DIFENATIL 650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Difenatil 650 mg Tablets

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 symptoms worsen or if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet

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

1. What is Difenatil and what is it used for

Paracetamol is effective for reducing pain and fever.

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

2. What you need to know before you take Difenatil

Do not take Difenatil

If you are allergic to paracetamol or 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 recommended 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 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 medicine to treat epilepsy, you should consult your doctor before taking this medicine, because when used at the same time, it decreases the effectiveness and increases the hepatotoxicity of paracetamol, especially in treatments with high doses of paracetamol (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 failure, respiratory failure, or anemia; 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.
• Paracetamol can 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 medicine 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 grams per day.
• The simultaneous use of this medicine with other medicines that contain paracetamol should be avoided; for example, medicines for flu and colds, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• If an overdose occurs, seek medical attention immediately (see "If you take more Difenatil than you should").
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.

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

If you have 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 malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medicines that contain 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 medicine.

Children and adolescents

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

Other medicines and Difenatil

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

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

• 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 convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in blood (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• Salicylamide, a medicine to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Medicines to treat HIV infections (zidovudine).

Inform your doctor or pharmacist if you are taking:

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

Interference with laboratory tests:

If you are going to have any laboratory tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine, 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

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, liquor, ... 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 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 medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before taking this medicine.

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

Fertility

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

Driving and using machines

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

3. How to take Difenatil

Follow exactly the administration instructions of this medicine 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 medicine is not intended for children under 15 years or weighing less than 50 kg. Ask your pharmacist.

Patients with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

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

In chronic alcoholics, the dose should not exceed 2 grams per day.

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

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 medicine is taken orally.

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

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

Always use the lowest effective dose.

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

The administration of this medicine is subject to the appearance of pain or fever. As they 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, you should interrupt treatment and consult your doctor.

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 symptoms, as they often do not appear until 3 days after ingestion of the overdose, 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).

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine.

Patients 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 to a medical center immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Difenatil

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the following doses with the indicated separation between doses in each case (at least 4 hours).

If you stop taking Difenatil

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

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

• Discomfort.
• Low blood pressure (hypotension).
• Increased levels of transaminases in blood.

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

• Kidney disease.
• Cloudy urine.
• Allergic dermatitis (skin rash).
• Jaundice (yellowing of the skin).
• Blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia).
• Hypoglycemia (low blood sugar).
• Very rare cases of severe skin reactions have been reported.

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

• A severe disease called metabolic acidosis (an anomaly in blood and fluids) in patients with severe disease who use paracetamol (see section 2).

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

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, 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 special storage conditions.

Do not use this medicine after the expiry date that appears on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Difenatil

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

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

Appearance of the product and pack contents

Difenatil are tablets. The tablets are white or almost white, elongated, biconvex, scored, and divisible. The dimensions of the tablet are: 17.2 mm x 8.1 mm ± 10%. They are presented in packages of 20 tablets packaged in PVC/Aluminum blisters.

Marketing authorization holder and responsible for the marketing authorization:

Laboratorios Normon, S.A.

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

Date of the last revision of this leaflet: February 2025

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