Leaflet: information for the user

Paracetamol Aristo 1 g tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Followexactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Paracetamol Aristo

3. How to take Paracetamol Aristo

4. Possible side effects

5. Storage of Paracetamol Aristo

6. Contents of the pack and additional information

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

This medicine is used for the symptomatic treatment of mild or moderate pain and fever in adults and adolescents 12 years of age and older and weighing more than 43 kg...

Do not take Paracetamol Aristo:

• if you are allergic (hypersensitive) to paracetamol or to any of the other components of this medication (listed in section 6)

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to takeParacetamol Aristo.

• Do not take more of the medication than recommended in section 3. How to takeParacetamol Aristo.
• Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g/24 hours of paracetamol.
• Do not recommend the consumption of alcohol during treatment.
• Patients with kidney disease due to the 1 g paracetamol content cannot take this medication. Those with liver, heart, or lung diseases and patients with anemia should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as it can reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Inform your doctor before taking this medication if you are an asthmatic patient sensitive to acetylsalicylic acid.
• Paracetamol can cause severe skin reactions, such asacute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions, and the use of the medication should be interrupted at the first sign of skin eruption or any other sign of hypersensitivity.
• The frequent use of analgesics over a long period can cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months, at least on alternate days, do not increase the dose of analgesics, but consult your doctor.

Inform your doctor immediately if you experience any of the following during treatment with paracetamol:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents:

Due to the paracetamol dose, this medication should not be administered to children (under 12 years) or adolescents with a weight of less than 43 kg. Ask your pharmacist about the available presentations that allow for proper dosing of these patients.

Interference with analytical tests::

Inform your doctor if you are to undergo any analytical tests (including blood, urine, etc.) as this medication may alter the results.

Paracetamol may alter the values of blood determinations of uric acid and glucose.

Other medications and Paracetamol Aristo:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, if you are taking any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Medications to prevent blood clots: Oral anticoagulants(acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics(lamotrigine, phenytoin, or other hydantoins, phenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: Isoniazid, rifampicin
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: Cholestyramine
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide)
• Medications used to treat gout: Probenecid and sulfinpyrazone
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid alteration (metabolic acidosis) that must be treated urgently (see section 2).

Paracetamol Aristo with food, drinks, and alcohol:

The consumption of paracetamol by patients who regularly consume alcohol can cause liver damage.

The taking of this medication with food does not affect its efficacy.

Pregnancy and lactation:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. If necessary, Efferalgan 1g can be used during pregnancy.

Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery:

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the medication administration instructions indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

This medication is taken orally.

According to your preferences, the tablets can be taken directly or divided in half with water. The tablets are scored, which allows dividing the tablet into equal doses. Half of the tablet dose is equivalent to 500 mg of paracetamol.

Always take the lower dose that is effective.

The recommended dose is:

Adults and adolescents over 15 years (and weight over 50 kg)

Half or 1 tablet (500 mg-1 g of paracetamol) every 6 – 8 hours, 3 or 4 times a day.

Never exceed 1 gram of paracetamol per dose. Do not take more than 4 g of paracetamol in 24 hours, divided into 4 doses.

Older patients: your doctor will indicate the frequency and if you need to reduce the dose.

Patients with liver disease: you must take the prescribed amount of medication with a minimum interval of 8 hours between each dose.

Do not take more than 2 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:before taking this medication, you must consult your doctor. You must take no more than half a tablet (500 milligrams) per dose.According to your disease, your doctor will indicate if you should take your medication with a minimum interval of 6 or 8 hours.

Use in children and adolescents:

Adolescents over 15 years (weight over 50 kg): follow the adult dosage.?Adolescents from 12 years and weight over 43 kg: can take half a tablet per dose (every 4 - 6 hours), and up to a maximum of 2 and a half tablets in 24 hours This medication is not suitable for children (see section 2: “Warnings and precautions”).

The taking of this medication is subject to the appearance of symptoms, pain, or fever. As these disappear, treatment should be discontinued.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time, as the risk of suffering adverse effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, you should consult your doctor and reevaluate the clinical situation

If you take more Paracetamol Aristo than you should:

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice) and abdominal pain.

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

When you have taken an overdose, the treatment of the overdose is more effective if it is initiated within 4 hours of taking the overdose medication.

Patients undergoing barbiturate treatment or chronic alcoholics, an overdose of paracetamol may be more toxic than for the rest of the patients.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possible adverse effects of Paracetamol Aristo are:

Rare adverse effects that may affect up to 1 in 1,000 people: discomfort, increased levels of transaminases in blood, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare adverse effects that may affect up to 1 in 10,000 people: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Rarely, severe skin reactions have been reported.

Adverse effects of unknown frequency that cannot be estimated from available data: purpura, a serious disease that can make blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or prolonged treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in the prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Aristo:

The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

The other components are: maize pregelatinized starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable-derived magnesium stearate.

Appearance of the product and content of the packaging:

Paracetamol Aristo is presented in the form ofoblong tablets, white in color and scored on one of their faces, in packaging of 20 and 40 tabletsconditioned in aluminum-PVC-PVDC blister packaging.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing:

Laboratorios Medicamentos Internacionales, S.A. (MEDINSA)

c/ Solana, 26

28850 Torrejón de Ardoz

Madrid – Spain

or

Advance Pharma GmbH

Wallenroder Str. 12-14

13435 Berlin

Germany

Last review date of this leaflet: February 2025

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/