PARACETAMOL BIOGARAN 500MG CAPSULES 16 capsules are a vignetted drug indicated for the symptomatic treatment of mild to moderate and / or febrile states pain.
Warning ! Analgesics are only used to relieve occasional pain. They don't treat evil. If the symptoms persist after a week, it is best to consult a specialist!
PARACETAMOL BIOGARAN 500 mg capsule is a vignette medication indicated for the symptomatic treatment of pain of mild to moderate intensity and / or febrile states .
PARACETAMOL BIOGARAN 500 mg capsule 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 500 MG. EXCIPIENTS: CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE; COLLOIDAL ANHYDROUS SILICA; TALC; SODIUM LAURYLSULFATE; PATENT BLUE; ERYTHROSINE; QUINOLEINE YELLOW; TITANIUM DIOXIDE ; GELATINE; QSP 1 CAPSULE.
Allergy to paracetamol or other constituents; hepatocellular insufficiency.
PARACETAMOL BIOGARAN 500 mg capsule 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.
Blister 16 capsules.
There are many medications for pain relief. But do you know that herbal medicine can also relieve certain pains?
When we talk about pain relieving plants, we often think of remedies against rheumatism: it is indeed in this indication that the analgesic needs are the most glaring ... and the use of plants the most frequent, for lack of ammunition of synthesis. Herbal teas and specialties also coexist to relieve stomach pain, headaches, etc. Find at Soin et Nature a selection of pain relieving plants:
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 14/03/2017
PARACETAMOL BIOGARAN 500 mg capsule
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 talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
1. What is PARACETAMOL BIOGARAN 500 mg, hard capsule and in which cases is it used?
2. What should I watch for before taking PARACETAMOL BIOGARAN 500 mg capsule?
3. How to take PARACETAMOL BIOGARAN 500 mg, capsule?
4. What are the possible side effects?
5. How to store PARACETAMOL BIOGARAN 500 mg capsule?
6. Package contents and other information.
1. WHAT IS PARACETAMOL BIOGARAN 500 mg, hard capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: N02BE01
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.
This presentation is reserved for the adult and the child from 27 kg (approximately from 8 years); read carefully "Posology".
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, capsule?
Do not take PARACETAMOL BIOGARAN 500 mg, capsule:
· if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medication mentioned in section 6.
· Severe liver disease.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking PARACETAMOL BIOGARAN 500 mg capsule .
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, so as not to exceed the recommended daily dose (see section "Dosage").
PRECA u job tions
· If the pain persists more than 5 days or fever more than 3 days , or if there is insufficient efficacy or any other signs, do not continue treatment without your doctor's advice.
· 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.
· In case of nutrition problems (malnutrition) or dehydration, PARACETAMOL BIOGARAN 500 mg capsule should be used with caution.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
children
The use of tablets and capsules is contraindicated in children before 6 years because it can swallow and choke.
Other medicines and PARACETAMOL BIOGARAN 500 mg capsule
Tell your doctor or prescriber about all prescription and nonprescription / herbal products you may use before using this medication.
Inform your doctor or pharmacist if you or your child are taking, have recently taken or may take any other medication.
PARACETAMOL BIOGARAN 500 mg, capsule with food and beverages
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 hard capsules contains
Not applicable.
3. HOW TO TAKE PARACETAMOL BIOGARAN 500 mg capsule?
Dosage
This presentation is reserved for the adult and the child from 27 kg (approximately from 8 years).
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 approximately 60 mg / kg per day, divided into 4 or 6 doses, ie approximately 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 capsule per dose, to be renewed if necessary after 6 hours, but not more than 4 capsules per day.
For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 capsule per dose, to be renewed if necessary after 4 hours, not to exceed 6 capsules per day .
For adults and children weighing more than 50 kg (from about 15 years old);
The usual dosage is 1 or 2 capsules to 500 mg per dose (depending on the intensity of the pain), to be renewed if necessary after 4 hours minimum.
It is generally not necessary to exceed 3 g of paracetamol per day, ie 6 capsules per day. However, in case of more intense pain, and on advice from your doctor , the total dose can be increased up to 4 g per day, ie 8 capsules per day.
However,
· 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 at least 8 hours apart and the total daily dose should not exceed 6 capsules (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 disease
· chronic alcoholism
· chronic malnutrition
· dehydration
If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
IN CASE OF DOUBT, ASK FOR YOUR PHYSICIAN OR YOUR PHARMACIST.
Method and route of administration
Oral use.
The capsules should be swallowed as is with a drink (eg water, milk, fruit juice).
The use of tablets and capsules is contraindicated in children under 6 years of age because they can swallow and choke. Use another form.
Frequency of Administration
Systematic catches help to avoid oscillations of pain or fever.
In children, they should be regularly spaced, including at night, preferably 6 hours , and at least 4 hours.
In adults, they must be spaced at least 4 hours apart.
In case of severe kidney disease (severe kidney failure), catches will be spaced at least 8 hours apart.
Duration of treatment
The duration of treatment is limited:
· 5 days in case of pain
· to 3 days in case of fever
If the pain persists for more than 5 days or fever for more than 3 days or if it worsens, do not continue treatment without your doctor's advice (see section "Precautions for use").
If you take more PARACETAMOL BIOGARAN 500 mg capsule than you should:
In case of overdose or accidental poisoning, notify a doctor immediately.
If you forget to take PARACETAMOL BIOGARAN 500 mg capsule:
Do not take a double dose to make up for a missed dose.
If you stop taking PARACETAMOL BIOGARAN 500 mg capsule:
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 control of the blood balance have been observed: abnormally low levels of certain white blood cells or certain blood cells such as platelets that can result in nosebleeds or gums. In this case, consult a doctor.
· Very rare cases of severe skin reactions have been reported.
DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR PHARMACIST
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 capsule?
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 carton. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C.
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: capsule
· The active substance is:
Paracetamol................................................. .................................................. 500 mg
for a capsule.
· The other components are:
Crosslinked sodium carboxymethyl cellulose, anhydrous colloidal silica, talc, sodium lauryl sulfate.
Capsule envelope composition: patented blue, erythrosine, quinoline yellow, titanium dioxide, gelatin.
What is PARACETAMOL BIOGARAN 500 mg capsule and contents of the pack
This medication is in the form of a capsule.
Box of 16 capsules.
Bottle of 16 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
KRAFFT ZI
67150 ERSTEIN
OR
OPODEX INDUSTRIE LABORATORIES
USINE VILLENEUVE 2
34-46 AVENUE OF THE OLD PATH OF SAINT DENIS
BP 32
92391 VILLENEUVE-LA-GARENNE CEDEX
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:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
ADVICE / HEALTH EDUCATION
WHAT TO DO IN CASE OF FEVER:
Normal body temperature varies from person to person and is between 36 ° C and 37 ° C. A rise in temperature above 38 ° C may be considered a fever.
This medication is intended for adults and children up to 27 kg (from 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 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
. 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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