MEGAPAR 1000 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Megapar Forte, 1000 mg, effervescent tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
3. What is Megapar Forte and what is it used for
4. Important information before taking Megapar Forte
   1. When not to take Megapar Forte
   2. Warnings and precautions
   3. Children and adolescents
   4. Megapar Forte and other medicines
   5. Megapar Forte with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Megapar Forte contains sodium and sorbitol
5. How to take Megapar Forte
   1. Using a higher dose of Megapar Forte than recommended
   2. Missing a dose of Megapar Forte
6. Possible side effects
   1. Stop taking Megapar Forte and consult a doctor immediately if the patient experiences any of the following side effects:
   2. Reporting side effects
7. How to store Megapar Forte
8. Contents of the packaging and other information
   1. What Megapar Forte contains
   2. What Megapar Forte looks like and what the packaging contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Importer:
   6. Date of last revision of the leaflet: 05/2022

Leaflet attached to the packaging: patient information

Megapar Forte, 1000 mg, effervescent 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 advised by
a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet,
  they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Megapar Forte and what is it used for

Megapar Forte effervescent tablets contain paracetamol, which is a mild analgesic and antipyretic.
It is recommended to use the tablets to treat pain of various origins (headaches, toothaches, joint pain,
muscle pain, menstrual pain, neuralgia, and others) and fever.

2. Important information before taking Megapar Forte

When not to take Megapar Forte

Hypersensitivity to paracetamol, propacetamol hydrochloride (a precursor to paracetamol), or any
of the excipients listed in section 6.1.
Do not use in individuals with a body weight of less than 50 kg.
Severe liver failure or active, uncompensated liver disease.
Severe kidney failure.
Alcoholism.
Treatment with MAO inhibitors and for 14 days after the end of treatment.

Warnings and precautions

Tell your doctor if:

• the patient has liver disease, including conditions caused by excessive alcohol consumption
• the patient has Gilbert's syndrome (a mild form of jaundice)
• the patient has kidney disease
• the patient is dehydrated or severely malnourished, with anorexia
• the patient has a low body mass index (BMI)
• the patient regularly consumes alcohol
• the patient has a severe infection that may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deep, rapid, and labored breathing, feeling of nausea, vomiting, and loss of appetite, general malaise.

Immediately contact a doctor if the patient experiences any of the above symptoms simultaneously.

• the patient is undergoing long-term treatment with high doses of paracetamol
• the patient has asthma with aspirin sensitivity
• the patient is taking other medications containing paracetamol
• the patient has a fever, even after finishing treatment with paracetamol
• the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase and/or methemoglobin reductase
• the patient has hemolytic anemia (abnormal decrease in red blood cells) Overdose of paracetamol can lead to liver failure, which can result in liver transplantation or death.

Never take more Megapar Forte tablets than recommended.
Increasing the dose does not increase the analgesic effect but may cause serious liver damage.
Symptoms of liver damage occur after a few days. Therefore, it is essential to contact a doctor as soon as possible if the patient has taken more Megapar Forte tablets than recommended.

Children and adolescents

Do not use Megapar Forte 1000 mg in children and adolescents under 16 years of age and with a body weight of less than 50 kg.

Megapar Forte and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take, including those available without a prescription.
Before taking Megapar Forte, inform your doctor about taking:

• medicines that prevent blood clotting (anticoagulants, e.g., warfarin, other coumarins)
• antiemetic medicines (e.g., metoclopramide, domperidone)
• medicines used to treat patients with high cholesterol levels in the blood (cholestyramine)
• probenecid (a medicine used to treat high levels of uric acid in the blood, gout)
• a medicine with a mild analgesic or antipyretic effect (non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, salicylamide)
• certain sedative or antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine)
• tricyclic antidepressants, MAO inhibitors (medicines used to treat depression), and for 14 days after the end of treatment with MAO inhibitors
• medicines used to treat seizure attacks (lamotrigine)
• medicines used to treat tuberculosis (rifampicin, isoniazid)
• flucloxacillin (an antibiotic), due to the high risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.

Paracetamol's effect on laboratory tests:
Results of tests evaluating uric acid and blood sugar levels may be altered.

