In this manual :
1. What is EFFERALGANTAB 1 g, film-coated tablet and what is it used for?
2. What do you need to know before taking EFFERALGANTAB 1 g, film-coated tablet?
3. How do I take EFFERALGANTAB 1 g, film-coated tablet?
4. What are the possible side effects?
5. How do I keep EFFERALGANTAB 1 g, film-coated tablet?
6. Additional information.
1. WHAT IS EFFERALGANTAB 1 g, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine contains paracetamol: an analgesic (pain reliever) and an antipyretic (fever reducer).
It is indicated in case of pain and/or fever such as headaches, flu, toothache, aches and pains, painful periods.
This presentation is reserved for adults and children weighing more than 50 kg (from about 15 years of age).
Read carefully How to take EFFERALGANTAB 1 g, film-coated tablet
For children of different weights, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
2. WHAT YOU SHOULD KNOW BEFORE TAKING EFFERALGANTAB 1 g, film-coated tablet
List of information needed before taking the medicine
Not applicable.
Never take EFFERALGANTAB 1 g, film-coated tablet in the following cases:
- known allergy to paracetamol or other constituents,
- severe liver disease,
- children under 15 years of age.
In case of doubt, it is essential to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Take caution with EFFERALGANTAB 1 g, film-coated tablet:
Special Warnings
In case of overdose or if you take too much by mistake, consult your doctor immediately.
This medicine contains paracetamol. Other medicines contain paracetamol. Do not combine them, so as not to exceed the recommended daily dose(see section 3. How to take EFFERALGANTAB 1 g, film-coated tablet).
Precautions for use
If the pain persists for more than 5 days or the fever for more than 3 days, or in case of insufficient efficacy or any other sign, do not continue the treatment without the advice of your doctor.
- In case of serious liver or kidney disease, or alcohol abuse, it is necessary to consult your doctor before taking paracetamol.
- Before starting treatment with this medicine, check that you are not taking any other medicines containing paracetamol. Tell your doctor if you are taking other medicines containing paracetamol.
- In case of nutritional problems (malnutrition) or dehydration, EFFERALGANTAB 1 g should be used with caution.
If in doubt, do not hesitate to ask your doctor or pharmacist for advice.
Interactions with other medicines
Taking or using other medicines:
Report that you are taking this medicine if your doctor prescribes a blood uric acid test.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including medication obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
Paracetamol, under normal conditions of use, can be used during pregnancy and while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE EFFERALGANTAB 1 g, film-coated tablet
Instructions for proper use
CAUTION: this presentation contains 1000 mg (1 g) of paracetamol per tablet: do not take 2 tablets at once.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
This presentation is intended for adults and children from 50 kg (approximately 15 years of age).
The usual dosage is 1 tablet the usual dosage is 1000 mg per dose, to be repeated if necessary after at least 4 hours.
It is generally not necessary to exceed 3 g of paracetamol per day, i.e. 3 tablets per day.
However, in the case of more intense pain, and on the advice of your doctor, the total dose may be increased to 4 g per day, i.e. 4 tablets per day.
However:
- doses above 3 g of paracetamol per day require medical advice.
The maximum daily dose should not exceed 60 mg/kg (but not exceed 3 g) per day in the following situations:
- adults under 50 kg,
- severe liver damage,
- chronic alcoholism,
- chronic malnutrition,
- dehydration.
NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking into account all medicines containing paracetamol in their formula).
Always take it at least 4 hours apart.
Method of administration
Take by mouth.
The tablets should be swallowed as they are with a drink (e.g. water, milk, fruit juice).
In addition, if your child has a fever of more than 38.5°C, you can improve the effectiveness of the drug treatment by taking the following measures
- uncover your child,
- have your child drink,
- do not leave your child in a warm place.
Frequency of administration
Systematic administration avoids fluctuations in pain or fever:
- in adults, they should be spaced at least 4 hours apart.
In case of severe kidney disease (severe renal failure), the doses should be taken at least 8 hours apart.
Duration of treatment
|
The duration of treatment is limited:
- to 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, or if they worsen, do not continue the treatment without the advice of your doctor or pharmacist (see section entitled "Take care with EFFERALGANTAB 1 g, film-coated tablet", paragraph "Precautions for use").
Symptoms and instructions in case of overdose
If you have taken more EFFERALGANTAB 1 g film-coated tablet than you should have: in case of overdose or accidental poisoning, seek urgent medical attention.
Instructions in case of missed dose(s)
If you forget to take EFFERALGANTAB 1 g, film-coated tablet:
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, EFFERALGANTAB 1 g, film-coated tablet is likely to have side effects, although not everyone is susceptible.
- In rare cases, a rash or redness of the skin or an allergic reaction may occur, which may include sudden swelling of the face and neck or sudden discomfort with a fall in blood pressure. Treatment must be stopped immediately, your doctor must be informed and you must not take any other medication containing paracetamol.
- In exceptional cases, biological changes requiring a blood test have been observed: disturbances in the functioning of the liver, abnormally low levels of certain white blood cells or certain blood cells such as platelets, which may result in nosebleeds or bleeding from the gums. In this case, consult a doctor.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE EFFERALGANTAB 1 g, film-coated tablet
Keep out of the reach and sight of children.
Do not use EFFERALGANTAB 1 g, film-coated tablet after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does EFFERALGANTAB 1 g, film-coated tablet contain?
The active substance is :
Paracetamol .............................................................................................................................. 1000.00 mg
For one film-coated tablet.
The other components are :
Core
Hydroxypropyl cellulose, croscarmellose sodium, glycerol behenate, magnesium stearate, colloidal anhydrous silica.
Film coating
OPADRY OY-S-38901: hypromellose, titanium dioxide (E 171), propylene glycol.
Pharmaceutical form and content
What is EFFERALGANTAB 1 g, film-coated tablet and what does it contain?
This medicine is presented as a film-coated tablet. Box of 8 or 100 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BRISTOL-MYERS SQUIBB
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Operator
BRISTOL-MYERS SQUIBB
3 RUE JOSEPH MONIER
BP 325
92506 RUEIL-MALMAISON CEDEX
Manufacturer
BRISTOL-MYERS SQUIBB
304 AVENUE DU DOCTEUR JEAN BRU
47000 AGEN
or
ELAIAPHARM
ROUTE DES CRETES
Z.I. LES BOUILLIDES
SOPHIA ANTIPOLIS
06560 VALBONNE
or
BRISTOL-MYERS SQUIBB
979, AVENUE DES PYRENEE
47720 LE PASSAGE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Ansm (France).
Information for healthcare professionals only
Not applicable.
ADVICE / HEALTH EDUCATION
WHAT TO DO IN CASE OF FEVER :
Normal body temperature 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 medicine is intended for adults and children weighing 50 kg or more (from about 15 years of age).
If the symptoms of fever are too severe, you can take this medicine, which contains paracetamol, at the indicated dosage.
To avoid the risk of dehydration, remember to drink frequently.
With this medication, the fever should come down quickly. Nevertheless:
- 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 if vomiting occurs,
CONSULT YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IN CASE OF PAIN :
The intensity of pain perception and the ability to withstand it varies from person to person.
- if there is no improvement after 5 days of treatment,
- if the pain is severe, unexpected, and comes on suddenly (such as a sharp pain in the chest) and/or recurs regularly,
- if it is accompanied by other signs such as general malaise, fever, unusual swelling of the painful area, or decreased strength in a limb,
- if it wakes you up at night.
CONSULT YOUR DOCTOR IMMEDIATELY.
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