Paracetamol medicinae

Package leaflet: Information for the user

PARACETAMOL MEDICINAE, 500 mg, tablets
Paracetamol
Read the entire leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, 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 you feel worse, consult your doctor.

Table of contents:

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

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

Paracetamol belongs to a group of medicines known as analgesics (pain relievers) and antipyretics (fever reducers). Paracetamol is indicated for the symptomatic relief of mild to moderate pain (e.g. headache, toothache, menstrual pain) and fever.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Paracetamol MEDICINAE

When not to take Paracetamol MEDICINAE:

• if the patient is allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Before starting to take Paracetamol MEDICINAE, discuss this with a 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 hepatitis,
  • if the patient is taking other medicines that may affect liver function,
  • if the patient has glucose-6-phosphate dehydrogenase deficiency,
  • if the patient has haemolytic anaemia.

Do not take any other medicines containing paracetamol at the same time.
In case of overdose, seek immediate medical help due to the risk of delayed, serious liver damage.
Do not exceed the recommended dose.
Do not exceed the dose of 4 g (8 tablets) within 24 hours in adults, elderly and adolescents aged over 16 years.
Do not exceed the dose of 2 g (4 tablets) within 24 hours in children aged over 10 years.
Paracetamol may alter the results of the following laboratory tests:

• serum uric acid levels when using phosphotungstic acid,
• blood glucose levels when using glucose oxidase and peroxidase. Children Do not use in children under 10 years of age. For children under 10 years of age, consult a doctor or pharmacist, as other dosage forms of the medicine with doses more suitable for this patient group are available. Paracetamol MEDICINAE and other medicines Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to the serious risk of a fluid and blood disorder (metabolic acidosis with a high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal dysfunction, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol. Before starting to take the tablets, inform the doctor or pharmacist if the patient is taking prescription medicines, especially metoclopramide or domperidone (for nausea or vomiting), cholestyramine (to lower blood cholesterol), opioids (for severe pain), or chloramphenicol (for bacterial infections). If the patient is taking blood-thinning medicines ( anticoagulants such as warfarin) and needs to take a painkiller regularly, this should be discussed with a doctor due to the risk of bleeding. However, occasional doses of Paracetamol MEDICINAE may be taken concomitantly with anticoagulants. Taking Paracetamol MEDICINAE with food, drink and alcohol

Use of paracetamol in patients who regularly consume alcohol (more than three alcoholic drinks per day – beer, wine, vodka, etc. – daily) 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Paracetamol MEDICINAE may be used during pregnancy if necessary.
The lowest recommended dose that reduces pain and (or) fever should be taken for the shortest possible duration and as infrequently as possible.
Consult a doctor if pain and (or) fever do not subside or if the patient needs to take the medicine more frequently.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been reported.

3. How to take Paracetamol MEDICINAE

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
Recommended dosage:
Adults, elderly patients, and adolescents aged 16 years and older: take one or two tablets
up to 4 times daily. Do not exceed 4 g (8 tablets) within 24 hours.
Children aged 10 to 15 years: take one tablet up to 4 times daily. Do not exceed 2 g (4 tablets)
within 24 hours.
Do not give to children under 10 years of age.
Doses should not be taken more frequently than every 4 hours, and no more than
4 doses should be administered within any 24-hour period.
Taking more than the recommended dose of Paracetamol MEDICINAE
If a patient takes more paracetamol than recommended, they must immediately seek
medical help from a doctor or call the National Toxicology Information Center hotline. If
a patient overdoses on this medicine, immediate hospitalization is required, even in the
absence of symptoms.
Symptoms of overdose within the first 24 hours may include: pallor, nausea, vomiting, loss of
appetite, and abdominal pain.
Treatment of overdose is most effective within the first 4 hours after ingestion.
In case of overdose, seek immediate medical assistance due to the risk of delayed,
severe liver damage.
If symptoms persist or headache becomes persistent, consult a doctor.
Missed dose of Paracetamol MEDICINAE
Do not take a double dose to make up for a missed tablet. Take the missed dose as soon as
remembered, and then continue taking subsequent doses at the prescribed intervals
(at least 4 hours apart).
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 experiences them.
This medicine may cause the following adverse effects:
Rare (may occur in no more than 1 in 1,000 people): discomfort, drop in blood pressure (hypotension), breathing difficulties (bronchospasm), asthma, and increased blood aminotransferase activity.
Very rare (may occur in no more than 1 in 10,000 patients): kidney disorders, cloudy urine, allergic skin inflammation (skin rash), jaundice, blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), hypoglycemia (decreased blood sugar concentration), angioedema (swelling), anuria, hematuria, and interstitial nephritis.
Paracetamol may cause liver damage when taken in high doses or for prolonged periods.
If patients experience any adverse effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
Very rare cases of severe skin reactions have been reported.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not mentioned in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to:
Department for Monitoring of Adverse Drug Reactions
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 MEDICINAE

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Paracetamol MEDICINAE contains
The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other ingredients are: pregelatinized maize starch (gluten-free), stearic acid (type 50),
povidone (K-30), crospovidone (type A), microcrystalline cellulose and magnesium stearate.

What Paracetamol MEDICINAE looks like and contents of the pack
Paracetamol MEDICINAE is supplied as an oral tablet in packaging containing: 1, 10, 12, 16, 20, 30, 50 and 60 tablets.
Not all pack sizes may be marketed.
The dimensions of the tablet are 18.3 ± 0.2 mm (length) x 8.2 ± 0.2 mm (width) x 5.1 ± 0.2 mm (thickness).
The break line on the tablet is only intended to facilitate splitting the tablet for ease of swallowing.

Marketing Authorisation Holder
Medicinae Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Tel. +48 800 200 100

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 authorised in the European Economic Area countries under the following names: