Difenatil 500 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Difenatil 500 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 instructions for administration of the medicine contained in this leaflet or those provided by your doctor, pharmacist, or nurse.
- 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, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if fever persists beyond 3 days of treatment, or if pain persists beyond 5 days.
Contents of the leaflet
- What Difenatil is and what it is used for
- What you need to know before taking Difenatil
- How to take Difenatil
- Possible adverse effects
- How to store Difenatil
- 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.
This medicine is used for the symptomatic relief of mild to moderate occasional pain and feverish conditions. Indicated for adults and adolescents over 12 years of age (body weight above 33 kg).
2. What you need to know before taking Difenatil
Do not take Difenatil
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Do not take more than the recommended dose stated in section 3. How to take Difenatil, as serious liver damage may occur.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking paracetamol if:
- You have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day).
- You have kidney problems.
- You have glucose-6-phosphate dehydrogenase deficiency.
- You suffer from anorexia, bulimia, cachexia, or chronic malnutrition.
- You are dehydrated or have hypovolemia.
- You are taking a medicine for epilepsy; you must consult your doctor before taking this medicine, as concomitant use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section).
- You have Gilbert's disease (also known as Meulengracht's disease).
- You have heart failure, respiratory failure, or anemia; in these cases, treatment should be administered under supervision and only for short periods.
- You have asthma and are sensitive to acetylsalicylic acid.
During treatment with Difenatil, inform your doctor immediately 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 over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
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 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.
Chronic alcoholics should be careful not to exceed 2 grams of paracetamol in 24 hours.
Concurrent use of this medicine with other medicines containing paracetamol (e.g., cold and flu remedies) should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor. If an overdose occurs, seek immediate medical attention.
If pain persists for more than 5 days, fever lasts more than 3 days, or if pain or fever worsens or new symptoms appear, your clinical condition should be evaluated by your doctor. This medicine should not be used for self-treatment 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.
Taking paracetamol doses higher than recommended poses a serious risk of severe liver injury. Medicines containing paracetamol should not be taken for longer 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 (see "If you take more than you should").
Children and adolescents
Due to the amount of paracetamol it contains, this medicine must not be given to children (under 12 years of age or weighing less than 33 kg).
Other medicines and Difenatil
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
In particular, if you are taking any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:
- Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
- Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines for tuberculosis: isoniazid, rifampicin.
- Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
- Medicines to lower blood cholesterol levels: colestyramine.
- 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 (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.
- Zidovudine (used in the treatment of HIV infections).
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap), which must be treated urgently.
Interference with laboratory tests
If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results. Paracetamol may affect the analytical values of uric acid and glucose.
Taking Difenatil with food, drinks, and alcohol
Taking this medicine 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 medicine.
Paracetamol may be used during pregnancy if necessary. 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 does not improve or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk; therefore, women who are breastfeeding 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 using machines
The effect of this medicine on the ability to drive and operate machinery is negligible or none.
3. How to take Difenatil
Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adolescents aged 12 to 18 years (weighing 33 kg – 50 kg)
- Weighing between 33 kg and 40 kg: Take 1 tablet every 4–6 hours as needed, up to a maximum of 4 tablets per day.
- Weighing between 41 kg and 50 kg: 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 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 medicine.
They should take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses.
They must not take more than 2 grams (4 tablets) of paracetamol in 24 hours.
Patients with kidney disease
Consult your doctor before taking this medicine.
Patients with moderate to severe renal disease should take a maximum of 500 mg of paracetamol per dose.
In case of renal insufficiency, reduce the dose depending on the degree of glomerular filtration rate according to the following table:
Glomerular filtration | Dosage |
10-50 ml/min | 500 mg every 6 h |
<10 ml/min | 500 mg every 8 h |
Administration method
The tablets are administered orally.
The tablets should be swallowed 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.
Do not exceed the recommended dose and always use the lowest effective dose.
High daily doses of paracetamol should be avoided for prolonged periods, as this increases the risk of adverse effects such as liver damage.
This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued. The medicine should be used for the shortest possible duration.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and a doctor should be consulted.
If you take more Difenatil than you should
Contact your doctor or pharmacist immediately.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
If an overdose has occurred, seek immediate medical attention, even if no symptoms are present, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Treatment for overdose is most effective if started within 4 hours of taking the excessive dose.
Patients undergoing treatment 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.
If you forget to take Difenatil
Do not take a double dose to make up for missed doses.
If you forget to take a dose, take the missed dose as soon as you remember, then continue with the next doses at the recommended intervals (at least 4 hours apart).
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 everyone experiences them.
The adverse effects that may occur in adults and adolescents are:
Uncommon adverse effects, may affect up to 1 in 1,000 people:
- Malaise.
- Hypotension (low blood pressure).
- Increased levels of transaminases in the blood.
Very rare adverse effects, may affect up to 1 in 10,000 people:
- Kidney disorders.
- Cloudy urine.
- Allergic dermatitis (including skin rash, angioedema, and Stevens-Johnson syndrome).
- Jaundice (yellowing of the skin).
- Blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (low blood sugar).
- Very rare cases of serious 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 caused by analgesic overuse.
- A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
Stop taking this medicine and contact 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 develop a skin rash or peeling, or mouth ulcers.
- You have previously had breathing problems with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), and experience a similar reaction with this medicine.
- You experience unexplained bruising or bleeding.
These reactions are rare.
Paracetamol can damage the liver when taken at high doses or during prolonged treatment.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Difenatil
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container 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 your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Difenatil
- The active substance is paracetamol.
- The other components (excipients) are povidone, pregelatinized corn starch and stearic acid.
Appearance of the product and contents of the pack
White or almost white, round, flat tablets, scored and breakable.
The tablet diameter is 13 mm. It is available in packs of 20 tablets, presented 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 most recent review of this leaflet: May 2025
Detailed 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/).