PARACETAMOL SAG MANUFACTURING 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol SAG Manufacturing 500 mg Tablets EFG

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

This medicine can be obtained without a prescription. However, to get the best results, it should be used with care.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• - You should consult your doctor if the fever worsens or persists after 3 days of treatment or the pain lasts for more than 5 days.

Contents of the Package Leaflet

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

1. What is Paracetamol SAG Manufacturing and what is it used for

Paracetamol belongs to the group of medicines called analgesics and antipyretics.

Paracetamol is used for the treatment of mild to moderate pain and febrile states in adults and children over 12 years old (or with a body weight over 40 kg).

2. What you need to know before taking Paracetamol SAG Manufacturing

Do not take Paracetamol SAG Manufacturing:

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

Be careful with Paracetamol SAG Manufacturing:

• Do not take more than the recommended dose of medicine as stated in section 3. How to take Paracetamol SAG Manufacturing.
• Avoid simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, or have anemia (reduced hemoglobin levels in the blood), you should consult your doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity increased when used together, especially with high doses of paracetamol.
• In chronic alcoholics, be cautious not to take more than 4 tablets of 500 mg or 2 grams of paracetamol per day.
• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, consult your doctor and reevaluate the clinical situation.

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

Other medicines and Paracetamol SAG Manufacturing:

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 convulsions: barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medicines for reducing cholesterol levels in the blood: cholestyramine
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used for treating gout: probenecid and sulfinpyrazone
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
• Medicines used for treating high blood pressure and heart rhythm disorders: 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, it can be administered occasionally as the analgesic of choice.

Warnings and precautions

During treatment with Paracetamol SAG Manufacturing, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol 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 analytical tests:

If you are going to have any analytical tests (including blood tests, 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 SAG Manufacturing with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and Breastfeeding

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

In case of necessity, Paracetamol SAG Manufacturing can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Small amounts of paracetamol may appear in breast milk; therefore, 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 negligible.

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

3. How to take Paracetamol SAG Manufacturing

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

Adults and children over 12 years old, or with a body weight over 40 kg:

Take 1 tablet every 4-6 hours as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams of paracetamol in 24 hours. The doses should be spaced at least 4 hours apart.

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.

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

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: 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Between 41 and 50 kg: 1 tablet per dose, every 4-6 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 prescribed amount of medicine 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 mg per dose.

Elderly patients: should consult their doctor.

Use in children and adolescents:

Do not use in children under 12 years old.

If the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.

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

If you take more Paracetamol SAG Manufacturing than you should:

Consult your doctor or pharmacist immediately.

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

If you have taken an overdose, 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.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.

Patient treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

If you forget to take Paracetamol SAG Manufacturing:

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the following doses with the indicated separation between doses (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 can occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

Very rare side effects that can 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, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Paracetamol can 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 disease using paracetamol (see section 2).

Reporting of side effects

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

5. Storage of Paracetamol SAG Manufacturing

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. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, 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 SAG Manufacturing:

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

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

Appearance of the product and pack contents:

Paracetamol SAG Manufacturing is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face.

The packaging is 20 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Galenicum Health, S.L.

Av. Diagonal 123, 11th floor

08005 – 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, 7th-1st, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona

Spain

Date of the last revision of this 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/