Laboratoria Polfavudi Paracetamol

Leaflet attached to the packaging: patient information

Laboratoria PolfaŁódź Paracetamol, 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 this patient leaflet or as advised 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 this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

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

1. What is Laboratoria PolfaŁódź Paracetamol and what is it used for

Laboratoria PolfaŁódź Paracetamol 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. Laboratoria PolfaŁódź Paracetamol 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:

• pains of various origins, including: headaches (including migraines), joint, muscle, menstrual, and post-traumatic and post-surgical pains;
• fever, e.g. in flu-like conditions and colds.

The medicine is indicated for use in adults and children over 12 years old (see section 3 for details).
If there is no improvement after 3 days or if the patient feels worse, they should consult a doctor.

2. Important information before taking Laboratoria PolfaŁódź Paracetamol

When not to take Laboratoria PolfaŁódź Paracetamol

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in case of alcoholism.

Warnings and precautions

Before starting to take Laboratoria PolfaŁódź Paracetamol, 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 liver function (e.g. due to chronic alcohol abuse, Gilbert's syndrome, jaundice).
• in patients taking medications 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 anorexia, or low BMI,
• taking several 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 can 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 medications, 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 impairment or 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 disease called metabolic acidosis (a blood and fluid disorder) in patients who take 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, nausea, and vomiting.

During treatment with Laboratoria PolfaŁódź Paracetamol, the patient should not drink alcoholic beverages.
It is not recommended to take paracetamol for a long time (more than 3 days) or frequently by patients themselves.
Long-term treatment should only be carried out under medical supervision.
Do 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 a doctor.
The medicine contains paracetamol.
Due to the risk of overdose, the patient should check if other medications they are taking contain paracetamol. Do not take other medications containing paracetamol (e.g. some medications used to relieve cold and flu symptoms) due to the risk of overdose and associated liver damage. It is not recommended to take the medicine for a long time or frequently.

Children and adolescents

The medicine is not intended for use in children under 12 years old and should not be used in this age group.

Laboratoria PolfaŁódź Paracetamol and other medicines

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

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

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

Laboratoria PolfaŁódź Paracetamol with food, drink, and alcohol

During the treatment period, the patient should not drink alcohol. In people who abuse alcohol, liver damage may occur.

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 before taking this medicine.
Laboratoria PolfaŁódź Paracetamol can be given to pregnant women if it is clinically justified. The lowest effective dose should be used, and the medicine should be taken for the shortest possible time. 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 a doctor.
In the case of breastfeeding women, the medicine should only be used if necessary.

Driving and using machines

Laboratoria PolfaŁódź Paracetamol, when used as recommended, does not affect the ability to drive vehicles or operate machines.

Laboratoria PolfaŁódź Paracetamol contains sorbitol (E420)

The medicine contains 170 mg of sorbitol in each tablet.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, fructose intolerance, in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.

3. How to take Laboratoria PolfaŁódź Paracetamol

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

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

• The lowest effective dose of the medicine should be used.
• The interval between consecutive doses should be at least 4 hours.
• Do not take the medicine with other medications containing paracetamol.
• Do not exceed the recommended doses, due to the risk of liver damage.
• Do 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), it is allowed to repeat the dose.
• If the pain or fever lasts longer than 3 days, or if the pain is stronger and the fever is higher, or if new symptoms appear, the treatment should be discontinued, and the patient should consult a doctor.
• Taking paracetamol during meals or drinks does not affect the medicine's action.
• In patients with renal or liver impairment, or Gilbert's syndrome, the dose should be reduced or the interval between consecutive doses should be extended.

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

Taking a higher dose of Laboratoria PolfaŁódź Paracetamol than recommended

The medicine should be taken as recommended.
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, vomiting should be induced (if it has been less than one hour since ingestion).
The patient should be taken to the hospital immediately.

Missing a dose of Laboratoria PolfaŁódź Paracetamol

Paracetamol is taken as needed. If a dose is missed and symptoms persist, the next dose should be taken.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Laboratoria PolfaŁódź Paracetamol

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects(less than 1 in 10,000 people):
allergic 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 impairment, interstitial nephritis, hematuria, anuria.
Rare side effects(less than 1 in 1,000 people):
decreased platelet count, leukopenia, anemia, 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, urticaria, erythema, exanthema, 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 (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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 to gather more information on the safety of the medicine.

5. How to store Laboratoria PolfaŁódź Paracetamol

Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
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 carton after EXP.
The expiry date refers to the last day of the month.
Do not use this medicine if the blister 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 Laboratoria PolfaŁódź Paracetamol contains

• The active substance of the medicine is paracetamol - 500 mg per tablet.
• Other ingredients (excipients) are: sorbitol (E420) (170 mg per tablet), potato starch, povidone, magnesium stearate.

What Laboratoria PolfaŁódź Paracetamol looks like and what the pack contains

The medicine is in the form of tablets, packaged in 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

Manufacturer

Wörwag Pharma Operations Spółka z ograniczoną odpowiedzialnością
General Langiewicz Street 58
95-050 Konstantynów Łódzki
Date of last revision of the leaflet:11.2024