French pharmacy
BIOGARAN Paracetamol 500 mg effervescent tablet is a vignetted drug indicated for the symptomatic treatment of mild to moderate and / or febrile states pain.
Paracetamol is often a first choice. Paracetamol is one of the most common pain relievers and antipyretics.
PARACETAMOL BIOGARAN 500 mg effervescent tablet is a vignette medication indicated for the symptomatic treatment of pain of mild to moderate intensity and / or febrile states .
PARACETAMOL BIOGARAN 500 mg effervescent tablet is reserved for adults and children from 8 years old. For children from 27 to 50 kg (approximately 8 to 15 years old). For the child, it is imperative to respect the dosages defined according to the weight of the child and therefore to choose a suitable presentation.
PARACETAMOL COMPAQ PVP 3; OR PARACETAMOL 500 MG. EXCIPIENTS: POVIDONE; SODIUM BICARBONATE ; CITRIC ACID ANHYRE; SORBITOL; LACTOSE MONOHYDRATE; SACCHARINE SODIUM; LEMON FLAVOR; LEUCINE; ASCORBIC ACID ; QSP 1 EFFERVESCENT TABLET.
Allergy to paracetamol or other constituents; hepatocellular insufficiency.
PARACETAMOL BIOGARAN 500 mg effervescent tablet 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. PARACETAMOL BIOGARAN 500 mg is possible during pregnancy and lactation under normal conditions of use. PARACETAMOL BIOGARAN 500 mg contains sorbitol, it is therefore not recommended in case of intolerance to fructose. Due to the presence of lactose, this medication is contraindicated in cases of congenital galactosemia, glucose-galactose malasorption syndrome or Lactase deficiency.
Tube 16 tablets.
A perception that varies from one individual to another
Pain is an extremely complex feeling to which everyone reacts in a completely different way. The same person can also react more or less strongly to pain depending on the time of day and the circumstances. Studies have shown that when we focus on pain, we feel it much more intensely. On the other hand, when our attention is diverted by something pleasant, we feel it less. Anxiety, stress and depression also reinforce one's perception of pain.
It is very important to intervene immediately so that the pain does not go from the acute stage to the chronic stage. In this context, analgesics are an effective aid. But any drug can, as we know, cause side effects. That is why painkillers not only are not suitable for everyone, but also that the dose cannot be increased infinitely. Hence the interest of alternative therapies which take over and make it possible to limit the use of analgesics.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 16/02/2017
PARACETAMOL BIOGARAN 500 mg, effervescent tablet
Paracetamol
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 of the 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 feel less well after 3 days in case of fever or 5 days in case of pain.
Do not use this medication for children.
1. What is PARACETAMOL BIOGARAN 500 mg, effervescent tablet and in which cases it is used?
2. What should I know before taking PARACETAMOL BIOGARAN 500 mg, effervescent tablet?
3. How to take PARACETAMOL BIOGARAN 500 mg, effervescent tablet?
4. What are the possible side effects?
5. How to store PARACETAMOL BIOGARAN 500 mg, effervescent tablet?
6. Package contents and other information.
1. WHAT IS PARACETAMOL BIOGARAN 500 mg, effervescent tablet AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code: N02BE01
Therapeutic indications
This medication is indicated for pain and / or fever such as headaches, flu-like conditions, dental pain, aching, painful periods.
This presentation is reserved for adults and children from 27 kg (starting at about 8 years of age): read carefully How to take PARACETAMOL BIOGARAN 500 mg, effervescent tablet.
For children weighing less than 27 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
2. BEFORE YOU TAKE PARACETAMOL BIOGARAN 500 mg, effervescent tablet?
Do not take PARACETAMOL BIOGARAN 500 mg, effervescent tablet:
· if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medication mentioned in section 6,
· if you have severe liver disease,
· to treat a child under the age of 6, as it can swallow and choke. Use another form.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking PARACETAMOL BIOGARAN 500 mg, effervescent tablet .
In case of overdosage or mistake of too high a dose, consult your doctor immediately.