Megapar Forte with food and drink

During treatment with the product, do not drink alcohol due to the increased risk of toxic liver damage.
A particular risk of liver damage exists in malnourished individuals and those who regularly consume alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Megapar Forte can be used during pregnancy if clinically justified. The lowest recommended dose should be taken to relieve pain or reduce fever, for as short a time as possible and as infrequently as possible. Consult a doctor if pain and/or fever do not decrease or if the patient needs to take the medicine more frequently.
Paracetamol passes into breast milk. Paracetamol can be used in therapeutic doses in breastfeeding women.

Driving and using machines

Paracetamol does not affect the ability to drive or use machines.

Megapar Forte contains sodium and sorbitol

The medicine contains 435.25 mg of sodium (the main component of common salt) in each effervescent tablet.
This corresponds to 21.76% of the maximum recommended daily sodium intake in the diet for adults.
If one or more effervescent tablets are taken daily for a long time, patients, especially those controlling their sodium intake, should consult a doctor or pharmacist.
The medicine contains 100 mg of sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.

3. How to take Megapar Forte

This medicine should always be taken exactly as described in the patient leaflet or as advised by
a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Megapar Forte is an effervescent tablet for oral administration. The tablet should be dissolved in a glass of water, and the prepared solution should be drunk immediately after preparation.
In case of doubt about the correct dose of Megapar Forte, consult a doctor.
The medicinal product Megapar Forte is intended only for adults and adolescents aged 16 and above and with a body weight above 50 kg.
Adults and adolescents with a body weight above 50 kg, aged 16 and above:
if necessary, 1 effervescent tablet (1000 mg), the dose can be repeated every 6 hours, and in no case more frequently than every 4 hours, not exceeding 3 effervescent tablets; in case of severe pain, the daily dose can be increased to 4 effervescent tablets.
Recommended maximum daily dose:

• The maximum daily dose of paracetamol for adults should not exceed 3 g; in case of severe pain, the daily dose can be increased to 4 g.
• The maximum single dose of paracetamol for adults is 1 g.

If the pain persists for more than 5 days or the fever lasts for more than 3 days, worsens, or other symptoms appear, treatment should be discontinued, and medical advice should be sought.
Without consulting a doctor, the medicine should not be used regularly for more than 3 days.
If symptoms persist or worsen, medical advice should be sought.
Do not exceed the recommended dose. The cap contains a desiccant, which is not suitable for consumption.
In case of doubts related to the use of the medicine, consult a doctor or pharmacist.
Method of administration
Megapar Forte is intended for oral use. The tablet should be dissolved in a full glass of water, allowed to dissolve completely, and then the prepared solution should be drunk.

Using a higher dose of Megapar Forte than recommended

In case of accidental ingestion of a significantly higher dose than recommended (overdose), immediately contact a doctor, even if the patient's condition is good, due to the possibility of delayed, severe liver damage.

Missing a dose of Megapar Forte

In case of a missed dose, take it as soon as remembered, unless it is close to the time for the next dose.
Do not take a double dose to make up for a missed dose. Remember to maintain at least 4-hour intervals between consecutive doses.

4. Possible side effects

Like all medicines, Megapar Forte can cause side effects, although not everybody gets them.

Stop taking Megapar Forte and consult a doctor immediately if the patient experiences any of the following side effects:

• -hypersensitivity reaction requiring treatment discontinuation (severe allergic reaction),
• anaphylactic shock (manifested by confusion, paleness, blood pressure drop, sweating, decreased urine production, rapid breathing, weakness, and fainting),
• fluid accumulation in the throat with accompanying itchy rash,
• throat swelling (symptoms of a severe allergic reaction), facial swelling, lip swelling, hand swelling (angioedema),
• life-threatening skin symptoms, such as a rash with blisters all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters bursting, skin peeling off in large patches, weakness, fever, and joint pain (Stevens-Johnson syndrome), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP).

