French pharmacy
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French pharmacy
Paracetamol is a medicine vignetted indicated for the symptomatic treatment of mild to moderate and / or febrile states pain.
For warnings, precautions for use and contraindications, please consult the instructions for use.
In what situations can paracetamol be used ?
EFFERALGAN 80 mg suppository is recommended for infants from 4 to 6 kg (i.e. from 1 month to 4 months). It is advisable to use 1 suppository at 80 mg, to be renewed if necessary after 6 hours, without exceeding 4 suppositories per day. The interval between two takes will be a minimum of 6 hours. Rectal route.
PARACETAMOL 80 MG. EXCIPIENTS: SEMI-SYNTHETIC GLYCERIDES; QSP 1 SUPPOSITORY.
Allergy to paracetamol or other constituents; hepatocellular insufficiency; recent history of proctitis; anite; rectal bleeding. EFFERALGAN 80 mg suppository 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. Suppositories are not suitable for diarrhea.
Blister 10 suppositories.
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.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 29/06/2017
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 80 mg, suppository and in which cases it is used?
2. What should be known before taking DAFALGAN 80 mg suppository?
3. How to take DAFALGAN 80 mg suppository?
4. What are the possible side effects?
5. How to store DAFALGAN 80 mg suppository?
6. Package contents and other information.
1. WHAT IS DAFALGAN 80 mg, suppository AND WHAT IT IS USED 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, body aches.
This presentation is reserved for infants weighing 4 to 6 kg (approximately 1 to 4 months) : 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 80 Mg, Suppository?
Do not take DAFALGAN 80 mg suppository:
· 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.
· If you have recent anal or rectal inflammation or a recent bleeding from the rectum.
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 80 mg suppository.
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").
With suppositories, there is a risk of local irritation, all the more frequent and intense as the duration of treatment is prolonged, the pace of administration is high and the dosage is high.
· 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 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).
If you have acute viral hepatitis or if acute viral hepatitis is discovered during your treatment with DAFALGAN 80 mg suppository, 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.
Other medicines and DAFALGAN 80 mg suppository
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 80 mg suppository should be considered.
You should contact your doctor if you are taking medication that slows down coagulation (oral anticoagulants). In high doses, DAFALGAN 80 mg, suppository 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).
Note that your child is taking this medication if your doctor prescribes a dosage of uric acid or blood sugar.
DAFALGAN 80 mg, suppository with food, drinks 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
For information: This medication 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 discontinuation of therapy.
Driving and using machines
Paracetamol has no or negligible effect on the ability to drive and use machines.
DAFALGAN 80 mg, suppository contains
Not applicable.
3. HOW TO TAKE DAFALGAN 80 Mg, Suppository?
Dosage
This presentation is reserved for infants weighing 4 to 6 kg (about 1 to 4 months).
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 child: it is approximately 60 mg / kg / day, divided into 4 doses, ie approximately 15 mg / kg every 6 hours.
Due to the risk of rectal irritation, suppository administration should be as short as possible, should not exceed 4 doses per day and should be replaced as soon as possible by oral therapy.
In case of diarrhea, the suppository form is not adapted.
Weight (age)
| Dose per administration | Interval of administration | Maximum Daily Dose |
4 kg to 6 kg (about 1 to 4 months) | 80 mg | 6 hours | 320 mg daily |
For children, the total dose of paracetamol should not exceed 80 mg / kg / day.
The maximum daily dose shall not exceed 60 mg / kg per day in the following situations:
· severe liver damage,
· Gilbert syndrome (non-hemolytic familial jaundice),
· chronic alcoholism,
· chronic malnutrition,
· dehydration.
If you feel that the effect of DAFALGAN 80 mg suppository 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
Rectal route.
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.
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 60 mg / kg / day.
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 DAFALGAN 80 mg suppository you should not have
In case of overdose or accidental poisoning, notify a doctor immediately.
If you forget to take DAFALGAN 80 mg suppository
Do not take a double dose to make up for a missed dose.
If you stop taking DAFALGAN 80 Mg, suppository
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.
· With the suppository form, there is a risk of rectal or anal irritation (see Warnings and Precautions)
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 80 mg suppository?
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.
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 DAFALGAN 80 mg contains, suppository
· The active substance is:
Paracetamol................................................. .................................................. 80 mg
For a suppository.
· The other components are:
Semi-synthetic glycerides.
What is DAFALGAN 80 mg, suppository and contents of the pack
This medication is in the form of suppositories.
Box of 10.
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 for the infant weighing 4 to 6 kg (about 1 to 4 months).
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:
