Paracetamol Aristo

Leaflet attached to the packaging: information for the user

Paracetamol Aristo, 1000 mg, effervescent tablets

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

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-relieving and antipyretic medicine. The medicine is indicated for the symptomatic treatment of mild to moderate pain and/or fever in adults.

2. Important information before taking Paracetamol Aristo

When not to take 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 treatment with Paracetamol Aristo, discuss it with your 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 concomitant use of both medicines reduces the efficacy and increases the hepatotoxicity 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 medical supervision 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 benzoesan sodium, 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 signs of severe skin reactions and stop taking the medicine if skin rash or other signs of hypersensitivity occur.
The total dose of paracetamol should not exceed 4 g (4000 mg) per day.
Avoid concomitant use of this medicine with other medicines that contain paracetamol, such as flu and cold 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").
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 in 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 tests, etc.), they should inform their doctor about taking this medicine, as it may affect laboratory test results.
Paracetamol may change the results of laboratory tests for uric acid and glucose levels.

Children and adolescents

This medicine is not recommended for children and adolescents (see section 3). This medicine is intended for adult patients only, aged 18 and above.

Paracetamol Aristo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Medicines used to treat seizures (antiepileptic medicines, such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine)
Concomitant use of paracetamol and antiepileptic medicines 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)
Concomitant 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 taking paracetamol 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 increase liver damage.
Salicylamide, a medicine used to treat fever and pain, may prolong the elimination phase of paracetamol (t ).
Medicines that lower cholesterol levels in the blood
Cholestyramine reduces the absorption of paracetamol. To avoid this, paracetamol should be taken 1 hour before or 4 hours after taking cholestyramine.
Medicines that prevent nausea and vomiting (metoclopramide and domperidone)
Concomitant use of paracetamol and medicines that accelerate gastric emptying, such as metoclopramide and domperidone, increases absorption and accelerates the expected onset of action of paracetamol. However, there is no need to avoid concomitant 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 under medical supervision only. With longer use of higher doses of paracetamol, increased warfarin effect has been observed.
Medicines that increase urine production (loop diuretics, such as furosemide)
Reduced effect of diuretics may occur.
Chloramphenicol, a medicine used to treat infections
Concomitant 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
Concomitant 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 concomitantly with AZT only according to the doctor's instructions.
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 your 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 blood and fluid disorder (metabolic acidosis with a large anion gap), which should be treated urgently 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 time. If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of taking the medicine, consult a doctor.
Paracetamol passes into breast milk. Therapeutic doses of paracetamol can be taken during breastfeeding.

Driving and using machines

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

Paracetamol Aristo contains benzoesan sodium, sorbitol, trace amounts of glucose and sucrose, and sodium.

The medicine contains 2.7 mg of benzoesan sodium (E 211) per effervescent tablet.
Benzoesan sodium 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 270 mg of sorbitol (E 420) per 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, they should consult their doctor before taking the medicine.
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 338 mg of sodium (the main component of table salt) per effervescent tablet.
This corresponds to 17% of the maximum recommended daily intake of sodium for adults.

3. How to take Paracetamol Aristo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The effervescent tablet should be completely dissolved in a glass of water before oral administration. The solution should be drunk immediately after preparation.
Adults
The recommended dose for adults is 1 tablet taken at intervals of 6 to 8 hours. If necessary, another tablet can be taken after a minimum of 4 hours.
It is usually not necessary to take doses higher than 3 g (3000 mg) per day, which corresponds to 3 tablets per day.
In case of more intense pain, the maximum dose can be increased to 4 g per day (4 tablets). There should always be an interval of at least 4 hours between doses.
Taking the medicine after a meal may delay the onset of action of the medicine.
Frequency of administration
Regular use prevents changes in the severity of pain or fever.
Kidney disease
Consult a doctor.
Patients with moderate to severe kidney function disorders should not take this medicine.
Liver disease
Take the dose of the medicine as prescribed by the doctor, with a minimum interval of 8 hours between doses.
Do not take more than 2 g (2000 mg) of paracetamol (2 tablets) in 24 hours.
In patients with chronic alcoholism, do not exceed the dose of 2 g (2000 mg) per day.
Elderly patients
Dose adjustment is not usually necessary.

Use in children and adolescents

This medicine is not intended for use in children and adolescents.

Taking a higher dose of Paracetamol Aristo than recommended

Immediately consult 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.
Overdose symptoms 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, take the next dose as soon as possible, unless it is close to the time for the next scheduled dose. Always maintain an interval of at least 4 hours between doses. Never take a double dose to make up for a missed dose.
If you have any doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed in patients taking Paracetamol Aristo:
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, including changes in the number of blood cells (such as abnormally low levels of certain blood components, which can cause nosebleeds or gum bleeding) 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 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 this 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 your 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 1000 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.
Pack sizes: 16, 32 (2x16), or 40 (2x20) 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, 1000 mg, comprimidos efervescentes EFG
Poland
Paracetamol Aristo, 1000 mg, tabletki musujące
Portugal
Paracetamol Aristo, 1000 mg, compresse effervescenti
Italy
Paracetamolo Aristo, 1000 mg, compresse effervescenti
Date of last revision of the leaflet:May 2022