PARACETAMOL GALENICUM VITAE 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Galenicum Vitae 500 mg Coated Tablets EFG

paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

Contents of the Package Leaflet

1. What is Paracetamol Galenicum Vitae and what is it 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. Storage of Paracetamol Galenicum Vitae
6. Package Contents and Additional Information

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

Paracetamol belongs to the group of medications 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 the pain worsens or does not improve after 5 days, or if the fever worsens or does not improve 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 medication (listed in section 6)

Warnings and Precautions:

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

Do not take more than the recommended dose in section 3. How to take Paracetamol Galenicum Vitae.

In patients with asthma who are sensitive to acetylsalicylic acid, you should consult with your doctor before taking this medication.

If you have any liver, kidney, heart, or lung disease, or if you have anemia (decreased hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult with your doctor before taking this medication.

When you are being treated with any medication for epilepsy, you should consult with your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially in high-dose treatments.

In chronic alcoholics, you should be cautious not to take more than 4 tablets of 500 mg or 2 g per day of paracetamol.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should discontinue treatment and consult your doctor.

Children

In children under 10 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Taking other medications and Paracetamol Galenicum Vitae:

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

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics 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 and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, paracetamol may be administered occasionally as the analgesic of choice.

Warnings and Precautions

During treatment with Paracetamol Galenicum Vitae, inform your doctor immediately if:

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

Interference with Laboratory Tests:

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, 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 regularly consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor, etc.) may cause liver damage.

Taking this medication 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, or think you may be pregnant or plan to become pregnant, consult your doctor before taking this medication.

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor. Small amounts of paracetamol may be present in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medication.

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

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

3. How to Take Paracetamol Galenicum Vitae

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

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

The recommended dose is:

Adults and adolescents over 15 years: the usual dose is 1 or 2 tablets 3-4 times a day. The 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 weight. The age of the child according to weight is given for informational purposes.

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

• Children between 33 and 40 kg in weight (10 to 12 years): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
• Between 41 and 50 kg in weight (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 medication, they must consult their doctor. They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose. Do not take more than 2 grams or 4 tablets of 500 mg of paracetamol in 24 hours.

Patients with kidney disease: before taking this medication, they must consult their doctor. Take a maximum of 500 milligrams per dose.

Elderly patients: they should consult their doctor.

Use in children and adolescents:

Do not use in children under 10 years of age.

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

When a dose lower than 500 mg of paracetamol per dose is required, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Galenicum Vitae than you should:

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

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

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

Treatment of overdose is more effective if started within 4 hours of taking the medication.

Patients being treated 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 forgotten dose when you remember, taking the next doses with the indicated interval between doses (at least 4 hours).

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Rare side effects that may occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Paracetamol may damage the liver when taken in high doses or for prolonged periods.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Galenicum Vitae

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Galenicum Vitae:

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

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

Appearance of the Product and Package Contents:

Paracetamol Galenicum Vitae is presented in the form of biconvex tablets, white in color and round in shape, in packages of 20 tablets and in a clinical package of 500 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Galenicum Vitae, S.L.U.

San Gabriel Street 50

08950 Esplugues de Llobregat

Spain

Manufacturer:

SAG Manufacturing S.L.U

N-I Highway, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Vitae, S.L.U.

San Gabriel Street 50

08950 Esplugues de Llobregat

Spain

Date of the last revision of this package leaflet: February 2025

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