In this manual :
1. WHAT IS EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet
3. HOW TO TAKE EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE EFFERALGANVITAMIN C 500 mg/200 mg, effervescent tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is an analgesic (pain reliever) and an antipyretic (fever reducer).
This medicine contains paracetamol.
It is indicated in cases of pain and/or fever such as headaches, flu, toothache, aches and pains, painful periods.
This presentation is reserved for adults and children weighing 27 kg or more (about 8 years);read carefully the section "How to take EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet".
For children weighing less than 27 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
2. WHAT YOU SHOULD KNOW BEFORE TAKING EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet SHOULD NOT BE USED in the following cases:
- known allergy to paracetamol or other constituents,
- severe liver disease,
- in case of kidney stones, when using high doses of vitamin C (above 1 g).
In case of doubt, do not hesitate to ask your doctor or pharmacist for advice.
Precautions for use; special warnings
Take special precautions with EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet:
Warnings
In case of overdose or if you take too much by mistake, consult your doctor immediately.
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This medicine contains paracetamol and vitamin C. Other medicines contain them. Do not take them together, so that you do not exceed the recommended daily dose (see "How to take EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet").
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Special precautions
If pain persists for more than 5 days or fever for more than 3 days, or in case of insufficient efficacy or any other sign, do not continue the treatment without your doctor's advice.
Precautions for use
Before starting treatment with this medication, make sure you are not taking other medications containing paracetamol.
Tell your doctor if you have liver or kidney disease, or if you abuse alcohol.
Tell your doctor if you are taking other medicines containing paracetamol.
EFFERALGANVITAMINEC 500 mg/200 mg effervescent tablets should be used with caution if you have problems with nutrition (malnutrition) or dehydration.
The use of this medicine is not recommended in patients with fructose intolerance (a rare hereditary disease).
This medicine contains sodium, this medicine contains 388 mg of sodium per tablet. To be taken into account in patients controlling their dietary intake of sodium.
In case of doubt, do not hesitate to ask your doctor or pharmacist for advice.
Interactions with other medicines
Taking or using other medications:
Report that you or your child is taking this medicine if your doctor prescribes a blood uric acid test for you or your child.
In order to avoid possible interactions between several medications, you should always inform your doctor or pharmacist of any other treatment you are taking.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy/Nursing
Paracetamol, under normal conditions of use, can be used during pregnancy and when breast-feeding.
In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
Notable excipients: sorbitol, sodium.
3. HOW TO TAKE EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
This medicine is intended for adults and children from 27 kg (approximately 8 years of age).
The dosage of paracetamol depends on the weight of the child; the ages are given for information purposes.
If you do not know the child's weight, you should weigh the child in order to give the most appropriate dose.
Paracetamol is available in many dosages, allowing the treatment to be adapted to each child's weight.
The recommended daily dose of paracetamol depends on the child's weight: it is about 60 mg/kg per day, divided into 4 or 6 doses, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
- For children weighing 27 to 40 kg (approximately 8 to 13 years), the dosage is 1 tablet per dose, repeated if necessary after 6 hours, not to exceed 4 tablets per day.
- For children weighing 41 to 50 kg (about 12 to 15 years), the dosage is 1 tablet per dose, to be repeated if necessary after 4 hours, but not exceeding 6 tablets per day.
For adults and children weighing more than 50 kg (from about 15 years): the usual dosage is 1 to 2 500 mg tablets per dose (depending on the severity of the pain), 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. 6 tablets per day. However, in 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. 8 tablets per day.
However:
- Doses above 3g of paracetamol per day require medical advice.
- NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL A DAY (taking into account all medicines containing paracetamol in their formula).
Always take it at least 4 hours apart.
In cases of severe kidney disease (severe renal failure), the doses should be taken 8 hours apart and the total daily dose should not exceed 6 tablets (3 g).
The maximum daily dose should not exceed 60 mg/kg (not to exceed 3 g) per day in the following situations
- adults under 50 kg,
- severe liver damage,
- chronic alcoholism,
- chronic malnutrition,
- dehydration.
If in doubt, ask your doctor or pharmacist for advice.
Oral use.
Allow the tablet to dissolve completely in a glass of water.
Systematic doses help to avoid fluctuations in pain or fever: they should be taken at least 4 hours apart.
- In children, they should be taken at regular intervals, including at night, preferably 6 hours apart and at least 4 hours apart.
- In adults, they should be at least 4 hours apart.
In cases of severe kidney disease (severe renal insufficiency), doses should be taken at least 8 hours apart.
The usual duration of treatment is
- 3 days in case of fever,
- 5 days in case of pain.
Symptoms and instructions in case of overdose
If you have taken more EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent 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 EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet: do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, EFFERALGAN VITAMIN C 500 mg/200 mg, effervescent tablet may have side effects:
- in some rare cases, a rash or redness of the skin or an allergic reaction may occur which may manifest itself as sudden swelling of the face and neck or sudden malaise 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: disturbance in the functioning of the liver, abnormally low levels of certain blood elements (platelets) which may result in nosebleeds or bleeding from the gums. In this case, consult a doctor;
- High doses of vitamin C (more than 1 g) may cause kidney stones in some people and may increase haemolysis (destruction of red blood cells) in G6PD deficient people.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO USE EFFERALGANVITAMIN C 500 mg/200 mg, effervescent tablet
Keep out of the reach and sight of children.
Do not use after the expiry date on the box.
Store in the outer packaging.
If necessary, warnings against certain visible signs of deterioration
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does EFFERALGANVITAMIN C 500 mg/200 mg effervescent tablet contain?
The active ingredients are
Paracetamol ................................................................................................................................ 500.00 mg
Ascorbic acid ......................................................................................................................... 200.00 mg
For one effervescent tablet.
The other components are:
Citric acid anhydrous, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, sodium benzoate, lemon flavour, saccharin sodium, povidone, docusate sodium.
Pharmaceutical form and content
What is EFFERALGANVITAMIN C 500 mg/200 mg, effervescent tablet and what does it contain?
This medicine is presented as an effervescent tablet.
Boxes of 8 and 16 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
B.P. 325
92506 RUEIL-MALMAISON CEDEX
Operator
UPSA CONSEIL
3, rue Joseph Monier
B.P. 325
92506 RUEIL-MALMAISON CEDEX
Manufacturer
BRISTOL-MYERS SQUIBB
304, avenue du Docteur Jean
Bru 47000 AGEN
or
BRISTOL-MYERS SQUIBB
979 Avenue des Pyrenees
47520 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 Afssaps (France).
Information for healthcare professionals only
Not applicable.
HEALTH EDUCATION ADVICE
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 27 kg or more (approximately 8 years old).
If the problems caused by fever are too troublesome, you can take this medicine, which contains paracetamol, at the indicated dosage.
To avoid any risk of dehydration, remember to drink frequently.
With this medicine, 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 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 vary 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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