Leaflet: information for the user

Paracetamol Sandoz Pharmaceutical 1 g tablets EFG

paracetamol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Paracetamol Sandoz Pharmaceutical

4. Possible side effects

5. Storage of Paracetamol Sandoz Pharmaceutical

6. Contents of the pack and additional information

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

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

Do not take Paracetamol Sandoz Farmacéutica

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

Be especially careful with Paracetamol Sandoz Farmacéutica:

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

Inform your doctor immediately if during treatment with paracetamol:

• In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication
• If you have any kidney, liver, heart, or lung disease, or have anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), consult your doctor before taking this medication.
• When you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as when used together, it reduces the efficacy and increases the hepatotoxicity of paracetamol, especially in high-dose paracetamol treatments.
• In chronic alcoholics, be careful 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 worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• In children under 15 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 chronic malnutrition, 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 distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medications and Paracetamol Sandoz Farmacéutica

Inform your doctor or pharmacist if you are using or have used recently 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, metharbital, primidone, carbamazepine).
• Medications for treating tuberculosis: (isoniazid, rifampicin).
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower cholesterol levels in the blood: (cholestyramine).
• Medications used to increase urine elimination (diuretics such as furosemide).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used in the treatment of high blood pressure (hypertension) 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 inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, this medication can be administered occasionally as the 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 medication, as it may alter the results of these tests.

Taking Paracetamol Sandoz Farmacéutica with food, drinks, and alcohol

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

The taking of 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 intend to become pregnant, consult your doctor before taking this medication.

In case of need, Paracetamol Sandoz Farmacéutica can 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 medication more frequently.

The consumption of 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, therefore, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery:

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

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it 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 usual dose is:

Adults and children over 15 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 4 tablets (4 g) should be taken in 24 hours.

Patients 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 grams of paracetamol in 24 hours, divided into 2 doses.

Patients 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.

Older patients:They should consult their doctor.

Use in children:Not to be used in children under 15 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 dosage.

If you take more ParacetamolSandoz Farmacéuticathan you should:

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice) and abdominal pain.

If you have ingested an overdose, you should go immediately to a medical center 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 the overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients 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 immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take ParacetamolSandoz Farmacéutica

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 (between 1 and 10 of every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in fewer than 1 of every 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 for prolonged periods.

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as 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 prospectus. 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 and blister, after CAD. 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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Paracetamol Sandoz Pharmaceutical :

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

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

Appearance of the product and contents of the packaging:

Paracetamol Sandoz Pharmaceutical is presented in oral tablets for administration.

The tablets are oblong, biconvex, white in color, with a groove 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 packaging of 20 and 40 tablets and clinical packaging of 500 tablets, conditioned in PVC/PVdC/Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.

Corporate Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet: January 2025

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