Paracetamol Aurovitas

Leaflet attached to the packaging: patient information

Paracetamol Aurovitas, 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 tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

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

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

The active substance of Paracetamol Aurovitas is paracetamol, which belongs to the group of pain-relieving medicines. Paracetamol Aurovitas is used to relieve pain and reduce fever. The tablets can relieve mild to moderate pain and/or fever [e.g., headache and toothache]. Paracetamol Aurovitas tablets can be used in adults and adolescents, but it is not suitable for use in children under 10 years of age.

2. Important information before taking Paracetamol Aurovitas

When not to take Paracetamol Aurovitas

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Paracetamol Aurovitas, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver disease (including Gilbert's syndrome or acute liver failure),
• if the patient has a deficiency of the enzyme called glucose-6-phosphate dehydrogenase,
• if the patient has hemolytic anemia (abnormal breakdown of red blood cells),
• if the patient regularly consumes large amounts of alcohol. Never take more than 2000 mg of paracetamol per day,
• if the patient has asthma and is allergic to acetylsalicylic acid,
• in case of dehydration or prolonged malnutrition.

While taking any medicines for the treatment of epilepsy, the patient should consult their doctor before taking paracetamol, as paracetamol may reduce the effectiveness of these medicines and increase the risk of liver damage, especially when taking high doses of paracetamol. In case of high fever, symptoms of secondary infection, or persistent symptoms for more than 3 days, the patient should consult their doctor or pharmacist. Headaches caused by excessive use of painkillers should not be treated by increasing the dose. In such cases, the patient should use painkillers after consulting their doctor. Do not take more paracetamol than recommended in section 3 "How to take Paracetamol Aurovitas". Always avoid taking this medicine with other medicines containing paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not take more than one medicine containing paracetamol without consulting a doctor. While taking Paracetamol Aurovitas, the patient should immediately inform their doctor if they have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins circulate 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 longer period or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Paracetamol Aurovitas with other medicines

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

Do not take Paracetamol Aurovitas in combination with other medicines containing paracetamol.

The patient should talk to their doctor before taking paracetamol if they are taking one of the following medicines:

• metoclopramide or domperidone (used to treat nausea and vomiting),
• cholestyramine (a cholesterol-lowering medicine),
• warfarin and other coumarins (blood-thinning medicines), especially if the patient is going to take paracetamol every day for a longer period,
• salicylamide (a pain-relieving medicine),
• probenecid (used in gout),
• isoniazid or rifampicin (used in tuberculosis),
• lamotrigine or phenytoin (antiepileptic medicines),
• barbiturates or carbamazepine (a group of medicines that cause relaxation and drowsiness),
• St. John's Wort (an antidepressant),
• chloramphenicol (an antibiotic),
• zidovudine (a medicine used to treat AIDS),
• flucloxacillin (an antibiotic), due to the serious risk of blood and fluid disorders (called metabolic acidosis), which requires urgent treatment (see section 2).

If the patient knows they will be undergoing laboratory tests (such as blood tests, urine analysis, allergy tests, etc.), they should inform their doctor about taking this medicine, as paracetamol may affect the results of these tests.

Paracetamol Aurovitas with food, drink, and alcohol

The patient should avoid consuming alcohol while taking Paracetamol Aurovitas.

Pregnancy, breastfeeding, and fertility

Pregnancy

If necessary, Paracetamol can be used during pregnancy. The patient should use the lowest possible dose that relieves pain and/or fever and for the shortest possible time. The patient should contact their doctor if the pain and/or fever do not improve or if they need to take the medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk, but in small amounts. At recommended doses, paracetamol can be used for a short period by breastfeeding women.

Fertility

No harmful effects on fertility have been observed during normal use of paracetamol. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking the medicine.

Driving and using machines

Paracetamol Aurovitas should not cause any reduction in the ability to drive or use machines.

Paracetamol Aurovitas contains sodium

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

3. How to take Paracetamol Aurovitas

Dosage

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, the patient should consult their doctor or pharmacist.

Recommended dosage:

Adults, elderly, and children over 16 years old (with a body weight over 55 kg): Take 1 to 2 Paracetamol Aurovitas 500 mg tablets at a time, up to 4 times a day. Do not take more than 6 tablets (3000 mg) of paracetamol per day. Children between 10 and 15 years old (with a body weight of 40-55 kg): Take 1 Paracetamol Aurovitas 500 mg tablet at a time, up to 4 times a day. Do not take more than 4 tablets (2000 mg) of paracetamol per day. This medicine should not be used in children under 10 years of age. The interval between doses must be at least 4 hours, and no more than 4 doses should be taken per day. The tablet should be swallowed whole with a large amount of water. Paracetamol Aurovitas is not suitable for children under 10 years of age.