This medicinal product contains paracetamol. Other medicines contain it. Do not combine them, in order not to exceed the recommended daily dose (see "Dosage").
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, check that you are not taking any other medicines containing paracetamol.
Tell your doctor if you have liver or kidney disease, or alcohol abuse.
Tell your doctor if you are taking other medicines containing paracetamol.
If you have problems with nutrition (malnutrition) or dehydration, PARACETAMOL BIOGARAN 500 mg, effervescent tablet should be used with caution.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
This medicine contains sodium. This medicine contains 317 mg sodium per effervescent tablet. To be taken into account in patients controlling their sodium dietary intake.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
Children and Youth
Not applicable.
Other medicines and PARACETAMOL BIOGARAN 500 mg, effervescent tablet
Inform your doctor or pharmacist if you or your child are taking, have recently taken or may take any other medication.
Tell your doctor or prescriber about all prescription, over-the-counter, over-the-counter medications you are taking.
PARACETAMOL BIOGARAN 500 mg, effervescent tablet with food and drink and alcohol
Not applicable.
Paracetamol, under normal conditions of use, may be used during pregnancy as well as during breastfeeding.
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.
Sport
Not applicable.
Driving and using machines
Not applicable.
PARACETAMOL BIOGARAN 500 mg contains lactose, sodium and sorbitol.
3. HOW TO TAKE PARACETAMOL BIOGARAN 500 mg, effervescent tablet?
Dosage
This presentation is reserved for the adult and the child from 27 kg (from about 8 years).
In the child
The dosage of paracetamol depends on the weight of the child; the ages are mentioned for information purposes.
If you do not know the weight of the child, weigh it to give it the best dose.
Paracetamol exists in many dosages, allowing the treatment to be adapted to the weight of each child.
The recommended daily dose of paracetamol is dependent on the weight of the infant: it is approximately 60 mg / kg per day, divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours or 10 mg / kg all the 4 hours .
The usual dosage is:
· For children weighing 27 to 40 kg (approximately 8 to 13 years), the dosage is 1 tablet at 500 mg per dose, to be renewed if necessary after 6 hours, without exceeding 4 tablets per day .
· For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 tablet at 500 mg per dose, to be renewed if necessary after 4 hours, but not more than 6 tablets per day .
· For adults and children weighing more than 50 kg (from about 15 years), the usual dosage is 1 or 2 tablets at 500 mg per dose (depending on the intensity of the pain), to be renewed in case of need after 4 hours minimum.
It is generally not necessary to exceed 3 g of paracetamol per day, ie 6 tablets per day.
However, in case of more severe pain, and on the advice of your doctor or pharmacist, the total dose can be increased up to 4 g per day, ie 8 tablets per day. If you feel that the effect of PARACETAMOL BIOGARAN 500 mg, effervescent tablet is too strong or too weak, talk to your doctor or pharmacist.
Warning:
· Dosages above 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.
In severe kidney disease (severe renal insufficiency), catch should be 8 hours apart and the total daily dose should not exceed 6 tablets (3 g).
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,
· chronic alcoholism,
· chronic malnutrition,
· dehydration.
Administration mode
Oral use.
Drink after complete dissolution in a glass of water.
The use of tablets is contra-indicated in children before 6 years because it can swallow and choke. Use another form.
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
Regular intakes prevent the pain or fever from returning: "see section Dosage".
In children, catches should be regularly spaced, including at night, preferably 6 hours , and at least 4 hours.
In adults, catches must be spaced at least 4 hours apart.
In case of severe kidney disease (severe kidney failure), you should wait at least 8 hours between each dose.
If you feel that the effect of PARACETAMOL BIOGARAN 500 mg, effervescent tablet is too strong or too weak, talk to your doctor or pharmacist.
Duration of treatment
Except for medical advice, the duration of treatment is limited: · at 5 days in case of pain, · at 3 days in case of fever. |
If the pain persists more than 5 days or fever more than 3 days, if they worsen, do not continue treatment without the advice of your doctor.
If you take more PARACETAMOL BIOGARAN 500 mg, effervescent tablet than you should:
In case of overdose or mistake of too high a dose, consult your doctor or pharmacist immediately.
If you forget to take PARACETAMOL BIOGARAN 500 mg, effervescent tablet:
Do not take a double dose to make up for the single dose that you have forgotten to take.
If you stop taking PARACETAMOL BIOGARAN 500 mg, effervescent tablet:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
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.
· 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.
· Very rare cases of severe skin reactions have been reported.
· Due to the presence of sorbitol, possibility of digestive disorders and diarrhea.
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 PARACETAMOL BIOGARAN 500 mg, effervescent 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 me .
Store at a temperature not exceeding + 25 ° C.
Keep the pillbox carefully closed, protected from moisture.
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 PARACETAMOL BIOGARAN 500 mg contains: effervescent tablet
· The active substance is:
paracetamol................................................. .................................................. 500 mg
In the form of paracetamol COMPAP PVP 3
For an effervescent tablet
· The other components are:
Povidone, sodium bicarbonate, anhydrous citric acid, sorbitol, lactose monohydrate, saccharin sodium, lemon flavoring, leucine, ascorbic acid.
What is PARACETAMOL BIOGARAN 500 mg, effervescent tablet and contents of the pack
This medication is in the form of an effervescent tablet. Pill box of 16.
Marketing Authorization Holder
15, BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
Marketing Authorization Operator
15, BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
39, RUE DU PARC INDUSTRIEL
6900 MARCHE-EN-FAMENNE
BELGIUM
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:
{MM / YYYY}
Detailed information on this medicine is available on the ANSM website (France).
ADVICE / HEALTH EDUCATION
WHAT TO DO IN THE EVENT 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, but it is not advisable to treat fever with a drug below 38.5 ° C.
This medicine is reserved for adults and children from 27kg (about 8 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.
Analgesic and antipyretic
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
PARACETAMOL BIOGARAN 300 mg: powder for oral solution (orange flavoring); box of 12 sachets-dose.
Refunded at 65%. - price: 1,14 euro (s).
PARACETAMOL BIOGARAN 500 mg: tablet; box of 16.
Refunded at 65%. - price: 1,08 euro (s).
PARACETAMOL BIOGARAN 500 mg: effervescent tablet (lemon flavoring); box of 16.
Refunded at 65%. - price: 1,08 euro (s).
PARACETAMOL BIOGARAN 500 mg: capsule; box of 16.
Refunded at 65%. - price: 1,08 euro (s).
PARACETAMOL BIOGARAN 500 mg: powder for oral solution (orange flavoring); box of 12 sachets-dose.
Refunded at 65%. - price: 1,08 euro (s).
PARACETAMOL BIOGARAN 1 g: tablet; box of 8.
Refunded at 65%. - price: 1,08 euro (s).
PARACETAMOL BIOGARAN 1 g: split effervescent tablet (lemon flavoring); box of 8.
Refunded at 65%. - price: 1,08 euro (s).
PARACETAMOL BIOGARAN 1000 mg: powder for oral solution (orange flavoring); box of 8 sachets-dose.
Refunded at 65%. - price: 1,08 euro (s).
Biogaran Laboratory
| p sachet | p cp | |
| Paracetamol | 300 mg | 500 mg |
| Sucrose | 0.8 mg | |
| aspartame | + |
| pcp efferv | p gel | p sachet | |
| Paracetamol | 500 mg | 500 mg | 500 mg |
| Sodium | 317 mg | ||
| Lactose | + | ||
| sorbitol | + | ||
| Sucrose | 1.34 mg | ||
| aspartame | + |
| p cp | pcp efferv | p sachet | |
| Paracetamol | 1 g | 1 g | 1 g |
| Sodium | 331 mg | ||
| Lactose | + | ||
| sorbitol | + | ||
| Sucrose | 2.68 mg | ||
| aspartame | + |
Usual dosage:
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