Package leaflet: Information for the patient

Paracetamol Polfa-Lodz, 500 mg, tablets
Paracetamolum
Please read all of this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents of the leaflet:

What Paracetamol Polfa-Łódź is and what it is used for
Important information before taking Paracetamol Polfa-Łódź
How to take Paracetamol Polfa-Łódź
Possible side effects
How to store Paracetamol Polfa-Łódź
Contents of the pack and other information

1. What Paracetamol Polfa-Łódź is and what it is used for

Paracetamol Polfa-Łódź is a medicine with analgesic and antipyretic properties. This effect is mainly due to paracetamol's ability to inhibit prostaglandin synthesis in the central nervous system. Paracetamol Polfa-Łódź has no anti-inflammatory action, does not damage the gastric mucosa, does not impair blood coagulation or platelet aggregation, and does not cause other adverse effects typical of non-steroidal anti-inflammatory drugs (NSAIDs).
Indications:
Symptomatic treatment of mild to moderate pain and fever.
This medicine is indicated for use in adults and children over 9 years of age (detailed information, see section 3).
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Important information before using Paracetamol Polfa-Lodz

When not to use Paracetamol Polfa-Lodz

if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
in severe renal or hepatic insufficiency,
in alcohol-related liver disease.

Warnings and precautions
Before starting treatment with Paracetamol Polfa-Lodz, consult your doctor or pharmacist.

Exercise particular caution:

in patients with impaired kidney function,
in patients with impaired liver function (e.g. due to chronic alcohol abuse, Gilbert's syndrome, jaundice),
in patients taking medicines affecting liver function, patients with glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia, alcohol abusers, dehydrated or chronically undernourished patients,
in patients with alcoholic liver disease, the risk of overdose is higher,
in patients with asthma who are hypersensitive to acetylsalicylic acid, mild bronchospasm has been reported,
in patients with sepsis, undernourished patients, with anorexia or low BMI,
taking several daily doses at once may cause severe liver damage; in such cases unconsciousness does not occur. However, due to the risk of irreversible liver damage, immediate medical help must be sought, even if the patient feels well. Long-term use may lead to liver damage unless paracetamol is used under medical supervision,
in children and adolescents treated with paracetamol, administration of other antipyretic medicines is not permitted; if treatment is ineffective, consult a doctor or pharmacist,
paracetamol overdose may cause severe liver damage, which may necessitate liver transplantation or may result in patient death,
in patients with severe diseases, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (abnormality of blood and fluids) have been reported in patients who take paracetamol at regular doses for prolonged periods or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

During treatment with Paracetamol Polfa-Lodz, alcoholic beverages must not be consumed.
Long-term or frequent self-medication with paracetamol is not recommended.
Long-term treatment should be conducted only under medical supervision.
Do not use doses higher than recommended.
In case of high fever, signs of secondary infection, or persistence of symptoms after 3 days, consult a doctor.
The medicine contains paracetamol.
Due to the risk of overdose, check whether other medicines being used contain paracetamol. Do not take other medicines containing paracetamol (including some cold and flu remedies) due to the risk of overdose and associated liver damage. Long-term or frequent use of the medicine is not recommended.

Children and adolescents
The medicine is not intended for use in children under 9 years of age and therefore should not be used in this age group.

Paracetamol Polfa-Lodz and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
In particular, inform about the use of:

non-steroidal anti-inflammatory drugs (NSAIDs) – risk of renal function disorders with long-term use,
flucloxacillin (an antibiotic), due to a serious blood and fluid disorder called metabolic acidosis, which requires urgent treatment (see section 2),
barbiturates (anticonvulsant and sedative medicines), tricyclic drugs (antidepressants), and medicines inducing liver enzymes – risk of liver damage,
chloramphenicol (an antibiotic) – prolonged chloramphenicol half-life, increased toxicity,
MAO inhibitors (medicines used in psychiatry and neurology, e.g. phenelzine) – risk of excitation and fever,
prokinetic drugs (promoting movement of food and digestive products through the gastrointestinal tract), e.g. metoclopramide or domperidone – accelerated absorption of paracetamol,
coumarin anticoagulants (e.g. warfarin) – enhanced anticoagulant effect and risk of bleeding,
zidovudine (an antiviral drug) – increased toxic effect of zidovudine on bone marrow, leading to more frequent occurrence of neuropathy,
probenecid (a diuretic) – delays elimination of paracetamol,
salicylamide (an analgesic and antipyretic) – prolongs elimination time of paracetamol,
cholestyramine (a cholesterol-lowering medicine) – reduces absorption rate,
isoniazid (an antituberculosis drug) – increases paracetamol toxicity,
lamotrigine (an antiepileptic drug) – paracetamol reduces lamotrigine bioavailability.

False laboratory test results: Paracetamol may affect test results for uric acid levels and blood glucose measurements using the glucose oxidase-peroxidase method.

