PARACETAMOL 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Paracetamol Synoptis, 500 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Paracetamol Synoptis and what is it used for
4. Important information before taking Paracetamol Synoptis
   1. When not to take Paracetamol Synoptis
   2. Warnings and precautions
   3. Children
   4. Paracetamol Synoptis and other medicines
   5. Paracetamol Synoptis with food and drink
   6. Pregnancy and breastfeeding
   7. Pregnancy
   8. Breastfeeding
   9. Driving and using machines
   10. Paracetamol Synoptis contains sodium
5. How to take Paracetamol Synoptis
   1. Duration of treatment
   2. Method and route of administration
   3. Taking a higher than recommended dose of Paracetamol Synoptis
   4. Missing a dose of Paracetamol Synoptis
   5. Stopping treatment with Paracetamol Synoptis
6. Possible side effects
   1. Reporting side effects
7. How to store Paracetamol Synoptis
8. Contents of the pack and other information
   1. What Paracetamol Synoptis contains
   2. What Paracetamol Synoptis looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer

Leaflet attached to the packaging: information for the user

Paracetamol Synoptis, 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 the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the 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 their doctor.

Table of contents of the leaflet

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

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

Paracetamol Synoptis contains the active substance paracetamol, which belongs to a group of pain-relieving medicines called analgesics. Paracetamol Synoptis is used to relieve mild or moderate pain and reduce fever.

Paracetamol Synoptis is indicated for:

• flu-like symptoms,
• fever (lasting less than 3 days),
• severe reactions after vaccination (hypersensitivity reactions),
• mild to moderate headaches,
• mild to moderate migraines in patients diagnosed with migraines,
• mild to moderate toothaches,
• mild to moderate earaches,
• mild to moderate menstrual cramps,
• mild to moderate post-traumatic, muscle, and joint pains.

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

2. Important information before taking Paracetamol Synoptis

When not to take Paracetamol Synoptis

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver failure,
• if the patient is under 12 years old,
• if the patient is taking other medicines containing paracetamol.

Warnings and precautions

Before starting to take Paracetamol Synoptis, the patient should discuss it with their doctor or pharmacist in the following cases:

• if the patient has kidney disease;
• if the patient has liver disease (e.g., hepatitis or liver inflammation caused by long-term alcohol consumption);
• if the patient has a rare and inherited metabolic disorder called Gilbert's syndrome (or Meulengracht's disease), characterized by yellowing of the skin and/or eyes;
• if the patient is taking medicines that affect liver function;
• if the patient has an inherited disease called glucose-6-phosphate dehydrogenase deficiency;
• if the patient has hemolytic anemia;
• if the patient has alcoholism;
• if the patient is dehydrated and chronically malnourished.

While taking Paracetamol Synoptis, the patient should immediately inform their doctor if they experience severe illnesses, 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 they are also taking flucloxacillin (an antibiotic).

There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a long time or take paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include severe breathing difficulties, rapid deep breathing, drowsiness, nausea, and vomiting.

Taking high doses of painkillers for a long time without justification may cause headaches that should not be treated with increased doses of Paracetamol Synoptis.

Long-term or frequent administration of Paracetamol Synoptis is not recommended. Long-term use of this medicine may cause kidney changes.

The risk of paracetamol overdose is higher in patients with liver disease than in those with alcoholic liver cirrhosis. Caution should be exercised in cases of chronic alcoholism. In such cases, the daily dose of paracetamol should not exceed 2 grams.

Alcohol should not be consumed during treatment with paracetamol.

Paracetamol Synoptis should not be taken without consulting a doctor if:

• the patient has a high fever (above 39°C),
• the fever lasts longer than 3 days,
• the fever subsides and returns (recurring fever). These situations may require a doctor's consultation and treatment.

Children

Paracetamol Synoptis is not recommended for children under 12 years old and weighing less than 40 kg due to the amount of paracetamol. Other strengths and forms of paracetamol are available that are more suitable for this patient group.

Paracetamol Synoptis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

In particular, the patient should inform their doctor about taking the following medicines:

• warfarin (an anticoagulant),
• probenecid (a medicine used to treat gout),
• antiepileptic drugs, such as carbamazepine, phenobarbital, and phenytoin,
• sedatives and anticonvulsants,
• rifampicin (a medicine used to treat tuberculosis),
• chloramphenicol (an antibiotic),
• zidovudine (an antiviral medicine),
• flucloxacillin (an antibiotic), due to the high risk of a serious blood and fluid disorder (called metabolic acidosis with a large anion gap), which requires emergency treatment (see section 2). The patient should not take other medicines containing paracetamol while taking Paracetamol Synoptis.

The patient should not take Paracetamol Synoptis with medicines that delay gastric emptying (e.g., propantheline) or accelerate gastric emptying (e.g., metoclopramide and domperidone).

If the patient is taking cholestyramine (a medicine that lowers blood cholesterol levels), they should take Paracetamol Synoptis 1 hour before or 4 hours after taking this medicine.

