DIFENATIL 500 mg TABLETS

2. What you need to know before taking Difenatil

Do not take Difenatil

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

Do not take more medication than recommended in section 3, as serious liver damage may occur.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take paracetamol

• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day).
• If you have kidney problems.
• If you have a deficiency of glucose-6-phosphate dehydrogenase.
• If you have anorexia, bulimia, cachexia, or chronic malnutrition.
• If you suffer from dehydration or hypovolemia.
• If you are taking a medication to treat epilepsy, you should consult your doctor before taking this medication, as it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially in high-dose treatments.
• If you have Gilbert's disease (also known as Meulengracht's disease).
• If you have heart, respiratory, or anemia failure; in these situations, administration should be carried out under surveillance and only for short periods.
• If you have asthma and are sensitive to acetylsalicylic acid.

During treatment with Difenatil, inform your doctor immediately if:

You have serious illnesses, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Paracetamol may cause severe 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 severe skin reactions and the use of the medication should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.

The total dose of paracetamol should not exceed 3 g per day.

Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.

The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately.

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 clinical situation should be evaluated by your doctor. This medication should not be used for self-medication of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless indicated by your doctor, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medications containing paracetamol should not be taken for more than a few days or in high doses unless indicated by your doctor.

Prolonged use of analgesics or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medication; consult "If you take more than you should").

Children and Adolescents

Due to the amount of paracetamol it contains, children (under 12 years old or weighing less than 33 kg) cannot take this medication.

Other Medications and Difenatil

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Medication to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications to treat tuberculosis: isoniazid, rifampicin.
• Medications to treat depression and convulsions: barbiturics (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower cholesterol levels in the blood: colestyramine.
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used to treat gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Salicylamide, a medication to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Zidovudine (used in the treatment of HIV infections).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion imbalance) that should be treated urgently.

Interference with Analytical Tests

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

Taking Difenatil with Food, Drinks, and Alcohol

Taking this medication with food does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Breastfeeding

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Fertility

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

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is zero or insignificant.

3. How to Take Difenatil

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adolescents from 12 to 18 years old (33 kg - 50 kg)

• Between 33 kg and 40 kg of weight: Take 1 tablet every 4-6 hours, as needed, up to a maximum of 4 tablets per day.
• Between 41 kg and 50 kg of weight: Take 1 tablet every 4-6 hours, as needed, up to a maximum of 5 tablets per day.

Adults (body weight over 50 kg)

Take 1 tablet, if necessary, every 4-6 hours, as needed, up to a maximum of 6 tablets per day. Do not take more than 3 grams in 24 hours.

Patients with liver disease

Consult your doctor before taking this medication.

They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose.

They should not take more than 2 grams (4 tablets) of paracetamol in 24 hours.

Patients with kidney disease

Consult your doctor before taking this medication.

Patients with moderate to severe renal disease should take a maximum of 500 mg of paracetamol per dose.

In case of renal failure, reduce the dose, depending on the degree of glomerular filtration according to the following table:

Method of Administration

The tablets are administered orally.

The tablets should be swallowed with a glass of liquid, preferably water. The tablets are scored, which allows them to be divided in half. The tablet can be divided into equal doses.

Do not exceed the established dose and always use the lowest effective dose.

The use of high daily doses of paracetamol for prolonged periods 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 they disappear, treatment should be discontinued. The medication should be used for the shortest possible time.

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, treatment should be discontinued and your doctor consulted.

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 taken an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

Treatment of the overdose is more effective if started within 4 hours of taking the overdose of the medication.

Patients treated with barbiturics 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 (telephone: 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Difenatil

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, take the forgotten dose as soon as you remember, taking the following doses with the indicated separation between doses (at least 4 hours).

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

The side effects that may occur in adults and adolescents are:

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

• Discomfort.
• Hypotension (low blood pressure).
• Increased levels of transaminases in the blood.

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

• Kidney disease.
• Cloudy urine.
• Allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome).
• Jaundice (yellowing of the skin).
• Blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).
• Very rare cases of severe skin reactions have been reported.
• Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

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

• Headache induced by analgesic abuse.
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Stop taking this medication and talk to a doctor immediately if:

• You experience allergic reactions such as skin rash or itching, sometimes with breathing difficulties or swelling of the lips, tongue, throat, or face.
• You suffer a rash or peeling of the skin, or ulcers in the mouth.
• You have previously experienced breathing difficulties with aspirin or non-steroidal anti-inflammatory drugs, and you experience a similar reaction with this medication.
• You experience unexplained bruising or bleeding.

These reactions are rare.

Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Difenatil

No special storage conditions are required.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Difenatil Composition

• The active ingredient is paracetamol.
• The other components (excipients) are povidone, pregelatinized cornstarch, and stearic acid.

Product Appearance and Package Contents

White or almost white tablets, round, flat, scored, and divisible.

The tablet diameter is 13 mm. It is presented in packages of 20 tablets in PVC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

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

Date of the Last Revision of this Package Leaflet: May 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).