PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamolo Zentiva Generics 500 mg film-coated tablets, 1000 mg film-coated tablets

Generic medicine
<[ Paracetamolo Zentiva Generics 1000 mg:]>
Read this entire 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

<[ Paracetamolo Zentiva Generics 500 mg:]>
Read this entire 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.

Keep this leaflet. You may need to read it again.
If you need further 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 experience worsening of symptoms after 3 days.

Contents of this leaflet:

What Paracetamolo Zentiva Generics is and what it is used for
What you need to know before taking Paracetamolo Zentiva Generics
How to take Paracetamolo Zentiva Generics
Possible side effects
How to store Paracetamolo Zentiva Generics
Contents of the pack and other information

1. What Paracetamolo Zentiva Generics is and what it is used for

Paracetamolo Zentiva Generics contains paracetamol, which belongs to a group of medicines called analgesics (painkillers). Paracetamolo Zentiva Generics is used to relieve mild to moderate pain and to reduce fever.
Paracetamolo Zentiva Generics can be used for the relief of headache, toothache, menstrual pain, muscle pain, and fever associated with the common cold.

2. What you need to know before taking Paracetamol Zentiva Generics

Do not take Paracetamol Zentiva Generics

if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Paracetamol Zentiva Generics must not be used in combination with alcoholic beverages, as it may severely damage the liver. The effect of alcohol is not enhanced by the addition of paracetamol.
Talk to your doctor before taking Paracetamol Zentiva Generics:

if you suffer from kidney or liver disease (including Gilbert's syndrome or hepatitis);
if you regularly consume large amounts of alcohol. You may require reduced doses and should limit use to a short period of time, otherwise your liver may be damaged;
if you are dehydrated or if your nutritional status is compromised, for example due to alcohol abuse, anorexia, or inadequate nutrition;
if you suffer from haemolytic anaemia (abnormal breakdown of red blood cells);
if you have a deficiency of a specific enzyme called glucose-6-phosphate-dehydrogenase;
if you are taking other medicines known to affect the liver;
if you are taking other medicines containing paracetamol, as this may severely damage the liver;
if you frequently use pain-relieving medicines over long periods of time, as prolonged use may cause headaches to become more severe or more frequent. Do not increase the dose of the medicine to relieve pain; instead, consult your doctor for advice;
if you are asthmatic;
if you are sensitive to acetylsalicylic acid and/or non-steroidal anti-inflammatory drugs (NSAIDs).

Warning: Taking higher than recommended doses may result in a risk of severe liver damage. Therefore, do not exceed the maximum daily dose of paracetamol. You should also be cautious when using other medicines that contain paracetamol at the same time.
See also section 3 "If you take more Paracetamol Zentiva Generics than you should".
If, during treatment with this medicine, you develop progressive skin rashes, often with blisters or mucosal lesions, stop taking Paracetamol Zentiva Generics and consult a doctor.
If you develop high fever or signs of infection after more than 3 days of treatment, or if pain persists after more than 5 days of treatment, consult a doctor.

Other medicines and Paracetamol Zentiva Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

chloramphenicol (used to treat infections), because Paracetamol Zentiva Generics may delay its elimination from the body;
metoclopramide or domperidone (used to treat nausea and vomiting), because they may increase the onset of effect of Paracetamol Zentiva Generics;
cholestyramine (used to lower cholesterol) and medicines that slow gastric emptying, because they may reduce the effect of Paracetamol Zentiva Generics;
probenecid (used to treat, for example, gout). Lower doses of Paracetamol Zentiva Generics may be required;
anticoagulants (blood-thinning medicines, e.g. warfarin and other vitamin K antagonists), if you need to take Paracetamol Zentiva Generics daily for a prolonged period;
salicylamide (used to treat fever or mild pain), because it may delay the elimination of Paracetamol Zentiva Generics from the body;
lamotrigine (used to treat epilepsy), because Paracetamol Zentiva Generics may reduce its effect;
medicines that may damage the liver, such as:
barbiturates or carbamazepine (used to treat mental disorders and epilepsy);
rifampicin (used to treat bacterial infections);
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap) that require 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;
isoniazid (used to treat tuberculosis);
phenytoin (used to treat epilepsy);
St John's wort ( Hypericum perforatum ) (used to treat depression).

Paracetamol Zentiva Generics may alter the results of certain laboratory tests, such as tests for uric acid and blood glucose.

Paracetamol Zentiva Generics and alcohol
The concomitant use of Paracetamol Zentiva Generics and alcohol consumption should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, Paracetamol Zentiva Generics 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 decrease, or if you need to take the medicine more frequently.
Paracetamol Zentiva Generics, at the recommended doses, may be used during breastfeeding.

Driving and using machines
Paracetamol does not affect the ability to drive vehicles or operate machinery.

