This medicine is indicated for the symptomatic treatment of occasional mild or moderate pain, in adults and children from 9 years of age.

You should see a doctor if fever worsens or if fever persists after 3 days or pain for 5 days.

DO NOT TAKE EFFERALDOL WITH VITAMIN C YES

• its weight is less than 27 kg
• are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6)
• if you have fructose intolerance

Warnings and cautions

Talk to your doctor or pharmacist before taking EFFERALDOL WITH VITAMIN C.

• Do not take more than the recommended in section 3. How to take vitamin C EFFERALDOL.
• Chronic alcoholics should be careful not to take more than 2 g / day of paracetamol.
• Patients with diseases of the kidney, the liver, the heart or the lung and in patients with anemia should consult with your doctor before taking the drug.
• When you are being treated with any medication to treat epilepsy, you should consult your doctor before taking this medication, because when used at the same time, the effectiveness is decreased and the hepatotoxicity of paracetamol is enhanced, especially in high dose treatments. of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• Acetaminophen can cause serious skin reactions, including acute generalized exanthematous pustulosis (AGEP) , Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed of the signs of serious skin reactions, and use of the drug should be discontinued at the first sign of a skin rash or any other sign of hypersensitivity.

Interference with analytical tests

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

Taking EFFERALDOL WITH VITAMIN C with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might have to use any other medicines.

In particular, if you are using some of the following medicines, as it may be necessary to modify the dose of some of them or to interrupt the treatment:

• Medicines 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 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 disorders (cardiac arrhythmias): propranolol.
• Ethyl alcohol
• Basic or Acidic Medications: Administration of high doses of vitamin C can decrease the excretion of acidic medications and increase the urinary excretion of basic medications.
• Iron: Vitamin C facilitates the absorption of iron in the digestive tract.
• 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.

Taking EFFERALDOL WITH VITAMIN C with food, drink and alcohol

Taking this medicine with food does not affect its effectiveness.

Pregnancy and Lactation

If you are pregnant or think you might be, consult your doctor before taking this medicine.

If necessary, EFFERALDOL WITH VITAMIN C 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.

Paracetamol passes into breast milk and there are limited data on the use of high doses of vitamin C during pregnancy and lactation, therefore the use of Efferaldol with Vitamin C is not recommended, except under the supervision of a physician.

Driving and using machines

The influence of paracetamol and vitamin C on the ability to drive and use machines is zero or negligible.

EFFERALDOL WITH VITAMIN C contains sorbitol and Sodium

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

Patients on low sodium diets should take into account that this medicine contains

329.53 mg (14.32 mmol) of sodium per tablet.

Follow exactly the instructions for administration of this medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

EFFERALDOL WITH VITAMIN C is restricted to adults and children weighing at least 27   kg .

The recommended dose is:

Adults and adolescents over 14 years:

Administer 1 to 2 tablets every 4-6 hours, as needed.

It will not exceed 8 tablets in 24 hours divided into several doses.

Patients with kidney diseases : before taking this medicine you should consult your doctor.

Take a maximum of 1 tablet per dose.

Depending on your illness, your doctor will tell you whether to take your medicine at least 6 to 8 hours apart.

Patients with liver diseases : before taking this medicine you should consult your doctor.

They should take the amount of medicine prescribed by their doctor with a minimum interval between each taking of 8 hours.

Do not take more than 6 tablets in 24 hours, divided into several doses.

Use in children

Children under 9 years old or weighing less than 27 kg cannot take this medicine.

Children 9-14 years old weighing more than 27 kg :

1 tablet every 4-6 hours as needed. It will not exceed 5 tablets in 24 hours divided into 5 doses.

This medicine is taken by mouth.

The effervescent tablets should be dissolved in a glass of water. Do not ingest until bubbling has completely stopped.

Always take the lowest dose that is effective.

The taking of this medicine is subject to the appearance of pain or fever. As these disappear, treatment should be stopped.

If the pain persists for more than 5 days in adults and 3 days in children, 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.

For a sore throat, the drug should not be taken for more than 2 days in a row, without consulting a doctor.

IF YOU TAKE MORE EFFERALDOL WITH VITAMIN C THAN YOU SHOULD

You should immediately consult your doctor or pharmacist.

Overdose symptoms may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have ingested an overdose, you should go immediately to a medical center even if you do not notice the symptoms, since these often do not appear until 3 days after the ingestion of the overdose, even in cases of severe poisoning.

When you have taken an overdose, the overdose treatment is most effective if it is started within 4 hours of taking the medicine .

Patients taking barbiturates or chronic alcoholics may be more susceptible to toxicity from a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone number 91 562 04 20), indicating the medicine and the amount ingested.

Like all medicines, EFFERALDOL WITH VITAMIN C can cause side effects, although not everyone gets them.

Possible side effects of EFFERALDOL WITH VITAMIN C are:

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).

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

High doses of vitamin C (above 1g) can cause in certain patients the

kidney stone formation and may increase hemolysis in G6PD-deficient subjects in chronic forms of hemolysis.

Gastrointestinal disorders (abdominal pain, diarrhea), nervous system disorders (dizziness), urinary tract and kidney disorders (chromaturia and hyperoxaluria), skin and subcutaneous disorders (rash and urticaria) have been observed without known frequency.

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.

Do not store above 25ºC.

Store in the original package to protect from moisture.

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.

Composition of EFFERALDOL WITH VITAMIN C

- The active principles are paracetamol and ascorbic acid (Vitamin C).

- The other ingredients (excipients) are sorbitol (E-420), monosodium carbonate, monopotassium carbonate, sodium benzoate (E-211), anhydrous citric acid, dioctyl sodium sulfosuccinate and polyvinylpyrrolidone.

What the product looks like and contents of the pack

EFFERALDOL WITH VITAMIN C is presented in a box with 2 tubes of 10 effervescent tablets each.

The tablets are effervescent, white and scored. The score line should not be used to divide the tablet.

Marketing authorization holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Responsible for manufacturing

UPSA

979, Avenue des Pyrénées

47520 Le Passage - FRANCE

or

UPSA

304, Av. Dr. Jean Bru - Agen

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