.r.l. may be used during pregnancy. It is advisable to use the lowest possible dose
that relieves pain and/or fever, and to take it for the shortest possible time. Contact your doctor if
pain and/or fever do not improve or if you need to take the medicine more frequently.
Paracetamol Zentiva S.r.l. passes into breast milk but is unlikely to affect breastfed infants.
It is not necessary to interrupt breastfeeding during short-term treatment with the recommended
doses of this medicine.
Driving and using machines
Paracetamol Zentiva S.r.l. does not affect the ability to drive or operate machinery.

3. How to take Paracetamolo Zentiva S.r.l.

Paracetamolo Zentiva S.r.l. 1000 mg tablets:
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Paracetamolo Zentiva S.r.l. 500 mg tablets:
Always take this medicine exactly as described in this leaflet or as told by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is shown in the table below.
Paracetamolo Zentiva S.r.l. 500 mg tablets

* The maximum daily dose of 8 tablets (4 g) may be taken by patients weighing
over 60 kg only after consulting a doctor.
The single dose may be repeated if necessary, at intervals of at least 4–6 hours.
Paracetamol Zentiva S.r.l. 500 mg is not intended for children under 6 years of age weighing
less than 21 kg.
Paracetamol Zentiva S.r.l. 1000 mg

* The maximum daily dose of 4 tablets (4 g) may be taken only after consulting a doctor.
The single dose may be repeated if necessary, at intervals of at least 4–6 hours.
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.
In patients with impaired renal or hepatic function, the doctor will determine the appropriate dose.
Do not exceed the recommended dosage.
Warning: taking doses exceeding the recommended amounts may result in the risk of serious liver damage.

Duration of treatment
If fever does not subside within 3 days, if pain does not diminish or if symptoms worsen within 5 days, or if new symptoms occur, consult a doctor for further treatment. Take this medicine without consulting a doctor for a maximum of 7 days.
Paracetamol Zentiva S.r.l. 500 mg: do not administer the product to children for more than 3 days without consulting a doctor.

Instructions for use
The tablets should be swallowed with a sufficient amount of liquid.
Paracetamol Zentiva S.r.l. 500 mg: the tablets may be divided into equal doses.
Paracetamol Zentiva S.r.l. 1000 mg: the score line is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing into equal doses.
Paracetamol Zentiva S.r.l. may be taken with or without food.

If you take more Paracetamol Zentiva S.r.l. than you should
Overdose may cause symptoms such as nausea, vomiting, or pallor. In all cases of suspected overdose or accidental ingestion by a child, seek immediate medical assistance, even if you or the child feel well, due to the risk of delayed, severe, and irreversible liver damage. Bring the empty packaging and this leaflet with you.

If you forget to take Paracetamol Zentiva S.r.l.
Do not take a double dose to make up for the missed dose. Take the missed dose as soon as you remember. Any subsequent dose should be taken only after the interval specified in section 3 above.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking the medicine immediately and seek immediate medical assistance
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 difficulties, 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 has similar problems after taking Paracetamolo 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):

• Liver dysfunction.

Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamolo Zentiva S.r.l.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after "Exp.". The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paracetamolo Zentiva S.r.l. contains

• The active substance is paracetamol. Each tablet contains 500 mg or 1000 mg of paracetamol.
• The other components are: pregelatinized starch; maize starch; talc (E 553); stearic acid (E 570); povidone (E 1201).

Description of the appearance of Paracetamolo Zentiva S.r.l. and package contents
Paracetamolo Zentiva S.r.l. 500 mg tablets: white capsule-shaped tablet with flat edges,
approximate size 17×7 mm, scored line (S|1) on one side.
Paracetamolo Zentiva S.r.l. 1000 mg tablets: white capsule-shaped tablet with bevelled edges,
approximate size 20×10 mm, scored line on one side.
Paracetamolo Zentiva S.r.l. is packaged in PVC/Al blisters.
Pack sizes:
Paracetamolo Zentiva S.r.l. 500 mg tablets are available in pack sizes of: 10, 12, 16, 20, 24, 30, 50, 100,
120, 300 tablets.
Paracetamolo Zentiva S.r.l. 1000 mg tablets are available in pack sizes of: 8, 16, 50, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
S.C. Zentiva S.A.
B-dul Theodor Pallady, Nr. 50
032266, Sector 3, Bucuresti
Romania

This medicinal product is authorized in the European Economic Area countries under the following names:

This patient information leaflet was last approved on: