Paracetamol Sandoz Care 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Sandoz Care 650 mg tablets EFG

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

Follow exactly the instructions for administration of this medicine contained in this leaflet or as directed by your doctor, pharmacist, or nurse.

This medicine is available without a prescription. However, to obtain the best results, it must be used carefully.

• 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen or if fever persists beyond 3 days of treatment or pain beyond 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 mild to moderate pain and febrile conditions in adults and adolescents aged 15 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 to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Take special care with Paracetamol Sandoz Care:

• Do not take more 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.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
  • If you have liver, kidney, heart or lung disease, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.
  • If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as the combined use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
  • 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, you should consult your doctor and reevaluate your clinical condition.
  • In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other dosage forms are available that are better suited for this patient group.
  • 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 over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Other medicines and Paracetamol Sandoz Care

Inform your doctor or pharmacist if you are 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 epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine elimination (loop 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 (cardiac arrhythmias): Propranolol
• 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 relieve 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 another medicine. In patients treated with 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 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 drinks: beer, wine, spirits, etc., per day) 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, this medicine may be used during pregnancy. 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 influence of this medicine on the ability to drive and use machines is negligible or none.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; 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 to be taken orally.

Remember to take your medicine. Paracetamol is to be taken orally.

The usual dose is:

Adults and adolescents over 15 years of age:

The usual dose is 1 tablet (650 mg paracetamol) every 4–6 hours. Doses should be spaced at least 4 hours apart. Do not exceed 3 grams (4 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, discontinue treatment and consult your doctor.

Patients with kidney disease:

Must consult their doctor before taking this medicine. Maximum dose per intake: 500 mg. Due to the dosage (650 mg paracetamol), this product is not indicated for this patient group.

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 feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When lower doses than 650 mg of paracetamol per intake are required, other paracetamol formulations suitable for the required dosage should be used.

If you take more Paracetamol Sandoz Care than 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 taken an overdose, 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 overdose.

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, go immediately to a medical center or call the Toxicology Information Service (telephone: 91 562 04 20), stating the name of the medicine 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 missed dose as soon as you remember, and then 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 everybody gets them.

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

Very rare adverse effects (may affect up to 1 in 10,000 people): 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 been reported.

Paracetamol may cause liver damage when taken at 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 critically ill patients using 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 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 EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Sandoz Care

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

The other components (excipients) are sodium starch glycolate from potato (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 as oral tablets.

The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PB" on the other. The tablet can be divided into two equal parts.

Packs contain 20 tablets, packaged in PVC/PVDC/Aluminium blisters.

Marketing Authorisation Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 most recent revision of this leaflet: January 2025

Detailed 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/