Efferalgan 500 MG EFFERVESCENT PARACETAMOL

NOTICE

ANSM - Last updated: 13/04/2017

Name of the medicinal product

EFFERALGANMED 500 mg, split effervescent tablet

Paracetamol

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects 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.

What is in this leaflet?

1. What is EFFERALGANMED 500 mg, split effervescent tablet and in which cases it is used?

2. What information should I take before taking EFFERALGANMED 500 mg, split effervescent tablet?

3. How to take EFFERALGANMED 500 mg, split effervescent tablet?

4. What are the possible side effects?

5. How to store EFFERALGANMED 500 mg, split effervescent tablet?

6. Package contents and other information.

1. WHAT IS EFFERALGANMED 500 mg, split effervescent tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: OTHER ANTALGS AND ANTIPYRETICS-ANILIDES - ATC code: N02BE01.

This medication contains paracetamol: an analgesic (it calms the pain) and an antipyretic (it lowers the fever).

It is indicated for pain and / or fever such as headaches, flu-like conditions, dental pain, muscle aches, painful periods.

This presentation is reserved for the adult and the child from 13 kg (from about 2 a ns): read the Posology section carefully . For children from 13 to 25 kg (approximately 2 to 10 years), the dosage is one half-tablet per dose.

For children of different weights, other forms of paracetamol are available: 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 EFFERALGANMED 500 mg, split effervescent tablet?

Do not take EFFERALGANMED 500 mg, split effervescent tablet :

· If you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6,

· If you have severe liver disease.

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Warnings and Precautions

Talk to your doctor or pharmacist before taking EFFERALGANMED 500 mg, split effervescent tablet.

In case of overdosage or mistake of too high a dose, consult your doctor immediately.

· If the pain persists more than 5 days or fever more than 3 days or if there is insufficient efficacy or any other signs, do not continue treatment without the advice of your doctor.

· Before starting treatment with this drug, make sure that you are not taking any other medicines containing paracetamol.

Tell your doctor before you take this medicine if any of the following apply to you:

· If you are adult and you weigh less than 50 kg,

· If you are taking other medicines containing paracetamol (medicines obtained with or without a prescription),

· If you have liver or kidney disease,

· If you have Gilbert's syndrome (non-haemolytic familial jaundice),

· Or alcohol abuse (excessive alcohol consumption (3 or more alcoholic beverages per day)),

· If you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (which can lead to hemolytic anemia),

· If you have problems with nutrition (malnutrition (low reserves of hepatic glutathione), anorexia, bulimia or cachexia (heavy weight loss)

· If you have problems with dehydration, hypovolemia (significant loss of body water).

This medicine contains sodium. This medicine contains 412.4 mg sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.

The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).

If you have acute viral hepatitis or acute viral hepatitis during your treatment with EFFERALGANMED 500 mg split effervescent tablet, talk to your doctor. 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 Youth

In a child treated with paracetamol, the association of another antipyretic is justified only in case of ineffectiveness. The association should be established and monitored only by a physician.

Other medicines and EFFERALGANMED 500 mg, split effervescent tablet

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

If concomitant treatment with probenecid is used, a dose reduction of EFFERALGANMED 500 mg, an effervescent tabletable tablet should be considered.

You should contact your doctor if you are taking medication that slows down coagulation (oral anticoagulants). In high doses, EFFERALGANMED 500 mg, split effervescent tablet can increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.

Inform your doctor or pharmacist if you are taking phenytoin, the simultaneous use of these drugs and paracetamol may damage the liver.

Inform your doctor or pharmacist if you are taking enzyme inducers (such as phenobarbital, carbamazepine, primidone, rifampicin).

Tell your doctor or prescriber about all prescription and nonprescription / herbal products you may use before using this medication.

EFFERALGANMED 500 mg, split effervescent tablet with food, drink and alcohol

Not applicable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy and breast feeding

This medicine may be used during pregnancy and lactation. Use the lowest dose to reduce your pain and / or fever for as short a time as possible and as often as possible. Contact your doctor or midwife if pain and / or fever does not decrease or if you need to take this medication more frequently during your pregnancy.

Fertility

It is possible that paracetamol may alter the fertility of women, reversibly upon cessation of treatment.

Driving and using machines

Paracetamol has no or negligible effect on the ability to drive and use machines.

EFFERALGANMED 500 mg, split effervescent tablet contains sodium and sorbitol.

3. HOW TO TAKE EFFERALGANMED 500 mg, split effervescent tablet?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.

Dosage

This presentation is reserved for the adult and the child from 13 kg (from about 2 years).

The dosage of paracetamol depends on the weight of the child; the ages are mentioned for information purposes.

If you do not know the weight of the child, weigh it to give it the best dose.

Paracetamol exists in many dosages, allowing the treatment to be adapted to the weight of each child.

The recommended daily dose of paracetamol depends on the child's weight: it is approximately 60 mg / kg / day, divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours or 10 mg / kg all the 4 hours.

