PARACETAMOL GALENICUM 500 mg TABLETS

2. What you need to know before taking Paracetamol Galenicum

Do not take Paracetamol Galenicum:

If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (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.

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

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

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

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 medicines and Paracetamol Galenicum:

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for treating tuberculosis: (isoniazid, rifampicin)
• Medicines for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines for lowering cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used for the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used for the treatment of 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 medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. 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, inform your doctor immediately if:

If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or 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 medicine, as it may alter the results of these tests.

Taking Paracetamol Galenicum with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor, 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 medicine.

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

Taking medicines 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 medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

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

3. How to take Paracetamol Galenicum

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, 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: 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 information purposes only.

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 (from 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 (from 12 to 15 years): 1 tablet per dose, every 4 hours, up to a maximum of 6 tablets per day.

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 2 grams or 4 tablets of 500 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, 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.

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

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

If you take more Paracetamol Galenicum 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 medicine 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 be: 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.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Galenicum:

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 interval between doses indicated in each case (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects that may occur (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 (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 treatments.

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

Reporting of 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 Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Galenicum

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

This medicine does not require 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 the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Galenicum:

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 contents of the pack:

Paracetamol Galenicum is presented in the form of biconvex, white, round tablets, in packs of 20 tablets and in a clinical pack of 500 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Galenicum Health, S.L.U

Sant Gabriel, 50

08950 - Esplugues de Llobregat

Barcelona

Spain

Manufacturer:

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat -

08950 Barcelona

Spain

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

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