In this manual :
1. WHAT IS EFFERALGANODIS 500 mg, orodispersible tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING EFFERALGANODIS 500 mg, orodispersible tablet
3. HOW DO I TAKE EFFERALGANODIS 500 mg, orodispersible tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE EFFERALGANODIS 500 mg, orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS EFFERALGANODIS 500 mg, orodispersible tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
This medicine contains paracetamol.
It is indicated in cases of pain and/or fever such as headaches, flu-like conditions, toothache, aches and pains, painful periods.
EFFERALGANODIS is for adults only.
For adults weighing less than 50 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
2. WHAT YOU SHOULD KNOW BEFORE TAKING EFFERALGANODIS 500 mg, orodispersible tablet
List of information needed before taking the medicine
Not applicable.
Never take EFFERALGANODIS 500 mg, orodispersible tablet in the following cases:
- You are allergic(hypersensitive) to the active substance (paracetamol) or to any of the other components of EFFERALGANODIS (see section 6 "Further Information"),
- You have severe liver disease,
- You are taking a medicine (kayexalate) to treat high levels of potassium in the blood,
- You have one of the following hereditary diseases: phenylketonuria or intolerance to certain sugars (see section "Important information about some of the ingredients of EFFERALGANODIS 500 mg, orodispersible tablet")
Precautions for use; special warnings
Take special precautions with EFFERALGANODIS 500 mg, orodispersible tablet:
Tell your doctor before taking this medicine if any of the following conditions apply to you:
- If you weigh less than 50 kg,
- If you have severe liver or kidney disease, or if you have chronic alcoholism,
- If you are taking other medicines containing paracetamol,
- If you have problems with nutrition (malnutrition) or dehydration.
Do not continue treatment without your doctor's advice if any of the following apply to you:
- If pain persists for more than 5 days or fever for more than 3 days,
- If the medicine does not seem to be working well enough,
- If any other health problems occur.
Interactions with other medicines
Taking or using other medicines:
To avoid possible interactions with other medicines, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are obtained without a prescription.
- EFFERALGANODIS and kayexalate
EFFERALGANODIS contains sorbitol. This component may interact with a medicine used to treat high levels of potassium in the blood.
If you are taking this medicine (kayexalate), you should not use EFFERALGANODIS unless your doctor tells you to.
- EFFERALGANODIS and oral anticoagulants
You should contact your doctor if you are taking a medicine that slows down clotting (oral anticoagulants). At high doses, EFFERALGANODIS may increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.
- EFFERALGANODIS and blood tests
Tell your doctor if you are taking EFFERALGANODIS and need to have a blood test: EFFERALGANODIS may interfere with the results if your doctor wants to check your blood uric acid level.
- EFFERALGANODIS and other medicines containing paracetamol or propacetamol(a precursor of paracetamol)
This medicine contains paracetamol. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose(see "How to take EFFERALGANODIS 500 mg, orodispersible tablet"). If you need to take other medicines containing paracetamol or propacetamol, you should first ask your doctor or pharmacist for advice.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
This medicine may be used during pregnancy and when 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
Important information about some of the ingredients of EFFERALGANODIS 500 mg, orodispersible tablet:
EFFERALGANODIS contains several components that you should consider, namely:
- Aspartam. This component may be harmful to people with a hereditary disease called phenylketonuria.
- Sodium (39 mg per tablet). You should take this into account if you are on a de-sodified or low-sodium diet.
- Sucrose, sorbitol and glucose. If your doctor has told you that you cannot tolerate certain sugars, consult your doctor before taking this medicine.
- Sorbitol may also interact with a drug (kayexalate) used to treat high blood potassium levels (see "Taking or using other medicines" section).
3. HOW TO TAKE EFFERALGANODIS 500 mg, orodispersible tablet
Instructions for proper use
Always follow the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
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EFFERALGANODIS 500 mg is intended for adults only. For adults weighing less than 50 kg, there are other forms of paracetamol: ask your doctor or pharmacist for advice.
