Leaflet: information for the user

Paracetamol Liderfen 1 g tablets

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

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

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, if the fever persists for more than 3 days or the pain lasts for more than 5 days

1. What is Paracetamol Liderfen and what it is used for

2. What you need to know before taking Paracetamol Liderfen

3. How to take Paracetamol Liderfen

4. Possible side effects

5. Storage of Paracetamol Liderfen

6. Contents of the pack and additional information

Paracetamol is effective in reducing pain and fever.

It is indicated for the relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (spasms) or back pain (lumbago) and in febrile states.

Paracetamol Liderfen is indicated in adults

Do not take Paracetamol Liderfen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• Do not take more than the recommended amount as stated in section 3. How to take Paracetamol Liderfen.
• Avoid using this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

Inform your doctor immediately if you experience any of the following during treatment with Efferaldol:

• Severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic). A severe 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

Do not use in children under 18 years old.

Other medications and Paracetamol Liderfen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, if you are using any of the following medications, as it may be necessary to adjust the dose of some of them or discontinue treatment:

- Blood clot prevention medication: Oral anticoagulants (acenocoumarol, warfarin)

- Epilepsy medication: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

- Tuberculosis medication: (isoniazid, rifampicin)

- Depression and seizure medication: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

- Medications to lower blood cholesterol levels: (cholestyramine)

- Diuretics (furosemide group) used to increase urine elimination

- Medications used to treat gout (probencid and sulfinpyrazone)

- Medications used to prevent nausea and vomiting: Metoclopramide and domperidone

- Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.

Do not use with other analgesics (pain medications) without consulting your doctor.

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

As a general rule, it is recommended to inform your doctor or pharmacist if you are taking any other medication. In the case of oral anticoagulants, Paracetamol Liderfen may be administered occasionally as the preferred analgesic.

Interference with analytical tests:

Inform your doctor if you are undergoing any analytical tests (including blood, urine, skin tests using allergens, etc.) as this medication may alter the results of these tests.

Taking Paracetamol Liderfen with food, drinks, and alcohol:

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

The taking of this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or plan to become pregnant before using this medication.

IMPORTANT FOR WOMEN

Paracetamol Liderfen may be used during pregnancy if necessary. Use the lowest possible dose to reduce pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not subside or if you need to take the medication more frequently.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

This medication has no or insignificant influence on the ability to drive and operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: take 1 tablet (1 g of paracetamol) every 6 – 8 hours, 3 times a day.Do not take more than3 g (3tablets)in 24 hours.

Always use the lowest effective dose

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. Do 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 gramof paracetamol, the medication is not indicated for this group of patients.

This medication should be taken orally.

The tablets can be swallowed whole or broken in half, with the help of a liquid, preferably water.

The groove is only for breaking the tablet if it is difficult to swallow whole

It should be avoided to use high daily doses of paracetamol for prolonged periods of time as it increases the risk of suffering adverse effects such as liver damage.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be suspended.

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, the patient should consult their doctor and reevaluate the clinical situation.

Use in children and adolescents:

Do not use this medication in children or adolescents under 18 years old.

When administering doses lower than 1 g of paracetamol per dose, other paracetamol presentations should be used that adapt to the required dosage.

If you take more Paracetamol Liderfen than you should

You should consult your doctor or pharmacist immediately. 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.

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 overdose is more effective if it is initiated within 4 hours of medication ingestion.

Patients undergoing barbiturate treatment or suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to take Paracetamol Liderfen

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 interval between doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Very rare adverse effects that may occur (in up to 1 in 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). Paracetamol can damage the liver when taken in high doses or for prolonged periods. Rarely, severe skin reactions have been reported.

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 on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment..

Composition of Paracetamol Liderfen

- The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

- The other components are: maize pregelatinized starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable origin magnesium stearate.

Appearance of the product and contents of the packaging

It is presented in the form of oblong tablets, white in color and scored on one of their faces, in packaging of 10 tablets conditioned in:

Aluminum-PVC-PVDC blister.

HDPE bottles with polypropylene closure.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

FARMALIDER S.A.

C/ Aragoneses 15, 28108 Alcobendas,

Madrid

Spain

Responsible for manufacturing

Toll Manufacturing Services, S.L.

C/ Aragoneses,

2 28108 Alcobendas - Madrid

Spain

Or

Farmalider, S.A.

C/ Aragoneses,

2 28108 Alcobendas - Madrid

Spain

Last review date of this leaflet:January 2025

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