Metafen Paracetamol

Leaflet attached to the packaging: patient information

Metafen 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 directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

Table of contents of the leaflet

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

Metafen Paracetamol 500 mg 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.
Indications for use
Pains of various origins, including:

• headaches
• migraines
• throat pains
• toothaches
• bone, joint, muscle pains
• menstrual pains
• In cases of colds and flu-like conditions. Fever.

If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.

2. Important information before taking Metafen Paracetamol

When not to take Metafen Paracetamol

• in severe renal or hepatic impairment
• in case of alcoholic disease.

Warnings and precautions

Read the leaflet before taking the medicine and follow the instructions.
Before starting to take Metafen Paracetamol, discuss it with your doctor or pharmacist.

The medicine contains paracetamol

Do not take a higher dose than recommended. Overdose of paracetamol can lead to severe liver damage.
Do not take this medicine at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms.
Consult a doctor before taking the medicine if:

• you have liver or kidney failure,
• you have a deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• you are underweight or malnourished, suffering from anorexia,
• you are a regular alcohol consumer.
• (it may be necessary to completely stop taking this medicine or reduce the dose).
• you have a severe infection (sepsis) that can increase the risk of metabolic acidosis.

During treatment with Metafen Paracetamol, immediately inform your doctor if you experience severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Symptoms of metabolic acidosis include:

• deep, rapid, and labored breathing,
• nausea, vomiting, and loss of appetite,
• general poor well-being.

Immediately contact a doctor if the patient experiences the above symptoms at the same time.
Consult a doctor if the patient suffers from chronic headaches.
Do not drink alcohol while taking the medicine due to the increased risk of liver damage. There is a particular risk of liver damage in malnourished patients and regular alcohol consumers. Existing liver disease increases the risk of liver damage associated with paracetamol use.
If symptoms persist, consult a 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:
It is not recommended to use this medicine in this patient group.
Metafen Paracetamol 500 mg tablets cannot be divided.

Metafen Paracetamol and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or plan to take.

Do not take other medicines containing paracetamol at the same time.

Consult a doctor when taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulant medicines such as warfarin in case of long-term use of painkillers,
• sleeping pills,
• antiepileptic medicines,
• antitubercular medicines,
• MAO inhibitors (medicines used in depression). Paracetamol used with MAO inhibitors can cause excitement and high temperature.
• nonsteroidal anti-inflammatory medicines (e.g., acetylsalicylic acid)
• flucloxacillin (an antibiotic) due to the high risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Metafen Paracetamol can be used during pregnancy if clinically justified. Take the lowest possible dose that reduces pain and/or fever, for the shortest possible time and as infrequently as possible.
Consult a doctor if pain and/or fever do not decrease or if you need to take the medicine more frequently. Like other medicines, this medicine should be used during pregnancy only if necessary.
Paracetamol passes into breast milk in amounts that are not clinically significant. 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 necessary.

Driving and using machines

Metafen Paracetamol 500 mg taken as directed does not affect the ability to drive and use machines.

The medicine contains paracetamol

Due to the risk of overdose, check if other medicines you are taking contain paracetamol.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Metafen Paracetamol

This medicine should always be taken exactly as described in this patient 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 (with a body weight over 50 kg)

Orally, 1 or 2 tablets up to 4 times a day.
Do not take the medicine more frequently than every 4 hours or take more than 8 tablets per day.
The maximum daily dose of paracetamol is 4 g.

Adolescents 12 years of age (with a body weight under 50 kg)

The dose is determined based on age and body weight.
A single dose should not exceed 10-15 mg/kg body weight.
For children for whom a single dose of 500 mg is too high based on body weight, medicines containing paracetamol are available in forms that allow for precise dose adjustment.
The recommended dose is 1 tablet (500 mg), not more frequently than every 4 hours, not more than 4 doses (4 tablets) per day.
The maximum daily dose is 60 mg/kg body weight in divided doses as above.
Do not take more than 4 doses (tablets) per day.
In case of any doubts about dosing, the child's caregiver should consult a doctor.
Do not take a higher dose than recommended.
Use the lowest effective dose for the shortest possible time.

Children under 12 years of age

It is not recommended to use this medicine in this patient group (see section 2).
Metafen Paracetamol 500 mg tablets do not have a dividing line and cannot be divided.

Do not take the medicine regularly for more than 3 days without consulting a doctor.

If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Taking a higher dose of Metafen Paracetamol than recommended

Take the medicine as directed.
In case of taking a higher dose than recommended, immediately consult a doctor, even if you feel well and have not observed any symptoms of poisoning, due to the risk of delayed, severe liver damage, which can result in liver transplantation or death. In case of taking paracetamol in a single dose of 5 g or more and if it has been less than an hour since ingestion, vomiting can be induced. Administer 60-100 g of activated charcoal orally, preferably mixed with water.
Overdose of paracetamol can cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may resolve the next day, despite the onset of liver damage, which will then manifest as abdominal distension, return of nausea, and jaundice.

Missing a dose of Metafen Paracetamol

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

Stopping treatment with Metafen Paracetamol

If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and consult a doctor if you experience:

• an allergic reaction (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 characterized by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pains or blisters under the skin, extensive skin peeling, and fever,
• breathing difficulties, especially if you have had similar problems in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory medicines,
• bruises or bleeding of unknown cause,
• liver function disorders.

The above side effects are very rare (less than 1 in 10,000 patients).

A serious condition called metabolic acidosis (a blood and body fluid disorder) may also occur in patients with severe disease taking paracetamol (see section 2). The frequency of this side effect is unknown (cannot be estimated from the available data).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 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 this medicine.

5. How to store Metafen Paracetamol

There are no special precautions for storage.
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 month.
Do not use this medicine if you notice that the blister is damaged or the appearance of the tablets has changed.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. 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 excipients are: sodium carboxymethyl starch (type A), cornstarch, povidone K-30, stearic acid.

What Metafen Paracetamol looks like and contents of the pack

The medicine is in the form of white, oblong tablets, packaged in PVC/Aluminum blisters, in a cardboard box.
The pack contains 10, 20, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel.: +48 22 364 61 01

Importer

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

Date of last revision of the leaflet: