Prospect: Information for the user

Paracetamol Aurovitas 1 g powder for oral solution EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Paracetamol Aurovitas

4.Possible adverse effects

5.Storage of Paracetamol Aurovitas

6.Contents of the package and additional information

Paracetamol belongs to the pharmacotherapeutic group of analgesics (medicines that reduce pain) that act at the same time as antipyretics (medicines that lower fever), with weak anti-inflammatory effects.

This medicine is used to reduce fever and relieve mild to moderate pain.

Do not takeParacetamol Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Aurovitas.

•If you have kidney or liver disease (including Gilbert's syndrome or acute hepatitis).

•If you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.

•If you have hemolytic anemia (abnormal breakage of red blood cells).

•If you habitually consume large quantities of alcohol. Never take more than 2 g of paracetamol per day.

•If you are asthmatic and sensitive to acetylsalicylic acid.

•In cases of dehydration or chronic malnutrition.

•If you weigh less than 50 kg.

If you are being treated with medication for epilepsy, consult your doctor before taking paracetamol, as when used together, the efficacy is reduced and the risk of liver damage is increased, especially with high doses of paracetamol.

Prolonged or frequent use is not recommended. Do not take other medications that contain paracetamol at the same time. Taking multiple doses in a single administration can severely damage the liver; however, loss of consciousness does not occur. Nevertheless, seek medical assistance immediately.

If you have high fever, signs of secondary infection, or if symptoms persist for more than 3 days, consult your doctor or pharmacist.

Headaches caused by analgesic abuse should not be treated by increasing the dose of analgesic. In these cases, analgesic use should be done after consulting a doctor.

Do not take paracetamol unless prescribed by your doctor if you have alcohol addiction or liver damage and do not use paracetamol with alcohol. Paracetamol does not potentiate the effect of alcohol.

The risk of overdose is higher in patients with non-cirrhotic alcoholic liver disease. Be cautious in cases of chronic alcoholism.

If you are already taking other analgesics that contain paracetamol, do not take this medication without consulting your doctor or pharmacist first.

Never take more paracetamol than recommended. A higher dose does not increase pain relief and may cause severe liver damage. Liver damage symptoms appear after a few days. It is very important to contact your doctor as soon as possible if you have taken more paracetamol than recommended in this leaflet.

Prolonged use of high doses of analgesics can cause headaches that should not be treated by increasing the dose of analgesic.

General administration of analgesics, particularly a combination of several analgesic medications, can cause permanent damage to the kidneys with a risk of renal insufficiency (analgesic nephropathy).

Do not take this medication for a prolonged period or at high doses without consulting your doctor or dentist.

Taking Paracetamol Aurovitas with other medications

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

Medications that may affect the effects of paracetamol:

•Alcohol.

•Probenecid (a medication used to treat gout).

•Medications that may cause liver damage, for example, phenobarbital (a sleeping medication), phenytoin, carbamazepine, primidone (medications used to treat epilepsy), isoniazid, rifampicin (medications used to treat tuberculosis), St. John's Wort (a medication based on plants to treat depression). The simultaneous use of these medications with paracetamol may cause liver damage.

•Metoclopramide and domperidone (medications used to treat nausea). They may increase the absorption and onset of paracetamol effects.

•Medications that delay gastric emptying. They may delay the absorption and onset of paracetamol effects.

•Colestyramine (a medication used to reduce high serum lipid levels). They may decrease the absorption and onset of paracetamol effects. Therefore, do not take colestyramine within one hour of paracetamol administration.

•Anticoagulant medications, especially warfarin. Repeated administration of paracetamol for more than a week increases the propensity for bleeding. Therefore, prolonged administration of paracetamol should only be done under medical supervision. Occasional administration of paracetamol has no significant effect on the propensity for bleeding.

•Flucloxacillin (an antibiotic), due to a severe risk of blood and fluid alteration (metabolic acidosis with high anion gap) that must be treated urgently and that may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

The simultaneous use of paracetamol and zidovudine (a medication used to treat HIV infection) increases the propensity for neutropenia (a decrease in white blood cells). This can affect the immune system and increase the risk of infections. Therefore, paracetamol should only be administered with zidovudine under medical advice.

Effect of paracetamol administration on analytical tests

Urinary acid and blood sugar determinations may be affected.

Taking Paracetamol Aurovitas with food, drinks, and alcohol

Alcohol consumption should be avoided during paracetamol treatment.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Paracetamol can be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever do not decrease or if you need to take the medication more frequently.

