Paracetamol Polfa-vudi

Leaflet attached to the packaging: patient information

Paracetamol Polfa-Łódź, 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 directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• 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 inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

Paracetamol Polfa-Łódź is a medicine with analgesic and antipyretic effects. This effect is mainly due to paracetamol's ability to inhibit prostaglandin synthesis in the central nervous system. Paracetamol Polfa-Łódź does not have anti-inflammatory effects, does not damage the gastric mucosa, does not inhibit blood clotting or platelet aggregation, and does not cause other side effects typical of non-steroidal anti-inflammatory drugs (NSAIDs).
Indications for use:
Symptomatic treatment of mild to moderate pain and fever.
The medicine is indicated for use in adults and children over 9 years old (see section 3 for details).
If there is no improvement after 3 days or if the patient feels worse, they should consult their doctor.

2. Important information before taking Paracetamol Polfa-Łódź

When not to take Paracetamol Polfa-Łódź

• if the patient is allergic to paracetamol or any other component of this medicine (listed in section 6),
• in severe renal or hepatic impairment,
• in case of alcoholic liver disease.

Warnings and precautions

Before starting Paracetamol Polfa-Łódź, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised:

• in patients with impaired renal function,
• in patients with impaired hepatic function (e.g., due to chronic alcohol abuse, Gilbert's syndrome, jaundice),
• in patients taking medicines that affect liver function, in patients with glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, alcohol abuse, dehydration, and chronic malnutrition,
• in patients with alcoholic liver disease, the risk of overdose is higher,
• in patients with asthma, who have hypersensitivity to acetylsalicylic acid, minor bronchospasm has been reported,
• in patients with sepsis, malnutrition, or low BMI,
• taking multiple daily doses at once may cause serious liver damage; in such cases, there is no loss of consciousness. However, due to the risk of irreversible liver damage, medical help should be sought immediately, even if the patient feels well. Long-term use may lead to liver damage, unless paracetamol is used under medical supervision,
• in the case of children and adolescents treated with paracetamol, it is not allowed to administer other antipyretic medicines, and in case of lack of efficacy, a doctor or pharmacist should be consulted,
• paracetamol overdose can cause severe liver damage, which may result in the need for a liver transplant or may be fatal,
• if the patient has severe diseases, including severe renal or hepatic impairment, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, alcoholism in the chronic phase, or when the patient is also taking flucloxacillin (an antibiotic). There have been reports of a severe condition called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol regularly 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.

During treatment with Paracetamol Polfa-Łódź, the patient should not drink alcoholic beverages.
It is not recommended to use paracetamol for a long time or frequently without medical supervision.
Long-term treatment should only be carried out under medical supervision.
The patient should not exceed the recommended doses due to the risk of liver damage.
In case of high fever, symptoms of secondary infection, or persistence of symptoms after 3 days, the patient should consult their doctor.
The medicine contains paracetamol.
Due to the risk of overdose, the patient should check if other medicines they are taking contain paracetamol. The patient should not take other medicines containing paracetamol (e.g., some medicines used to relieve cold and flu symptoms) due to the risk of overdose and associated liver damage. It is not recommended to use the medicine for a long time or frequently.

Children and adolescents

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

Paracetamol Polfa-Łódź and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor or pharmacist about the use of:

• non-steroidal anti-inflammatory drugs (NSAIDs) - risk of renal impairment in case of long-term use,
• flucloxacillin (an antibiotic), due to the risk of a severe blood and fluid disorder (metabolic acidosis), which requires emergency treatment (see section 2),
• barbiturates (anticonvulsant and sedative medicines), tricyclic medicines (antidepressants), and medicines that induce liver enzymes - risk of liver damage,
• chloramphenicol (an antibiotic) - prolonged half-life of chloramphenicol, increased toxicity,
• monoamine oxidase inhibitors (MAOIs) (medicines used in psychiatry and neurology, e.g., phenelzine) - risk of excitement and fever,
• medicines that enhance peristalsis (movement of food and digestive products in the digestive tract), e.g., metoclopramide or domperidone - accelerated absorption of paracetamol,
• anticoagulant medicines from the coumarin group (e.g., warfarin) - increased anticoagulant effect and risk of bleeding,
• zidovudine (an antiviral medicine) - increased toxic effect of zidovudine on the bone marrow, more frequent occurrence of neuropathy,
• probenecid (a diuretic medicine) - delayed elimination of paracetamol,
• salicylamide (a pain reliever and antipyretic medicine) - prolonged elimination half-life of paracetamol,
• cholestyramine (a cholesterol-lowering medicine) - reduced absorption rate,
• isoniazid (an antitubercular medicine) - increased toxicity of paracetamol,
• lamotrigine (an antiepileptic medicine) - paracetamol reduces the bioavailability of lamotrigine.

False laboratory test results: paracetamol may affect the results of uric acid level tests and glucose level tests in the blood using the oxidase-peroxidase method.