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Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
The usual dose is 1 tablet of 500 mg per dose, to be repeated if necessary after at least 4 hours.
In case of more intense pain or fever, 2 x 500 mg tablets, to be repeated if necessary after at least 4 hours.
Each tablet contains 500 mg of paracetamol. Do not exceed 8 tablets per day. If you are taking other medicines containing paracetamol or propacetamol, you must ensure that you never exceed the maximum dose of 4000 mg per day.
Frequency and duration of administration
- You should take your tablets regularly to avoid fluctuations in pain or fever.
- The tablets should be taken at least 4 hours apart.
- Do not continue treatment without your doctor's advice if pain persists for more than 5 days or fever for more than 3 days.
Special category of patients
If you have severe kidney disease (severe renal failure), you should consult your doctor before taking this medicine.
If your doctor prescribes this medicine, you should take it at least 8 hours apart.
How to take it
Oral use.
The tablets are orodispersible, which means that each tablet dissolves in the mouth in a few seconds.
Let the tablet melt on the tongue.
These tablets can be used without water.
If you feel that the effect ofEFFERALGANODIS 500 mg, orodispersible tablet is too strong or too weak, consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have taken more EFFERALGANODIS 500 mg, Orodispersible Tablet than you should have:
Consult your doctor or pharmacist immediately. In case of overdose, there is a risk of liver damage with nausea, vomiting, anorexia, paleness and abdominal pain.
Instructions in case of missed dose(s)
If you forget to take EFFERALGANODIS 500 mg, orodispersible tablet:
Do not take a double dose to make up for the 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, EFFERALGANODIS 500 mg, orodispersible tablet is likely to have side effects, although not everyone is susceptible.
- In some rare cases, an allergy may occur. You can identify signs of allergy by:
o a rash and/or redness of the skin,
o sudden swelling of the face or neck,
o sudden discomfort caused by a drop in blood pressure.
If an allergy occurs, stop treatment immediately and tell your doctor. Afterwards, never take any medication containing paracetamol again.
- In rare cases, this medicine may decrease the number of blood cells. This can lead to bleeding from the nose and 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 EFFERALGANODIS 500 mg, orodispersible tablet
Keep out of the reach and sight of children.
Do not use EFFERALGANODIS after the expiry date on the box. The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain 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 EFFERALGANODIS 500 mg orodispersible tablet contain?
Each orodispersible tablet contains 500 mg paracetamol (ethylcellulose microneedle paracetamol).
The other ingredients are: citric acid anhydrous, sodium bicarbonate, sorbitol, sodium carbonate anhydrous, sucrose for compression, crospovidone, sodium benzoate, orange flavouring, aspartam, acesulfame potassium.
Pharmaceutical form and content
What is EFFERALGANODIS 500 mg, orodispersible tablet and what does it contain?
The tablets are orodispersible, which means that each tablet dissolves in the mouth within a few seconds.
EFFERALGANODIS 500 mg, orodispersible tablet, is a white, round tablet.
EFFERALGANODIS is available in boxes of 8, 10, 16, 100 or 500 orodispersible tablets in a pillbox.
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
BP 325
92506 RUEIL-MALMAISON CEDEX
Operator
UPSA CONSEIL
3, RUE JOSEPH MONIER
BP 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
This medicinal product is authorised in member states of the European Economic Area under the following names:
In accordance with the regulations in force.
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 Afssaps website (France).
Information for health professionals only
Not applicable
For further information on this medicine, please contact the local representative of the marketing authorisation holder:
UPSA CONSEIL, Medical Information and Pharmacovigilance: tel (N°Azur): 0810 410 500.
ADVICE / HEALTH EDUCATION
WHAT TO DO IN CASE OF FEVER:
The normal body temperature varies from one person to another and is between 36°5 C and 37°5.C. A rise in temperature above 38°C can be considered a fever.
This medicine is intended for adults.
If the problems caused by fever are too troublesome, you can take this medicine, which contains paracetamol, at the indicated dosage.
To avoid the 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 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 resist 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 (e.g., 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, reduced strength in a limb,
- If it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY.
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