Metafen paracetamol

Package leaflet: Information for the patient

Metafen Paracetamol, 500 mg, tablets
Paracetamolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult a doctor.

Table of contents

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

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

Metafen Paracetamol 500 mg is a medicine with analgesic and antipyretic properties.
This effect is mainly due to paracetamol's ability to inhibit prostaglandin synthesis in the central nervous system.
Indications for use
Pain of various origins, including:

• headaches
• migraine
• sore throat
• toothache
• bone, joint, and muscular pain
• menstrual pain
• cold and flu-like conditions
• fever

If there is no improvement after 3 days or if you feel worse, consult a doctor.

2. Important information before using Metafen Paracetamol

When not to use Metafen Paracetamol

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
• in severe renal or hepatic insufficiency
• in case of alcohol-related disease.

Warnings and precautions
Please read the leaflet carefully before using the medicine and follow the instructions contained
therein.
Before starting to use Metafen Paracetamol, discuss it with your doctor or
pharmacist.
The medicine contains paracetamol
Do not take a dose higher than recommended. Paracetamol overdose may lead to
severe liver damage.
This medicine should not be used simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat symptoms of flu and colds.
Consult your doctor before using the medicine if:

• there is liver or kidney insufficiency,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• underweight or malnourished patients suffering from anorexia,
• patients who regularly consume alcohol.
• (it may be necessary to completely discontinue taking this medicine or reduce the dose).
• severe infection (sepsis), which may increase the risk of metabolic acidosis.

During treatment with Metafen Paracetamol, inform your doctor immediately if
the patient develops severe conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition,
chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these
situations, patients have been reported to develop a serious condition called metabolic acidosis
(abnormality in blood and body fluids) when taking paracetamol at regular doses
for a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
Symptoms of metabolic acidosis include, among others:

• deep, rapid and labored breathing,
• nausea, vomiting and loss of appetite,
• general feeling of being unwell.

Contact your doctor immediately if the patient experiences the above symptoms simultaneously.
Consult your doctor if the patient suffers from chronic headaches.
Do not drink alcohol while taking this medicine due to increased risk of liver damage. The risk of liver damage is particularly high in malnourished patients and those who regularly consume alcohol. Existing liver disease increases the risk of liver damage associated with paracetamol use.
If symptoms persist, consult your doctor.
Do not take a higher dose than recommended.
Keep the medicine out of sight and reach of children.
Children
Children under 12 years of age:
Use in this patient group is not recommended.
Metafen Paracetamol 500 mg tablets cannot be divided.
Metafen Paracetamol and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take other medicines containing paracetamol at the same time.
Consult your doctor if the patient is taking any of the following medicines:

• metoclopramide, domperidone (used for nausea and vomiting),
• cholestyramine (used to reduce high blood cholesterol levels),
• anticoagulants such as warfarin, if long-term pain relief is needed,
• sleeping medicines,
• antiepileptic medicines,
• antituberculosis medicines,
• MAO inhibitors (medicines used for depression). Paracetamol taken together with MAO inhibitors may cause excitation and high body temperature.
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid)
• flucloxacillin (antibiotic) due to serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Paracetamol use may lead to false results in certain laboratory tests (e.g. blood glucose measurement).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Metafen Paracetamol may be used during pregnancy if clinically justified. The lowest effective dose that reduces pain and (or) fever should be taken for the shortest possible duration and as infrequently as possible.
Consult your doctor if pain and (or) fever do not decrease or if the patient needs to take the medicine more frequently. Like other medicines, this medicine should be used during pregnancy only if clearly necessary.
Paracetamol passes into breast milk in clinically insignificant amounts. Available data do not indicate any contraindications to breastfeeding during treatment with this medicine. Like other medicines, this medicine should be used during breastfeeding only if clearly necessary.
Driving and operating machinery
Metafen Paracetamol 500 mg, when used as directed, does not affect the ability to
drive or operate machinery.
The medicine contains paracetamol
Due to the risk of overdose, check whether other medicines being used contain paracetamol.
The medicine contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Metafen Paracetamol

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only.

