Leaflet: information for the user

Paracetamol Sandoz Care 650 mg tablets EFG

Read this leaflet carefully before you start to take this medicine, because it contains important information for you

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

This medicine can be purchased without a prescription. Nevertheless, for 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 any 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.

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

Paracetamol is used for the treatment of mild to moderate pain and febrile states in adults and adolescents 15 years of age and older (or a body weight of 50 kg or more).

Do not take Paracetamol Sandoz Care

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

Be particularly careful with Paracetamol Sandoz Care:

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

Inform your doctor immediately during treatment with paracetamol:

-Use of this medication with other medications containing paracetamol, such as cold and flu medications, should be avoided as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

-In patients sensitive to aspirin, consult your doctor before taking this medication.

• If you have liver, kidney, heart, or lung disease, or anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.
• If you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as the combination may reduce its effectiveness and increase the risk of liver damage, especially with high doses of paracetamol.
• In chronic alcoholics, be careful not to take more than 2g of paracetamol in 24 hours.
• If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate your clinical condition.
• In children and adolescents under 15 years old, consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.
• If you have severe diseases, 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 severe 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medications and Paracetamol Sandoz Care

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Paracetamol may interact with the following medications:

• Blood thinners: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for tuberculosis: (isoniazid, rifampicin)
• Medications for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid 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 severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other pain relievers without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are being treated with another medication. In the case of oral anticoagulants, this medication can be used occasionally as a pain reliever of choice.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Paracetamol Sandoz Care with food, drinks, and alcohol

Use of paracetamol in patients who regularly 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 lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication can be used during pregnancy if necessary. 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 do not decrease or if you need to take the medication more frequently.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

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

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

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

The usual dose is:

Adults and adolescents over 15 years:

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.

It is recommended to avoid high daily doses of paracetamol for prolonged periods of time as it 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 if the pain or fever worsens or other symptoms appear, you should interrupt treatment and consult your doctor.

Patients with kidney disease:

Before taking this medication, you must consult your 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.

Older adults:should consult your doctor

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

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

When requiring doses lower than 650 mg of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

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, yellowish discoloration 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 the symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the overdose of the medication.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of paracetamol.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol Sandoz Care

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare adverse effects may affect up to 1 in 1,000 people::discomfort, hypotension (blood pressure drop), and increased levels of transaminases in the blood.

Very rare adverse effects may affect up to 1 in 10,000 people: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (blood sugar drop). Severe skin reactions have been reported very rarely.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medicines that you no longer need.This will help protect the environment.

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 maize starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and contents of the packaging

Paracetamol Sandoz Careis presented in oral tablets.

The tablets are oblong, biconvex, white in color, with a groove 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, conditioned in a PVC/PVDC/Aluminum blister.

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Corporate Park North

Roble Building

Serrano Galvache Street, 56

28033 Madrid

Spain

Responsible for manufacturing:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

or

SAG Manufacturing S.L.U

Highway N-I, Km 36

28750 San Agustin de Guadalix,

Madrid – Spain

Last review date of this leaflet:January 20225

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/