Leaflet: information for the user

Paracetamol Sandoz Care 1 g tablets

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 is Paracetamol Sandoz Care and what it is used for

2.What you need to know before starting to take Paracetamol Sandoz Care

3.How to take Paracetamol Sandoz Care

4.Possible side effects

5.Storage of Paracetamol 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 moderate intensity pain and febrile states in adults and adolescents aged 16 years and above (or body weight of 50 kg and above).

Do not take Paracetamol Sandoz Care.

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

Be careful with Paracetamol Sandoz Care:

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

Inform your doctor immediately during treatment with paracetamol:

• Avoid using this medicine with other medicines that contain paracetamol, for example, cold and flu medicines, as high doses can cause liver damage. Do not use more than one medicine that contains 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 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 medicine.
• When taking antiepileptic medication, consult your doctor before taking this medicine, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially with high doses of paracetamol.
• In chronic alcoholics, be careful not to take more than 2 g in 24 hours of paracetamol.
• If the pain lasts for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• For adolescents under 16 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. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medicines and Paracetamol Sandoz Care:

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

Paracetamol may interact with the following medicines:

• Medicine to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methyphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: isoniazid, rifampicin.
• Medicines to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood: cholestyramine.
• Medicines used to increase urine elimination (diuretics such as furosemide).
• Medicines used to treat gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anionic imbalance) that must be treated urgently and that may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that must be treated urgently (see section 2).

Do not use with other painkillers (medicines that reduce pain) without consulting your doctor.

As a general rule for any medicine, it is recommended to inform your doctor or pharmacist systematically if you are taking another medicine. In the case of treatment with oral anticoagulants, it may be administered occasionally as a 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 medicine, 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 (3 or more alcoholic beverages per day: beer, wine, liquor…) may cause liver damage.

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

Pregnancy and breastfeeding

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

In case of need, Paracetamol Sandoz Care may 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 medicine more frequently.

Small amounts of paracetamol may appear in breast milk, therefore, consult your doctor or pharmacist before taking this medicine.

Driving and operating machines

The influence of paracetamol on the ability to drive and operate machines is negligible or insignificant.

Paracetamol Sandoz Care contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”.

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 adolescents over 16 years:

The usual dose is 1 tablet (1 g of paracetamol) 3 times a day.Doses should be spaced at least 4 hours apart. No more than 3 grams (3 tablets) should be taken in 24 hours.

High daily doses of paracetamol should be avoided for prolonged periods of time 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 if the pain or fever worsen or other symptoms appear, treatment should be discontinued and your doctor consulted.

Patients with liver disease:

Before taking this medication, you must consult your doctor.

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

You should not take more than 2 tablets of paracetamol in 24 hours, divided into 2 doses.

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, 1 g of paracetamol is not indicated for this group of patients.

Older patients:

You should consult your doctor.

Use in children and adolescents:

Not to be used in children and adolescents under 16 years.

If it is estimated that the action of paracetamol is too strong or too weak, inform your doctor or pharmacist. When administration of doses less than 1 g of paracetamol per dose is required, other presentations of paracetamol should be used that adapt to the required dosing.

If you take more Paracetamol Sandoz Carethan 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 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 a paracetamol overdose.

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 forget 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 that may occur (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 (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.

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

Unknown frequency (cannot be estimated from available data): A serious 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 leaflet. 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 about 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/EXP. 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 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 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 1 g of paracetamol.
• The other components are: potato starch glycolate sodium (Type A), pregelatinized maize starch, 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 oblong, biconvex, white in color, with a groove on one face and marked with PC on the other face.

The packaging is 10 tablets, conditioned 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 Building Oak

Serrano Galvache Street, 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 Street, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Last review date of this leaflet: January 2025

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