PARACETAMOL SANDOZ CARE 650 mg TABLETS

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

Do not take Paracetamol Sandoz Care

• If you are allergic to paracetamol or 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, inform your doctor immediately:

• 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 lead to 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 (a decrease in 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 any 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 2g of paracetamol in 24 hours.
• 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 and adolescents under 15 years of age, consult your doctor or pharmacist, as there are other formulations 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:

• Medications 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 for reducing cholesterol levels in the blood: (cholestyramine)
• 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 anomalies (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 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 Sandoz Care with food, beverages, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) 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 this medication on the ability to drive and use machines is negligible or nonexistent.

This medication contains less than 1 mmol of sodium (23 mg) per film-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.

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

The normal dose is:

Adults and adolescents over 15 years of age:

The usual dose is 1 tablet (650 mg of paracetamol) every 4-6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (4 tablets) in 24 hours.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse 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 discontinue treatment and consult your doctor.

Patient with kidney disease:

Before taking this medication, they must consult their doctor. Take a maximum of 500 mg per dose. Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: Do not use in children and adolescents under 15 years of age.

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

When lower doses of paracetamol are required (less than 650 mg per dose), other formulations of paracetamol that are suitable for 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 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 taking the overdose, even in cases of severe poisoning.

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

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

In case of overdose or accidental ingestion, go to a medical center 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 between doses (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, which may affect up to 1 in 1,000 people, include: discomfort, hypotension (low blood pressure), and increased levels of transaminases in the blood.

Very rare side effects, which may affect up to 1 in 10,000 people, include: 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 can cause liver damage 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 Pharmacovigilance System for Human Use Medications: 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 the 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 collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Sandoz Care

Each tablet contains 650 milligrams of paracetamol as the active ingredient.

The other components (excipients) are sodium 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 Sandoz Care is presented in film-coated tablets for oral administration.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PB on the other face. The tablet can be divided into two equal halves.

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

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid – Spain

Date of the last revision of this package leaflet:January 20225

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/