Paracetamolum Farmalider

1.

What is Paracetamolum Farmalider and what is it used for
Paracetamol belongs to a group of pain-relieving and antipyretic medicines. Paracetamol is
indicated for the symptomatic treatment of mild and moderate pain (e.g. headache, toothache, menstrual
cramps) and fever.

2.

Important information before taking Paracetamolum Farmalider
When not to take Paracetamolum Farmalider:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsBefore starting to take Paracetamolum Farmalider, the patient should discuss it with their doctor or pharmacist: if the patient has kidney disease, if the patient has liver disease (including Gilbert's syndrome and alcoholic liver disease), if the patient has acute liver inflammation, if the patient is taking other medicines that may affect liver function, if the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase, if the patient has hemolytic anemia. The patient should not take any other medicines containing paracetamol at the same time.

In case of overdose, the patient should immediately seek medical attention due to the risk of
delayed, severe liver damage.
The patient should not exceed the recommended dose.
The patient should not take more than 4 grams (4 tablets) in 24 hours.
Paracetamol may affect the results of the following laboratory tests:

• uric acid concentration using phosphotungstic acid,
• blood glucose concentration using glucose oxidase and peroxidase.

Children

Paracetamolum Farmalider should not be used in children under 16 years of age. For children under 16 years of age, the use of Paracetamolum Farmalider should be discussed with a doctor or pharmacist, as there are other forms of the medicine with doses suitable for this group of patients.

Paracetamolum Farmalider and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take.
The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic), due to the serious risk of a disorder affecting the blood and body fluids (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking the maximum daily doses of paracetamol. Before starting to take the tablets, the patient should tell their doctor or pharmacist if they are taking prescription medicines, in particular metoclopramideor domperidone(for nausea or vomiting), cholestyramine(to lower blood cholesterol levels), opioids(for acute pain) or chloramphenicol(for bacterial infections). If the patient is taking blood-thinning medicines (anticoagulants), e.g. warfarin, and needs to take a pain reliever every day, they should consult their doctordue to the risk of bleeding. However, the patient can occasionallytake doses of Paracetamolum Farmalider with anticoagulant medicines.

Taking Paracetamolum Farmalider with food, drink, and alcohol

Taking paracetamol in patients who regularly consume alcohol (more than three alcoholic drinks per day - beer, wine, vodka... every day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
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 or pharmacist before taking this medicine.
Paracetamolum Farmalider can be used during pregnancy if necessary.
The patient should take the smallest possible dose that reduces pain and (or) fever, for the shortest possible time and as infrequently as possible.
The patient should consult their doctor if the pain and (or) fever do not decrease or if they need to take the medicine more frequently.

Driving and using machines

Paracetamol does not affect or has negligible effects on the ability to drive and use machines.

3.

How to take Paracetamolum Farmalider
This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults (including the elderly) and adolescents over 16 years of age: one tablet to four times a day as needed.
The patient should not take it more often than every 4 hours.
The patient should not take more than 4 tablets in 24 hours.
Use in childrenParacetamolum Farmalider should not be used in children and adolescents under 16 years of age.
If the patient thinks that the effect of Paracetamolum Farmalider is too strong or too weak, they should consult their doctor or pharmacist.
If it is necessary to administer less than 1000 mg of paracetamol per dose, the patient should use other strengths of the medicine corresponding to the required dose.
Taking a higher dose of Paracetamolum Farmalider than recommended
The patient should immediately consult their doctor or pharmacist. In case of overdose or accidental ingestion, the patient should immediately go to the hospital or call the poison control center, providing the name of the medicine and the amount taken.
If the patient overdoses on this medicine, they should immediately go to the hospital, even if they do not have any symptoms.
Symptoms of overdose within the first 24 hours include: pallor, nausea, vomiting, loss of appetite, and abdominal pain.
Treatment of overdose is more effective within the first 4 hours of taking the medicine.
In case of overdose, the patient should immediately seek medical attention due to the risk of delayed, severe liver damage.
If the patient's symptoms persist or the headache becomes persistent, they should consult their doctor.
Missing a dose of Paracetamolum Farmalider
The patient should not take a double dose to make up for a missed tablet. The patient should take the missed dose as soon as they remember, and the next doses should be taken at the recommended intervals (at least every 6 hours).
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, Paracetamolum Farmalider can cause side effects, although not everybody gets them.
This medicine can cause the following side effects:
Rare (may affect up to 1 in 1,000 people): feeling of discomfort, decrease in blood pressure (hypotension), breathing difficulties (bronchospasm), asthma, and increased activity of aminotransferases in the blood.
Very rare (may affect up to 1 in 10,000 people): kidney disease, cloudy urine, allergic skin inflammation (skin rash), jaundice, blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), hypoglycemia (low blood sugar), angioedema (swelling), anuria, and hematuria, interstitial nephritis.
Taking paracetamol in high doses or for a long time may cause liver damage.
If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist.
Very rare cases of severe skin reactions have been reported.
Reporting side effects
If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the
Department for Monitoring of Adverse Reactions to Medicinal Products,
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5.

How to store Paracetamolum Farmalider
The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton and blister after EXP. 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. 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 packaging and other information

What Paracetamolum Farmalider contains

The active substance of the medicine is paracetamol. Each tablet contains 1000 mg of paracetamol.
The other excipients are: maize starch, cornstarch (gluten-free), stearic acid (type 50), povidone (K-30), crospovidone (type A), microcrystalline cellulose, and magnesium stearate.
What Paracetamolum Farmalider looks like and contents of the pack
Paracetamolum Farmalider is available in the form of tablets for oral administration in packs of: 1, 6, 8, 10, 12, 18, 20, 30, 32, and 100 tablets.
Not all pack sizes may be marketed.
The dimensions of the tablet are 21.4 mm (length) x 10.2 mm (width) x 8.4 mm (thickness).
The break line on the tablet is only to facilitate breaking and swallowing.

Marketing authorization holder

Farmalider S.A.
C/ La Granja, 1, Alcobendas
28108 Madrid
Spain

Manufacturer/Importer:

Toll Manufacturing Services S.L
C/ Aragoneses, 2, Alcobendas
28108 Madrid
Spain
FROSST IBÉRICA, S.A.
Vía Complutense, 140, Alcalá de Henares
28805 Madrid
Spain

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

Date of last revision of the leaflet: 11/2024

For more detailed information, the patient should consult their local representative of the marketing authorization holder.