Leaflet: information for the user

Difenatil®1 g tablets

Paracetamol

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, pharmacist, or nurse.

This medicine can be purchased without a prescription. Nevertheless, for the best results, it should be used with care.

• 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if the fever worsens or persists after 3 days of treatment or the pain lasts for more than 5 days.

Difenatil contains paracetamol as its active ingredient.Paracetamol belongs to a group of medicines called analgesics and antipyretics.

Paracetamol is used for the treatment of moderate intensity pain and febrile states in adults and adolescents 16 years of age and older (or with a body weight of 50 kg or more).

Do not take Difenatil

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Difenatil.

• Do not take more of the medication than recommended in section 3. How to take Difenatil.Difenatil.

• Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, should be avoided as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
• Patients with asthma sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Patients with kidney, liver, heart, or lung disease or anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells) should consult their doctor before taking this medication.
• Patients undergoing treatment with antiepileptic medications should consult their doctor before taking this medication, as concomitant use may decrease the efficacy and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.
• If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• Adolescents under 16 years old should consult their doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

Inform your doctor immediately during treatment with Difenatil:

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 malnutrition, chronic alcoholism, or if you 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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medications and Difenatil

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:

• Blood thinners: 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 used 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 to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (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 oral anticoagulants, this medication can be administered occasionally as the preferred analgesic.

Interference with laboratory tests:

If you are to undergo any laboratory test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking/using this medication, as it may alter the results of these tests.

Taking Difenatil with food, drinks, and alcohol

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

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

Pregnancy and Lactation

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

This medication can be used during pregnancy if necessary. 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.

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

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 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 adolescents over 16 years:The usual dose is 1 tablet (1 gram of paracetamol)3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

It is recommended to avoid high daily doses of paracetamol for prolonged periods of time as it increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should interrupt treatment and consult your doctor.

Patients with liver disease: Before taking this medication, you must consult your doctor. You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

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

Patients with kidney disease: Before taking this medication, you must consult your doctor. Take a maximum of 500 mg per dose.

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

Older adults: You should consult your doctor.

Use in children and adolescents: Do not use in children and adolescents under 16 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 gram of paracetamol per dose is required, other presentations of paracetamol should be used that adapt to the required dosage.

If you take more Difenatil 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 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 an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of an overdose of paracetamol.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Difenatil

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 have 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 prolonged treatments.

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.

This medication does not require special storage conditions.

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.

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 Difenatil

• The active ingredient is paracetamol. Each tablet contains 1 gram of paracetamol.
• The other components (excipients) are sodium starch glycolate (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

Difenatilis presented in tablets for oral administration.

The tablets are oblong, biconvex, white in color, with a notch on one face and marked with PC on the other face. The tablet can be divided into two equal halves.

In packs of 10 tablets, conditioned in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

(SPAIN)

Responsible for Manufacturing

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

Last review date of this leaflet:February 2025

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