Paracetamol Polfa-Lodz with food, drink and alcohol
Do not consume alcohol during treatment. In patients who abuse alcohol, liver damage may occur.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Paracetamol Polfa-Lodz may be administered to pregnant women if necessary. Use the lowest effective recommended dose to relieve pain or reduce fever, and take the medicine for as short a duration as possible. If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult a doctor.
In breastfeeding women, the medicine should be used only if clearly necessary.
There are no data on the effect on fertility.

Driving and operating machinery
Paracetamol Polfa-Lodz, when used as directed, does not affect the ability to drive or operate machinery.

3. How to use Paracetamol Polfa-Lodz

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine contains paracetamol. Due to the risk of overdose, check whether other medicines being taken also contain paracetamol.
Recommended dosage:
Adults and adolescents over 15 years of age (body weight above 55 kg):
1 or 2 tablets at a time (500 or 1000 mg), maximum 6 tablets (3000 mg) per day.
Children and adolescents up to 15 years of age:
9-12 years: 1 tablet at a time, maximum 3-4 times per day.
12-15 years: 1 tablet at a time, maximum 4-6 times per day.
Do not use in children under 9 years of age.
Dosage recommendations:

Use the lowest effective dose possible.
The interval between doses should be at least 4 hours.
Do not use together with other medicines containing paracetamol.
Do not exceed the recommended doses due to the risk of liver damage.
Do not exceed the recommended maximum daily dose.
Less frequent dosing applies to children at the lower end of the age range.
If symptoms recur (fever and pain), re-administration of the medicine is permitted.
If pain persists for more than 5 days, or fever lasts longer than 3 days, or if pain becomes more severe, fever increases, or new symptoms appear, discontinue treatment and consult a doctor.
Taking paracetamol with food or drink does not affect the medicine's action.
In patients with renal impairment, hepatic impairment, or Gilbert's syndrome, the dose should be reduced or the interval between doses extended.

Method of administration:
Oral administration.
Swallow the tablet with water.
Use of a higher than recommended dose of Paracetamol Polfa-Lodz
This medicine should be taken as recommended.
If a higher than recommended dose is taken, overdose symptoms may occur:
gastrointestinal disturbances (nausea, vomiting, anorexia), pallor, abdominal pain, disturbances in liver and kidney function. Jaundice may occur after two days.
In any case of single intake of paracetamol at a dose of 5 g or more, induce vomiting (if less than one hour has passed since ingestion).
The patient must be taken to hospital immediately.
Missed dose of Paracetamol Polfa-Lodz
Paracetamol is taken as needed. If a dose is missed and symptoms persist, take the next dose as recommended.
Do not take a double dose to make up for a missed dose.
Discontinuation of Paracetamol Polfa-Lodz
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very rare adverse reactions (occurring in less than 1 in 10,000 people):
hypersensitivity reactions (angioedema, breathing difficulties, sweating, nausea, hypotension, shock, anaphylaxis), severe skin reaction, bronchospasm in patients sensitive to aspirin or other NSAIDs, decreased blood cell counts, hepatotoxicity, liver enlargement, hypoglycaemia, pyuria, renal function disorders, interstitial nephritis, blood in urine, anuria.

Rare adverse reactions (occurring in less than 1 in 1,000 people):
decreased number of: platelets, leukocytes, red blood cells, allergies, depression, confusion, hallucinations, convulsions, headache, visual disturbances, bleeding, abdominal pain, diarrhoea, nausea, vomiting, changes in liver function, liver failure, liver necrosis, jaundice, itching, rash, sweating, erythema, urticaria, exanthema, skin inflammation, dizziness, malaise, fever, sedation, overdose and poisoning.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
acute generalized exanthematous pustulosis, toxic necrolysis, drug-induced dermatosis, Stevens-Johnson syndrome.

A serious condition which 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 reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 reactions can also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Paracetamol Polfa-Lodz

No special storage instructions are required for this medicinal product.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton after EXP.
The expiry date refers to the last day of the stated month.
Do not use this medicine if the blister is damaged or if the tablets have changed in appearance.
Medicines should 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 Polfa-Lodz contains

The active substance is paracetamol - 500 mg/tablet.
The other ingredients (excipients) are: Sodium carboxymethyl starch (type A), Gelatinized corn starch, Povidone K-30, Stearic acid (type 50).

What Paracetamol Polfa-Lodz looks like and contents of the pack
The medicine is in the form of tablets, packed in transparent or opaque blisters. One blister contains 6 or 10 tablets.
The outer packaging contains 6, 10, 20, 50, 500 or 1000 tablets in blisters and the patient information leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
URGO Sp. z o.o.
Al. Jerozolimskie 142 B
02-305 Warsaw
tel/fax: 22 616 33 48 / 22 617 69 21

Importer
Medicofarma SA
Tarnobrzeska 13
26-613 Radom