Paracetamol Synoptis with food and drink

While taking Paracetamol Synoptis, the patient should not consume alcohol. Alcohol may increase the toxic effect of paracetamol on the liver.

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 using this medicine.

Pregnancy

Paracetamol Synoptis can be given to pregnant women if necessary. The patient should use the smallest effective dose that relieves pain or reduces fever and take the medicine for the shortest possible time. If the pain is not relieved or the fever does not subside, or if it becomes necessary to increase the frequency of taking the medicine, the patient should consult their doctor.

Breastfeeding

Paracetamol passes into breast milk. So far, no negative effects have been proven in infants, so it is usually not necessary to stop treatment with Paracetamol Synoptis.

Driving and using machines

Paracetamol Synoptis does not affect the ability to drive or use machines. However, the patient should avoid performing these activities if they experience side effects such as mild drowsiness or dizziness.

Paracetamol Synoptis contains sodium

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

3. How to take Paracetamol Synoptis

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

The recommended dose depends on age and body weight. Paracetamol Synoptis is intended for oral use in adults (including the elderly) and children over 12 years old.

The intervals between doses should be 6 to 8 hours. If necessary, the intervals can be at least 4 hours. The patient should not exceed the dose of 6 tablets per day.

Recommended paracetamol dosing:

Maximum daily dose

The maximum daily dose of paracetamol should not exceed 3 g per day. Paracetamol (acetaminophen) is a common ingredient in many combination medicines. This should be taken into account to avoid exceeding the maximum daily dose of paracetamol.

Duration of treatment

The patient should not take Paracetamol Synoptis in high doses unless otherwise instructed. If symptoms worsen or persist for more than 3 days, the patient should consult their doctor.

Method and route of administration

Paracetamol Synoptis should be taken orally. The tablets can be taken whole or crushed and mixed with water.

Taking the medicine after a meal may delay its effect.

Special patient groups

Patients with liver or kidney failure, as well as those with Gilbert's syndrome, should consult their doctor to determine the appropriate dose and frequency of administration.

Taking a higher than recommended dose of Paracetamol Synoptis

In case of taking a higher than recommended dose of Paracetamol Synoptis, the patient should consult their doctor or go to the hospital emergency department. The first symptoms that usually occur are nausea, vomiting, increased sweating, drowsiness, and malaise. The patient should seek medical help even if they do not experience these symptoms, as they may not be aware that they have liver damage. The doctor will provide appropriate treatment and supportive measures.

Missing a dose of Paracetamol Synoptis

The patient should not take a double dose to make up for a missed dose. They should continue taking the medicine according to the established dosing schedule.

Stopping treatment with Paracetamol Synoptis

Sudden cessation of painkillers after unjustified and long-term use of high doses may cause dizziness, fatigue, muscle pain, and irritability. These symptoms will subside within a few days. The patient should not take other painkillers or resume taking Paracetamol Synoptis until these symptoms have subsided, unless their doctor advises otherwise.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Synoptis can cause side effects, although not everybody gets them. The patient should stop taking the medicine and consult their doctor if they experience:

swelling of the face, especially around the mouth (tongue and/or throat), difficulty breathing, sweating, nausea, and a sudden drop in blood pressure. These symptoms may indicate a severe allergic reaction, which can be life-threatening but is very rare (occurs in less than 1 in 10,000 patients).

The following side effects may occur:

Common (occurring in less than 1 in 10 patients):

• mild drowsiness,
• nausea,
• vomiting.

Uncommon (occurring in less than 1 in 100 patients):

• dizziness,
• drowsiness,
• nervousness,
• a burning sensation in the throat,
• diarrhea,
• abdominal pain (including cramps and burning),
• constipation,
• headaches,
• increased sweating,
• excessive lowering of body temperature.

Rare (occurring in less than 1 in 1,000 patients):

• increased activity of certain liver enzymes (transaminases),
• redness of the skin.

Very rare (occurring in less than 1 in 10,000 patients):

• blood disorders (reduced platelet count, reduced white blood cell count, reduced count of all morphological elements of the blood),
• breathing difficulties (asthma) in sensitive patients,
• hypersensitivity reactions (skin rash and urticaria). Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from the available data):

• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 to gather more information on the safety of this medicine.

5. How to store Paracetamol Synoptis

The medicine should be stored out of sight and reach of children.

There are no special precautions for storing the medicine.

Do not use this medicine after the expiry date stated on the blister, carton, or label: EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Synoptis contains

• The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: povidone K30, corn starch, sodium carboxymethylcellulose (type A), stearic acid (type 50).

What Paracetamol Synoptis looks like and contents of the pack

Paracetamol Synoptis is a white, capsule-shaped tablet with the inscription "500" on one side and a smooth surface on the other, packaged in an HDPE bottle with a child-resistant closure or a transparent PVC/Aluminum blister or a white, opaque PVC/Aluminum blister. The whole thing is in a cardboard box.

Package sizes: 6, 10, 20, or 50 tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzędz

Date of last revision of the leaflet:January 2025