Paracetamol Aristo

Leaflet attached to the packaging: information for the user

Paracetamol Aristo, 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 directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• 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 after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Paracetamol Aristo is a pain reliever (analgesic) and antipyretic (fever reducer). The medicine is indicated for short-term, symptomatic treatment of mild to moderate pain (lasting no longer than 5 days) and/or fever (lasting no longer than 3 days) in adults and adolescents from 13 years of age and weighing over 33 kg.

2. Important information before taking Paracetamol Aristo

When not to take Paracetamol Aristo:

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

Warnings and precautions

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

• if the patient has liver function disorders, including those caused by excessive alcohol consumption (3 or more alcoholic beverages per day);
• if the patient has kidney problems;
• if the patient has a glucose-6-phosphate dehydrogenase deficiency;
• if the patient has anorexia, bulimia, cachexia (wasting of the body) or chronic malnutrition;
• if the patient is dehydrated or has hypovolemia (reduced blood volume);
• if the patient is taking a medicine used to treat epilepsy, they should consult their doctor before taking this medicine, as the simultaneous use of both medicines can reduce the effectiveness and increase the hepatotoxicity (toxic effect on the liver) of paracetamol, especially when taking high doses of paracetamol (see below, section Paracetamol Aristo and other medicines);
• if the patient has Gilbert's syndrome (also known as Meulengracht's disease);
• if the patient has heart failure or respiratory failure, anemia; in such cases, the use of the medicine should be under the supervision of a doctor and only for a short time;
• if the patient has asthma and shows signs of hypersensitivity to acetylsalicylic acid;
• if the patient is on a low-sodium diet or a sodium-free diet (see information "Paracetamol Aristo contains sodium benzoate (E 211), sorbitol, trace amounts of glucose and sucrose, and sodium").

Paracetamol may cause severe skin reactions, such as: acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. The patient should be informed about the symptoms of severe skin reactions and stop taking the medicine if they experience a skin rash or any other signs of hypersensitivity.

Do not take more than the recommended dose of paracetamol. Avoid taking this medicine with other medicines that contain paracetamol, such as cold and flu medicines, as high doses of paracetamol can lead to liver damage. Do not take more than one medicine containing paracetamol without consulting a doctor.

In case of overdose, seek medical advice immediately (see information "Taking a higher dose of Paracetamol Aristo than recommended").

Do not use this medicine to treat high body temperature (above 39°C), fever lasting longer than 3 days, or recurring fever, unless advised by a doctor, as these situations may require an assessment of the patient's condition and appropriate treatment.

Taking higher doses of paracetamol than recommended is associated with a risk of severe liver damage. Medicines containing paracetamol should not be taken for longer than a few days or in high doses, unless advised by a doctor.

Long-term use of painkillers or improper use of high doses can cause headaches, which should not be treated with increased doses of paracetamol.

Effect on laboratory test results

If the patient is going to undergo laboratory tests (including blood, urine, etc.), they should inform their doctor about taking this medicine, as it may affect the results of laboratory tests.

Paracetamol may change the results of laboratory tests for uric acid and glucose levels.

Children and adolescents

Do not give this medicine to children under 13 years of age and weighing less than 33 kg.

Paracetamol Aristo and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.

Medicines used to treat seizures (antiepileptic drugs, such as: carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine)

Simultaneous use of paracetamol and antiepileptic drugs may cause or increase liver damage.

Lamotrigine

The effect of lamotrigine may be reduced.

Medicines used to treat high blood pressure and heart rhythm disorders (propranolol)

Simultaneous use of paracetamol and propranolol may increase the effect and/or toxicity of these medicines.

Medicines used to treat gout

Probenecid almost doubles the elimination of paracetamol. When paracetamol is given simultaneously with probenecid, the dose of paracetamol should be considered for reduction.

Medicines used to treat tuberculosis (rifampicin, isoniazid)

Simultaneous use of paracetamol and rifampicin or isoniazid may cause or increase liver damage.

Salicylamide, a medicine used to treat fever and pain, may prolong the elimination half-life of paracetamol (t).

Cholesterol-lowering medicines

Cholestyramine reduces the absorption of paracetamol. To avoid this, paracetamol should be given 1 hour before or 4 hours after taking cholestyramine.

Medicines that prevent nausea and vomiting (metoclopramide and domperidone)

Simultaneous intake of paracetamol and medicines that accelerate gastric emptying, such as metoclopramide and domperidone, increases the absorption and accelerates the expected onset of action of paracetamol. However, there is no need to avoid simultaneous use of these medicines.

Medicines that prevent blood clotting (oral anticoagulants, such as acenocoumarol, warfarin)

Paracetamol may increase the effect of oral anticoagulants. Long-term use of paracetamol in patients treated with oral anticoagulants should be carried out only under medical supervision. With longer use of higher doses of paracetamol, an increased effect of warfarin has been observed.

Medicines that increase urine production (loop diuretics, such as furosemide)

The effect of diuretics may be reduced.

Chloramphenicol, a medicine used to treat infections

Simultaneous use of paracetamol and chloramphenicol may significantly delay the elimination of chloramphenicol, increase its concentration in the blood, and increase the risk of toxicity.

Zidovudine (AZT), a medicine used to treat viral diseases

Simultaneous use of paracetamol and AZT may increase the frequency of neutropenia or worsen it (reduce the number of white blood cells). Paracetamol can be used simultaneously with AZT only as directed by a doctor.

Caution should be exercised when using paracetamol with substances that induce liver enzymes, such as: barbiturates, carbamazepine, isoniazid, rifampicin, or ethanol, as they may increase the toxic effect of paracetamol.

