Efferaldol Flas 500 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efferaldol Flas 500 mg orodispersible tablets

Paracetamol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if fever persists for more than 3 days or pain for more than 5 days.

Leaflet contents

1. What Efferaldol Flas is and what it is used for
2. What you need to know before taking Efferaldol Flas
3. How to take Efferaldol Flas
4. Possible adverse effects
5. How to store Efferaldol Flas
6. Contents of the pack and other information

1. What Efferaldol Flas is and what it is used for

This medicine contains paracetamol.

It is used for the relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and in febrile conditions in adults.

2. What you need to know before taking Efferaldol Flas

Do not take Efferaldol Flas

If you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Do not take more medicine than recommended in section 3 "How to take Efferaldol Flas".

Concurrent use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Consult your doctor or pharmacist before starting to take Efferaldol Flas:

• If you weigh less than 50 kg.

• If you have kidney, liver, heart, or lung disease, or anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).

• If you suffer from chronic malnutrition or dehydration, or have a history of alcohol abuse. Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.

• Alcohol consumption is not recommended during treatment.

• If you have chronic malnutrition, anorexia, cachexia, bulimia, or fasting.

• If you are taking any medication for epilepsy, as the simultaneous use may reduce paracetamol's efficacy and increase its hepatotoxicity, especially with high-dose paracetamol regimens.

• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

• Frequent and long-term use of analgesics may cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months, at least on alternate days, do not increase the dose of analgesics but consult your doctor instead.

During treatment with Efferaldol Flas, 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 have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances 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.

Do not continue treatment without consulting your doctor if you are in any of the following situations:

• Pain persists for more than 5 days or fever for more than 3 days,
• You feel the effect of this medicine is too weak,
• A new health problem arises.

Interference with laboratory tests

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Paracetamol may alter analytical values for uric acid and glucose.

Other medicines and Efferaldol Flas

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, especially if you are taking any of the following, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: colestyramine
• Medicines used to increase urine excretion (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
• Concurrent use of this medicine is not recommended because it contains sorbitol (E-420) and sodium polystyrene sulfonate (used to treat hyperkalemia), as it may cause gastrointestinal necrosis
• Other medicines containing paracetamol or propacetamol (a paracetamol precursor) to avoid exceeding the recommended daily dose (see section 3 "How to take Efferaldol Flas")
• Flucloxacillin (antibiotic): due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Use of Efferaldol Flas with food, drinks, and alcohol

Using paracetamol in patients who habitually consume alcohol may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, Efferaldol Flas may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever does not improve or if you need to take the medicine more frequently.

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is negligible or none.

Efferaldol Flas contains sorbitol (E-420), aspartame (E-951), sodium, glucose, sucrose, and sodium benzoate (E-211).

This medicine contains 31 mg of sorbitol (E-420) in each tablet.

This medicine contains 4.8 mg of aspartame (E-951) in each tablet. Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 39 mg of sodium (a main component of table/cooking salt) in each tablet. This corresponds to 1.95% of the maximum daily sodium intake recommended for an adult.

This medicine contains glucose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 25 mg of sodium benzoate in each tablet.

This medicine may contain traces of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Efferaldol Flas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults:

The recommended dose is one tablet, which may be repeated if necessary after an interval of at least 4 hours.

Each tablet contains 500 mg of paracetamol. Never take more than 6 tablets per day. If you are using other medicines containing paracetamol, make sure you do not exceed the maximum daily dose of paracetamol. Do not take more than 3 grams in 24 hours.

Patients with liver disease:

Before taking this medicine, you must consult your doctor.

Patients with kidney disease:

Before taking this medicine, you must consult your doctor.

Take a maximum of 1 tablet per dose.

Depending on your condition, your doctor will advise whether you should take the medicine at minimum intervals of 6 or 8 hours.

Elderly patients:

Dose adjustment is usually not necessary in elderly patients. However, other concomitant risk factors—some of which are more frequent in the elderly—should be taken into account, as they may require dose adjustment.

Method of administration

This medicine is administered orally.

The tablets are buccodispersible, meaning they dissolve in the mouth within a few seconds.

To administer, place the tablet on the tongue and allow it to dissolve. It is taken without water.

Frequency and duration of administration

• For short-term use only.
• Take the tablets regularly to prevent recurrence of fever or pain.
• Wait at least 4 hours between each dose.
• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsens or new symptoms appear, discontinue treatment and consult your doctor.

The prolonged use of high daily doses of paracetamol should be avoided, as it increases the risk of adverse effects such as liver damage.

If you think the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Efferaldol Flas than you should

If you have taken more of the medicine than you should, contact your doctor or pharmacist immediately.

In cases of overdose, there is a risk of liver damage with symptoms such as nausea, vomiting, anorexia, pallor, and abdominal pain.

The following events have been observed after paracetamol overdose:

• Acute kidney failure.
• A condition in which small blood clots form in the bloodstream, blocking blood vessels.
• Rare cases of inflammation of the pancreas.

If you forget to take Efferaldol Flas

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, increased blood transaminase levels, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare adverse effects (may affect up to 1 in 10,000 people): 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). Very rarely, serious skin reactions have been reported.

Adverse effects with unknown frequency: purpura, fixed drug eruption (red or purple skin patch that reappears in the same location), bronchospasm (excessive and prolonged contraction of the muscles in the airways causing breathing difficulty), and a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efferaldol Flas

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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 at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efferaldol Flas

The active substance is paracetamol. Each orodispersible tablet contains 500 mg of paracetamol (as microencapsulated paracetamol with ethylcellulose).

The other components (excipients) are: anhydrous citric acid, anhydrous sodium carbonate, sorbitol (E-420), compressible sucrose (composed of sucrose, maltodextrin and glucose), crospovidone, sodium benzoate (E-211), orange flavour, aspartame (E-951), acesulfame potassium.

Appearance of Efferaldol Flas and contents of the pack

Round, white tablets.

Presented in a cardboard pack containing 2 polypropylene tubes, each with a polyethylene cap containing a desiccant, with 8 tablets each.

Pack size: 16 tablets.

Marketing Authorization Holder

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer

UPSA
304, Av. Dr. Jean Bru
47000 Agen - FRANCE
or
UPSA
979, Avenue des Pyrénées
47520 Le Passage
FRANCE

Local representative

NEWLINE PHARMA, S.L.U.
Calle Tarragona 151-157, 11th Floor, Door 1, Block A
08014 Barcelona (Spain)
Tel.: 931851380

Date of latest review of this leaflet: January 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.es/).