Rarely (occurring in 1 to 10 out of 10,000 patients): edema (abnormal fluid accumulation under the skin), vision disturbances, skin rash or urticaria (red rash on the skin), bleeding, abdominal pain, diarrhea, nausea, vomiting, dizziness, fever, malaise, sedation, platelet disorders (coagulation disorders), disorders related to stem cells (disorders of blood cell production in the bone marrow), abnormal liver function, liver failure, liver necrosis (death of liver cells), jaundice, overdose, and poisoning, tremors, headache, depression, confusion, hallucinations, sweating, itching (pruritus), angioedema.
Very rarely (occurring less frequently than in 1 out of 10,000 patients): hepatotoxicity (liver damage caused by chemicals), hypersensitivity reaction requiring treatment discontinuation (severe allergic reaction), thrombocytopenia (decreased platelet count, which increases the risk of bleeding and bruising), leukopenia (decreased white blood cell count), neutropenia (decreased granulocyte count in the blood), agranulocytosis (decreased granulocyte count in the blood, which can lead to severe infections), hemolytic anemia (abnormal red blood cell count, which can cause weakness or pallor), hypoglycemia (low blood sugar level), cloudy urine, and kidney disorders.
There have been reports of severe skin reactions.
Other side effects of paracetamol, whose frequency cannot be determined based on available data: erythema multiforme (allergic reaction or skin infection), fluid accumulation in the throat, anaphylactic shock, anemia (decreased red blood cell count), liver function disorders, hematuria (blood in the urine), kidney changes (severe kidney disorders, interstitial nephritis, anuria), gastrointestinal symptoms, and dizziness. There have been reports of breathing difficulties, wheezing, coughing, and shortness of breath while taking paracetamol; however, the occurrence of these symptoms is more likely in patients with asthma and sensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as ibuprofen.
Very rarely, severe skin reactions have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell a doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Megapar Forte

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month.
Polypropylene tube:
Do not use the product after 30 days from the first opening.
Store in a temperature below 25°C. Store the polypropylene tube tightly closed. Store in the original packaging to protect from light and moisture.
Soft Aluminum/LDPE blisters or blisters with laminated foil Paper/PE/Aluminum/Surlyn:
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Do not use the product if there are any visible signs of spoilage, such as brown or black spots on the tablets, bulging, or discoloration of the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Megapar Forte contains

• The active substance of the medicine is paracetamol. Each effervescent tablet contains 1000 mg of paracetamol.

Other ingredients of the medicine are: anhydrous citric acid, sorbitol, sodium carbonate anhydrous, sodium bicarbonate, povidone K25, simethicone, sodium saccharin, macrogol 6000, lemon flavor Powdarome Lemon Premium.
Lemon flavor Powdarome Lemon Premium: flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, gum arabic, α-tocopherol, water.

What Megapar Forte looks like and what the packaging contains

Megapar Forte, 1000 mg, effervescent tablets are white or almost white, round, flat, with beveled edges, smooth on both sides.
This medicinal product is available in two types of packaging: soft Aluminum/LDPE blisters or blisters with laminated foil Paper/PE/Aluminum/Surlyn and polypropylene tubes.
Soft Aluminum/LDPE blisters or blisters with laminated foil Paper/PE/Aluminum/Surlyn
The soft blisters are made of two layers of aluminum foil laminated with LDPE film or 4-layer laminated foil Paper/PE/Aluminum/Surlyn.
Each blister contains 4 or 10 effervescent tablets. The blisters are packed in cardboard boxes containing: 4, 8, 10, 16, 20, 24, 30, 32, 36, or 40 tablets.
Polypropylene tube
White, opaque, straight polypropylene tube with a white, opaque polyethylene cap with a desiccant and a tamper-evident seal. Each tube contains 4, 8, 10, or 12 effervescent tablets.
Pack size: 8, 10, 16, 20, 24, 30, 32, 36, or 40 tablets in a cardboard box.
WARNING:The cap contains a desiccant. Do not eat it.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw

Manufacturer:

Accord Healthcare Limited
Ground Floor, Sage House
319 Pinner Road
North Harrow, HA1 4HF
Middlesex
United Kingdom

Importer:

Accord Healthcare Limited
Ground Floor, Sage House
319 Pinner Road
North Harrow, HA1 4HF
Middlesex
United Kingdom
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Poland

Date of last revision of the leaflet: 05/2022