Paracetamol Aurovitas 1 g powder for oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Paracetamol Aurovitas 1 g oral solution powder EFG

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

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

Leaflet Contents

1. What Paracetamol Aurovitas is and what it is used for
2. What you need to know before taking Paracetamol Aurovitas
3. How to take Paracetamol Aurovitas
4. Possible side effects
5. How to store Paracetamol Aurovitas
6. Contents of the pack and other information

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

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

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

2. What you need to know before taking Paracetamol Aurovitas

Do not take Paracetamol Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before taking 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 breakdown of red blood cells).
• If you regularly consume large amounts of alcohol. Never take more than 2 g of paracetamol per day.
• If you are asthmatic and sensitive to acetylsalicylic acid.
• In case of dehydration or chronic malnutrition.
• If you weigh less than 50 kg.

If you are being treated with any medication for epilepsy, you should consult your doctor before taking paracetamol, as when used together, the efficacy of paracetamol may be reduced and the risk of liver damage may be increased, especially with high-dose paracetamol treatment.

Prolonged or frequent use is not recommended. Do not take other medicines containing paracetamol at the same time. Taking multiple daily doses in a single administration can severely damage the liver; in such cases, loss of consciousness does not occur. However, immediate medical assistance must be sought.

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

Headaches caused by analgesic overuse should not be treated by increasing the analgesic dose. In such cases, analgesics should only be used 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 together with alcohol. Paracetamol does not enhance the effect of alcohol.

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

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

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

With prolonged use of high doses of analgesics, headaches may occur that should not be treated by increasing the analgesic dose.

In general, habitual use of analgesics, particularly a combination of different analgesic medicines, may cause permanent kidney damage with risk of kidney failure (analgesic nephropathy).

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

During treatment with paracetamol, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Taking Paracetamol Aurovitas with other medicines

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

Medicines that may affect the effects of paracetamol:

• Alcohol.
• Probenecid (a medicine used to treat gout).
• Medicines that may cause liver damage, for example, phenobarbital (a sleeping medicine), phenytoin, carbamazepine, primidone (medicines used to treat epilepsy), isoniazid, rifampicin (medicines used to treat tuberculosis), St. John's wort (a herbal medicine used to treat depression). Concurrent use of these medicines with paracetamol may cause liver damage.
• Metoclopramide and domperidone (medicines used to treat nausea). These may increase the absorption and onset of action of paracetamol.
• Medicines that delay gastric emptying. These may delay the absorption and onset of action of paracetamol.
• Colestipol (a medicine used to reduce high serum lipid levels). These may reduce the absorption and onset of action of paracetamol. Therefore, colestipol should not be taken within one hour after administration of paracetamol.
• Medicines to make the blood thinner (oral anticoagulants, especially warfarin). Repeated administration of paracetamol for more than one week increases the tendency to bleed. Therefore, prolonged administration of paracetamol should only be done under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

Concurrent use of paracetamol and zidovudine (a medicine used to treat HIV infection) increases the risk of reduced white blood cells (neutropenia). This may 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 laboratory tests

Analytical determinations of uric acid and blood sugar may be affected.

Taking Paracetamol Aurovitas with food, drinks, and alcohol

Alcohol consumption should be avoided during treatment with paracetamol.

Pregnancy, breastfeeding, and fertility

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

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not subside or if you need to take the medicine more frequently.

Driving and using machines

The use of paracetamol does not affect the ability to drive or operate machinery.

Paracetamol Aurovitas contains sucrose and aspartame (E951)

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 40.00 mg of aspartame per gram of oral solution powder. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially "sodium-free".

3. How to take Paracetamol Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The respective dosing intervals depend on symptoms and the maximum daily dose. A minimum interval of at least 6 hours should be maintained between doses, meaning a maximum of 4 doses per day.

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

1 g sachets:

This medicine is not recommended for children and adolescents under 16 years of age.

Route/administration method

Paracetamol is administered orally.

Shake the sachet before use. Empty the contents of the sachet 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 impaired renal function, it is recommended to reduce the dose and increase the minimum interval between doses to at least 6 hours, unless otherwise directed by a physician.

This medicine is not suitable for patients with impaired renal function who require dose reduction. Other more appropriate pharmaceutical forms are available for these cases.

Hepatic function impairment

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

• Adults weighing less than 50 kg.
• Mild to moderate hepatic insufficiency, Gilbert's syndrome (familial non-haemolytic jaundice).
• Dehydration.
• Chronic malnutrition.

Elderly patients

Experience indicates that the normal adult dose is usually adequate. However, in elderly, frail and immobile patients, or in elderly patients with renal or hepatic impairment, it may be advisable to reduce the dose or frequency of administration.

Children and adolescents with low body weight

The 1 g paracetamol dose is not suitable for children or adolescents under 16 years of age and weighing less than 55 kg, as the dose is not appropriate for this age group. Other more suitable doses/formulations are available for these patients.

If you take more Paracetamol Aurovitas than you should

IN CASE OF OVERDOSE, SEEK IMMEDIATE MEDICAL ASSISTANCE, EVEN IF YOU FEEL WELL, due to the risk of delayed severe liver damage. Symptoms of paracetamol overdose include nausea, vomiting, and loss of appetite. Loss of consciousness generally does not occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Paracetamol Aurovitas

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The possible adverse effects are listed below and are classified as follows:

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

• Various blood disorders including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hemolytic anemia, leukopenia, platelet disorders (coagulation disorders), and cytopoietic disorders (disorders of blood-forming cells in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disorders.
• 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), hepatic necrosis (death of liver cells).
• Skin rash, itching, sweating, urticaria, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat, or tongue.
• Dizziness, general malaise, fever, sedation, interaction with other medicines.
• Overdose and poisoning.

Very rare adverse 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, breathing difficulty, 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 medicines.
• Hematuria (blood in the urine).
• Anuria (inability to urinate).

Frequency not known (frequency cannot be estimated from the available data)

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in severely ill patients using paracetamol (see section 2).
• Generalized acute exanthematous pustulosis (drug eruption characterized by numerous small, sterile, mainly non-follicular pustules).
• Severe skin rash or skin peeling.
• Stevens-Johnson syndrome (a serious, potentially life-threatening skin disorder).
• Skin redness, blisters, or rash due to ingestion of paracetamol.

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

Reporting of 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 this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and outer packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be handed over to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Aurovitas

• The active substance is paracetamol. Each sachet contains 1 g of paracetamol.
• The other components are: sucrose, sodium saccharin, aspartame (E951), povidone (K-30) and orange flavour.

Appearance of the medicinal product and contents of the pack

Powder for oral solution.

Paracetamol Aurovitas is available in packs containing 10, 12, 16, 20 and 40 sachets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora, 2700-487

Portugal

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

Date of the last review of this leaflet: January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).