PARAFUDETEN 650 mg EFFERVSCENT TABLETS

2. Before taking Parafludetén

Do not take Parafludetén

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

Be careful with Parafludetén

• Do not take more than the recommended dose in section 3. How to take Parafludetén.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have any liver, kidney, heart, or lung disease, or if you have anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medicine.
• When you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially in treatments with high doses of paracetamol.
• In chronic alcoholics, you should 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, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should consult your doctor and reevaluate the clinical situation.
• In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.
• If you have severe diseases, such as severe renal failure 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 serious disease called metabolic acidosis (an anomaly in the 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.

Use of other medicines

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

Paracetamol may interact with the following medicines:

• Medicine 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 the 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.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that should be treated urgently (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 recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests:

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

Taking Parafludetén with food and drinks

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

Taking this medicine with food does not affect its efficacy.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

In case of necessity, Parafludetén can be used during pregnancy. You should use the lowest possible dose that reduces the 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 using any medicine.

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

Driving and using machines

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

Important information about some of the components of Parafludetén

This medicine 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 your doctor or pharmacist if you need to take 2 or more tablets per day for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Parafludetén

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

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

The effervescent tablets should be taken dissolved completely in half a glass of water. Before ingesting the medicine, it is necessary that the effervescence or bubbling ceases.

Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Adults and adolescents over 15 years: the usual dose is 1 tablet (650 mg of paracetamol) every 4 or 6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 6 tablets in 24 hours.

Patient 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 between each dose of 8 hours. Do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, 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.

Elderly patients: should consult their doctor

Use in children:

Do not use in children and adolescents under 15 years of age

If you think the action of Parafludetén is too strong or too weak, tell your doctor or pharmacist.

If you take more Parafludetén than you should

You should consult your doctor or pharmacist immediately. 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 have ingested an overdose, you should go immediately to a medical center, 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), and abdominal pain.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Parafludetén

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated interval between them (at least 4 hours).

4. Possible side effects

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

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

Very rare side effects that can occur (in less than 1 out of 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol can damage the liver when taken in high doses or for prolonged treatments.

Frequency not known (cannot be estimated from the available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Very rare cases of severe skin reactions have been reported.

Reporting of side effects:

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

5. Storage of Parafludetén

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

Do not use Parafludetén after the expiration date stated on the packaging (after CAD.). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point (or any other pharmaceutical waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Parafludetén

• The active ingredient is paracetamol.
• The other ingredients 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 packaging content

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

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Madrid

Date of the last revision of this leaflet: February 2025

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