Leaflet: information for the user

Efferaldol Flas 500 mg buccal dispersible tablets

Paracetamol

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your fever worsens or does not improve within 3 days or if your pain worsens or does not improve within 5 days.

1. What isEfferaldol Flasand what it is used for

2. What you need to know before starting to takeEfferaldol Flas

3. How to takeEfferaldol Flas

4. Possible side effects

5. Storage ofEfferaldol Flas

6. Contents of the pack and additional information

This medication contains paracetamol.

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

Do not takeEfferaldol Flas

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

Warnings and precautions

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

Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, may lead to liver damage. Do not take more than one medication 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, anemia (decreased hemoglobin levels in the blood, with or without a decrease in red blood cells).
• If you suffer from chronic malnutrition or dehydration or have a history of alcohol abuse. Chronic alcoholics should not take more than 2 g/24 hours of paracetamol.
• Do not consume alcohol during treatment.
• If you have chronic malnutrition, anorexia, cachexia, bulimia, or fasting.
• If you are being treated with antiepileptic medications, as the combination may reduce the efficacy and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• The frequent use of analgesics over a long period 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.

During treatment with Efferaldol Flas, inform your doctor immediately if:

• You have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or 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 distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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

• The pain persistsfor more than 5 daysor the feverfor more than 3 days
• If you estimate that the effect of this medication is too weak,
• If another health problem appears.

Interactions with laboratory tests

Inform your doctor that you are taking this medication if you are to undergo any laboratory tests (including blood, urine, etc.), as it may alter the results.

Paracetamol may alter the values of uric acid and glucose determinations.

Other medications and Efferaldol Flas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, particularly if you are taking any of the following medications, as it may be necessary to modify the dose of some of them or interrupt treatment:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptic drugs (lamotrigine, phenytoin, or other hydantoins, phenobarbital, metharbital, primidone, carbamazepine)
• Medications to treat tuberculosis: Isoniazid, rifampicin
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: Cholestyramine
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide)
• Medications used to treat gout: Probenecid 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
• Concomitant use of this medication with polystyrene sulfonate (to treat hyperkalemia) is not recommended, as it may cause gastrointestinal necrosis due to the presence of sorbitol (E-420).
• Other medications containing paracetamol or propacetamol (a precursor of paracetamol) to avoid exceeding the recommended daily dose (see section 3 “How to take Efferaldol Flas”)
• Flucloxacillin (antibiotic): due to a high risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Use of Efferaldol Flas with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If necessary, Efferaldol Flas 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 or midwife if the pain or fever do not decrease or if you need to take the medication more frequently.

Consuming medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Paracetamol passes into breast milk, so women breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

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

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

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

This medication contains 4.8 mg of aspartame (E-951) in each tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the inability of the body to eliminate it correctly.

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

This medication contains glucose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

This medication 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).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults:

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

Each tablet contains 500 mg of paracetamol. Do not take more than 6 tablets per day. If you are using other medications that contain 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 medication, you must consult your doctor.

Patients with kidney disease:

Before taking this medication, you must consult your doctor.

Take a maximum of 1 capsule per dose.

According to your disease, your doctor will indicate whether you should take your medication with a minimum interval of 6 or 8 hours.

Patients of advanced age:

No adjustment of the dose is usually necessary in patients of advanced age. However, other concomitant risk factors, some of which are more frequent in the elderly, and which require a dose adjustment, should be taken into account.

Administration form

This medication is administered orally.

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

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

Frequency and duration of administration

• For short-term use.
• Take the tablets regularly to avoid the recurrence of fever or pain.
• Wait at least 4 hours between each administration.
• If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, you must interrupt the treatment and consult your doctor.

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

If you estimate that the action ofthis medicationis too strong or too weak, inform your doctor or pharmacist.

If you take moreEfferaldol Flasthan you should

If you have taken morequantity of the medicationthan you should, consult your doctor or pharmacist immediately.

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

The following events have been observed after a paracetamol overdose:

- Acute inability of the kidneys to function correctly.

- Disease in which small blood clots form in the bloodstream that obstruct blood vessels.

- Rare cases of pancreatitis inflammation.

If you forgot to takeEfferaldol Flas

Do not take a double dose to compensate for the missed doses.

Like all medications,this medicationmay cause adverse effects, although not everyone will experience them.

Rare adverse effects that may affect up to 1 in 1,000 people: discomfort, increased levels of transaminases in the blood, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare adverse effects that may affect up to 1 in 10,000 people: 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). Rarely, severe skin reactions have been reported.

Adverse effects of unknown frequency: purpura, fixed drug eruption (reddish/purple patch on the skin that reappears in the same location), bronchospasm (excessive and prolonged contraction of the respiratory tract muscles that causes breathing difficulty) and a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Reporting Adverse Effects

If you experienceany type of adverse effect,consult your doctor orpharmacist, even if it is apossibleadverse effect not listed in this leaflet.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.Reporting adverse effects can help provide more information about the safety of this medication.

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

No special storage conditions are required.

Do not usethis medicationafter 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 disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. 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 Efferaldol Flas

The active ingredient is paracetamol. Each buccal dispersible 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), compression sugar (composed of sucrose, maltodextrin, and glucose), crospovidone, sodium benzoate (E-211), orange flavor, aspartame (E-951), potassium acesulfame, sodium bicarbonate.

Appearance of Efferaldol Flas and content of the packaging

Round white tablets.

It is presented in a cardboard container containing 2 polypropylene tubes, with a polyethylene plug containing a desiccant, with 8 tablets each.

Container of 16 tablets.

Holder of the marketing authorization

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Responsible for manufacturing

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, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Last review date of this prospectus:January 2025

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