Paracetamol Zentiva

Leaflet attached to the packaging: patient information

Paracetamol Zentiva, 500 mg, tablets

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days (in case of fever) or 5 days (in case of pain) there is no improvement or the patient feels worse, they should contact a doctor.
• Do not give this medicine to children for more than 3 days without consulting a doctor.

Table of contents of the leaflet

• 1. What is Paracetamol Zentiva and what is it used for
• 2. Important information before taking Paracetamol Zentiva
• 3. How to take Paracetamol Zentiva
• 4. Possible side effects
• 5. How to store Paracetamol Zentiva
• 6. Contents of the packaging and other information

1. What is Paracetamol Zentiva and what is it used for

The medicine contains paracetamol, an active substance with antipyretic and analgesic effects.
Paracetamol Zentiva tablets are used for 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) to reduce fever.
Paracetamol Zentiva 500 mg is intended for adults, adolescents, and children with a body weight
over 21 kg (from 6 years of age and above).
If after 3 days (in case of fever) or 5 days (in case of pain) there is no improvement or the patient feels worse, they should tell their doctor.
Do not give this medicine to children for more than 3 days without consulting a doctor.

2. Important information before taking Paracetamol Zentiva

When not to take Paracetamol Zentiva

If the patient:

• has been diagnosed with hypersensitivity to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• has severe liver failure,
• has acute liver inflammation.

Warnings and precautions

Do not take Paracetamol Zentiva at the same time as other medicines containing paracetamol.

Taking higher doses than recommended may lead to a risk of severe liver damage.

Do not drink alcohol while taking this medicine.
Before starting to take Paracetamol Zentiva, discuss it with a doctor or pharmacist if:

• the patient has liver disease,
• the patient has kidney disease,
• the patient abuses alcohol,
• the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase,
• the patient has a low red blood cell count due to their abnormal breakdown (hemolytic anemia),
• the patient is elderly,
• the patient is dehydrated or malnourished.

While taking Paracetamol Zentiva, immediately inform a doctor if:
If the patient has severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, alcoholism in the chronic phase, or if the patient is also taking flucloxacillin (an antibiotic).
Severe metabolic acidosis (a blood and fluid disorder) has been reported in patients who take paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Do not take this medicine without consulting a doctor if the patient has problems with drinking alcohol.

Children and adolescents

Paracetamol Zentiva 500 mg, due to the content of the active substance in the tablet, is not intended for children under 6 years of age and with a body weight below 21 kg.

Paracetamol Zentiva and other medicines

Tell a doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.

Do not take Paracetamol Zentiva at the same time as other medicines containing paracetamol.

Paracetamol may affect the action of other medicines, and other medicines taken at the same time may affect the action of paracetamol.
Before taking Paracetamol Zentiva, discuss it with a doctor or pharmacist if the patient is taking any 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 nonsteroidal 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 medicines containing St. John's Wort,
• zidovudine (used to treat HIV infection),
• isoniazid (used to treat tuberculosis),
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment.

Paracetamol Zentiva with food, drink, and alcohol

Do not drink alcoholic beverages while taking this medicine. Long-term consumption of alcohol significantly increases the risk of liver damage. If the patient has problems with drinking alcohol, they should discuss it with a doctor before taking Paracetamol Zentiva.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Paracetamol Zentiva may be used during pregnancy if necessary. The smallest possible dose should be used to reduce pain and (or) fever, and it should be used for the shortest possible time. The patient should contact a doctor if pain and (or) fever do not improve or if it is necessary to take the medicine more frequently.
Paracetamol Zentiva passes into breast milk, but it is unlikely to affect the breastfed child. There is no need to stop breastfeeding during short-term treatment with the recommended doses of this medicine.

Driving and using machines

Paracetamol Zentiva does not affect the ability to drive or use machines.

3. How to take Paracetamol Zentiva

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dosing is shown in the table below:
* The maximum daily dose of 8 tablets (4 g) can only be taken by patients with a body weight over 60 kg after consulting a doctor.
If necessary, a single dose can be repeated at intervals of at least 4 to 6 hours.
Paracetamol Zentiva 500 mg is not intended for children under 6 years of age with a body weight below 21 kg.
For patients with kidney or liver disorders, the dose will be determined by a doctor.

Do not exceed the recommended dose.

Warning:taking higher doses than recommended may lead to a risk of severe liver damage.
Duration of treatment
If fever does not decrease within 3 days, and pain does not improve or symptoms worsen within 5 days, or other symptoms appear, the patient should consult a doctor to determine further treatment.
Do not give this medicine to children for more than 3 days without consulting a doctor.
Method of administration
Tablets should be swallowed with a sufficient amount of liquid.
Tablets can be divided into equal doses.
Paracetamol Zentiva can be taken with or without food.

Taking a higher dose of Paracetamol Zentiva than recommended

Overdose may cause nausea, vomiting, or paleness. In any case of suspected overdose or accidental ingestion by a child, immediately seek medical help, even if the patient or child feels well, due to the risk of delayed, severe, and irreversible liver damage. Show the used packaging and this leaflet.

Missing a dose of Paracetamol Zentiva

Do not take a double dose to make up for a missed dose. The patient should take the missed dose as soon as they remember.
The next dose should be taken, maintaining the interval indicated in section 3 above.
In case of any further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and immediately seek medical help if any of the following side effects occur:

• hypersensitivity reactions, such as rash or itching (rare - may occur in up to 1 in 1000 people), which may be accompanied by breathing problems, swelling of the lips, tongue, throat, or face (very rare - may occur in up to 1 in 10,000 people),
• severe skin reactions, including peeling of the skin or blisters in the mouth (very rare - may occur in up to 1 in 10,000 people),
• previously experienced breathing problems after taking acetylsalicylic acid or other painkillers belonging to the group of nonsteroidal anti-inflammatory drugs, and similar problems occur when taking Paracetamol Zentiva (very rare - may occur in up to 1 in 10,000 people),
• unexplained bruising (very rare - may occur in up to 1 in 10,000 people).

Other side effects

Very rare (may occur in up to 1 in 10,000 people):

• liver function disorders.

Frequency not known (frequency cannot be estimated from the available data):

• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Paracetamol Zentiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and blister.
The expiry date refers to the last day of the month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Zentiva contains

• The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: maize starch, maize starch paste, talc (E 553), stearic acid (E 570), povidone (E 1201).

What Paracetamol Zentiva looks like and contents of the pack

Paracetamol Zentiva 500 mg are white tablets, capsule-shaped, with flat edges, approximately 17×7 mm in size, with a dividing line S1 (S|1) on one side.
Paracetamol Zentiva is packaged in a PVC/Aluminum blister pack in a cardboard box.
Pack sizes: 10, 12, 16, 20, 24, 30, 50, 100, 120, or 300 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer

S.C. Zentiva S.A.
B-dul Theodor Pallady nr 50, sector 3
032266, Bucharest
Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information on the medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:January 2025