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Efferalgan 1 g film-coated tablets
Over-the-counter medication

Efferalgan 1 g film-coated tablets

Brand : UPSA BMS UPSA BMS
€1.80 EXCL. VAT €1.99 INCL. VAT
In stock
Reference : 3400936485464
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EFFERALGAN is a medication indicated for the symptomatic treatment of mild to moderate pain and / or febrile states.

For warnings, precautions for use and contraindications, please consult the instructions for use of Efferalgan 1g.

Indications

Efferalgan 1g is a medicine indicated for the symptomatic treatment of mild to moderate pain or feverish conditions . Efferalgan 1g film-coated tablet is used for the symptomatic treatment of pain in osteoarthritis.

Directions for use and dosage

This medication is for adults and children over 15 years old (over 50 kg). For adults and children over 15 years, use 1 tablet of Efferalgan 1 g to be renewed every 4 hours, without exceeding 4 tablets per day. Oral route.

Composition

Paracetamol 1g. excipients: anhydrous citric acid; sodium bicarbonate ; sorbitol; anhydrous sodium carbonate; povidone; sodium docusate; potassium benzoate; aspartame; acesulfame potassium; grapefruit aroma; orange aroma; qsp 1 film-coated tablet. Aspartame; sodium; sorbitol.

Precaution of use

Contraindication and warning

  • Allergy to paracetamol or other constituents;
  • Hepatocellular insufficiency;
  • Phenylketonuria.

Efferalgan 1 g film-coated tablets is a medicine containing paracetamol. It is essential to avoid overdose by checking the absence of paracetamol in the composition of other drugs. The maximum recommended dose should not be exceeded. This treatment is contraindicated in children under 15 years old. This medication can be taken during pregnancy and lactation under normal conditions of use. Efferalgan 1g contains sorbitol, so it is not recommended in case of fructose intolerance. In the event of a deodorized or low sodium diet, take into account the presence of sodium in the daily ration.

Introducing Efferalgan 1g

Plate of 8 tablets

Warnings about painkillers

Please note that the drug Efferalgan 1g is not a product like any other. Read the instructions for the medication carefully before ordering it. Do not leave Efferalgan 1g medicines within the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your online pharmacist of current treatments in order to identify any incompatibilities. The order validation form contains a custom message field provided for this purpose.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 13/04/2017

Name of the medicinal product

EFFERALGAN 1000 mg film-coated 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 if you 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 EFFERALGAN 1000 mg film-coated tablets and when is it used?

2. What information should I take before taking EFFERALGAN 1000 mg film-coated tablets?

3. How to take EFFERALGAN 1000 mg film-coated tablet?

4. What are the possible side effects?

5. How to store EFFERALGAN 1000 mg film-coated tablets?

6. Package contents and other information.

1. WHAT IS EFFERALGAN 1000 mg film-coated 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 50 kg (from about 15 years) : read carefully the Dosage section.

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 EFFERALGAN 1000 mg film-coated tablet?

Do not take EFFERALGAN 1000 mg film-coated tablets:

· 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 you are a child under 15 years old.

IN CASE OF DOUBT, IT IS ESSENTIAL TO REQUEST THE NOTICE OF YOUR DOCTOR OR

OF YOUR PHARMACIST.

Warnings and Precautions

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

This medicinal product contains paracetamol. Other medicines contain it.

Make sure you do not take any other medicines containing paracetamol, including medicines obtained without a prescription.

Do not combine them, so as not to exceed the recommended daily dose (see "Dosage" and "Symptoms and Instructions for Overdose").

· If the pain persists more than 5 days or the 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).

If you have acute viral hepatitis or if acute viral hepatitis is discovered during treatment with EFFERALGAN 1000 mg film-coated tablets, talk to your doctor. Your treatment may be suspended by your doctor.

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR 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 EFFERALGAN 1000 mg film-coated tablet

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

In case of concomitant treatment with probenecid, a dose reduction of EFFERALGAN 1000 mg film-coated tablet should be considered.

You should contact your doctor if you are taking medication that slows down coagulation (oral anticoagulants). In high doses, EFFERALGAN 1000 mg, film-coated tablet may 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.

EFFERALGAN 1000 mg, film-coated tablets with food, beverages 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 discontinuation of therapy.

Driving and using machines

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

EFFERALGAN 1000 mg film-coated tablet contains

Not applicable.

3. HOW TO TAKE EFFERALGAN 1000 mg film-coated 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.

CAUTION: This tablet contains 1000 mg (1 g) of paracetamol per tablet: do not take 2 tablets at a time .

Dosage

This presentation is reserved for adults and children from 50 kg (from about 15 years).

