PARACETAMOL SANDOZ 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Sandoz Pharmaceutical 1 g Coated Tablets EFG

paracetamol

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

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• 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.

Contents of the Package Leaflet

1. What Paracetamol Sandoz Pharmaceutical is and what it is used for
2. What you need to know before taking Paracetamol Sandoz Pharmaceutical
3. How to take Paracetamol Sandoz Pharmaceutical
4. Possible side effects
5. Storage of Paracetamol Sandoz Pharmaceutical
6. Package Contents and Additional Information

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

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

It is indicated for the treatment of symptoms of pain and fever.

2. What you need to know before taking Paracetamol Sandoz Pharmaceutical

Do not take Paracetamol Sandoz Pharmaceutical

• If you are allergic (hypersensitive) to paracetamol or any of the other components of this medication (listed in section 6).

Be careful with Paracetamol Sandoz Pharmaceutical:

Do not take more than the recommended dose in section 3. How to take Paracetamol Sandoz Pharmaceutical.

During treatment with paracetamol, inform your doctor immediately if:

• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have any kidney, liver, heart, or lung disease, or have anemia (decreased hemoglobin level in the blood, with or without a decrease in red blood cells), you should consult your doctor before taking this medication.
• When being treated with any medication for epilepsy, consult your doctor before taking this medication, as the effectiveness of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, caution should be exercised not to take more than 2 g/24 hours of paracetamol.

• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• In children under 15 years of age, 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 damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medications and Paracetamol Sandoz Pharmaceutical

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

Paracetamol may interact with the following medications:

• Medications 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: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower cholesterol levels in the blood: (cholestyramine).
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used for the treatment of gout (probenecid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used in the treatment of high blood pressure 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 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 have any analytical tests (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 Pharmaceutical with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

If necessary, Paracetamol Sandoz Pharmaceutical can be used during pregnancy. You should 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 does not decrease or if you need to take the medication more frequently.

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may appear in breast milk, so 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 nil or insignificant.

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

3. How to take Paracetamol Sandoz Pharmaceutical

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 children over 15 years: 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 4 tablets (4 g) in 24 hours.

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.

Do not take more than 2 grams 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 milligrams per dose.

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

Elderly patients: should consult their doctor.

Use in children: Do not use in children under 15 years of age.

If the effect 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 Pharmaceutical 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 taking the medication.

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go to a medical center 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 Pharmaceutical

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 between doses (at least 4 hours).

4. Possible side effects

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

Rare side effects that may occur (between 1 and 10 in 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in less than 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, 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 periods.

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 Pharmaceutical

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 shown on the packaging and blister, after CAD. 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 point in the pharmacy. 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 Pharmaceutical:

Each tablet contains 1 g of paracetamol as the active ingredient.

The other components (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and package contents:

Paracetamol Sandoz Pharmaceutical is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face. The dimensions of the tablets are: 21.0 ± 0.5 mm in length.

The tablet can be divided into two equal halves.

It is presented in packages of 20 and 40 tablets and a clinical package of 500 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Pharmaceutical, 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/