Paracetamol Polfa-Łódź with food, drinks, and alcohol

During treatment with the medicine, the patient should not drink alcohol. In people who abuse alcohol, liver damage may occur.
Sodium
The medicine contains less than 1mmol (23mg) of sodium per tablet, which means the medicine is considered "sodium-free"

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 their doctor before taking this medicine.
Paracetamol Polfa-Łódź can be given to pregnant women if necessary. The patient should use the lowest effective dose that relieves pain or reduces fever and take the medicine for as short a time as possible. If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.
In the case of breastfeeding women, the medicine should only be used if absolutely necessary.
There is no data on the effect on fertility.

Driving and using machines

Paracetamol Polfa-Łódź, when used as directed, does not affect the ability to drive vehicles and operate machinery.

3. How to take Paracetamol Polfa-Łódź

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine contains paracetamol. Due to the risk of overdose, the patient should check if other medicines they are taking contain paracetamol.
The recommended dose is:

Adults and adolescents over 15 years old (body weight over 55 kg):
1 or 2 tablets at a time (500 or 1000 mg), up to 6 tablets (3000 mg) per day.
Children and adolescents up to 15 years old:
9-12 years: 1 tablet at a time, up to 3-4 times a day.
12-15 years: 1 tablet at a time, up to 4-6 times a day.
The medicine should not be used in children under 9 years old.
Recommendations for use:

• The patient should use the lowest effective dose of the medicine.
• The interval between consecutive doses should be at least 4 hours.
• The patient should not take the medicine with other medicines containing paracetamol.
• The patient should not exceed the recommended doses due to the risk of liver damage.
• The patient should not exceed the recommended maximum daily dose.
• A less frequent dosing regimen applies to children in the lower age range.
• In case of recurrence of symptoms (fever and pain), the patient may take the medicine again.
• If the pain persists for more than 5 days, or the fever lasts for more than 3 days, or if new symptoms appear, the patient should stop treatment and consult their doctor.
• Taking paracetamol during meals or drinks does not affect the action of the medicine.
• In patients with renal or hepatic impairment, or Gilbert's syndrome, the dose should be reduced or the interval between consecutive doses prolonged.

Method of administration:
Oral administration.
The tablet should be swallowed with water.

Using a higher dose of Paracetamol Polfa-Łódź than recommended

The medicine should be taken as directed.
In case of taking a higher dose than recommended, overdose symptoms may occur:
gastrointestinal disorders (nausea, vomiting, anorexia), pallor, abdominal pain, liver and kidney function disorders. After two days, jaundice may occur.
In every case of taking paracetamol in a dose of 5 g or more at once, the patient should induce vomiting (if it has been less than one hour since ingestion).
The patient should be taken to the hospital immediately.

Missing a dose of Paracetamol Polfa-Łódź

Paracetamol is used as needed. If a dose is missed and symptoms persist, the patient should take the next dose of the medicine.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Paracetamol Polfa-Łódź

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Polfa-Łódź can cause side effects, although not everybody gets them.
Very rare side effects(less than 1 in 10,000 people):
hypersensitivity reactions (angioedema, breathing difficulties, sweating, nausea, hypotension, shock, anaphylaxis), severe skin reactions, bronchospasm in patients sensitive to aspirin or other NSAIDs, decreased blood cell count, hepatotoxicity, liver enlargement, hypoglycemia, pyuria, renal function disorders, interstitial nephritis, hematuria, anuria.
Rare side effects(less than 1 in 1,000 people):
decreased platelet count, decreased white blood cell count, decreased red blood cell count, allergies, depression, confusion, hallucinations, seizures, headaches, vision changes, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver function changes, liver failure, liver necrosis, jaundice, itching, rash, sweating, flushing, urticaria, eczema, skin inflammation, dizziness, malaise, fever, sedation, overdose, and poisoning.
Frequency not known(frequency cannot be estimated from the available data):
acute generalized exanthematous pustulosis, toxic epidermal necrolysis, drug rash, Stevens-Johnson syndrome.
A serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
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
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +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 gather more information on the safety of the medicine.

5. How to store Paracetamol Polfa-Łódź

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the blister pack and carton after EXP.
The expiration date refers to the last day of the given month.
The medicine should not be used if the blister pack is damaged or the appearance of the tablets has changed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Polfa-Łódź contains

• The active substance of the medicine is paracetamol - 500 mg per tablet.
• The other ingredients (excipients) are: sodium carboxymethyl starch (type A), pregelatinized maize starch, povidone K-30, stearic acid (type 50).

What Paracetamol Polfa-Łódź looks like and contents of the pack

The medicine is in the form of tablets, packaged in transparent or non-transparent blisters. One blister contains 6 or 10 tablets.
The outer packaging contains 6, 10, 20, 50, 500, or 1000 tablets in blisters, as well as the patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Importer

Medicofarma SA
Tarnobrzeska 13
26-613 Radom
Date of last revision of the leaflet:11.2024