French pharmacy
Dafalgan Caps Paracetamol 500MG 16 Capsules is a nonprescription medicine indicated for the symptomatic treatment of mild to moderate pain and febrile states, for sale in pharmacies .
For warnings, precautions for use and contraindications, please consult the instructions for use of the drug without prescription Dafalgan Caps Paracetamol 500MG 16 capsules.
Fever and pain are common ailments. They are not dangerous to their health; they are simply signs that the body is sending to let you know that something is wrong.
Paracetamol is an active substance which fights against fevers (antipyretic) and against pain (analgesic). Its main advantage is that it is very well tolerated by most organisms, including children. It can thus be used in 1st intention by almost everyone.
Dafalgan Caps 500 mg capsule is reserved for adults and children from 8 years old.
PARACETAMOL (DCI) 500 MG. EXCIPIENTS: MAGNESIUM STEARATE; GELATINE; TITANIUM DIOXIDE (E 171); AZORUBINE (E 122); QSP 1 CAPSULE.
Allergy to paracetamol or other constituents; hepatocellular insufficiency. Dafalgan Caps 500 mg hard 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. Taking the drug DALFAGAN 500 mg in capsule which is possible during pregnancy and lactation under normal conditions of use.
Blister 16 capsules of Dafalgan Caps Paracetamol 500MG 16 capsules
Please note, the non-prescription drug Dafalgan Caps Paracetamol 500MG 16 capsules is not a product like any other. 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.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 13/04/2017
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 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.
1. What is DAFALGAN 500 mg, hard capsule and in which cases is it used?
2. What information should I take before taking DAFALGAN 500 mg capsule?
3. How to take DAFALGAN 500 mg capsule?
4. What are the possible side effects?
5. How to store DAFALGAN 500 mg capsule?
6. Package contents and other information.
1. WHAT Dafalgan 500mg, capsule AND WHAT USE IS IT FOR?
Pharmacotherapeutic group: OTHER ANTALGS AND ANTIPYRETICS-ANILIDES - ATC code: N02BE01.
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 (from about 8 years): read the leaflet carefully, chapter "Dosage".
For children of different weights, other forms of paracetamol are available: ask your doctor or pharmacist for advice.
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.
2. BEFORE YOU TAKE Dafalgan 500 mg, capsule?
Do not take Dafalgan 500 mg, capsule :
· If you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· If you have severe liver disease
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking DAFALGAN 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.
Make sure you do not take any other medicines containing paracetamol, including medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose.
(see "Posology" and "Symptoms and Instructions for Overdose").
· 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 before you take this medicine if any of the following apply to you:
· If you are adult and you weigh less than 50 kg,
· If you are taking other medicines containing paracetamol (medicines obtained with or without a prescription),
· If you have liver or kidney disease,
· If you have Gilbert's syndrome (non-haemolytic familial jaundice),
· Or alcohol abuse (excessive alcohol consumption (3 or more alcoholic beverages per day)),
· If you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (which can lead to hemolytic anemia),
· If you have problems with nutrition (malnutrition (low reserves of hepatic glutathione), anorexia, bulimia or cachexia (heavy weight loss)
· If you have problems with dehydration, hypovolemia (significant loss of body water).
This medication contains an azo dye (E122 azorubine) and may cause allergic reactions.
If you have acute viral hepatitis or if you have an acute viral hepatitis during your treatment with DAFALGAN 500 mg hard capsules, talk to your doctor. Your treatment may be suspended by your doctor.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
Children and Youth
In a child treated with paracetamol, the association of another antipyretic is justified only in case of ineffectiveness. The association should be established and monitored only by a physician.
Capsule or tablet is contraindicated in children before 6 years because it can swallow and choke. Use another form.
Other medicines and Dafalgan 500 mg capsule
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
In case of concomitant treatment with probenecid, a dose reduction of DAFALGAN 500 mg capsule should be considered.
You should contact your doctor if you are taking medication that slows down coagulation (oral anticoagulants). In high doses, DAFALGAN 500 mg, capsule can increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.
Inform your doctor or pharmacist if you are taking phenytoin, the simultaneous use of these drugs and paracetamol may damage the liver.
Inform your doctor or pharmacist if you are taking enzyme inducers (such as phenobarbital, carbamazepine, primidone, rifampicin).
Tell your doctor or prescriber about all prescription and nonprescription / herbal products you may use before using this medication.
Dafalgan 500 mg, capsule with food, beverages and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
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.
Pregnancy and breast feeding
This medicine may be used during pregnancy and lactation. Use the lowest dose to reduce your pain and / or fever for as short a time as possible and as often as possible. Contact your doctor or midwife if pain and / or fever does not decrease or if you need to take this medication more frequently during your pregnancy.
Fertility
It is possible that paracetamol may alter the fertility of women, reversibly upon cessation of treatment.
Driving and using machines
Paracetamol has no or negligible effect on the ability to drive and use machines.
Dafalgan 500 mg, capsule contains azorubine (E122).
3. HOW TO TAKE Dafalgan 500 mg capsule?
Dosage
This presentation is reserved for the adult and the child from 27 kg (from about 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 depends on the child's weight: it is approximately 60 mg / kg / day, divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours or 10 mg / kg all the 4 hours .
