PARACETAMOL SANDOZ CARE 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Sandoz Care 1 g Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

This medication can be purchased without a prescription. Nevertheless, to obtain the best results, it should be used with caution.

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

Contents of the Package Leaflet

1. What is Paracetamol Sandoz Care and what is it 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. Storage of Paracetamol Sandoz Care
6. Package Contents and Additional Information

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

Paracetamol belongs to the group of medications called analgesics and antipyretics.

Paracetamol is used for the treatment of moderate-intensity pain and febrile states in adults and adolescents from 16 years old (or with a body weight over 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 medication (listed in section 6).

Be cautious with Paracetamol Sandoz Care:

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

During treatment with paracetamol, immediately inform your doctor:

• You should avoid taking this medication simultaneously with other medications that contain paracetamol, such as medications for the flu and colds, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.
• If you have any liver, kidney, heart, or lung disease, or if you have anemia (decreased hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medication.
• When you are being treated with any medication for epilepsy, you should consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, you should be cautious not to take more than 2 g of paracetamol in 24 hours.
• 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 consult your doctor and reevaluate the clinical situation.
• In adolescents under 16 years old, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.
• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic), a serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties 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 recently used, 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 convulsions: barbiturics (used as hypnotics, sedatives, and anticonvulsants).
• Medications for reducing cholesterol levels in the blood: colestyramine.
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used for treating gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used for treating high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis with high anion imbalance) that should be treated urgently and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that should receive 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 systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests:

If you are going to undergo any analytical test (including blood tests, urine tests, skin tests that use 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 habitually consume alcohol (3 or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy and breastfeeding:

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

If necessary, Paracetamol Sandoz Care can be used during pregnancy. You should use the lowest possible dose that reduces the pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

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

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is zero or insignificant.

Paracetamol Sandoz Care contains sodium:

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

3. How to take Paracetamol Sandoz Care

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 old:

The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The 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 during prolonged periods, as the risk of side effects such as liver damage increases.

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 stop the treatment and consult your doctor.

Patient with liver disease:

Before taking this medication, they must consult their doctor.

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

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

Patient with kidney disease:

Before taking this medication, they must consult their 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.

Elderly patients:

They should consult their doctor.

Use in children and adolescents:

Do not use in children and adolescents under 16 years old.

If you think the action of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of paracetamol are required, other presentations of paracetamol that adapt to the required dosage should be used.

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, 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 symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medication.

Patient taking barbiturics 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 Toxicology Information Service (telephone 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 make up for forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Rare side effects that may occur (up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

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

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

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Sandoz Care

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 shown on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Sandoz Care:

• The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.
• The other components are: potato starch glycolate (Type A), pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and package contents:

Paracetamol Sandoz Care is presented in tablets for oral administration.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face.

The packaging is 10 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

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 last revision of this package leaflet:January 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/