Driving and operating machinery

Paracetamol use does not affect the ability to drive or operate machinery.

Paracetamol Aurovitas contains saccharose and aspartame (E951)

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains 40.00 mg of aspartame per gram of oral solution powder. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 23 mg of sodium (1 mmol); that is, it is essentially "sodium-free".

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

The dose depends on the data in the following table. The paracetamol dose depends on age and body weight.

The respective administration intervals depend on symptoms and maximum daily dose. A minimum interval of 6 hours between doses should be respected, which means a maximum of 4 times a day.

If symptoms persist for more than 3 days, you should consult a doctor.

1 g tablets:

This medication is not recommended for children and adolescents under 16 years old.

Form/administration route

Paracetamol is administered orally.

Shake the tablet before use. Pour the contents of the tablet into a glass and add a small amount of liquid (e.g., water, milk, fruit juice).

Special patient groups

Renal function impairment

When administering paracetamol to patients with renal function impairment, it is recommended to reduce the dose and increase the minimum interval between each dose to at least 6 hours, unless a doctor indicates otherwise.

This medication is not suitable for patients with renal function impairment who require a dose reduction. Other pharmaceutical forms are available for these cases.

Liver function impairment

In the following situations, the maximum daily dose should not exceed 60 mg/kg/day (up to 2 g/day):

•Adults with a body weight under 50 kg.

•Mild to moderate hepatic insufficiency, Gilbert syndrome (familial non-hemolytic jaundice).

•Dehydration.

•Chronic malnutrition.

Older adults

Experience indicates that the usual adult dose is usually sufficient. However, in frail, immobile older adults or older adults with renal or hepatic insufficiency, it may be advisable to reduce the dose or administration frequency.

Children and adolescents with low body weight

The 1 g paracetamol dose is not suitable for children or adolescents under 16 years old and with a body weight under 55 kg, as the dose is not suitable for this age group. Other doses/formulations are available for these patients.

If you take moreParacetamolAurovitasthan you should

IN CASE OF OVERDOSE, SEEK MEDICAL ASSISTANCE IMMEDIATELY, EVEN IF YOU FEEL WELL, due to the risk of severe late liver damage. The symptoms of paracetamol overdose are nausea, vomiting, and decreased appetite. Loss of consciousness usually does not occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeParacetamolAurovitas

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects are listed below and are classified as:

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

•Various blood disorders including agranulocytosis, thrombocytopenia, thrombotic purpura, hemolytic anemia, leukopenia, platelet disorders (coagulation disorders) and disorders of the hematopoietic cells (bone marrow disorders).

•Allergic reactions.

•Depression, confusion, hallucinations.

•Tremor, headache.

•Visual disturbances.

•Edema (abnormal accumulation of fluid under the skin).

•Abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting.

•Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver necrosis (death of liver cells).

•Skin rash, itching, sweating, urticaria, red skin patches, angioedema with symptoms such as facial swelling, lips, throat, or tongue.

•Dizziness, general discomfort, fever, sedation, interaction with other medications.

•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 requiring discontinuation of treatment, including angioedema, difficulty breathing, sweating, nausea, hypotension, shock, and anaphylaxis.

•Low blood sugar levels.

•Hepatotoxicity (liver damage caused by chemical substances).

•Cloudy urine and kidney disorders.

•Bronchospasm (difficulty breathing) in patients sensitive to acetylsalicylic acid and other anti-inflammatory medications.

•Hematuria (blood in the urine).

•Anuria (inability to urinate).

Unknown frequency(frequency cannot be estimated from available data)

•Acute generalized exanthematous pustulosis (drug eruption characterized by numerous small, sterile pustules, mainly non-follicular).

•Severe skin rash or skin peeling.

•Stevens-Johnson syndrome (severe skin disorder potentially fatal).

•Redness of the skin, blisters, or rash due to paracetamol intake.

Once you stop taking the medicine, these side effects should disappear. If any of them worsen, consult your doctor or pharmacist.

Reporting side effects

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

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

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

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofParacetamol Aurovitas

-The active ingredient is paracetamol. Each sachet contains 1 g of paracetamol.

-The other components are: sucrose, sodium saccharin, aspartame (E951), povidone (K-30) and orange aroma.

Appearance of the product and contents of the packaging

Oral solution powder.

Paracetamol Aurovitas is available in packaging with 10, 12, 16, 20 and 40 sachets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora, 2700-487

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).