Weight (age)
| Dose per administration | Interval of administration | Maximum Daily Dose |
27 kg to 40 kg (about 8 to 13 years) | 500 mg | 6 hours | 2000 mg per day |
41 kg to 50 kg | 500 mg | 4 hours minimum | 3000 mg daily |
Adults and children over 50 kg (from about 15 years old) | 500 mg to 1000 mg | 4 hours minimum | 3000 mg daily |
For children, the total dose of paracetamol should not exceed 80 mg / kg / day.
For adults and children weighing more than 50 kg (from about 15 years), the usual dosage is 1 to 2 capsules to 500 mg per dose depending on the intensity of the pain, to be renewed in case 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 the advice of your doctor, the total dose can be increased up to 4 g per day, ie 8 capsules per day.
However,
· doses greater than 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.
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,
· Gilbert syndrome (non-hemolytic familial jaundice),
· chronic alcoholism,
· chronic malnutrition,
· dehydration.
If you feel that the effect of DAFALGAN 500 mg capsule is too strong or too weak, talk to your doctor or pharmacist.
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR 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 a tablet or capsule is contraindicated in children under 6 years of age 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
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.
Renal failure
In case of kidney disease (kidney failure), the minimum interval between 2 doses should be modified according to your renal function according to the following table:
Creatinine clearance | Interval of administration |
cl ≥ 50 mL / min | 4 hours |
cl 10-50 mL / min | 6 hours |
cl <10 mL / min | 8 hours |
The total dose of paracetamol should not exceed 3 g / day, ie 6 capsules.
Duration of treatment
The duration of treatment is limited:
· to 5 days in case of pain,
· at 3 days in case of fever.
If the pain persists more than 5 days or the fever more than 3 days, if they worsen, do not continue treatment without the advice of your doctor or pharmacist.
If you take more than D afalgan 500 mg, capsule you should not have
In case of overdose or accidental poisoning, notify a doctor immediately.
If you forget to take D afalgan 500 mg capsule
Do not take a double dose to make up for a missed dose.
If you stop taking D afalgan 500 mg capsule
Not applicable.
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.
· In some rare cases, severe skin reactions have been reported. 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.
· Cases of diarrhea, abdominal pain, increased liver enzymes, increased or decreased INR have been reported.
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 Dafalgan 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 package. The expiry date refers to the last day of that month.
No special storage conditions.
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 DAFALGAN contains 500 mg capsule
· The active substance is:
Paracetamol................................................. .................................................. ........... 500.00 mg
For one capsule
· The other components are:
Magnesium stearate.
Composition of capsule No. 0: Gelatin, azorubine (E122) and titanium dioxide (E171).
What is Dafalgan 500 mg capsule and contents of the pack
This medication is in the form of a capsule. Box of 16 or 100.
Marketing Authorization Holder
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing Authorization Operator
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
304, avenue du docteur jeaN bru
47000 agen
or
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
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]
{month YYYY}.
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
WHAT TO DO IN CASE 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.
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 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
paracetamol
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
DAFALGAN pediatric: oral solution (caramel-vanilla flavor); bottle of 90 ml with measuring system graduated in kg (from 3 to 16 kg).
Refunded at 65%. - price: 1,29 euro (s).
DAFALGAN 80 mg: effervescent powder for oral solution; box of 12 bags.
Refunded at 65%. - price: 1,08 euro (s).
DAFALGAN 80 mg: suppository; box of 10.
Refunded at 65%. - price: 1,12 euro (s).
DAFALGAN 150 mg: effervescent powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,14 euro (s).
DAFALGAN 150 mg: suppository; box of 10.
Refunded at 65%. - price: 1,20 euro (s).
DAFALGAN 250 mg: effervescent powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,21 euro (s).
DAFALGAN 300 mg: suppository; box of 10.
Refunded at 65%. - price: 1,25 euro (s).
DAFALGAN 500 mg: tablet; box of 16.
Refunded at 65%. - price: 1,08 euro (s).
DAFALGAN 500 mg: split effervescent tablet; box of 16.
Refunded at 65%. - price: 1,08 euro (s).
DAFALGAN 500 mg: capsule (red and white); box of 16.
Refunded at 65%. - price: 1,08 euro (s).
DAFALGAN 600 mg Adult: suppository (white); box of 10.
Refunded at 65%. - price: 1,36 euro (s).
DAFALGAN 1 g: tablet (white); box of 8.
Refunded at 65%. - price: 1,08 euro (s).
DAFALGAN 1 g: split effervescent tablet (flavors: grapefruit, orange); box of 8.
Refunded at 65%. - price: 1,08 euro (s).
UPSA Laboratory
| p dose-kg | p sachet | p assumed | |
| Paracetamol | 15 mg | 80 mg | 80 mg |
| Sodium | 66 mg | ||
| sorbitol | + | ||
| Sugar | 0.17 g |
| p sachet | p assumed | p sachet | |
| Paracetamol | 150 mg | 150 mg | 250 mg |
| aspartame | + | + | |
| Sodium | 55.7 mg | 93 mg | |
| sorbitol | + | + |
| p assumed | p cp | pcp efferv | |
| Paracetamol | 300 mg | 500 mg | 500 mg |
| Sodium | 412.4 mg | ||
| sorbitol | + |
| p gel | p assumed | |
| Paracetamol | 500 mg | 600 mg |
| p cp | pcp efferv | |
| Paracetamol | 1 g | 1 g |
| Sodium | 565 mg | |
| aspartame | + |
Usual dosage:
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