Paracetamol Sandoz Care 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Sandoz Care 1 g tablets

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse.

This medicine is available without a prescription. However, to achieve the best results, it must be used with care.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if fever persists for more than 3 days of treatment, or if pain lasts longer than 5 days.

Leaflet contents

1. What Paracetamol Sandoz Care is and what it is used for
2. What you need to know before taking Paracetamol Sandoz Care
3. How to take Paracetamol Sandoz Care
4. Possible side effects
5. How to store Paracetamol Sandoz Care
6. Contents of the pack and other information

1. What Paracetamol Sandoz Care is and what it is used for

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

Paracetamol is used for the treatment of moderate pain and febrile conditions in adults and adolescents aged 16 years and older (or with a body weight above 50 kg).

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 medicine (listed in section 6).

Take special care with Paracetamol Sandoz Care:

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

During treatment with paracetamol, inform your doctor immediately:

• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• If you are an asthmatic patient sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• If you are being treated with antiepileptic medicines, consult your doctor before taking this medicine, as their combined use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.
• In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.
• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reassess the clinical situation.
• In adolescents under 16 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.
• If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Other medicines and Paracetamol Sandoz Care:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines for treating epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: isoniazid, rifampicin.
• Medicines for treating depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol levels: colestyramine.
• Medicines used to increase urine output (loop diuretics such as furosemide).
• Medicines used in the treatment of gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

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

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Taking Paracetamol Sandoz Care with food, drinks and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding:

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

Paracetamol Sandoz Care may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

The effect of paracetamol on the ability to drive or operate machinery is negligible or non-existent.

Paracetamol Sandoz Care contains sodium:

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

3. How to take Paracetamol Sandoz Care

Follow these instructions unless your doctor has given you different ones. Remember to take your medicine. Paracetamol is taken orally.

The usual dose is:

Adults and adolescents over 16 years of age:

The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

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

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be discontinued and a doctor consulted.

Patients with liver disease:

Before taking this medicine, they must consult their doctor.

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

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

Patients with kidney disease:

Before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose.

Due to the dosage, 1 g of paracetamol is not indicated for this group of patients.

Elderly patients:

They should consult their doctor.

Use in children and adolescents:

Do not use in children and adolescents under 16 years of age.

If you feel that the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses than 1 g of paracetamol per dose are required, other paracetamol formulations appropriate for the required dosage should be used.

If you take more Paracetamol Sandoz Care than you should:

You should contact your doctor or pharmacist immediately.

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

If you have ingested an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Sandoz Care:

Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of severe skin reactions have also been reported.

Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Sandoz Care

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Sandoz Care:

• The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
• The other components are: sodium starch glycolate from potato (Type A), 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 as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PC" on the other side.

The packs contain 10 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 most recent revision of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/