DIFENATIL 650 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Difenatil 650 mg tablets

paracetamol

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if fever persists for more than 3 days or pain for more than 5 days.

Contents of the leaflet

1. What Difenatil is and what it is used for
2. What you need to know before taking Difenatil
3. How to take Difenatil
4. Possible side effects
5. How to store Difenatil
6. Contents of the pack and other information

1. What Difenatil is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain and for feverish conditions in adults and adolescents over 15 years of age (body weight over 50 kg).

2. What you need to know before starting Difenatil

Do not take Difenatil

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Difenatil.

• Do not take more medicine than the recommended dose stated in section 3, How to take Difenatil.
• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day).
• If you have kidney problems.
• If you have glucose-6-phosphate dehydrogenase deficiency.
• If you suffer from anorexia, bulimia, cachexia, or chronic malnutrition.
• If you are dehydrated or have hypovolemia.
• If you are taking a medicine to treat epilepsy, you must consult your doctor before taking this medicine, as its simultaneous use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section, Other medicines and Difenatil).
• If you have Gilbert's disease (also known as Meulengracht's disease).
• If you have heart, respiratory failure, or anemia; in these cases, treatment should be administered under supervision and only for short periods.
• If you have asthma and are sensitive to acetylsalicylic acid.
• Paracetamol may cause serious skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the medicine should be discontinued at the first sign of a skin rash or any other sign of hypersensitivity.
• The total daily dose of paracetamol must not exceed 3 g per day.
• Concomitant use of this medicine with other medicines containing paracetamol should be avoided; for example, cold and flu remedies, as high doses may lead to liver damage. Do not use more than one paracetamol-containing medicine without consulting your doctor.
• If an overdose occurs, seek immediate medical attention (see “If you take more Difenatil than you should”).
• Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.

During treatment with Difenatil, inform your doctor immediately:

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, your clinical condition should be evaluated by your doctor. This medicine should not be used for self-medication of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless directed by your doctor, as these situations may require medical evaluation and treatment.

If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Administration of paracetamol doses higher than recommended carries a risk of severe liver injury. Medicines containing paracetamol should not be taken for more than a few days or in high doses unless directed by your doctor.

Prolonged use of analgesics or inappropriate use of high doses may cause headaches, which should not be treated with higher doses of the medicine.

Children and adolescents

This medicine must not be used in children under 15 years of age or weighing less than 50 kg.

Other medicines and Difenatil

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

In particular, if you are using any of the following medicines, dose adjustment or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: (isoniazid, rifampicin).
• Medicines to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol levels (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide group).
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Salicylamide, a medicine used to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Medicines used in the treatment of HIV infection (zidovudine).

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results. Paracetamol may affect analytical measurements of uric acid and glucose.

Taking Difenatil with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If necessary, Difenatil may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before taking this medicine.

Paracetamol passes into breast milk, therefore women who are breast-feeding should consult their doctor or pharmacist before taking this medicine.

Fertility

No harmful effects on fertility are known with normal use of paracetamol.

Driving and operating machinery

The effect of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Difenatil

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and adolescents over 15 years of age (body weight above 50 kg): 1 tablet 3-4 times a day, depending on the intensity of symptoms.

Doses should be spaced at least 4 hours apart.

Maximum dosage: do not exceed 3 grams of paracetamol (4 tablets) in 24 hours.

This medicine is not intended for children under 15 years of age or those weighing less than 50 kg. Please consult your pharmacist.

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

Do not take more than 2 g of paracetamol (3 tablets) in 24 hours.

In chronic alcoholics, the daily dose should not exceed 2 g.

Patients with kidney disease: consult your doctor before taking this medicine.

In patients with moderate or severe renal impairment, the recommended dose is half a tablet (325 mg of paracetamol) every 6-8 hours, respectively.

This medicine is for oral use.

The tablets should be swallowed whole or split in half, with a glass of liquid, preferably water.

The tablets are scored, allowing them to be split in half. The tablet can be divided into equal doses.

Always use the lowest dose that proves effective.

High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.

Administration of this medicine should be based on the occurrence of pain or fever. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you must stop treatment and consult your doctor.

If you take more Difenatil than you should

You should immediately consult your doctor or pharmacist.

If you have ingested an overdose, you must go immediately to a medical center even if you do not experience symptoms, as symptoms often do not appear until 3 days after the overdose has been taken, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and inflammation of the pancreas (pancreatitis).

Treatment of overdose is most effective if started within 4 hours after taking the medicine.

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 Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Difenatil

Do not take a double dose to make up for missed doses. Instead, take the missed dose as soon as you remember, then continue taking the following doses at the recommended intervals (at least 4 hours apart).

If you stop treatment with Difenatil

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

The following adverse effects have been reported:

Rare: may affect up to 1 in 1,000 people:

• Malaise.
• Drop in blood pressure (hypotension).
• Increased blood transaminase levels.

Very rare: may affect up to 1 in 10,000 people:

• Kidney disorders.
• Cloudy urine.
• Allergic dermatitis (skin rash).
• Jaundice (yellowing of the skin).
• Blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia).
• Hypoglycaemia (low blood sugar).
• Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data):

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or during prolonged treatment.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Difenatil

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Difenatil

The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.

The other components are: Povidone, pregelatinized corn starch and stearic acid.

Appearance of the product and contents of the pack

Difenatil are tablets. The tablets are white or almost white, elongated in shape, biconvex, scored, and breakable. Tablet dimensions are: 17.2 mm x 8.1 mm ± 0.10%. Packaged in packs of 20 tablets in PVC/aluminum blisters.

Marketing Authorization Holder and Responsible Person for Authorization:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/