Paracetamol zentiva

Package leaflet: Information for the user

Paracetamol Zentiva, 500 mg, tablets
Paracetamolum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days (in case of fever) or 5 days (in case of pain), or if you feel worse, consult your doctor.
• Do not administer this medicine to children for longer than 3 days without consulting a doctor.

Table of contents

1. What Paracetamol Zentiva is and what it is 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 pack and other information

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

This medicine contains paracetamol, an active substance with antipyretic and analgesic properties.
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 associated with influenza and colds, and/or for reduction of fever.
Paracetamol Zentiva 500 mg is intended for adults, adolescents, and children weighing over 21 kg (aged 6 years and above).
If there is no improvement after 3 days (in case of fever) or 5 days (in case of pain), or if you feel worse, inform your doctor.
Do not administer this medicine to children for longer than 3 days without consulting a doctor.

2. Important information before using Paracetamol Zentiva

When not to use Paracetamol Zentiva
Do not use Paracetamol Zentiva if the patient:

• has a known hypersensitivity to paracetamol or to any of the other ingredients of this medicine (listed in section 6),
• has severe hepatic insufficiency,
• has acute hepatitis.

Warnings and precautions
Do not take Paracetamol Zentiva together with other medicines containing
paracetamol.
Taking higher than recommended doses may lead to risk of severe liver damage.
Do not drink alcohol while taking this medicine.
Before starting treatment with Paracetamol Zentiva, consult a doctor or
pharmacist if:

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

During treatment with Paracetamol Zentiva, inform the doctor immediately if:
If the patient has severe conditions, including severe kidney function disorders or sepsis
(when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition,
chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Cases of a serious condition called metabolic acidosis (an abnormality in blood and
body fluids) have been reported in patients who take paracetamol regularly for a prolonged
period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may
include: severe breathing difficulties, including rapid deep breathing, drowsiness,
nausea and vomiting.
Do not take this medicine without medical advice if the patient has problems with
alcohol consumption.

Children and adolescents
Paracetamol Zentiva 500 mg, due to the amount of active substance per tablet, is not
intended for children under 6 years of age or weighing less than 21 kg.

Paracetamol Zentiva and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Paracetamol Zentiva together with 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, talk to a doctor or pharmacist if the patient is taking any of the following medicines:

• certain anticoagulants (e.g. warfarin),
• medicines for nausea and vomiting (e.g. metoclopramide or domperidone) or cholesterol-lowering agents (cholestyramine),
• acetylsalicylic acid, other pain-relieving and antipyretic medicines belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (rifampicin, chloramphenicol),
• certain medicines used in the treatment of gout (probenecid),
• certain antiepileptic medicines (phenobarbital, phenytoin, carbamazepine),
• herbal medicines containing St. John's wort (Hypericum perforatum),
• zidovudine (used in the treatment of HIV infection),
• isoniazid (used in the treatment of tuberculosis),
• flucloxacillin (an antibiotic), due to the serious risk of a blood and body 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 alcohol consumption
greatly increases the risk of liver damage. If the patient has problems with alcohol consumption, they should discuss this with a doctor before taking Paracetamol Zentiva.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
If necessary, Paracetamol Zentiva may be used during pregnancy. The lowest possible dose that relieves pain and (or) fever should be used, and for the shortest possible duration. Contact a doctor if pain and (or) fever persist or if more frequent dosing is required.
Paracetamol Zentiva passes into breast milk, but it is unlikely to affect the breastfed infant. There is no need to interrupt breastfeeding during short-term treatment with recommended doses of this medicine.

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

3. How to use Paracetamol Zentiva

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Recommended dosage is shown in the table below:

* The maximum daily dose of 8 tablets (4 g) may be taken only by patients weighing
over 60 kg after consultation with a doctor.
If necessary, a single dose may 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 weighing
less than 21 kg.
For patients with impaired kidney or liver function, the dose should be determined by a doctor.
Do not exceed the recommended dose.
Warning: taking doses higher than recommended may lead to risk of severe liver damage.
Duration of treatment
If fever does not subside within 3 days, or if pain persists or symptoms worsen within 5 days,
or if other symptoms appear, the patient should consult a doctor to determine further treatment.
Do not administer this medicine to children for longer than 3 days without consulting a doctor.
Method of administration
Tablets should be swallowed with an adequate amount of liquid.
Tablets may be divided into equal doses.
Paracetamol Zentiva may be taken with or without food.
Use of a higher than recommended dose of Paracetamol Zentiva
Overdose may be manifested by nausea, vomiting, or pallor. In any case of suspected overdose or accidental ingestion by a child, seek immediate medical help, even if the patient or child feels well, due to the risk of delayed, severe, and irreversible liver damage. The used packaging and this leaflet should be shown to the healthcare provider.
Missed 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 remembered.
The next dose should be taken, maintaining the interval indicated in point 3 above.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking the medicine immediately and seek medical help without delay
if any of the following adverse effects occur:

• allergic reactions such as rash or itching (rare - may occur in no more than 1 in 1,000 people), sometimes accompanied by breathing difficulties, swelling of the lips, tongue, throat or cheeks (very rare - may occur in no more than 1 in 10,000 people),
• severe skin reactions, including skin peeling or formation of blisters in the mouth (very rare - may occur in no more than 1 in 10,000 people),
• previous history of breathing problems after taking acetylsalicylic acid or other painkillers belonging to the group of non-steroidal anti-inflammatory drugs, and similar problems occur after taking Paracetamol Zentiva (very rare - may occur in no more than 1 in 10,000 people),
• unexplained bruising (very rare - may occur in no more than 1 in 10,000 people).

Other adverse effects
Very rare (may occur in no more than 1 in 10,000 people):

• liver function disorders.

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

• serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

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

5. How to store Paracetamol Zentiva

Keep this 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 indicated. There are no special storage
instructions for this medicine. Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Zentiva contains

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: pregelatinized maize starch, maize starch, 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, capsule-shaped tablets with flat edges, approximately 17×7 mm in size, with a division line S1 (S|1) on one side.

Paracetamol Zentiva is packed in PVC/Aluminium blisters in cardboard boxes.
Pack sizes: 10, 12, 16, 20, 24, 30, 50, 100, 120 or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 no. 50, sector 3
032266, Bucharest
Romania
This medicinal product is authorised in the European Economic Area countries under the following names:

For more detailed information about the medicinal product, please contact the
representative of the responsible entity in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00