For children, the total dose of paracetamol should not exceed 80 mg / kg / day (see section 4.9).

For adults and children weighing more than 50 kg (from about 15 years), the usual dosage is 1 to 2 tablets at 500 mg per dose depending on the intensity of the pain, to be renewed in case after 4 hours minimum.
It is generally not necessary to exceed 3 g of paracetamol per day, ie 6 tablets per day. However, in case of more intense pain, and on advice from your doctor, the total dose can be increased up to 4 g per day, ie 8 tablets per day.

However,

· doses greater than 3 g of paracetamol per day require medical advice.

· NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking all medicines containing paracetamol into their formula).

Always respect an interval of at least 4 hours between the catches.

The maximum daily dose shall not exceed 60 mg / kg (not to exceed 3 g) per day in the following situations:

· adults less than 50 kg ,

· severe liver damage,

· Gilbert syndrome (non-hemolytic familial jaundice),

· chronic alcoholism,

· chronic malnutrition,

· dehydration.

If you feel that the effect of EFFERALGANMED 500 mg, split effervescent tablet is too strong or too weak, talk to your doctor or pharmacist.

IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.

Method and route of administration

Oral use.

Allow the tablet to dissolve completely in a glass of water, if necessary after breaking it in half.

Do not swallow or chew the tablets.

In addition, if your child has a fever greater than 38.5 ° C, you can improve the effectiveness of the drug treatment by:

· discover your child,

· make the drink,

· do not leave your child in a place too hot.

Frequency of Administration

Systematic catches help to avoid oscillations of pain or fever.

· In children, they should be regularly spaced, including at night, preferably 6 hours, and at least 4 hours.

· In adults, they must be spaced at least 4 hours apart.

Renal failure

In case of kidney disease (kidney failure), the minimum interval between 2 doses should be modified according to your renal function according to the following table:

The total dose of paracetamol should not exceed 3 g / day, ie 6 tablets.

Duration of treatment

If the pain persists more than 5 days or the fever more than 3 days, if they worsen, do not continue treatment without the advice of your doctor or pharmacist.

If you take more EFFERALGANMED 500 mg, split effervescent tablet than you should

In case of overdose or accidental poisoning, notify a doctor immediately.

If you forget to take EFFERALGANMED 500 mg, split effervescent tablet

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

If you stop taking EFFERALGANMED 500 mg, split effervescent tablet

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· In some rare cases, it is possible that a rash or reddening or allergic reaction can occur, which can be manifested by a sudden swelling of the face and neck or by a sudden discomfort with drop in blood pressure. Immediately stop treatment , tell your doctor and never take any medicines containing paracetamol.

· In some rare cases severe skin reactions have been reported. Immediately stop treatment, tell your doctor and never take any medicines containing paracetamol.

· Exceptionally, biological changes requiring blood check have been observed: liver function disorders, abnormally low levels of certain white blood cells or certain blood cells such as platelets which can result in nosebleeds or gums. In this case, consult a doctor.

· Cases of diarrhea, abdominal pain, increased liver enzymes, increased or decreased INR have been reported.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE EFFERALGANMED 500 mg, split effervescent tablet?

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

Do not use this medicine after the expiry date which is stated on the package after the abbreviation used for the expiration date. The expiry date refers to the last day of that month.

No special storage conditions.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What EFFERALGANMED 500 mg contains, split effervescent tablet

· The active substance is:

Paracetamol................................................. .................................................. 500 mg

· The other components are:

Anhydrous citric acid, anhydrous sodium carbonate, sodium bicarbonate, sorbitol, sodium saccharin, sodium docusate, povidone, sodium benzoate.

What is EFFERALGANMED 500 mg, split effervescent tablet and contents of the pack

This medication is in the form of a splittable effervescent tablet. Box of 10 or 16 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 medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

{month YYYY}.

Other

Health Education Council:

WHAT TO DO IN CASE OF FEVER:

The normal temperature of the body varies from person to person and is between 36.5 ° C and 37.5 ° C. A rise in temperature above 38 ° C may be considered a fever.

This medication is intended for adults and children from 13 kg (from about 2 years).

If the disorders that the fever causes are too troublesome, you can take this drug that contains paracetamol in accordance with the indicated dosages.

To avoid any risk of dehydration, consider drinking frequently.

With this medication, the fever should drop rapidly. However :

· if other unusual signs appear,

· if the fever persists for more than 3 days or if it worsens,

· if the headache becomes violent, or in case of vomiting.

CONSULT YOUR DOCTOR IMMEDIATELY.

WHAT TO DO IF PAIN:

The intensity of the perception of pain and the ability to resist it vary from person to person.

· If there is no improvement after 5 days of treatment,

· if the pain is violent, unexpected and occurs suddenly (including severe pain in the chest) and / or reverses regularly,

· if accompanied by other signs such as general malaise, fever, unusual swelling of the painful area, decreased strength in a limb,

· if it wakes you up at night.

CONSULT YOUR DOCTOR IMMEDIATELY.

VIDAL OF THE FAMILY

EFFERALGANMED