Parafludeten 650 mg effervescent tablets

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Parafludetén 650 mg effervescent tablets

paracetamol

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Parafludetén is and what it is used for
2. Before you take Parafludetén
3. How to take Parafludetén
4. Possible side effects
5. How to store Parafludetén
6. Further information

1. What Parafludetén is and what it is used for

Parafludetén belongs to a group of medicines called analgesics and antipyretics.

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

2. Before taking Parafludetén

Do not take Parafludetén

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

Take special care with Parafludetén

• Do not take more than the recommended dose indicated 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 liver, kidney, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• If you are being treated with medications for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.
• In chronic alcoholics, caution should be exercised not to exceed 3 tablets of 650 mg paracetamol in 24 hours.
• 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 the clinical situation.
• For children under 15 years of age, consult your doctor or pharmacist, as other dosage forms are available that are better suited for this patient group.
• 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 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, malaise (nausea), and vomiting.

Use of other medicines

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

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 elimination (loop diuretics such as furosemide group)
• 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
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) that require urgent treatment (see section 2).

Do not use with other analgesics (medicines that reduce pain) 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 patients treated with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Taking Parafludetén with food and drink

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

Taking this medicine with food does not affect its effectiveness.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

If necessary, Parafludetén 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.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

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 influence of paracetamol on the ability to drive and operate machinery is negligible or none.

Important information about some of the components of Parafludetén

This medicine contains 251 mg of sodium (main component of table/cooking salt) per tablet. This corresponds 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 daily over a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

This medicine contains sorbitol. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Parafludetén

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

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

Effervescent tablets must be completely dissolved in half a glass of water before use. Wait until effervescence or bubbling has completely stopped before taking the medicine.

If you have any doubts, consult your doctor or pharmacist.

The usual dose is:

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

Patients with liver disease: You must consult your doctor before taking this medicine. You should take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 3 tablets of 650 mg paracetamol in 24 hours.

Patients with kidney disease: You must consult your doctor before taking this medicine.

Maximum dose per intake: 500 milligrams.

Due to the dosage (650 mg paracetamol), this medicine is not indicated for this patient group.

Elderly patients: You should consult your doctor.

Use in children:

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

If you feel that the effect of Parafludetén is too strong or too weak, inform your doctor or pharmacist.

If you take more Parafludetén than you should

Contact 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 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.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of 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.

If you forget to take Parafludetén

Do not take a double dose to make up for a missed dose. 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, Parafludetén may cause adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in between 1 and 10 out of every 10,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in fewer than 1 out of every 10,000 people) include: 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). Paracetamol may cause liver damage when taken at 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 severely ill patients using paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.

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 not listed in this leaflet. You may also report them directly through 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 Parafludetén

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Parafludetén

• The active substance 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 pack

Parafludetén is available as effervescent tablets for oral administration, in a bottle containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Madrid

Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Madrid

or

Laboratorios Alter, S.A.

C/ Zeus, 6

6 Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent review 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/