Difenatil 1 g tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Difenatil® 1 g tablets
Paracetamol
Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.
Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor, pharmacist, or nurse.
This medicine is available without a prescription. However, to achieve the best results, it must be used carefully.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult your doctor if you worsen or if fever persists beyond 3 days of treatment, or pain 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 side effects
- How to store Difenatil
- Contents of the pack and additional information
1. What Difenatil is and what it is used for
Difenatil contains the active substance paracetamol. Paracetamol belongs to the group of medicines known as analgesics and antipyretics.
Paracetamol is used for the treatment of moderate pain and febrile conditions in adults and adolescents aged 16 years and older (or with body weight above 50 kg).
2. What you need to know before taking Difenatil
Do not take Difenatil
- If you are allergic (hypersensitive) 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 taking Difenatil.
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Do not take more medicine than the recommended dose stated in section 3, How to take Difenatil.
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Avoid using this medicine together with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
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In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
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If you suffer from kidney, liver, heart or lung disease, or have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
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If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
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Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.
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If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reassess your clinical condition.
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Adolescents under 16 years of age should consult their doctor or pharmacist, as other formulations with doses adapted to this patient group are available.
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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations 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 difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Other medicines and Difenatil
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Paracetamol may interact with the following medicines:
- 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: (cholestyramine).
- Medicines used to increase urine output (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.
Inform your doctor or pharmacist if you are taking:
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).
Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Interference with diagnostic tests:
If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medicine, as it may alter the results of such tests.
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 and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
If necessary, this medicine may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.
Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and using machines
The effect of paracetamol on the ability to drive and use machines is negligible or none.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".
3. How to take Difenatil
Follow these instructions unless your doctor has given you different ones.
Remember to take your medicine. Paracetamol should be taken orally.
The usual dose is:
Adults and adolescents over 16 years of age: The usual dose is 1 tablet (1 gram of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.
High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.
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.
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 paracetamol tablets in 24 hours, divided into 2 doses.
Patients with kidney disease: You must consult your doctor before taking this medicine. Take a maximum of 500 mg per dose.
Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this group of patients.
Elderly patients: You should consult your doctor.
Use in children and adolescents: Do not use in children and adolescents under 16 years of age.
If you think the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses than 1 gram of paracetamol per dose are required, other paracetamol formulations suitable for the required dosage should be used.
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 you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, 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 medicine.
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. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Rare adverse effects (occurring in between 1 and 10 out of 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.
Very rare adverse effects (occurring in less than 1 out of 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar level). Very rare cases of severe skin reactions have been reported.
Paracetamol may damage the liver when taken in high doses or during prolonged treatment.
Frequency not known (cannot be estimated from 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).
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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 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 unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly 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. Each tablet contains 1 gram of paracetamol.
- The other components (excipients) are sodium starch glycolate from potato (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).
Appearance of the product and contents of the pack
Difenatil is presented as tablets for oral administration.
The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PC" on the other side. The tablet can be divided into equal halves.
Packaged in packs of 10 tablets, contained in PVC/PVDC/Aluminium blisters.
Marketing Authorization Holder
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid
(SPAIN)
Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat, 08950,
Barcelona – Spain
or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain
Date of the most recent revision 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 Medical Devices (AEMPS) http://www.aemps.gob.es/