This medicine contains paracetamol.

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

Do not take Efferaldol Flas

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

Warnings and cautions

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

Simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and colds, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Talk to your doctor or pharmacist before taking Efferaldol Flas:

• If you weigh less than 50 kg,

• if you suffer from kidney, liver, heart or lung disease, anemia (decrease in the level of hemoglobin in the blood, whether or not due to a decrease in red blood cells).
• if you are chronically malnourished or dehydrated or have a history of alcohol abuse. Chronic alcoholics should be careful not to take more than 2 g / in 24 hours of paracetamol.
• If you are being treated with any medicine to treat epilepsy, because when used at the same time, the efficacy is decreased and the hepatotoxicity of paracetamol is enhanced, especially in treatments with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

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

• pain lasts more than 5 days or fever more than 3,
• if you think that the action of this medicine is too weak,
• if another health problem appears.

Interference with analytical tests

If you are going to do any analytical test (including blood, urine, etc ...) tell your doctor that you are taking this medicine, as it may alter the results.

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

Other medicines and Efferaldol Flas:

Tell your doctor or pharmacist if you are using, have recently used or might have to use any other medicine, in particular if you are taking any of the following medicines, as it may be necessary to modify the dose of some of them or to interrupt the treatment:

• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Drugs to treat tuberculosis: isoniazid, rifampicin
• Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: cholestyramine
• Medicines used to increase urine output (loop diuretics such as those of the 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 disturbances (cardiac arrhythmias): Propranolol.
• The simultaneous use of this medicine is not recommended, as it contains sorbitol (E-420), with sodium polystyrene sulphonate (to treat hyperkalaemia) because it can cause gastrointestinal necrosis.
• Other medicines containing paracetamol or propacetamol (a paracetamol precursor) not to exceed the recommended daily dose (see section 3 “How to take Efferaldol Flas ”).
• Flucloxacillin: Caution is advised when administered concomitantly with paracetamol due to an increased risk of metabolic acidosis particularly in patients with severe renal impairment, sepsis, malnutrition and chronic alcoholism.

Efferaldol Flas with food, drink and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks a day - beer, wine, liquor ... a day) can cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist before using this medicine.

If necessary, 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 subside or if you need to take the medicine more often.

The consumption of medications during pregnancy can be dangerous for 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 medicine.

Driving and using machines

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

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

- This medicine contains 30.5 mg sorbitol (E-420) per tablet. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

- This medicine contains 4.80 mg of aspartame (E-951) per tablet. Aspartame can be harmful for people with phenylketonuria because it is a source of phenylalanine.

- This medicine contains 39 mg of sodium per tablet. Patients on low sodium diets should take into account the sodium content of this medicine.

- This medicine contains glucose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If in doubt, ask 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 a day. If you are using other medicines containing paracetamol, make sure that you do not exceed the maximum daily dose of paracetamol. You should not take more than 3 grams in 24 hours.

Patients with kidney or liver disease :

Before taking this medicine you have to consult your doctor.

Form of administration

This medicine is administered orally.

The tablets are orodispersible, which means that they dissolve in the mouth in a few seconds.

For administration, 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.
• Take the tablets regularly to prevent the fever or pain from coming back.
• 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 stop the treatment and consult your doctor.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided as the risk of suffering adverse effects such as liver damage is increased.

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

If you take more Efferaldol Flas than you should

If you have taken more Efferaldol Flas than you should, consult your doctor or pharmacist immediately.

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

If you forget to take Efferaldol Flas

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

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

Rare side effects that may affect up to 1 in 1,000 people: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.

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, leukopenia, neutropenia, hemolytic anemia) and hypoglycaemia (low blood sugar). Very rare cases of serious skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or in long-term treatments.

Communication of adverse effects

If you experience any kind of side effect ,   Consult your doctor or pharmacist, even if it is about possible side effects that do not appear in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: www.notificaRAM.es . By reporting side effects you can help provide more information on the safety of this medicine.

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

It does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required . This way you will help to protect the environment.

What Efferaldol Flas contains

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

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

What the product looks like and contents of the pack

Efferaldol Flas are round, white tablets.

It is presented in a cardboard container that contains 2 polypropylene tubes, with a polyethylene cap containing a blotter, with 8 tablets each.

Holder of the marketing authorization and responsible for manufacturing

Marketing authorization holder:

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, SL

Tarragona Street 151-157, Floor 11, Door 1, Block A

08014 Barcelona (Spain)

Tel .: 931851380

Date of the last revision of this leaflet: October 2019

Detailed information on this drug is available on page