Adults and adolescents over 12 years of age (weighing over 50 kg)
Orally, 1 or 2 tablets up to 4 times daily.
Do not take the medicine more frequently than every 4 hours, and do not exceed 8 tablets per day.
The maximum daily dose of paracetamol is 4 g.

Adolescents aged 12 years (weighing less than 50 kg)
The dose should be determined according to age and body weight.
The single dose should not exceed 10–15 mg/kg body weight.
For children for whom a single dose of 500 mg is too high relative to body weight, alternative paracetamol formulations are available that allow precise dose adjustment.
The recommended dose is 1 tablet (500 mg), not more frequently than every 4 hours, and not more than 4 doses (4 tablets) per day.
The maximum daily dose is 60 mg/kg body weight, divided into doses as described above.
Do not exceed 4 doses (tablets) per day.
In case of any doubts regarding dosing, the child’s caregiver should consult a doctor.
Do not use a higher than recommended dose.
Use the lowest effective dose for the shortest possible duration.

Children under 12 years of age
Use is not recommended in this patient group (see section 2).
Metafen Paracetamol 500 mg tablets do not have a score line and cannot be divided.

Do not use this medicine regularly for longer than 3 days without consulting a doctor.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Overdose of Metafen Paracetamol
The medicine should be used according to recommendations.
In any case of ingestion of a dose higher than recommended, seek immediate medical advice, even if the patient feels well and no symptoms of poisoning are observed, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death.
If a single dose of paracetamol of 5 g or more has been taken and less than one hour has passed since ingestion, vomiting may be induced. Administer 60–100 g of activated charcoal orally, preferably mixed with water.

Paracetamol overdose may cause symptoms within several to up to twelve hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may resolve the next day, despite the onset of liver damage, which may later manifest as upper abdominal discomfort, recurrence of nausea, and jaundice.

Missed dose of Metafen Paracetamol
Paracetamol is taken on an as-needed basis. If a dose is missed and symptoms persist, take the next dose as soon as possible.
Do not take a double dose to make up for a missed dose.

Stopping Metafen Paracetamol
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine immediately and consult your doctor if any of the following occur:

• allergic reactions (hypersensitivity) such as skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat or face,
• skin rash or severe skin reaction manifested by acute generalized pustular rash or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing large subcutaneous blisters, extensive skin erosions, peeling of large skin sheets and fever,
• breathing difficulties, especially if similar problems occurred previously during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• unexplained bruising or bleeding,
• liver function disorders.

The above adverse reactions occur very rarely (in less than 1 out of 10,000 patients).
A serious condition causing blood acidification (so-called metabolic acidosis) may also occur in patients with severe illness taking paracetamol (see section 2). The frequency of this adverse reaction is unknown (frequency cannot be estimated from available data).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows gathering further information on the safety of the medicine.

5. How to store Metafen Paracetamol

There are no special storage instructions for this medicine.
Keep the medicine 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 stated month.
Do not use this medicine if you notice that the blister is damaged or if the appearance of the tablets has changed.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer used. This will help
protect the environment.

6. Contents of the pack and other information

What Metafen Paracetamol 500 mg contains

• The active substance is paracetamol.
• Each tablet contains 500 mg of paracetamol.
• The other ingredients are: sodium carboxymethyl starch (type A), pregelatinized corn starch, povidone K-30, stearic acid.

What Metafen Paracetamol looks like and contents of the pack
Metafen Paracetamol is in the form of white, elongated tablets, packed in PVC/Aluminium blisters, inside a cardboard box.
The pack contains 10, 20 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel.: + 48 22 364 61 01

Importer
Qualimetrix S.A.
579 Mesogeion Avenue, Agia Paraskevi,
Athens, 15343
Greece