PATIENT INFORMATION LEAFLET

Parafludetén 650 mg effervescent tablets

paracetamol

Parafludeténbelongs to a group of medicines called analgesics and antipyretics.

Parafludeténis indicated for the treatment of mild to moderate pain symptoms and fever.

Do not take Parafludetén

• If you are allergic (hypersensitive) to paracetamol, propacetamol or any of the other components of Parafludetén.

Take special care with Parafludetén

• Do not take more than the recommended dose as stated in section 3. How to take Parafludetén.
• In patients with asthma sensitive to acetylsalicylic acid, consult with your doctor before taking this medication.
• If you have any liver, kidney, heart or lung disease, or have anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult with your doctor before taking this medication.
• If you are being treated with any medication for epilepsy, consult with your doctor before taking this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially in high-dose paracetamol treatments.
• In chronic alcoholics, be careful not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.
• If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult with your doctor and reevaluate the clinical situation.
• In children under 15 years, consult with your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: (cholestyramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (called metabolic acidosis) that must be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are being treated with another medication. In the case of oral anticoagulants, Parafludetén can be administered occasionally as the preferred analgesic.

Interference with analytical tests:

Inform your doctor if you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.) as this medication may alter the results of these tests.

Taking Parafludetén with food and beverages

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

The taking of this medication with food does not affect the efficacy of the medication.

Pregnancy

Consult with your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, consult with your doctor before taking this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

In case of need, Parafludetén can be used during pregnancy. 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 do not decrease or if you need to take the medication more frequently.

Lactation

Consult with your doctor or pharmacist before using any medication.

Small amounts of paracetamol may appear in breast milk, therefore it is recommended to consult with your doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Important information about one of the components of Parafludetén

This medication contains 251 mg of sodium (main component of table salt/cooking salt) in each tablet. This is equivalent to 13% of the maximum daily sodium intake recommended for an adult.

Consult with your doctor or pharmacist if you need 2 or more tablets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication. Parafludetén must be taken orally.

The effervescent tablets must be taken completely dissolved in half a glass of water. Before ingesting the medication, it is necessary to cease the effervescence or bubbling.

Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults and adolescents over 15 years old: the usual dose is 1 tablet (650 mg of paracetamol) every 4 or 6 hours. Doses should be spaced at least 4 hours apart. No more than 6 tablets should be taken in 24 hours.

Patients with liver disease: before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of8h.They should not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

Older patients: they must consult their doctor

Use in children:

Do not use in children and adolescents under 15 years old

If it is estimated that the action of Parafludetén is too strong or too weak, inform your doctor or pharmacist.

If you take moreParafludeténthan you should

You must consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone91 562 04 20), indicating the medication and the amount ingested.

If you have ingested an overdose, you must go immediately to a medical center even if you do not notice the symptoms, as they often do not manifest until 3 days after the ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice) and abdominal pain.

The treatment of overdose is more effective if it is initiated within 4 hours of ingesting the medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to takeParafludetén

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

Like all medications,Parafludeténmay produce adverse effects, although not all people will experience them.

Rare adverse effects that may occur (between 1 and 10 of every 10,000 people), are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in fewer than 1 of every 10,000 people) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Unknown frequency(cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

There have been very rarely reported cases of severe skin reactions.

Reporting of Adverse Effects:

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

Keep out of the reach and sight of children.

This medication does not require special conditions for conservation.

Do not useParafludeténafter the expiration date that appears on the packaging (after CAD.). The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Parafludetén

• The active ingredient is paracetamol.
• The other components are: citric acid, sodium saccharin, sodium bicarbonate, mannitol (E-421), sorbitol (E-420), anhydrous sodium carbonate, sodium citrate, povidone 30, sodium docusate.

Appearance of the product and contents of the packaging

Parafludeténis presented in the form of effervescent tablets for oral administration, in a tube of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Madrid

Last review date of this leaflet: February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/