Paracetamol aristo

Package leaflet: Information for the user

Paracetamol Aristo, 500 mg, effervescent tablets
Paracetamolum
Please read the entire leaflet carefully before using 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If symptoms do not improve after 3 days, or if the patient feels worse, consult a doctor.

Table of contents

1. What Paracetamol Aristo is and what it is 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 pack and other information

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

Paracetamol Aristo is an analgesic (pain-relieving) and antipyretic (fever-reducing) medicine. It 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 aged 13 years and older with body weight above 33 kg.

2. Information before using Paracetamol Aristo

When not to use Paracetamol Aristo:

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

Warnings and precautions
Before starting to use Paracetamol Aristo, discuss this with your doctor or pharmacist:

• if the patient has liver function disorders, including those caused by excessive alcohol consumption (3 or more alcoholic drinks per day);
• if the patient has kidney problems;
• if the patient has glucose-6-phosphate dehydrogenase deficiency;
• if the patient suffers from anorexia, bulimia, cachexia (wasting syndrome), or chronic malnutrition;
• if the patient is dehydrated or has hypovolemia (reduced circulating blood volume);
• if the patient is taking a medicine used to treat epilepsy, they should consult their doctor before taking this medicine, as concomitant use of both medicines reduces efficacy and increases hepatotoxicity (toxic effect on the liver) of paracetamol, especially when high doses of paracetamol are used (see below, section Paracetamol Aristo with other medicines);
• if the patient has Gilbert's syndrome (also known as Meulengracht's disease);
• if the patient has heart failure or respiratory failure, or has anaemia; in such cases, the medicine should be used under medical supervision and only for a short period;
• if the patient has asthma and symptoms of hypersensitivity to acetylsalicylic acid;
• if patients are on a sodium-free or low-sodium diet while taking the medicine (see information: “Paracetamol Aristo contains benzoic acid salt (sodium benzoate), 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 may be fatal. The patient should be informed about the symptoms of severe skin reactions and must stop using the medicine if symptoms of skin rash or any other signs of hypersensitivity appear.
Do not take a higher dose of paracetamol than recommended in section 3 “How to use Paracetamol Aristo”.
Avoid taking this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, because high doses of paracetamol may lead to liver damage. Do not take more than one paracetamol-containing medicine without consulting a doctor.
In case of overdose, seek immediate medical advice (see information: “Taking more than the recommended dose of Paracetamol Aristo”).
Do not use this medicine for self-treatment of high body temperature (above 39°C), fever lasting longer than 3 days, or recurring fever, unless advised by a doctor, as such conditions may require patient evaluation and appropriate treatment.
Taking higher than recommended doses of paracetamol carries a risk of severe liver damage. Paracetamol-containing medicines 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 inappropriate use in high doses may cause headaches, which should not be treated with increased doses of paracetamol.

Effect on laboratory test results
If the patient is scheduled for laboratory tests (including blood, urine, etc.), inform the doctor about taking this medicine, as it may affect laboratory test results.
Paracetamol may alter laboratory results of 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Medicines used to treat epileptic seizures (antiepileptic drugs such as: carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine)
Concomitant use of paracetamol and antiepileptic drugs may cause or worsen liver damage.

Lamotrigine
The effect of lamotrigine may be reduced.

Medicines used to treat high blood pressure and heart arrhythmia (propranolol)
Concomitant use of paracetamol and propranolol may enhance the effect and/or toxicity of these medicines.

Medicines used to treat gout (probenecid)
Probenecid nearly doubles the reduction in paracetamol excretion. When paracetamol is administered concomitantly with probenecid, consider reducing the dose of paracetamol.

Medicines used to treat tuberculosis (rifampicin, isoniazid)
Concomitant use of paracetamol and rifampicin or isoniazid may cause or worsen liver damage.

Salicylamide, a medicine used to treat fever and pain, may prolong the elimination half-life (t_½) of paracetamol.

Medicines that lower blood cholesterol levels
Cholestyramine reduces the absorption of paracetamol. To avoid this, administer paracetamol 1 hour before or 4 hours after cholestyramine.

Medicines to prevent nausea and vomiting (metoclopramide and domperidone)
Concomitant use of paracetamol and medicines that accelerate gastric emptying, such as metoclopramide and domperidone, increases the absorption of paracetamol and accelerates the expected onset of its action. However, there is no need to avoid concomitant use of these medicines.

Medicines preventing blood clots (oral anticoagulants such as acenocoumarol, warfarin)
Paracetamol may enhance the effect of oral anticoagulants. Long-term use of paracetamol in patients treated with oral anticoagulants should be conducted under medical supervision only. Prolonged use of higher doses of paracetamol has been associated with enhanced warfarin effect.

Medicines increasing urine excretion (loop diuretics such as furosemide)
Diuretic effect may be reduced.

Chloramphenicol, a medicine used to treat infections
Concomitant use of paracetamol and chloramphenicol may significantly delay the excretion of chloramphenicol, increase its plasma concentration, and increase the risk of toxicity.

Zidovudine (AZT), a medicine used in viral diseases
Concomitant use of paracetamol and AZT may increase the frequency or severity of neutropenia (reduced white blood cell count). Paracetamol may be used concomitantly with AZT only as directed by a doctor.