3. How to take Paracetamolo Zentiva Generics

Instructions for use
The tablet should be swallowed with a glass of water.
Dosage
<[ Paracetamolo Zentiva Generics 1000 mg:]>
Always use this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
<[ Paracetamolo Zentiva Generics 500 mg:]>
Always use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Do not exceed the recommended dose. Doses higher than those recommended may cause a risk of severe liver damage.
500 mg tablets:
Paediatric dosing should be based on body weight, and an appropriate dosage form should be used. The age information provided below for children in each weight group is indicative only.
Adults and adolescents weighing over 50 kg
The usual dose is 1–2 tablets (500–1000 mg) every 4–6 hours as needed, up to a maximum of 6 tablets (3 g) per day.
Children and adolescents weighing between 43 and 50 kg (approximately 12–15 years of age)
The usual dose is 1 tablet (500 mg) every 4 hours as needed, up to a maximum of 5 tablets (2.5 g) per day.
Children weighing between 34 and 43 kg (approximately 11–12 years of age)
The usual dose is 1 tablet (500 mg) every 6 hours as needed, up to a maximum of 4 tablets (2 g) per day.
Children weighing between 26 and 34 kg (approximately 8–11 years of age)
The usual dose is ½ tablet (250 mg) every 4 hours or 1 tablet (500 mg) every 6 hours as needed, up to a maximum of 3 tablets (1.5 g) per day.
Paracetamolo Zentiva Generics 500 mg must not be administered to children weighing less than 26 kg.
1000 mg tablets:
Adults and adolescents weighing over 50 kg
The usual dose is ½–1 tablet (500–1000 mg) every 4–6 hours as needed, up to a maximum of 3 tablets (3 g) per day. Do not take more than one tablet at a time.
Paracetamolo Zentiva Generics 1000 mg must not be administered to children and adolescents weighing less than 50 kg.
If you have high fever or signs of infection after more than 3 days of treatment, or if pain persists beyond 5 days of treatment, consult a doctor.
Patients with impaired renal or hepatic function
In patients with impaired renal or hepatic function and in patients with Gilbert's syndrome, the dose should be reduced or the dosing interval prolonged. In patients with severe renal impairment, the dosing interval for Paracetamolo Zentiva Generics should be at least 8 hours. Consult your doctor or pharmacist.
Elderly
Dosage adjustment is not required in elderly patients.
Patients with chronic alcoholism
Chronic alcohol consumption may increase the risk of paracetamol toxicity. The interval between doses should be at least 8 hours. Do not exceed 2 g of paracetamol per day.
If you take more Paracetamolo Zentiva Generics than you should
In case of overdose, seek immediate medical attention, even if you feel well, because there is a risk of delayed severe liver damage. To prevent possible liver damage, it is important that a doctor administers an antidote as soon as possible. Symptoms of liver damage typically do not appear until several days after ingestion. Symptoms of overdose may include nausea, vomiting, anorexia (loss of appetite), pallor, and abdominal pain, which usually occur within 24 hours of ingestion.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience difficulty breathing, swelling of the face, lips, neck, tongue or throat (severe allergic reactions), stop treatment with this medicine and contact your doctor immediately.

Rare: may affect up to 1 in 1,000 people:

Changes in blood platelets (coagulation disorders), changes in stem cells (disorders of blood-forming cells in the bone marrow).
Depression, confusion, hallucinations.
Tremor, headache.
Vision disorders.
Edema (abnormal accumulation of fluid under the skin).
Abdominal pain, bleeding in the stomach or intestines, diarrhea, nausea, vomiting.
Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), hepatic necrosis (death of liver cells).
Itching, sweating, red patches on the skin.
Dizziness, general feeling of malaise, fever, drowsiness, interaction with other medicines.
Overdose and poisoning.

Very rare: may affect up to 1 in 10,000 people:

Blood disorders (reduction in platelets, white blood cells and neutrophils in the blood).
Low blood glucose levels.
Hepatotoxicity (liver damage caused by chemicals).
Erythema, skin rash and urticaria.
Cloudy urine and kidney disorders.

Frequency not known: frequency cannot be estimated based on available data
Allergic reactions such as anaphylactic shock; swelling of the lips, face, neck and throat (angioedema); erythema multiforme (allergic reaction or skin infection); progressive skin rashes often with blisters or mucosal lesions (which may also be due to toxic epidermal necrolysis and Stevens-Johnson syndrome, two very serious conditions); fluid accumulation in the larynx, bronchospasm (reduction in bronchial diameter due to abnormal contraction of smooth muscle, resulting in reduced airflow); anemia (reduction in red blood cells); agranulocytosis (marked decrease, up to disappearance, of blood granulocytes); hemolytic anemia (abnormal breakdown of red blood cells); allergic coronary spasm leading to vasospastic myocardial ischemia or infarction (Kounis syndrome); changes in liver function and hepatitis (liver inflammation); kidney disorders (severe kidney impairment, blood in urine, inability to urinate); stomach and intestinal disorders; dizziness.

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 the following address: 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 Generics

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP.”.
The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Paracetamolo Zentiva Generics contains

The active substance is paracetamol. Each film-coated tablet contains 500 mg of paracetamol.
The active substance is paracetamol. Each film-coated tablet contains 1000 mg of paracetamol.
The other components are: tablet core: pregelatinized maize starch, hydroxypropylcellulose, talc, and magnesium stearate; film coating: polyvinyl alcohol, macrogol 3350, and talc.

Description of the appearance of Paracetamolo Zentiva Generics and contents of the pack
500 mg tablets:
White, film-coated, capsule-shaped tablet measuring 17.0 mm x 7.2 mm, with a score line on one side and smooth on the other.
The tablet can be divided into two equal halves.
1000 mg tablets:
White, film-coated, capsule-shaped tablet measuring 21.4 mm x 9.0 mm, with a score line on one side and smooth on the other.
The tablet can be divided into two equal halves.
Pack sizes:
500 mg
Blister packs: 20 tablets
1000 mg
Blister packs: 16 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7
20121 Milano
Italy
Manufacturer
Balkanpharma – Dupnitsa AD
3, Samokovsko Shosse Str., 2600 Dupnitsa
Bulgaria

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Paracetamolo Zentiva Generics

This Patient Information Leaflet was last approved on: