MEGAPAR 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Megapar, 500 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 and what is it used for
4. Important information before taking Megapar
   1. When not to take Megapar
   2. Warnings and precautions
   3. Megapar with other medicines
   4. Megapar with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Megapar contains sodium and sorbitol
5. How to take Megapar
   1. Overdose of Megapar
   2. Missed dose of Megapar
6. Possible side effects
   1. The use of Megapar should be discontinued and the doctor should be contacted immediately if the patient experiences the following side effects:
   2. Reporting side effects
7. How to store Megapar
8. Contents of the packaging and other information
   1. What Megapar contains
   2. What Megapar 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, 500 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 inform 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 and what is it used for
• 2. Important information before taking Megapar
• 3. How to take Megapar
• 4. Possible side effects
• 5. How to store Megapar
• 6. Contents of the packaging and other information

1. What is Megapar and what is it used for

The effervescent tablets Megapar contain paracetamol, which is a mild analgesic and antipyretic.
It is recommended to use the tablets for the treatment of moderate pain of various origins, such as:
headache, including migraine and tension headache, toothache, neuralgia, back pain, rheumatic and
muscle pain, menstrual pain, sore throat, as well as fever and pain associated with colds or flu.

2. Important information before taking Megapar

When not to take Megapar

• if the patient is hypersensitive to paracetamol or any of the other ingredients of this medicine listed in section 6,
• if the patient has alcoholic liver disease,
• if the patient has severe liver or kidney failure.

Warnings and precautions

The doctor should be informed 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. The symptoms of metabolic acidosis include: deep, rapid, and difficult breathing, feeling of nausea, vomiting, and loss of appetite, general poor condition. The doctor should be contacted immediately if the patient experiences 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 medicines containing paracetamol
• the patient has a fever, even after finishing paracetamol treatment
• the patient has a deficiency of the enzyme glucose-6-phosphate dehydrogenase and (or) methemoglobin reductase
• the patient has hemolytic anemia (abnormal decrease in the number of red blood cells) Overdose of paracetamol can lead to liver failure, which can result in liver transplantation or death.

Megapar with other medicines

The doctor or pharmacist should be informed 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, the doctor should be informed about the use of:

• medicines that prevent blood clotting (anticoagulants, e.g., warfarin, other coumarins)
• anti-emetic medicines (e.g., metoclopramide, domperidone)
• medicines used to treat high cholesterol levels in the blood (cholestyramine)
• probenecid (a medicine used to treat high uric acid levels in the blood, gout)
• medicines with mild analgesic or antipyretic effects (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)
• medicines used to treat seizure attacks (lamotrigine)
• medicines used to treat tuberculosis (rifampicin, isoniazid)
• flucloxacillin (an antibiotic), due to the high risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires immediate 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, as well as in patients taking maximum daily doses of paracetamol.

Effect of paracetamol on laboratory tests:
The results of tests evaluating uric acid and blood sugar levels may be altered.

Megapar with food and drink

During treatment with the product, alcohol should not be consumed due to the increased risk of toxic liver damage. A particular risk of liver damage exists for 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 their doctor or pharmacist before taking this medicine.
Megapar can be used during pregnancy if it is clinically justified. The lowest recommended dose should be taken to relieve pain or reduce fever, for the shortest possible time and as infrequently as possible. The doctor should be consulted if the 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 operating machinery

Paracetamol does not affect the ability to drive vehicles and operate machinery.

Megapar contains sodium and sorbitol

The medicine contains 418.5 mg of sodium (the main component of common salt) in each effervescent tablet.
This corresponds to 20.92% of the maximum recommended daily intake of sodium 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 their 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 their doctor before taking the medicine or giving it to their child.

3. How to take Megapar

This medicine should always be taken exactly as described in the patient leaflet or as advised by
a doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The medicine is intended for use in adults and adolescents aged 12 and over.
Children and adolescents:

• Children under 12 years of age: should not be given to children under 12 years of age.
• Adolescents aged 12 to 15 years with a body weight of 41 to 50 kg: if necessary, 1 effervescent tablet, the dose can be repeated every 6 hours, and in no case more frequently than every 4 hours. The dose should not exceed 4 effervescent tablets (2 g of paracetamol) per day.
• Adolescents aged 16 to 18 years with a body weight over 50 kg: the same dosage as for adults.

Adults:
if necessary, 1 or 2 effervescent tablets, the dose can be repeated every 6 hours, and in no case more frequently than every 4 hours. The maximum daily dose is 6 effervescent tablets, in case of severe pain the daily dose can be increased to 8 effervescent tablets (4g).
If the pain persists for more than 5 days or the fever lasts for more than 3 days, worsens, or other symptoms appear, the 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 the symptoms persist or worsen, medical advice should be sought.
The recommended dose should not be exceeded. The cap contains a desiccant, which is not suitable for consumption.
Megapar can be taken with food and drink or independently of meals. The rate of absorption is reduced when paracetamol is taken with food.
In case of doubts related to the use of the medicine, the doctor or pharmacist should be consulted.
Method of administration
Megapar is intended for oral use. The tablets should be dissolved in a full glass of water, allowed to dissolve completely, and then the prepared solution should be drunk.

Overdose of Megapar

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

Missed dose of Megapar

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

4. Possible side effects

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

The use of Megapar should be discontinued and the doctor should be contacted immediately if the patient experiences the following side effects:

• -hypersensitivity reaction requiring treatment discontinuation (severe allergic reaction),
• anaphylactic shock (manifested by confusion, paleness, low blood pressure, 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) swelling of the face, lips, hands (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, shedding of large skin flakes, weakness, fever, and joint pain (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis).

Rarely (occurring in 1 to 10 out of 10,000 patients): edema (abnormal fluid accumulation under the skin), vision disturbances, skin rash or hives (dark red rash on the skin), bleeding, abdominal pain, diarrhea, nausea, vomiting, dizziness, fever, malaise, sedation, platelet disorders (bleeding 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 in less than 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 paleness), hypoglycemia (low blood sugar level), clouding of urine, and kidney disorders.
Severe skin reactions have been reported.
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 urine), kidney changes (severe kidney disorders, interstitial nephritis, anuria (inability to urinate)), gastrointestinal symptoms, and dizziness. Cases of breathing difficulties, wheezing, coughing, and shortness of breath have been reported during paracetamol use, but the occurrence of these symptoms is more likely in patients with asthma and hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as ibuprofen.
Very rarely, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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
Jerozolimskie Avenue 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 gather more information on the safety of the medicine.

5. How to store Megapar

Store in a place out of sight and reach of children.
Megapar should not be used after the expiry date stated on the label after EXP. The expiry date refers to the last day of the specified month.
Propylene tube: The product should not be used after 30 days from the date of first opening the tube.
Store at a temperature below 30°C. Store in the original packaging to protect from light and moisture. Store the polypropylene tube tightly closed.
The product should not be used if any signs of spoilage are visible, 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. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Megapar contains

• The active substance of the medicine is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
• Other ingredients of the medicine are: anhydrous citric acid, sorbitol, anhydrous sodium carbonate, sodium bicarbonate, povidence K 25, simethicone, sodium saccharin, macrogol 6000, lemon flavor Powderarome Lemon Premium.

Powdarome Lemon Premium: flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, gum arabic, α-tocopherol, water.

What Megapar looks like and what the packaging contains

Megapar, 500 mg, effervescent tablets are white or almost white, round, flat, with beveled edges, smooth on both sides.
The effervescent tablets Megapar are packaged in PP tubes with an LDPE cap containing a desiccant, with a tamper-evident closure, in a cardboard box.
Pack size: 4, 5, 8, 10, 16, 20, 24, 30, 32, 60, and 100 effervescent tablets.
WARNING!The cap contains a desiccant. It must not be eaten.
The effervescent tablets are also packaged in soft aluminum/LDPE blisters or paper/PE/aluminum/Surlyn blisters, in a cardboard box.
Pack size: 4, 5, 8, 10, 12, 16, 20, 24, 30, 32, 60, and 100 effervescent tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 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 Street 50
95-200 Pabianice
Poland

Date of last revision of the leaflet: 05/2022