EFFERALDOL FLAS 500 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Efferaldol Flas 500 mg Oral Dispersible Tablets

Paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the Package Leaflet

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 side effects
5. Storage of Efferaldol Flas
6. Package Contents and Additional Information

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

This medication contains paracetamol.

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

2. What you need to know before taking Efferaldol Flas

Do not takeEfferaldol Flas

If you are allergic (hypersensitive) to the active ingredient or 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.

The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use 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 (reduced hemoglobin level in the blood, due to or not due to a reduction in red blood cells).
• If you suffer from chronic malnutrition or dehydration, or if you have a history of alcohol abuse. Chronic alcoholics should take no more than 2 g/24 hours of paracetamol.
• Alcohol consumption is not recommended during treatment.
• If you have chronic malnutrition, anorexia, cachexia, bulimia, or fasting.
• If you are being treated with any medication for epilepsy, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Frequent use of analgesics for a long time can 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 illnesses, 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 are also taking flucloxacillin (an antibiotic). A severe 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 breathing difficulties 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 persists for more than 5 days or the fever for more than 3,
• if you think the action of this medication is too weak,
• if another health problem appears.

Interactions with Analytical Tests

If you are going to have any analytical tests (including blood, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

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

Other Medications and Efferaldol Flas

Inform your doctor or pharmacist if you are using, have recently used, 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 for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: isoniazid, rifampicin
• Medications for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: colestyramine
• Medications used to increase urine elimination (loop diuretics 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 (cardiac arrhythmias): Propranolol
• The simultaneous use of this medication, which contains sorbitol (E-420), with sodium polystyrene sulfonate (to treat hyperkalemia) is not recommended, as it may cause gastrointestinal necrosis
• Other medications that contain paracetamol or propacetamol (a precursor to paracetamol) to not exceed the recommended daily dose (see section 3 "How to take Efferaldol Flas")
• Flucloxacillin (antibiotic): due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that must be treated urgently (see section 2).

Use of Efferaldol Flas with Food, Beverages, and Alcohol

The use of paracetamol in patients who habitually 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

In case of need, Efferaldol Flas can be used during pregnancy. You should 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 does not decrease or if you need to take the medication more frequently.

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

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

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is negligible or nonexistent.

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 case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication contains 39 mg of sodium (main component of table salt/cooking salt) in each tablet. This is equivalent to 1.95% of the maximum recommended daily sodium intake 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 can 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 can accumulate in the body and cause adverse effects (metabolic acidosis).

3. How to Take Efferaldol Flas

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly. 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. Never take more than 6 tablets per day. If you are using other medications that contain paracetamol, ensure that you do not exceed the maximum daily dose of paracetamol. Do not take more than 3 grams in 24 hours.

Patient with liver disease:

Before taking this medication, they must consult their doctor.

Patient with kidney disease:

Before taking this medication, they must consult their doctor.

Take a maximum of 1 tablet per dose.

Depending on your condition, your doctor will indicate whether you should take your medication with a minimum interval of 6 or 8 hours.

Elderly patients:

The dose does not usually need to be adjusted in elderly patients. However, other concurrent risk factors, some of which are more frequent in the elderly, should be taken into account, and may require a dose adjustment.

Method of administration

This medication is administered orally.

The tablets are oral dispersible, which means they dissolve in the mouth in a few seconds.

For administration, 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 the pain or fever worsens, or other symptoms appear, you should interrupt treatment and consult your doctor.

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

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

If you take moreEfferaldol Flasthan you should

If you have taken more medication than 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 kidney failure.
• A disease in which small clots form in the bloodstream that obstruct blood vessels.
• Rare cases of pancreatitis.

If you forget to takeEfferaldol Flas

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Rare side 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 side effects that may affect up to 1 in 10,000 people: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Side effects of unknown frequency: purpura, fixed drug eruption (red/purple skin patch that reappears in the same place), bronchospasm (excessive and prolonged contraction of the muscles of the airways that causes difficulty breathing), and a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol may cause liver damage when taken in high doses or for prolonged periods.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Efferaldol Flas

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Efferaldol Flas

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

Appearance of Efferaldol Flas and Package Contents

Round, white tablets.

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

Package of 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, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Date of the Last Revision of this Package Leaflet:January 2025

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