Weight

(Age)

Dose per administration

Interval of administration

Maximum Daily Dose

Adults and children from 50 kg (from about 15 years old)

1000 mg
(1 tablet)

4 hours minimum

3000 mg

(3 tablets)

It is generally not necessary to exceed 3 g of paracetamol per day, ie 3 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, or 4 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 EFFERALGAN 1000 mg film-coated tablets 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.

The tablets should be swallowed as is with a drink (eg water, milk, fruit juice).

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 adults and children over 15 years of age, 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:

Creatinine clearance

Interval of administration

cl ≥ 50 mL / min

4 hours

cl 10-50 mL / min

6 hours

cl <10 mL / min

8 hours

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

Duration of treatment

The duration of treatment is limited:

· to 5 days in case of pain,

· at 3 days in case of fever.

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 EFERALGAN 1000 mg film-coated tablets than you should

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

If you forget to take EFFERALGAN 1000 mg film-coated tablet

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

If you stop taking EFFERALGAN 1000 mg, film-coated 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 or pharmacist. 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 EFERALGAN 1000 mg film-coated 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. 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 EFERALGAN 1000 mg contains, film-coated tablets

· The active substance is:

Paracetamol................................................. .................................................. .............. 1000 mg

For a film-coated tablet.

· The other components are:

Core :

Hydroxypropylcellullose, croscarmellose sodium, glycerol behenate, magnesium stearate, anhydrous colloidal silica.

Laminating:

OPADRY OY-S-38901: hypromellose, titanium dioxide (E171), propylene glycol.

What is EFERALGAN 1000 mg film-coated tablets and contents of the pack

This drug is in the form of film-coated tablet. Box of 8 or 100 tablets

Not all pack sizes may be marketed.

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

ELAIAPHARM

crest road

ZI the boils

sophia antipolis

06560 valbonne

or

UPSA SAS

979, avenue des pyrénées

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:

[to be completed later by the holder]

{month YYYY}.

Other

Detailed information on this medicine is available on the ANSM website (France).

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 50 kg (from about 15 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

EFFERALGAN tablet

Analgesic and antipyretic

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

EFFERALGAN 1 g: tablet; box of 8.
-

UPSA Laboratory

COMPOSITION (summary)
p cp
Paracetamol 1 g

INDICATIONS (summary)
This medication is an analgesic and an antipyretic that contains paracetamol.
It is used to lower fever and in the treatment of painful conditions.
CONTRAINDICATIONS (summary)
This medication should not be used in patients with severe liver disease.
WARNING (Contents)
Paracetamol is present alone or in combination with other substances in many medicines: make sure not to take several medicines containing paracetamol simultaneously, as a joint dose leads to a risk of overdosage, which can be toxic to the liver.
Precautions are necessary in people weighing less than 50 kg or suffering from severe renal insufficiency, liver failure , alcoholism or dehydration.
DRUG INTERACTIONS (summary)
If treated with oral anticoagulant and paracetamol at maximum doses (4 g / day) for at least 4 days, increased monitoring of anticoagulant therapy may be required.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
The scientific studies currently available have not revealed any particular problem when using paracetamol in pregnant women.

Breastfeeding:
At the usual doses, the use of this medication is possible during breastfeeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication can be taken indifferently during or between meals, respecting a minimum interval of 4 hours between 2 catches. In case of renal insufficiency , the interval between 2 takes must be at least 8 hours.
The tablets should be swallowed as is with a drink.

Usual dosage:

  • Adult and child over 50 kg (approximately 15 years): 1 tablet, 1 to 3 times a day. Do not exceed 3 g of paracetamol per day without medical advice.
    In severe pain and particularly in osteoarthritis , the maximum dose can be increased to 1 g of paracetamol, 4 times a day, only on medical prescription.
TIPS (summary)
Abundant sweating usually accompanies the drop in temperature during the treatment of high fevers. This is normal.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Exceptionally: allergic reaction , abnormal blood count .


GLOSSARY (summary)


analgesic
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Synonym: analgesic.


anticoagulant
Medication that prevents blood from coagulating and therefore prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also prevent the formation of clots in the heart during rhythm disorders such as atrial fibrillation or in the case of an artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: INR (formerly TP);
  • injectable anticoagulants derived from heparin, the efficacy of which can be controlled by the blood assay of anti-Xa activity, Howell's Time (TH) or Cephalin Kaolin Time (TCK) depending on the products used. A regular dosage of blood platelets is necessary throughout the life of a heparin derivative.


antipyretic
Medication used to lower the body temperature during bouts of fever.


osteoarthritis
Wear of cartilage, responsible for joint pain and limitation of movement.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


blood count
The count measures the number of red blood cells (red blood cells), white blood cells (leukocytes) and platelets in the blood. The blood formula specifies the percentage of different white blood cells: neutrophils, eosinophils, basophils, lymphocytes, monocytes.
Abbreviation: NFS.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.

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