Leaflet: information for the user

Difenatil 650 mg tablets

paracetamol

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 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 you worsen or if the fever persists for more than 3 days or the pain for more than 5 days.

1. What isDifenatiland what it is used for

2. What you need to know before starting to takeDifenatil

3. How to takeDifenatil

4. Possible side effects

5. Storage ofDifenatil

6. Contents of the pack and additional information

Paracetamol is effective in reducing pain and fever.

It is indicated for symptomatic relief of occasional mild to moderate pain and in febrile statesin adults and adolescents over 15 years old (body weight over 50 kg).

Do not take Difenatil

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 Difenatil.

During treatment with Difenatil, inform your doctor immediately:

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

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 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.

Administration of paracetamol doses above the recommended amounts involves a high risk of severe liver damage. Medications containing paracetamol should not be taken for more than a few days or at high doses unless your doctor indicates it.

Prolonged use of analgesics or excessive use of high doses can cause headaches, which should not be treated with higher doses of the medication.

Children and adolescents

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

Other medications and Difenatil

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 modify the dose of some of them or discontinue treatment:

Inform your doctor or pharmacist if you are taking:

Interference with laboratory tests:

If you are to undergo any laboratory test (including blood, urine, etc. tests), inform your doctor that you are taking this medication, as it may alter the results. Paracetamol may alter the values of uric acid and glucose determinations.

Taking Difenatil with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

If necessary, Difenatil 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 do not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before taking this medication.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor or pharmacist before taking this medication.

Fertility

No adverse effects on fertility have been reported with the normal use of paracetamol.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

The doses should be spaced at least 4 hours apart.

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

This medication is not intended for children under 15 years or with a body weight less than 50 kg. Ask your pharmacist.

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 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 medication.

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

This medication is taken orally.

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

The tablets are scored, which allows them to be broken in half. The tablet can be broken into equal doses.

Always use the smallest effective dose.

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

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

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

If you take more Difenatil than you should

You should consult your doctor or pharmacist immediately.

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, even in cases of severe poisoning.

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

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

Patients taking 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 (phone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget 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 (at least 4 hours).

If you interrupt treatment with Difenatil

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

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

The following adverse effects have been reported:

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

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

• Renal disease.
• Turbid urine.
• Allergic dermatitis (skin rash).
• Ictericia (yellow discoloration of the skin).
• Blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia).
• Hypoglycemia (low blood sugar).
• Severe skin reactions have been reported very rarely.

Unknown frequency (cannot be estimated from available data):

• A severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Reporting of 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 of Pharmacovigilance of Medicines 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 in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Difenatil

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

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

Appearance of the product and content of the packaging

Difenatil are tablets. The tablets are white or almost white, elongated, biconvex, scored, and breakable. The dimensions of the tablet are: 17.2 mm x 8.1 mm ± 10%. It is presented in packs of 20 tablets conditioned in PVC/Aluminium blister.

Holder of the marketing authorization and responsible for the authorization:

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet: February 2025

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