Difenatil 1G 10 Tablets

Difenatil contains paracetamol as the active ingredient. Paracetamol belongs to the group of medicines called analgesics and antipyretics.

Paracetamol is used for the treatment of pain of moderate intensity and febrile states in adults and adolescents from 16 years of age (or body weight greater than 50 kg).

Do not take Difenatil

- If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and Cautions

Talk to your doctor or pharmacist before taking Difenatil.

- Do not take more medication than recommended in section 3. How to take Difenatil.

- The simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and cold, should be avoided, since high doses can lead to liver damage. Do not use more than one medication that contains acetaminophen without consulting your doctor.

- In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

- If you suffer from kidney, liver, heart or lung disease or have anemia (decreased level of hemoglobin in the blood, due or not to a decrease in red blood cells), you should consult your doctor before taking this medicine.

- When you are being treated with any medication to treat epilepsy, you should consult your doctor before taking this medication, because when they are used at the same time, the efficacy of paracetamol is decreased and hepatotoxicity is enhanced, especially in treatments with high doses of paracetamol.

- In chronic alcoholics, they should be careful not to take more than 2 grams in 24 hours of paracetamol.

- If the pain persists for more than 5 days, the fever lasts for more than 3 days, or the pain or fever worsens or other symptoms appear, a doctor should be consulted and the clinical situation reassessed.

- In adolescents under 16 years of age, consult your doctor or pharmacist as there are other presentations with doses that are adapted to this group of patients.

Other medicines and Difenatil

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Acetaminophen may interact with the following medications:

- Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)

- Drugs to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

- Drugs to treat tuberculosis: (isoniazid, rifampicin)

- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants)

- Drugs to lower blood cholesterol levels: (cholestyramine)

- Medicines used to increase urine output (loop diuretics such as those of the furosemide group)

- Drugs used for the treatment of gout (probenecid and sulfinpyrazone)

- Medications used to prevent nausea and vomiting: Metoclopramide and domperidone

- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disturbances (cardiac arrhythmias): Propranolol.

Tell your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (high anion gap metabolic acidosis) which must be treated urgently and which can occur particularly in severe renal failure, sepsis (when bacteria and its toxins circulate in the blood resulting in organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.

Do not use with other analgesics (medicines that reduce pain) without consulting a doctor.

As a general rule for any medication, it is advisable to systematically inform the doctor or pharmacist if you are being treated with another medication. In case of treatment with oral anticoagulants it can be administered occasionally as an analgesic of choice.

Interferences with analytical tests:

If you are going to have any analytical test (including blood tests, urine tests, skin tests that use allergens, etc...) tell your doctor that you are taking/using this medicine, as it can alter the results of these tests.

Difenatil with food, drink and alcohol

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor,... per day) can cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy and Lactation

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor before taking this medicine. 

If necessary, this medicine can be used during pregnancy. You should use the lowest possible dose that will reduce pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever do not subside or if you need to take the medicine more often.

Small amounts of paracetamol may appear in breast milk, therefore it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Paracetamol has no or negligible influence on the ability to drive and use machines.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet; that is, essentially "sodium-free."

Follow these instructions unless your doctor has given you other directions.

Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

Adults and adolescents over 16 years of age: the usual dose is 1 tablet (1 gram of paracetamol) 3 times a day. The drinks must be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

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

If the pain persists for more than 5 days, the fever lasts for more than 3 days, or the pain or fever worsens or other symptoms appear, you should stop treatment and consult your doctor.

Patients with liver diseases : before taking this medicine you have to consult your doctor. They must 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 paracetamol tablets in 24 hours, divided into 2 doses.

Patients with kidney diseases : before taking this medicine you have to consult your doctor. Take a maximum of 500 mg per dose.

Due to the dose, 1 gram of paracetamol, is not indicated for this group of patients.

Elderly patients : should consult their doctor.

Use in children and adolescents : Do not use in children and adolescents under 16 years of age.

If the action of paracetamol is considered to be too strong or weak, tell your doctor or pharmacist. When the administration of doses of less than 1 gram of paracetamol per dose is required, other presentations of paracetamol should be used that adapt to the required dosage.

If you take more Difenatil than you should

You should immediately consult your doctor or pharmacist.

Overdose symptoms may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have ingested an overdose, you should immediately go to a medical center even if you do not notice the symptoms, since these often do not appear until 3 days after ingesting the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of taking the drug.

Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of acetaminophen.

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 medication and the amount ingested.

If you forget to take Difenatil

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

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

Rare side effects that may occur (between 1 and 10 in 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in less than 1 in 10,000 people) are: Kidney disease, cloudy urine, allergic dermatitis (rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anemia) and hypoglycaemia (low blood sugar). Cases of serious skin reactions have been reported very rarely.

Paracetamol can damage the liver when taken in high doses or in long-term treatments.

Reporting of adverse effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

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 which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of down the drain or in the trash. Deposit the containers and medications that you do not need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way you will help to protect the environment.

Composition of Difenatil

• The active substance is paracetamol. Each tablet contains 1 gram of paracetamol.
• The other ingredients (excipients) are sodium potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570) and crospovidone (E-1202).

What the product looks like and contents of the pack

Difenatil is presented as tablets for oral administration.

The tablets are oblong, biconvex, white, scored on one side and marked PC on the other side. The compressed can be divided into equal halves.

In packages of 10 tablets, packaged in PVC/PVDC/Aluminium blister packs.

Leaflet Difenatil 1G 10 Tablets