NOTICE
ANSM - Updated on: 10/29/2020
Name of the drug
EFFERALGAN 1000 mg, effervescent tablet
Paracetamol
Framed
Read all of this leaflet carefully before taking this medicine because it contains important information for you.
You should always take this medicine strictly following the information given in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 3 days in case of fever, or 5 days in case of pain.
DO NOT LEAVE THIS MEDICATION WITHIN THE REACH OF CHILDREN.
What does this booklet contain ?
1. What is EFFERALGAN 1000 mg, effervescent tablet and in which cases is it used?
2. What information should I know before taking EFFERALGAN 1000 mg, effervescent tablet?
3. How to take EFFERALGAN 1000 mg, effervescent tablet?
4. What are the possible side effects?
5. How to store EFFERALGAN 1000 mg, effervescent tablet?
6. Contents of the pack and other information.
1. WHAT IS EFFERALGAN 1000 mg, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group : OTHER ANALGESICS and ANTIPYRETICS-ANILIDES
ATC code: N02BE01.
This medication contains paracetamol: an analgesic (relieves pain) and an antipyretic (lowers fever).
It is indicated in the event of pain and / or fever such as headache, flu-like symptoms, dental pain, stiffness, painful periods.
This presentation is reserved for adults and children from 50 kg (from about 15 years old): carefully read the “Dosage” section.
For children weighing less than 50 kg (around 15 years), there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
You should contact your doctor if you experience no improvement or feel less well after 3 days in case of fever, or 5 days in case of pain.
2. BEFORE YOU TAKE EFFERALGAN 1000 mg, effervescent tablet?
Never take EFFERALGAN 1000 mg, effervescent tablet:
· if you are allergic to paracetamol or to any of the other ingredients of this medicine, mentioned in section 6,
· if you have severe liver disease
· child under 50 kg (about 15 years old).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking EFFERALGAN 1000 mg, effervescent tablet .
In case of overdose or mistakenly taking too high a dose, consult your doctor immediately.
This medicine contains paracetamol. Other medicines contain it.
Check that you are not taking other medicines containing paracetamol , including if they are medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose (see section 3 “How to take EFFERALGAN 1000 mg, effervescent tablet?”).
· If the pain persists for more than 5 days or the fever for more than 3 days , or in the event of insufficient efficacy or of any other sign, do not continue the treatment without the advice of your doctor.
Tell your doctor or pharmacist before taking this medicine if any of the following conditions apply to you:
· If you are an adult and you weigh less than 50 kg,
· If you are taking other medicines containing paracetamol (medicines obtained without a prescription),
· If you have liver or kidney disease,
· If you have Gilbert's syndrome (familial non-hemolytic jaundice),
· Or in case of alcohol abuse,
· If you have nutrition problems (malnutrition) (low reserves of hepatic glutathione), anorexia or cachexia (significant weight loss),
· If you are dehydrated.
· Talk to your doctor if you suffer from acute viral hepatitis or if you discover acute viral hepatitis while taking EFFERALGAN 1000 mg, effervescent tablet. Your treatment may be suspended by your doctor.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
Children and adolescents
In a child treated with paracetamol, the combination of another drug used to lower fever (antipyretic) is only justified in case of ineffectiveness. The combination should only be initiated and monitored by a doctor.
Other medicines and EFFERALGAN 1000 mg, effervescent tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should contact your doctor if you are taking any medicine that slows down coagulation (oral anticoagulants). In high doses, EFFERALGAN 1000 mg, effervescent tablet can increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.
You should contact your doctor if you are taking flucloxacillin (a penicillin-class antibiotic) because of the increased risk of metabolic acidosis, especially if you have a risk factor for glutathione deficiency such as severe kidney failure. sepsis (serious general infection of the body by pathogenic germs), malnutrition or chronic alcoholism.
Tell them that you or your child are taking this medicine if your doctor gives you or your doctor a test for uric acid or blood sugar.
EFFERALGAN 1000 mg, effervescent tablet with food, drinks and alcohol
The absorption of alcohol during this treatment is not recommended.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, EFFERALGAN 1000 mg, effervescent tablet can be used during pregnancy and lactation. You should use the lowest possible dose that will relieve pain and / or fever and take it for the shortest possible time. Contact your doctor if the pain and / or fever does not improve or if you need to take the medicine more frequently.
It is possible that paracetamol can alter the fertility of women, reversibly upon discontinuation of treatment.
Driving and using machines
Paracetamol has no or negligible influence on the ability to drive and use machines.
EFFERALGAN 1000 mg, effervescent tablet contains aspartame (E951) (source of phenylalanine), sodium benzoate (E211), sodium, sorbitol (E420) and lactose.
This medicine contains 39 mg of aspartame (E951) per effervescent tablet. Aspartame contains a source of phenylalanine. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by the build-up of phenylalanine that cannot be eliminated properly.
This medicinal product contains 120 mg of sodium benzoate (E211) per effervescent tablet.
This medicine contains 474.1 mg of lactose. If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicinal product contains 370 mg sodium (main component of table salt) per effervescent tablet. This is equivalent to 18.5% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need one or more effervescent tablets daily for an extended period of time, especially if you must be on a low salt (sodium) diet.
