Description
OQUELUSEDAL PARACETAMOL 100 mg, suppository
1. WHAT IS COQUELUSEDAL PARACETAMOL 100 mg, suppository AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: ANTALGIC, ANTIPYRETIC – ATC code: N02BE51
(N. Central nervous system)- (R. Respiratory system)
This medicine contains paracetamol.
It is indicated in cases of pain and/or fever such as headaches, flu-like illness, dental pain, aches.
This presentation is reserved for children weighing 5 to 8 kg; Read section 4.a “Dosage” carefully .
For children of different weights, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING COQUELUSEDAL PARACETAMOL 100 mg, suppository?
Never take COQUELUSEDAL PARACETAMOL 100 mg, suppository:
Known allergy to paracetamol or other constituents,
Severe liver disease,
Recent anal or rectal inflammation or recent bleeding from the rectum.
IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
In case of overdose or taking too high a dose by mistake, consult your doctor immediately.
| This medicine contains paracetamol. Other medications contain it. Do not combine them, so as not to exceed the recommended daily dose ( see section 4.2. Dosage ). |
With suppositories, there is a risk of local irritation, which is all the more frequent and intense as the treatment duration is prolonged, the rate of administration is high and the dosage is high.
If the pain persists for more than 5 days or the fever for more than 3 days , or in the event of insufficient effectiveness or the occurrence of any other sign, do not continue treatment without consulting your doctor.
In case of serious liver or kidney disease, it is necessary to consult your doctor before taking paracetamol.
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Children.
Not applicable.
Other medicines and COQUELUSEDAL PARACETAMOL 100 mg, suppository
Report that your child is taking this medicine if your doctor prescribes a uric acid or blood sugar level test.
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SYSTEMATICALLY REPORT ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR PHARMACIST.
COQUELUSEDAL PARACETAMOL 100 mg, suppository with food
Not applicable.
Pregnancy and breast feeding
Do not use this medicine during pregnancy.
Fertility
It is possible that paracetamol can impair women’s fertility, reversibly upon stopping treatment.
Driving and using machines
Not applicable.
COQUELUSEDAL PARACETAMOL 100 mg, suppository contains propylene glycol.
3. HOW TO USE COQUELUSEDAL PARACETAMOL 100 mg, suppository?
The dosage of paracetamol depends on the child’s weight; ages are given for information purposes.
If you do not know the weight of the infant, you must weigh him in order to give him the best dose.
Paracetamol exists in numerous dosages, allowing 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 per day, divided into 4 or 6 doses, or 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 will be replaced as soon as possible by oral treatment.
In case of diarrhea, the suppository form is not suitable.
This presentation is reserved for children weighing 5 to 8 kg (approximately 2 to 9 months).
The dosage is one 100 mg suppository, to be renewed if necessary after 6 hours, without exceeding 4 suppositories per day.
Rectal route.
In addition, if your child has a fever above 38.5°C, you can improve the effectiveness of drug treatment by the following measures:
∙ discover your infant,
∙ make him drink,
∙ do not leave your baby in a place that is too hot.
Systematic intake helps avoid fluctuations in pain or fever.
In infants and children, they must be regularly spaced, including at night, preferably by 6 hours , and at least 4 hours.
In the event of serious kidney disease (severe renal failure), doses will be spaced at least 8 hours apart.
If you have the impression that the effect of COQUELUSEDAL PARACETAMOL 100 mg, suppository is too strong or too weak, consult your doctor or pharmacist.
If the pain persists for more than 4 to 5 days, do not continue treatment without consulting your doctor.
If you take more COQUELUSEDAL PARACETAMOL 100 mg, suppository than you should
In the event of overdose or accidental poisoning, contact a doctor immediately.
If you forget to take COQUELUSEDAL PARACETAMOL 100 mg, suppository
Do not take a double dose to make up for a dose you forgot to take.
If you stop taking COQUELUSEDAL PARACETAMOL 100 mg, suppository
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
∙ in certain rare cases, it is possible that a rash or redness of the skin or an allergic reaction may occur which may manifest as sudden swelling of the face and neck or as sudden discomfort with a drop in blood pressure. You must stop treatment immediately, notify your doctor and never take medications containing paracetamol again;
∙ Exceptionally, biological changes requiring monitoring of the blood test may have been observed: abnormally low levels of certain white blood cells or certain blood cells such as platelets which may result in nose or gum bleeding. In this case, consult a doctor
∙ Risk of rectal or anal irritation ( see warning ).
Reporting of side effects
If you experience any side effects, tell <your doctor> <or> <,> <your pharmacist> <or your nurse>. This also applies to any side effects that are 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 Pharmacovigilance Centers – Website: www.signalement-sante.gouv.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE COQUELUSEDAL PARACETAMOL 100 mg, suppository?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box.
The expiration date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What COQUELUSEDAL PARACETAMOL 100 mg contains, suppository
∙ The active substances are:
Paracetamol …………………………………………. ………………………………………….. ………….. 100 mg
Soft hydro-alcoholic extract of grindelia ……………………………………. ……………………….. 10 mg
Soft hydroalcoholic extract of gelsemium ……………………………………. ……………………… 5 mg
For a suppository.
∙ The other components are:
Solid semi-synthetic glycerides, propylene glycol.
What COQUELUSEDAL PARACETAMOL 100 mg is, suppository and contents of the pack
This medication comes in the form of a suppository.
Box of 10 suppositories.
Marketing authorization holder
ELERTE LABORATORIES
181-183, RUE ANDRE KARMAN
93303 AUBERVILLIERS CEDEX
Marketing authorization operator
ELERTE LABORATORIES
181-183, RUE ANDRE KARMAN
93303 AUBERVILLIERS CEDEX
Maker
ELERTE LABORATORIES
181-183, RUE ANDRE KARMAN
93303 AUBERVILLIERS CEDEX
