Paracetamol Medicinae

Leaflet attached to the packaging: information for the user

PARACETAMOL MEDICINAE, 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, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, you should 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 after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Paracetamol MEDICINAE and what is it 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 is Paracetamol MEDICINAE 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 pain) and fever.
If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Paracetamol MEDICINAE

When not to take Paracetamol MEDICINAE:

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

Warnings and precautions

Before taking Paracetamol MEDICINAE, 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 help due to the risk of delayed, severe liver damage.

Do not exceed the recommended dose.
Do not exceed a dose of 4 g (8 tablets) in 24 hours for adults, elderly, and adolescents over 16 years old.
Do not exceed a dose of 2 g (4 tablets) in 24 hours for children over 10 years old.
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

Do not use in children under 10 years old. For children under 10 years old, the use of this medicine should be discussed with a doctor or pharmacist, as there are other forms of the medicine with more suitable doses for this age group.

Paracetamol MEDICINAE with food, drink, and alcohol

Taking paracetamol in patients who regularly consume alcohol (more than three alcoholic drinks per day – beer, wine, vodka... 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Paracetamol MEDICINAE can be used during pregnancy if necessary.
The patient should take the lowest 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 pain and/or fever do not decrease or if they need to take the medicine more frequently.

Driving and using machines

No effects on the ability to drive and use machines 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, the patient should consult their doctor or pharmacist.
The recommended dose is:
adults, elderly, and adolescents over 16 years old: take one or two tablets up to 4 times a day. Do not exceed a dose of 4 g (8 tablets) in 24 hours.
Children over 10 years old: take one tablet up to 4 times a day. Do not exceed a dose of 2 g (4 tablets) in 24 hours.
Do not give to children under 10 years old.
Doses should not be given more frequently than every 4 hours, and no more than 4 doses should be given in a 24-hour period.

Taking a higher dose of Paracetamol MEDICINAE than recommended

If the patient takes a higher dose of paracetamol than they should, they must immediately seek medical help or call the National Poison Information Center. 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 help due to the risk of delayed, severe liver damage.
If the patient's symptoms persist or their headache becomes persistent, they should consult their doctor.

Missing a dose of Paracetamol MEDICINAE

Do not take a double dose to make up for a missed tablet. Take the missed dose as soon as you remember, and take the next doses at the scheduled intervals (at least every 4 hours).
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol MEDICINAE 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), difficulty breathing (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 (decrease in blood sugar), angioedema (swelling), anuria, and hematuria, interstitial nephritis.
Paracetamol may cause liver damage when taken in high doses or for a long time.
If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist.
Very rare cases of severe skin reactions have been reported.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. 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
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 this medicine.

5. How to store Paracetamol MEDICINAE

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol MEDICINAE contains

The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
The other ingredients are: maize starch, pregelatinized (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 available in the form of tablets for oral administration in packs of: 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 to facilitate breaking and swallowing.

Marketing authorization holder

Medicinae Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Phone: +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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: