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500MG TABLETS EFFERALGANODIS DISPERSBLES
Over-the-counter medication

500MG TABLETS EFFERALGANODIS DISPERSBLES

Brand : UPSA BMS UPSA BMS
€2.84 EXCL. VAT €3.12 INCL. VAT
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Reference : 3400934821523
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EFFERALGAN is a drug indicated for the symptomatic treatment of mild to moderate and / or febrile states pain

EFFERALGANODIS 500MG DISPERSBLE TABLETS

For warnings, precautions for use and contraindications, please consult the instructions for use.

Description EFFERALGANODIS 500MG DISPERSBLE TABLETS

Indications
EFFERALGANODIS orodispersible tablet is indicated for the symptomatic treatment of pain of mild to moderate intensity and / or febrile states .

using advice

Dosage EFFERALGANODIS 500MG DISPERSBLE TABLETS
EFFERALGANAN ODIS 500 mg orodispersible tablet is reserved for adults. Use 1 tablet per day, to renew if necessary after 4 hours minimum, without exceeding 6 tablets per day. Oral use.

Well-known composition and excipients

PARACETAMOL MICROENCAPSULE WITH ETHYLECELLULOSE 540.5 MG; OR PARACETAMOL (DCI) 500 MG. EXCIPIENTS: CITRIC ACID ANHYDROUS; SODIUM BICARBONATE ; SORBITOL; ANHYDROUS SODIUM CARBONATE; SACCHAROSE FOR COMPRESSION; (SUCROSE; MALTODEXTRIN; GLUCOSE); CROSPOVIDONE; SODIUM BENZOATE; ASPARTAM; POTASSIC ACESULFAME; AROMA ORANGE 501189TPO551; (ORANGE ESSENTIAL OIL; ACETALDEHYDE; ETHYLBUTYRATE; ACETIC ACID; TOCOPHEROL; MALTODEXTRIN); QSP 1 ORODISPERSIBLE TABLET.

Contraindication and warning

Allergy to paracetamol or other constituents; hepatocellular insufficiency; phenylketonuria. EFFERALGAN ODIS 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. EFFERALGAN ODIS is possible during pregnancy and lactation under normal conditions of use. EFFERALGANODIS contains sorbitol, it is therefore not recommended in case of fructose intolerance.

Precaution

Medicines are active substances that can quickly turn into poison when too much is consumed. In order to guard against complications due to an overdose, it will be necessary to respect:

  • Dosage
  • a sufficient time interval between two takes
  • the maximum daily dose.

Similarly, it is essential not to combine or alternate painkillers of different composition, unless your doctor prescribes it.
If the analgesic treatment you have chosen is not quickly effective and the pain persists, consult your doctor. The body keeps in mind the pain, which after a certain time can become chronic.

Conditioning

Tube 17 tablets

Warnings on pain relievers

Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of 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 the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
  • Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 18/08/2015

Name of the medicinal product

EFFERALGAN 500 mg orodispersible tablet

paracetamol

framed

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

If you have any further questions, ask your doctor or pharmacist.

· This medication is a specialty of self-medication which can be used without consultation or prescription from a doctor.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms persist after 3 days, in case of fever or 5 days in case of pain, or if they become worse, consult your doctor.

· If you notice any side effects not listed in this leaflet, or if any of the side effects gets worse, tell your doctor or pharmacist.

Review summary

In this notice :

1. What is EFFERALGAN 500 mg orodispersible tablet and in which cases it is used?

2. What information should I take before taking EFFERALGAN 500 mg orodispersible tablet?

3. How to take EFFERALGAN 500 mg orodispersible tablet?

4. What are the possible side effects?

5. How to store EFFERALGAN 500 mg orodispersible tablet?

6. Additional Information

1. WHAT IS EFFERALGAN 500 mg orodispersible tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

Not applicable.

Therapeutic indications

This medicinal product contains paracetamol.

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

EFFERALGAN 500 mg orodispersible tablet 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. BEFORE YOU TAKE EFFERALGAN 500 mg orodispersible tablet?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take EFFERALGAN 500 mg orodispersible tablet if:

· You are allergic (hypersensitive) to the active substance (paracetamol) or any of the other ingredients of EFFERALGAN 500 mg orodispersible tablet ( see section 6. "Additional Information" ),

· You have a serious liver disease,

· You are taking a medication (kayexalate) to treat too high a level of potassium in the blood,

· You have one of the following hereditary diseases: phenylketonuria or intolerance to certain sugars ( see section "Important information about certain components of EFFERALGAN 500 mg orodispersible tablet" )

Precautions for use; special warnings

Take special care with EFFERALGAN 500 mg orodispersible tablet:

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

· If you weigh less than 50 kg,

· If you have severe liver or kidney disease, or if you suffer from chronic alcoholism,

· If you are taking other medicines containing paracetamol,

· If you have problems with nutrition (malnutrition) or dehydration.

Do not continue treatment without the advice of your doctor if you experience any of the following:

· If the pain persists more than 5 days or fever more than 3 days ,

· If the efficacy of the drug appears to be insufficient,

· If there is any other health problem.

Interaction with other medicines

Taking or using other medicines:

To prevent possible interactions between several medications, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

· EFFERALGAN 500 mg, orodispersible tablet and kayexalate
EFFERALGAN 500 mg, orodispersible tablet contains sorbitol. This component may interact with a drug used to treat an excessively high level of potassium in the blood.
If you are taking this medication (kayexalate), you should not use EFFERALGAN 500 mg orodispersible tablet unless your doctor has advised you.

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

· EFFERALGAN 500 mg, orodispersible tablet and blood tests
Inform your doctor if you are taking EFFERALGAN 500 mg orodispersible tablet and you need to undergo a blood test. This medication may interfere with the results if your doctor wants to check your uric acid level in the blood.

· EFFERALGAN 500 mg, orodispersible tablet and other medicines containing paracetamol or propacetamol ( a precursor of paracetamol )

This medicinal product contains paracetamol. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose ( see section "How to take EFFERALGAN 500 mg orodispersible tablet" ). If you are taking any other medicines containing paracetamol or propacetamol, you should first seek advice from your doctor or pharmacist.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

This medication can be used during pregnancy as well as in breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Important information about some of the ingredients of EFFERALGAN 500 mg orodispersible tablet:

EFFERALGAN 500 mg orodispersible tablet contains several components that you need to consider:

· Aspartame . This component can be dangerous for people suffering from a hereditary disease called phenylketonuria.

· Sodium (39 mg per tablet). You should take this into account if you are following a diet that is either deodorized or low-sodium.

· Sucrose, sorbitol . If your doctor has informed you that you do not tolerate certain sugars, consult it before taking this medication.

· Sorbitol may also interact with a drug (kayexalate) used to treat high levels of potassium in the blood ( see section "Taking or using other medicines" ).

3. HOW TO TAKE EFFERALGAN 500 mg orodispersible tablet?

Instructions for proper use

Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.

EFFERALGAN 500 mg orodispersible tablet is for adults only. For adults weighing less than 50 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

The usual dosage is 1 tablet to 500 mg per dose, to be renewed if necessary after 4 hours minimum.

In case of pain or fever more intense, 2 tablets to 500 mg, to renew if necessary after 4 hours minimum.

Each tablet contains 500 mg of paracetamol. Never exceed 8 tablets per day. If you are taking other medicines containing paracetamol or propacetamol, you should make sure never to exceed the maximum dose of 4000 mg per day.

Frequency and duration of administration

· You should take your tablets regularly to avoid oscillations of pain or fever.

· The catch must be spaced at least 4 hours apart.

· Do not continue the treatment without the advice of your doctor if the pain persists more than 5 days or fever more than 3 days.

Special category of patients

In case of serious kidney disease (severe renal failure), you should consult your doctor before taking this medication.

If your doctor prescribes this medicine, the dosage will be at least 8 hours apart.

Administration mode

Oral use.

The tablets are orodispersible, which means that each tablet dissolves in the mouth in seconds.

Allow the tablet to melt on the tongue.

These tablets are used without water.

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

Symptoms and Instructions for Overdose

If you take more EFFERALGAN 500 mg orodispersible tablet than you should:

Immediately consult your doctor or pharmacist. In case of overdose, there is a risk of liver damage with nausea, vomiting, anorexia, paleness and abdominal pain.

Instructions for omission of one or more doses

If you forget to take EFFERALGAN 500 mg orodispersible tablet:

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

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, EFFERALGAN 500 mg orodispersible tablet is likely to have side effects, although not everyone is.

· In some rare cases, an allergy may occur. You can identify allergy signs by:

o rash and / or redness of the skin,

o a sudden swelling of the face or neck,

o a sudden discomfort caused by a fall in blood pressure.

If an allergy occurs, stop treatment immediately and notify your doctor. Never take medicines containing paracetamol.

· In rare cases, this drug may decrease the number of blood cells. Nose bleeds and gums can then occur. In this case, consult a doctor.

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 EFFERALGAN 500 mg orodispersible tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use EFFERALGAN 500 mg orodispersible tablet after the expiry date stated on the carton. The expiry date refers to the last day of the month.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to remove unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does EFFERALGAN 500 mg contain, orodispersible tablet contains?

Each orodispersible tablet contains 500 mg of paracetamol (paracetamol micronecapsulated with ethylcellulose).

The other components are: anhydrous citric acid, sodium bicarbonate, sorbitol, anhydrous sodium carbonate, sucrose for compression, crospovidone, sodium benzoate, orange flavor, aspartame, acesulfame potassium.

Pharmaceutical form and content

What is EFFERALGAN 500 mg orodispersible tablet and contents of the pack?

The tablets are orodispersible, which means that each tablet dissolves in the mouth in seconds.

EFFERALGAN 500 mg, orodispersible tablet, is a white round tablet.

EFFERALGAN 500 mg orodispersible tablet is available in packs of 8, 10, 16, 100 or 500 tablets orodispersible in pills.

Not all pack sizes may be marketed.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

UPSA SAS

3 RUE JOSEPH MONIER

92500 RUEIL-MALMAISON

exploiting

UPSA SAS

3 RUE JOSEPH MONIER

92500 RUEIL-MALMAISON

Maker

UPSA SAS

979, AVENUE DES PYRENEES

47520 THE PASSAGE

or

UPSA SAS

304, AVENUE OF DOCTOR JEAN BRU

47000 AGEN

Names of the medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

In accordance with the regulations.

Date of approval of the notice

The last date on which this notice was revised is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

Not applicable

Other

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

UPSA COUNCIL, Medical Information and Pharmacovigilance: tel (N ° Azur): 0810 410 500.

SANITARY EDUCATION COUNCILS

WHAT TO DO IN THE EVENT OF FEVER:

The normal body temperature varies from person to person and ranges from 36 ° C to 37 ° C. A rise in temperature above 38 ° C may be considered a fever.

This medication is for adults.

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 abruptly (including severe pain in the chest) and / or reverses regularly,

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

· If she wakes you up at night,

CONSULT YOUR DOCTOR IMMEDIATELY .

Analgesic and antipyretic

paracetamol

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

PRESENTATIONS (summary)

EFFERALGAN 500 mg: orodispersible tablet (white, orange flavoring); box of 16.
-

UPSA Laboratory

COMPOSITION (summary)
p cp
Paracetamol 500 mg
aspartame +
sorbitol +
Sodium 39 mg

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 the following cases:
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.
In addition, persons weighing less than 50 kg or suffering from severe renal insufficiency, hepatic impairment , alcoholism or dehydration should not exceed the dose of 3 g of paracetamol per day to avoid any risk of overdosage.
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 cases of renal insufficiency , catches should be spaced at least 8 hours apart.
Allow the tablet to melt on the tongue.

Usual dosage:

  • Adult: 1 or 2 tablets per dose, to be renewed if necessary, without exceeding 6 tablets per day.
    In patients with severe pain in the adult and particularly in osteoarthritis, the maximum dose can be increased to 1 g of paracetamol (2 tablets), 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 skin reaction .


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.


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.


orodispersible
Categorizes a tablet that breaks up in the mouth in contact with saliva. It can also be dispersed in a glass of water before ingestion.


phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.


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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