Metafen paracetamol max

Package leaflet: Information for the patient

Metafen Paracetamol MAX, 1000 mg, tablets
Paracetamolum
Please read the entire leaflet carefully before use, 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 for future reference.
• If you need advice or further information, 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 you feel worse, consult a doctor.

Contents of the leaflet

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

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

Metafen Paracetamol Max 1000 mg is an analgesic and antipyretic medicine.
This effect is primarily due to paracetamol's ability to inhibit prostaglandin synthesis in the central nervous system.
Indications for use
Pain of various origins, including:

• headaches
• migraine headaches
• sore throat
• toothache
• bone, joint, and muscle 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. Information before using Metafen Paracetamol Max

When not to use Metafen Paracetamol Max

• 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 impairment
• in alcoholic liver disease.

Do not use Metafen Paracetamol Max in children under 12 years of age.
Warnings and precautions
Please read the leaflet carefully before using the medicine and follow the instructions provided.
Before starting to use Metafen Paracetamol Max, consult your doctor or pharmacist.
The medicine contains paracetamol.
Do not exceed the recommended dose. Overdosing on paracetamol may lead to severe liver damage.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat cold and flu symptoms.
Consult your doctor before using the medicine if:

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

During treatment with Metafen Paracetamol Max, inform your doctor immediately if the patient develops serious 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 (an imbalance in blood and body fluids) when taking paracetamol regularly over a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe 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 malaise.

Seek immediate medical attention 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 exceed the recommended dose.
Keep the medicine out of sight and reach of children.
Children under 12 years of age
Do not give Metafen Paracetamol Max to children under 12 years of age or weighing less than 50 kg.
Metafen Paracetamol Max 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 drugs,
• antituberculosis medicines,
• MAO inhibitors (medicines used for depression). Paracetamol taken together with MAO inhibitors may cause agitation and high fever.
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid),
• flucloxacillin (antibiotic) due to serious risk of blood and body fluid disturbances (called metabolic acidosis), which must be treated urgently (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 baby, she should consult her doctor or pharmacist before using this medicine.
Metafen Paracetamol Max may be used during pregnancy if clinically justified.
Use the lowest effective dose needed to relieve pain and (or) fever, for the shortest possible duration and as infrequently as possible.
Consult your doctor if pain and (or) fever do not subside 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 Max 1000 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 taken contain paracetamol.
The medicine contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free."

3. How to use Metafen Paracetamol Max

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
For oral use only.
Adults and adolescents over 12 years of age (weighing over 50 kg)
Orally, ½ or 1 tablet up to 4 times daily.
Do not take the medicine more frequently than every 4 hours or exceed 4 tablets per day.
The maximum daily dose of paracetamol is 4 g.
Do not exceed the recommended dose.
Use the lowest effective dose for the shortest possible duration.
The break line on the tablet allows it to be divided into two equal doses.
Children under 12 years of age (weighing less than 50 kg)
Not recommended for use in this patient group.
Do not use this medicine regularly for more than 3 days without consulting a doctor.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Metafen Paracetamol Max
This medicine should be used according to the recommendations.
In any case of overdose, 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 a few to several hours, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside 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 Max
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.
Discontinuation of Metafen Paracetamol Max
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• 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 manifesting as acute generalized blistering rash or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing large subepidermal blisters, extensive skin erosions, peeling of large sheets of skin and fever,
• breathing problems, especially if similar problems occurred previously during use of 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 in 10,000 patients).
A serious condition causing blood acidification (so-called metabolic acidosis) may also occur in patients with severe disease who are taking paracetamol (see section 2). The frequency of this adverse reaction is unknown (frequency cannot be estimated from the available data).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Metafen Paracetamol Max

There are no special storage requirements 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 following 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 tablets have changed in appearance.
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 pack and other information

What Metafen Paracetamol Max contains

• The active substance is paracetamol.
• Each tablet contains 1000 mg of paracetamol. The other excipients are: sodium carboxymethyl starch (type A), pregelatinized corn starch, povidone K-30, stearic acid.

What Metafen Paracetamol Max 1000 mg looks like and contents of the pack
The medicine is in the form of white or almost white, elongated tablets, with a score line on both sides,
packed in PVC/Aluminium blisters, and placed in a cardboard box.
The pack contains 10 tablets.
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