Leaflet: information for the user

Paracetamol Sandoz Care 500 mg tablets EFG

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

Follow exactly the administration instructions for 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.

1. What isParacetamol Sandoz Careand what it is used for

2. What you need to know before starting to takeParacetamol Sandoz Care

3. How to takeParacetamol Sandoz Care

4. Possible side effects

5. Storage ofParacetamol Sandoz Care

6. Contents of the pack and additional information

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

Paracetamol is used for the treatment of pain of mild to moderate intensity and febrile states in adults and children aged 12 years and above (or body weight of 40 kg or more).

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 particularly careful with Paracetamol Sandoz Care:

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

Inform your doctor immediately during treatment with paracetamol:

- Avoid using this medication with other medications that contain paracetamol, for example, medications for the flu and cold, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor

- In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

- If you have any liver, kidney, heart, or lung disease, or have 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.

- When undergoing treatment with any medication for epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially in treatments with high doses of paracetamol.

- In chronic alcoholics, be careful 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 the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.

- In children under 10 years, 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 renal insufficiency 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 (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 respiratory difficulty 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:

• 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 seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications used to lower blood cholesterol levels: cholestyramine.
• Medications used to increase urine elimination (diuretics such as furosemide).
• Medications used to treat gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used to treat high blood pressure (hypertension) 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 inform your doctor or pharmacist if you are undergoing treatment with another medication. In the case of oral anticoagulants, this medication can be administered occasionally as the preferred analgesic.

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.

Taking Paracetamol Sandoz Care with food, drinks, and alcohol

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

The taking of this medication with food does not affect its efficacy.

Pregnancy and lactation

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

In case of need, this medication can be used during pregnancy. 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, therefore, consult your doctor or pharmacist before taking this medication.

Driving and operating machines

The influence of paracetamol on the ability to drive and operate machines 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 medicine. Paracetamol must be taken orally.

The normal dose is:

Adults and children 12 years of age or older, or a body weight of 40 kg or more:

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.

It is necessary to avoid the use of high daily doses of paracetamol for prolonged periods of time as it increases the risk of suffering 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 worsen or other symptoms appear, you must interrupt the treatment and consult your doctor.

Children: It is necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 doses per day, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

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

Patients with liver disease:

Before taking this medication, you must consult your doctor.

You must take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

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

Patients with kidney disease:

Before taking this medication, you must consult your doctor. Take a maximum of 500 mg per dose.

Older adults: you must consult your doctor.

Use in children and adolescents:

Do not use in children under 12 years of age

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

When requiring the administration of doses less than 500 mg of paracetamol 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 must 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 must go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of 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 medication.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist 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 interval 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 that may occur (in up to 1 in 1,000 people), are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

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

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

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

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 of Pharmacovigilance of Medicines 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 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Sandoz Care:

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

The other components are: potato starch glycolate sodium (Type A), purified water, pregelatinized cornstarch, povidone K30 (E1201), stearic acid (E570) and crospovidone (E1202).

Appearance of the product and contents of the packaging:

Paracetamol Sandoz Care is presented in tablets for oral administration.

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

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Corporate Park North

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

SAG Manufacturing S.L.U

N-I Highway, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Last review date of this leaflet:January 2025

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