PARACETAMOL SANDOZ CARE 500 mg TABLETS

2. What you need to know before taking Paracetamol Sandoz Care

Do not take Paracetamol Sandoz Care:

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

Be cautious when taking Paracetamol Sandoz Care:

• Do not take more medication than recommended in section 3. How to take Paracetamol Sandoz Care

During treatment with paracetamol, immediately inform your doctor:

• You should avoid taking this medication simultaneously with other medications that contain paracetamol, such as medications for the flu and colds, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, you should consult 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 your doctor before taking this medication.
• When you are being treated with medication for epilepsy, you should consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, you should be cautious not to take more than 4 tablets of 500 mg or 2 grams 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 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 that are suitable for this group of patients.
• 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medications and Paracetamol Sandoz Care:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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: barbiturics (used as hypnotics, sedatives, and anticonvulsants).
• Medications for reducing cholesterol levels in the blood: colestyramine.
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used for treating gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used for treating 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, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests:

If you are going to undergo any analytical test (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 Sandoz Care with food, drinks, and alcohol

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

Taking this medication 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 medication.

If necessary, this medication 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 medication 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 medication.

Driving and using machines

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

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

3. How to take Paracetamol Sandoz Care

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

The normal dose is:

Adults and children over 12 years old, or with a body weight of 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.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

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 stop treatment and consult your doctor.

Children: It is necessary to respect the defined dosages based on weight. The child's age based on weight is provided 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: 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Between 41 and 50 kg in weight: 1 tablet per dose, every 4-6 hours, up to a maximum of 6 tablets per day.

Patient with liver disease:

Before taking this medication, they must consult their doctor.

They should take the prescribed amount of medication by their doctor, with a minimum interval of 8 hours between each dose.

They should not take more than 2 grams (4 tablets of 500 mg) of paracetamol in 24 hours.

Patient with kidney disease:

Before taking this medication, 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 you think 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 that adapt to the required dosage should be used.

If you take more Paracetamol Sandoz Care than you should:

You should consult your doctor or pharmacist immediately.

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

If you have taken 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.

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

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 Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Paracetamol Sandoz Care:

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 (at least 4 hours).

4. Possible side effects

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

Rare side effects that may 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 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.

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).

Paracetamol can damage the liver when taken in high doses or during prolonged treatment.

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 Sandoz Care

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 CAD. 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 collection point in the pharmacy. In case of doubt, 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 Sandoz Care:

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

The other components 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 Sandoz Care is presented in tablets for oral administration.

The tablets are biconvex, white, and round in shape.

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

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

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