Paracetamol Galenicum Vitae 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Galenicum Vitae 500 mg tablets EFG

paracetamol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms of illness, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents

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

1. What Paracetamol Galenicum Vitae is and what it is used for

Paracetamol belongs to a group of medicines called analgesics and antipyretics. It is indicated for the treatment of symptoms of mild to moderate pain and fever.

You should consult a doctor if your condition worsens or does not improve, pain after 5 days, or fever after 3 days.

2. What you need to know before taking Paracetamol Galenicum Vitae

Do not take Paracetamol Galenicum Vitae:

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

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Paracetamol.

Do not exceed the recommended dose indicated in section 3, How to take Paracetamol Galenicum Vitae.

In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

If you have liver, kidney, heart, or lung disease, or if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.

If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce the effectiveness of paracetamol and increase its hepatotoxic potential, especially when high doses of paracetamol are used.

In chronic alcoholics, caution should be taken not to exceed 4 tablets of 500 mg or 2 g of paracetamol per day.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.

Children

For children under 10 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

Taking other medicines and Paracetamol Galenicum Vitae:

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

Paracetamol may interact with the following medicines:

• Medicines used to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines used to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines used to treat tuberculosis: (isoniazid, rifampicin)
• Medicines used to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines used to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Warnings and precautions

During treatment with Paracetamol Galenicum Vitae, 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 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 concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Galenicum Vitae with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor. Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of paracetamol on the ability to drive and operate machinery is none or negligible.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially "sodium-free".

3. How to take Paracetamol Galenicum Vitae

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

Remember to take your medicine. Paracetamol should be taken orally.

The recommended dose is:

Adults and adolescents over 15 years of age: The usual dose is 1 or 2 tablets 3–4 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 8 tablets (4 g) in 24 hours.

Children: It is necessary to respect the dosages defined according to body weight. The child's age corresponding to body weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Children weighing between 33 and 40 kg (aged 10 to 12 years): 1 tablet per dose every 6 hours, up to a maximum of 4 tablets per day.
• Children weighing between 41 and 50 kg (aged 12 to 15 years): 1 tablet per dose every 4 hours, up to a maximum of 6 tablets per day.

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 2 grams or 4 tablets of 500 mg paracetamol in 24 hours.

Patients with kidney disease: Before taking this medicine, you must consult your doctor. Take a maximum of 500 milligrams per dose.

Elderly patients: You should consult your doctor.

Use in children and adolescents:

Do not use in children under 10 years of age.

If you feel that the effect of Paracetamol is too strong or too weak, inform your doctor or pharmacist.

When lower doses than 500 mg of paracetamol per administration are required, other paracetamol formulations adapted to the required dosage should be used.

If you take more Paracetamol Galenicum Vitae than you should:

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

Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Galenicum Vitae:

Do not take a double dose to make up for forgotten doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of severe skin reactions have also been reported.

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Galenicum Vitae

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Paracetamol Galenicum Vitae:

The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components are: sodium starch glycolate from potato (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and contents of the pack:

Paracetamol Galenicum Vitae is presented as white, round, biconvex tablets, in packs of 20 tablets and hospital packs of 500 tablets, packed in PVC/PVdC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Galenicum Vitae, S.L.U.

Calle San Gabriel 50

08950 Esplugues de Llobregat

Spain

Manufacturer:

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Vitae, S.L.U.

Calle San Gabriel 50

08950 Esplugues de Llobregat

Spain

Date of the most recent revision of this leaflet: February 2025

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