• The interval between consecutive doses should be at least 4 hours.
• Do not use in combination with other medicines containing paracetamol.
• Do not exceed the recommended daily dose.
• The tablets of Paracetamol Aurovitas contain a dividing line to facilitate the use of the medicine by children.
• If the pain persists for more than 5 days or the fever lasts for more than 3 days or worsens, or if other symptoms occur, the patient should stop the treatment and consult their doctor.

The effective daily dose should not exceed 60 mg/kg body weight per day (up to 2 g/day) in the following cases:

• adults with a body weight of less than 50 kg,
• mild or moderate liver failure, Gilbert's syndrome (familial non-hemolytic jaundice),
• dehydration,
• prolonged malnutrition.

The patient should follow the instructions provided, unless their doctor has advised otherwise. If the patient feels that the effect of Paracetamol Aurovitas is too strong or too weak, they should consult their doctor or pharmacist.

Method of administration:

The tablet should be swallowed with a glass of water.

Taking a higher dose of Paracetamol Aurovitas than recommended

SEEK MEDICAL ADVICE IMMEDIATELY IN CASE OF OVERDOSAGE, EVEN IF THE PATIENT FEELS WELL, due to the risk of delayed, serious liver damage. Symptoms of paracetamol overdose are nausea, vomiting, and decreased appetite. Loss of consciousness usually does not occur.

Missing a dose of Paracetamol Aurovitas

The patient should not take a double dose to make up for a missed dose. In this case, the patient should skip the missed dose and take the next dose at the usual time. If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Aurovitas can cause side effects, although not everybody gets them. Possible side effects are listed below:

Rare side effects(may affect up to 1 in 1,000 people):

• Certain blood diseases, including agranulocytosis, thrombocytopenia, purpura, hemolytic anemia, leukopenia, disorders affecting platelets (coagulation disorders) and disorders affecting stem cells (disorders affecting blood cells in the bone marrow).
• Allergic reactions.
• Depression, confusion, and hallucinations.
• Seizures and headaches.
• Visual disturbances.
• Edema (abnormal accumulation of fluid under the skin).
• Abdominal pain, gastrointestinal bleeding, diarrhea, nausea, vomiting.
• Liver function disorders, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver cirrhosis (death of liver cells).
• Rash, itching, sweating, urticaria, red spots on the skin, angioedema with symptoms such as facial swelling, lip swelling, throat or tongue swelling.
• Dizziness, general malaise, fever, sedation, interactions with other medicines.
• Overdose and poisoning.

Very rare side effects(may affect up to 1 in 10,000 people):

• Pancytopenia (reduction in the number of blood cells).
• Allergic reactions (which should then be discontinued), including angioedema, breathing difficulties, sweating, nausea, decreased blood pressure, shock, and anaphylaxis.
• Low blood sugar levels.
• Hepatotoxicity (liver damage caused by chemicals).
• Cloudy urine and kidney disorders.
• Bronchospasm (difficulty breathing) in patients with aspirin sensitivity and other anti-inflammatory medicines.
• Hematuria (blood in the urine).
• Involuntary urination (inability to urinate).

Unknown(frequency cannot be estimated from the available data):

• A serious disease that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).
• Acute generalized exanthematous pustulosis (a drug rash characterized by numerous, small, mainly non-pustular, sterile pustules).
• Severe rash or peeling skin.
• Stevens-Johnson syndrome (a life-threatening skin disease).
• Skin edema, blisters, or rash caused by taking paracetamol.

After stopping the medicine, these symptoms should disappear. If any of the side effects worsen, the patient should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Paracetamol Aurovitas

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister, carton, and bottle after: EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Aurovitas contains

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: maize starch, colloidal silica, hypromellose (low viscosity), sodium carboxymethylcellulose (type A), talc, magnesium stearate.

What Paracetamol Aurovitas looks like and contents of the pack

Tablet. White or almost white, uncoated, round tablets with engraved "A" and "8" with a dividing line on one side and smooth on the other. The tablet can be divided into equal doses. Paracetamol Aurovitas is available in blisters containing 10, 12, 16, 20, 24, 30, 32, 40, 50, 60, 90, 100, 120, and 540 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19 2700-487 Amadora Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Paracetamol AB 500 mg/ 1000 mg tablets Czech Republic: Paracetamol Aurovitas Italy: Paracetamolo Aurobindo Italia Netherlands: Paracetamol Sanias 500 mg,/ 1000 mg tablets Poland: Paracetamol Aurovitas Portugal: Paracetamol Aurobindo 500 mg/ 1000 mg

Date of last revision of the leaflet: 01/2025