This medicinal product contains 252.2 mg of sorbitol (E420) per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disorder characterized by an inability to to break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
3. HOW TO TAKE EFFERALGAN 1000 mg, effervescent tablet?
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
WARNING: this presentation contains 1000 mg (1 g) of paracetamol per tablet: do not take 2 tablets at the same time.
Dosage
This presentation is reserved for adults and children from 50 kg (from about 15 years old).
The lowest effective dose should generally be used, for the shortest possible time.
Weight (approximate age) | Dose by plug | Administration interval | Maximum dose per day |
Adults and children from 50 kg (from about 15 years old) | 1 tablet 1000 mg | 4 hours minimum | 3 tablets 1000 mg per day |
Never exceed 3000 mg of paracetamol per day (3 tablets of 1000 mg), or the dose prescribed by your doctor: a higher dose will not relieve your pain more, but can have serious consequences on your liver.
To avoid a risk of overdose, check the absence of paracetamol in the composition of other drugs, including drugs obtained without a prescription.
If you have the impression that the effect of EFFERALGAN 1000 mg, effervescent tablet is too strong or too weak, consult your doctor or pharmacist.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Patients with renal impairment, hepatic impairment, Gilbert's syndrome (non-hemolytic familial jaundice)
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if in doubt.
Duration of treatment
Unless medical advice, the duration of treatment is limited:
· at 5 days in case of pain,
· to 3 days in case of fever.
If the pain persists for more than 5 days or the fever for more than 3 days, if it gets worse, do not continue the treatment without your doctor's advice.
Method and route of administration
Oral route.
Let the tablet dissolve completely in a glass of water.
Do not swallow or chew the tablets.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
If you take more EFFERALGAN 1000 mg, effervescent tablet than you should:
Stop treatment and consult your doctor or medical emergency immediately .
Overdose can be fatal.
In the first 24 hours, the main symptoms of poisoning are: vomiting, abdominal pain, pallor .
If you forget to take EFFERALGAN 1000 mg, effervescent tablet:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking EFFERALGAN 1000 mg, effervescent tablet:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· In rare cases, a rash or redness of the skin or an allergic reaction may occur, which may manifest as sudden swelling of the face and neck or sudden discomfort with a drop in blood pressure. You should stop treatment immediately, tell your doctor and never take medicines containing paracetamol again.
· Very rare cases of severe skin rashes have been reported. You should stop treatment immediately, tell your doctor and never take medicines containing paracetamol again.
· Exceptionally, biological changes requiring a check of the blood test have been observed: functioning disorders of the liver, abnormally low level of certain white blood cells or of certain blood cells such as platelets which may result in nosebleeds or gums. In this case, consult a doctor.
· Cases of INR imbalance have been reported in case of combination of an AVK and paracetamol at maximum dose (4g / d) for a period of at least 4 days
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr .
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE EFFERALGAN 1000 mg, effervescent tablet?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiration date refers to the last day of that month .
Store in the original packaging in order to protect from moisture.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What EFFERALGAN 1000 mg contains, effervescent tablet
· The active substance is:
Paracetamol................................................. .................................................. .............. 1000 mg
For an effervescent tablet.
· The other ingredients are:
Anhydrous citric acid, sodium bicarbonate *, anhydrous sodium carbonate *, sorbitol (E420), sodium docusate *, povidone, sodium benzoate (E211) *, anhydrous lactose, aspartame (E951), acesulfame potassium, red fruit flavor. * See section 2.
What EFFERALGAN 1000 mg, effervescent tablet looks like and contents of the pack
This medication is in the form of effervescent tablets of off-white color, with bevelled angles, soluble in water producing an effervescence.
Tube of 8 tablets.
Marketing authorization holder
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing authorization operator
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Maker
UPSA SAS
304 AVENUE DU DOCTEUR JEAN BRU
47000 AGEN
or
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medication is available on the ANSM website (France).
Health Education Council
WHAT TO DO IN CASE OF FEVER:
Normal body temperature varies from person to person and ranges from 36.5 ° C to 37.5 ° C. A rise in temperature above 38 ° C can be considered a fever, but it is not recommended to treat the fever with any medicine below 38.5 ° C.
This medication is reserved for adults and children from 50 kg (from about 15 years old).
If the disorders that the fever causes are too bothersome, you can take this medication which contains paracetamol in accordance with the dosages indicated.
You can improve the effectiveness of drug treatment by the following measures:
· to discover yourself,
· drink regularly to avoid any risk of dehydration
· do not stay in a place that is too hot
With this medicine, the fever should drop quickly. However :
· if other unusual signs appear,
· if the fever persists for more than 3 days or if it gets worse,
· if the headache becomes severe, or in case of vomiting,
SEEK YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IN CASE OF PAIN:
The intensity of pain perception and the ability to resist it varies from person to person.
· If there is no improvement after 5 days of treatment,
· if the pain is violent, unexpected and occurs suddenly (especially a strong pain in the chest) and / or on the contrary comes back regularly,
· if it is accompanied by other signs such as generally feeling unwell, fever, unusual swelling of the painful area, decreased strength in a limb,
· if she wakes you up at night,
SEEK YOUR DOCTOR IMMEDIATELY.