Tell the doctor about taking this medicine with medicines that delay gastric emptying (e.g., propanteline) or accelerate it (e.g., metoclopramide and domperidone).

Flucloxacillin (an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney function disorders, 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.

Paracetamol Aristo with alcohol

Patients should not drink alcohol during treatment with paracetamol.

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.

Paracetamol Aristo can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible duration. If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.

Paracetamol passes into breast milk. Therapeutic doses of paracetamol can be given during breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or use machines. However, it should be taken into account that during treatment with paracetamol, side effects such as slight drowsiness and dizziness may occur.

Paracetamol Aristo contains sodium benzoate (E 211), sorbitol, trace amounts of glucose and sucrose, and sodium.

The medicine contains 1.35 mg of sodium benzoate (E 211) in each effervescent tablet.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

The medicine contains 135 mg of sorbitol (E 420) in each effervescent tablet.

Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, 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.

The medicine contains trace amounts of glucose from maltodextrin and sugar (sucrose).

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

The medicine contains 169 mg of sodium (the main component of table salt) in each effervescent tablet.

This corresponds to 8.5% of the maximum recommended daily intake of sodium for adults.

3. How to take Paracetamol Aristo

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

The effervescent tablets should be completely dissolved in a sufficient amount of water before administration.

When taking two tablets at the same time, it is recommended to use a larger amount of water (at least 150 ml). The solution should be drunk immediately after preparation.

The recommended dose for adults is 1 to 2 tablets, taken 1 to 3 times a day (maximum 6 tablets per day), dissolved in a large glass of water.

Maximum daily dose: 3 g (3000 mg) per day.

Long-term use of high daily doses of paracetamol should be avoided, as it increases the risk of side effects, such as liver damage.

If the pain persists for more than 5 days, or the fever lasts longer than 3 days, or if the pain and/or fever worsen or other symptoms occur, the patient should stop taking the medicine and consult a doctor.

Liver disease

Before taking this medicine, the patient should consult their doctor.

The patient should take the dose of the medicine prescribed by the doctor, with an interval of at least 8 hours between doses.

Do not take more than 2 g (2000 mg) of paracetamol (4 tablets) in 24 hours.

In patients with chronic alcoholism, the dose should not exceed 2 g (2000 mg) per day.

Kidney disease

Before taking this medicine, the patient should consult their doctor.

The patient can take a maximum of 1 tablet per dose.

Depending on the severity of the disease, the doctor will inform the patient whether to take the medicine at intervals of at least 6 or 8 hours.

Elderly patients

Dose modification is not usually necessary.

Use in children and adolescents

• from 13 to 15 years old (and weighing over 33 kg): 1 tablet, 1 to 3 times a day, dissolved in a large glass of water.
• from 15 years old (and weighing over 55 kg): follow the dosage recommendations for adults.
• This medicine is not intended for use in children and adolescents under 13 years of age or weighing less than 33 kg. In such cases, consult a doctor or pharmacist.

Taking a higher dose of Paracetamol Aristo than recommended

Immediately contact a doctor or pharmacist, even if the patient feels well.

The onset of symptoms of toxic liver damage may be delayed by 1-2 days after taking the medicine. Paracetamol overdose requires proper monitoring and immediate treatment. Despite the lack of early symptoms, the patient should be immediately referred to a hospital and treated.

Symptoms of overdose include: nausea, vomiting, loss of appetite, pallor, general malaise, increased sweating, and abdominal pain, usually occurring within the first 24 hours.

Missing a dose of Paracetamol Aristo

If a dose is missed, the patient should take the next dose as soon as possible, unless it is close to the time for the next scheduled dose. The patient should remember to maintain an interval of at least 4 hours between doses. Never take a double dose to make up for a missed dose.

In case of any doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

In patients taking Paracetamol Aristo, the following side effects have been observed:

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

• low blood pressure (hypotension)
• increased liver enzyme activity
• discomfort
• Very rare:occurring in less than 1 in 10,000 patients
• changes in blood cell count (such as: abnormally low levels of some blood components, which can cause e.g., nosebleeds or bleeding gums) and other bleeding
• hypersensitivity reactions (symptoms such as: swelling, shortness of breath, sweating, nausea, sudden drop in blood pressure)
• decreased blood sugar levels
• jaundice (yellowing of the skin), liver failure
• skin reactions, such as: allergic skin inflammation, hives, itching, rash
• changes in urination (difficult or painful urination, decreased urine output, and blood in the urine)

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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.: 22 49-21-301, fax: 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 the medicine.

5. How to store Paracetamol Aristo

Store the container tightly closed to protect from moisture.

Keep the medicine out of the sight and reach of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Aristo contains

• The active substance is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
• The other ingredients are: maltodextrin (from corn starch, contains trace amounts of glucose), povidone K90, citric acid, sodium dihydrogen citrate, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), copovidone, lemon flavor PHS-135460 (contains trace amounts of sugar), sodium cyclamate, sodium saccharin (E 954), a mixture of sodium dokuzate (85%) and sodium benzoate (E 211) (15%).

What Paracetamol Aristo looks like and contents of the pack

The effervescent tablets are white or almost white, round in shape, and come in polypropylene containers with a polyethylene LDPE cap and a desiccant.

Package size: 16 or 20 (2x10) effervescent tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH

Wallenroder Str. 8–10

13435 Berlin

Germany

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

Spain

Paracetamol Edigen, 500 mg, effervescent tablets EFG

Poland

Paracetamol Aristo, 500 mg, effervescent tablets

Portugal

Paracetamol Aristo, 500 mg, effervescent tablets

Italy

Paracetamolo Aristo, 500 mg, effervescent tablets

Date of last revision of the leaflet: May 2022