Paracetamol synoptis

Package leaflet: Information for the user

Paracetamol Synoptis, 500 mg, tablets
Paracetamolum
Please read the entire leaflet carefully before taking this 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 for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

• flu-like symptoms,
• fever (lasting less than 3 days),
• severe reactions following vaccination (hyperergic reactions),
• mild headaches,
• mild to moderate migraine attacks in patients diagnosed with migraine,
• mild to moderate toothache,
• mild to moderate earache,
• mild to moderate menstrual pain,
• mild to moderate pain due to injury, muscles, and joints.

If there is no improvement after 3 days or if your condition worsens, consult your 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 of age,
• if the patient is taking other medicines containing paracetamol.

Warnings and precautions
Before starting to take Paracetamol Synoptis, consult a doctor or pharmacist in the following cases:

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

During treatment with Paracetamol Synoptis, inform a doctor immediately if:
The patient has severe illnesses, 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).
Cases of a serious condition called high anion gap metabolic acidosis (a blood and fluid abnormality) have been reported in patients who take paracetamol at regular doses over a prolonged period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Unjustified long-term use of high doses of painkillers may cause headaches, which should not be treated by increasing the dose of Paracetamol Synoptis.
Long-term or too frequent use of Paracetamol Synoptis is not recommended. Prolonged use of this medicine may cause kidney damage.
The risk of paracetamol overdose is higher in patients with liver disease than in those with alcoholic cirrhosis of the liver. Caution is advised 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.
Do not take Paracetamol Synoptis without consulting a doctor if:

• the patient has high fever (above 39°C),
• fever lasts longer than 3 days,
• fever subsides and then returns (recurrent fever). These situations may require medical consultation and treatment.

Children
Paracetamol Synoptis is not recommended for children under 12 years of age and weighing less than 40 kg due to the amount of paracetamol. Other strengths and formulations of paracetamol are more suitable for this patient group.
Paracetamol Synoptis and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

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

Do not take Paracetamol Synoptis at the same time as medicines that delay gastric emptying (e.g. propantheline) or that accelerate gastric emptying (e.g. metoclopramide and domperidone).
If the patient is taking cholestyramine (a medicine that lowers blood cholesterol levels), Paracetamol Synoptis should be taken one hour before or four hours after taking cholestyramine.
Paracetamol Synoptis with food and drink
Do not consume alcohol while taking Paracetamol Synoptis. Alcohol may increase the toxic effects of paracetamol on the liver.
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 a doctor or pharmacist before using this medicine.
Pregnancy
Paracetamol Synoptis may be given to pregnant women if necessary. Use the lowest effective dose to relieve pain or reduce fever, and take the medicine for the shortest possible time. If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult a doctor.
Breastfeeding
Paracetamol passes into breast milk. To date, no adverse effects have been demonstrated in infants; therefore, treatment with Paracetamol Synoptis usually does not need to be discontinued.
Driving and using machines
Paracetamol Synoptis has no effect on the ability to drive or operate machinery. However, patients should avoid these activities if they experience adverse effects such as mild drowsiness or dizziness.
Paracetamol Synoptis contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take the medicine 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, consult a doctor or pharmacist.
The recommended dose depends on age and body weight. Paracetamol Synoptis is intended for oral use in adults (including elderly people) and children aged 12 years and above.
Intervals between doses should be 6 to 8 hours. If necessary, intervals may be at least 4 hours. Do not exceed a dose of 6 tablets per day.
Recommended dosing of paracetamol:

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 medicinal products. This should be
taken into account to avoid exceeding the maximum daily dose of paracetamol.
Duration of treatment
Do not take Paracetamol Synoptis in high doses unless otherwise directed.
If symptoms worsen or persist for more than 3 days, consult a doctor.
Method and route of administration
Paracetamol Synoptis tablets should be administered orally. The tablets may be taken whole or
crushed and mixed with water.
Taking the medicine after a meal may delay its effect.
Special patient groups
Patients with hepatic impairment, renal impairment, or Gilbert's syndrome should
consult a doctor to determine the appropriate dose and frequency of administration.
Taking more than the recommended dose of Paracetamol Synoptis
If an overdose of Paracetamol Synoptis is taken, seek medical advice from a doctor or go to the nearest hospital emergency department. The first symptoms that usually occur are:
nausea, vomiting, increased sweating, drowsiness, and malaise. Medical help should be sought even if such symptoms are not present, as the patient may be unaware of liver damage. The doctor will initiate appropriate treatment and supportive measures.
Missed dose of Paracetamol Synoptis
Do not take a double dose to make up for a missed dose. Continue taking the medicine according to the prescribed dosing schedule.
Discontinuation of Paracetamol Synoptis
Sudden discontinuation of analgesic medicines after unjustified, long-term use of high doses may cause, among others, dizziness, fatigue, muscle pain, and irritability. These symptoms will resolve within a few days. Do not take other analgesic medicines or restart taking Paracetamol Synoptis until these symptoms have resolved, unless otherwise advised by a doctor.
If you have any further doubts 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 they do not occur in everyone.
Treatment must be discontinued immediately and medical advice should be sought if the patient experiences:
swelling of the face, particularly around the mouth (tongue and/or throat), difficulty breathing, sweating,
nausea and sudden drop in blood pressure. These symptoms may indicate a severe allergic reaction, which
can be life-threatening, but occurs very rarely (in fewer than 1 in 10,000 patients).

The following adverse reactions may occur:

Common (affects less than 1 in 10 patients):

• mild drowsiness,
• nausea,
• vomiting.

Uncommon (affects less than 1 in 100 patients):

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

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

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

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

• blood formation disorders (reduced platelet count, reduced white blood cell count, reduced count of all blood cells),
• 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 available data):

• serious condition causing the blood to become more acidic (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Paracetamol Synoptis

Keep this medicine out of sight and reach of children.
No special requirements for storage.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Paracetamol Synoptis contains

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: povidone K30, pregelatinized corn starch, sodium carboxymethyl starch (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 imprint "500" on one side and smooth on the other side, packed in HDPE bottles with child-resistant closure or in transparent PVC/Aluminum blisters or white, opaque PVC/Aluminum blisters. All packed in a cardboard box.
Pack sizes: 6, 10, 20 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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