Caution is advised when using paracetamol concomitantly with substances that induce liver enzymes, such as: barbiturates, carbamazepine, isoniazid, rifampicin, or ethanol, as they may enhance the toxic effects of paracetamol.

Inform your doctor if you are taking this medicine together with medicines that delay gastric emptying (e.g. propantheline) or accelerate it (e.g. metoclopramide and domperidone).

Flucloxacillin (antibiotic), due to the serious risk of a disorder affecting blood and body fluids (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly 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, and in patients taking maximum daily doses of paracetamol.

Paracetamol Aristo and alcohol
Patients should not drink alcohol during treatment with paracetamol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Paracetamol Aristo may be given to pregnant women if necessary. Use the lowest effective dose that adequately relieves pain or reduces fever, and take the medicine for as short a time as possible. If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, consult a doctor.
Paracetamol passes into breast milk. Therapeutic doses of paracetamol may be used during breastfeeding.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery. However, consider that during treatment with paracetamol, adverse effects such as mild drowsiness and dizziness may occur.

Paracetamol Aristo contains benzoic acid salt (sodium benzoate), 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 age).
The medicine contains 135 mg of sorbitol (E 420) in each effervescent tablet.
Sorbitol is a source of fructose. If the patient (adult or child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact their doctor before taking the medicine or giving it to a child.
The medicine contains trace amounts of glucose from maltodextrin and sugar (sucrose).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact 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 sodium intake for adults.

3. How to use Paracetamol Aristo

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Effervescent tablets must be completely dissolved in a sufficient amount of water before administration.
When administering two tablets simultaneously, it is recommended to use a larger amount of water
(at least 150 ml). The solution should be consumed immediately after preparation.
The recommended dose for adults is 1 to 2 tablets taken one to three times daily (maximum 6 tablets per day),
dissolved in a large glass of water.
Maximum daily dose: 3 g (3,000 mg) per day.
Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse
reactions, such as liver damage.
If pain persists for more than 5 days, or fever lasts longer than 3 days, or if pain and/or fever worsen or
new symptoms occur, discontinue use of the medicine and consult a physician.

Liver disease
Consult a physician before using this medicine.
Take the dose prescribed by the physician, with at least 8 hours between consecutive doses.
Do not exceed 2 g (2,000 mg) of paracetamol (4 tablets) within 24 hours.
In patients with chronic alcoholism, the daily dose should not exceed 2 g (2,000 mg).

Kidney disease
Consult a physician before using this medicine.
A maximum of 1 tablet may be taken per single dose.
Depending on the severity of the disease, the physician will inform the patient whether the medicine should be taken
every 6 or every 8 hours.

Elderly patients
Dose adjustment is usually not required.

Use in children and adolescents

• aged 13 to 15 years (and body weight >33 kg): 1 tablet, one to three times daily, dissolved in a large glass of water.
• aged 15 years and above (body weight >55 kg): follow the dosing recommendations for adults.
• This medicine is not intended for use in children and adolescents under 13 years of age or with body weight below 33 kg. In such cases, consult a physician or pharmacist.

Taking more Paracetamol Aristo than recommended
Seek immediate medical advice from a physician or pharmacist, even if the patient feels well.
Signs of toxic liver damage may be delayed by 1–2 days after ingestion.
Paracetamol overdose requires appropriate monitoring and immediate treatment. Despite the absence of early symptoms,
the patient should be promptly referred to hospital and treatment initiated. Symptoms of overdose include: nausea, vomiting,
anorexia, pallor, general malaise, increased sweating, and abdominal pain, which usually appear within the first 24 hours.

Missed dose of Paracetamol Aristo
If a dose is missed, take the next dose as soon as possible, unless the time for the next scheduled dose is approaching.
Remember to maintain at least a four-hour interval between doses. Never take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed in patients taking Paracetamol Aristo:
Rare: occurring no more frequently than in 1 out of 1,000 patients

• low blood pressure (hypotension)
• increased activity of liver enzymes
• discomfort. Very rare: occurring no more frequently than in 1 out of 10,000 patients
• blood morphology changes may occur, including changes in blood cell counts (such as abnormally low levels of certain blood components, which may cause, for example, 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 concentration
• jaundice (yellowing of the skin), liver failure
• skin reactions such as drug hypersensitivity dermatitis, urticaria, itching, rash
• changes in urination (difficulty or pain during urination, reduced urine output, blood in urine).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 to provide more information on the safety of the medicine.

5. How to store Paracetamol Aristo

Keep the container tightly closed to protect from moisture.
Keep the medicine out of 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 dihydrogencitrate, sodium hydrogen carbonate, sodium carbonate, sorbitol (E 420), copovidone, lemon flavour PHS-135460 (contains trace amounts of sugar), sodium cyclamate, sodium saccharin (E 954), a mixture of sodium docucinate (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 available in polypropylene containers with an LDPE polyethylene cap and a moisture-absorbing agent.
Pack sizes: 16 or 20 (2x10) effervescent tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Str. 8–10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Spain Paracetamol Edigen, 500 mg, effervescent tablets EFG
Poland Paracetamol Aristo, 500 mg, effervescent tablets
Portugal Paracetamol Aristo, 500 mg, comprimidos efervescentes
Italy Paracetamolo Aristo, 500 mg, compresse effervescenti