Description
COQUELUSEDAL PARACETAMOL 250 mg suppository
Paracetamol
Grindélia (soft extract)
Gelsemium (soft extract)
Read all of this leaflet carefully before you use this medicine because it contains important information for you.
You should always use this medicine strictly as described in this leaflet or by your doctor or pharmacist.
∙ Keep this leaflet. You may need to read it again.
- WHAT COQUELUSEDAL PARACETAMOL 250 mg suppository IS IT USED FOR AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: central nervous system and respiratory system, ATC code: N02B and R05.
This drug is an antipyretic, analgesic and antitussive.
This medicine contains paracetamol.
It is indicated in case of pain and / or fever such as headache, flu-like conditions, dental pain, body aches.
This presentation is reserved for children from 13 to 20 kg; Read section 3 carefully. “HOW TO USE COQUELUSEDAL PARACETAMOL 250 mg, suppository”.
For children with a different weight, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
- WHAT YOU NEED TO KNOW BEFORE YOU USE COQUELUSEDAL PARACETAMOL 250 mg Suppository
Do not take COQUELUSEDAL PARACETAMOL 250 mg suppository in the following cases:
∙ known allergy to paracetamol or other constituents,
∙ severe liver disease,
∙ recent or rectal inflammation or recent bleeding from the rectum.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Take special care with COQUELUSEDAL PARACETAMOL 250 mg suppository:
Special warnings
In case of overdose or mistakenly taking too high a dose, consult your doctor immediately.
| This medicine contains paracetamol. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose (see section 3 HOW TO USE COQUELUSEDAL PARACETAMOL 250 mg suppository). |
With suppositories, there is a risk of local irritation, all the more frequent and intense the longer the duration of treatment, the rate of administration is high, and the dosage is high.
Precautions for use
If pain persists for more than 5 days or fever for more than 3 days, or if insufficient efficacy or any other signs occur, do not continue treatment without your doctor’s advice.
Before starting treatment with this medicine, check that you are not taking other medicines containing paracetamol.
Tell your doctor if you have liver or kidney disease.
Tell your doctor if you are taking other medicines containing paracetamol.
In case of problems with nutrition (malnutrition) or dehydration, COQUELUSEDAL PARACETAMOL 250 mg suppository should be used with caution.
IN CASE OF DOUBT DO NOT HESITATE TO ASK THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Other medicines and COQUELUSEDAL PARACETAMOL 250 mg suppository
Report that your child is taking this medication if your doctor prescribes a uric acid or blood sugar test.
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, IT IS NECESSARY TO SYSTEMATICALLY REPORT ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR PHARMACIST, including a drug obtained without a prescription.
COQUELUSEDAL PARACETAMOL 250 mg, suppository with food, beverages and alcohol
Not applicable.
Pregnancy and breastfeeding
Do not use this medicine during pregnancy.
Fertility
It is possible that paracetamol may impair fertility in women, reversibly when treatment is stopped.
Driving and operating machines
Not applicable.
COQUELUSEDAL PARACETAMOL 250 mg suppository contains propylene glycol.
- HOW TO USE COQUELUSEDAL PARACETAMOL 250 mg suppository
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
The dosage of paracetamol depends on the weight of the child; Ages are mentioned for information purposes.
If you do not know the weight of the child, it must be weighed to give him the most appropriate 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 weight of the child: it is about 60 mg / kg per day, divided into 4 or 6 doses, or about 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 with oral therapy.
In case of diarrhea, the suppository form is not suitable.
This presentation is reserved for children from 13 to 20 kg (about 2 to 7 years old).
The dosage is one suppository at 250 mg, to be renewed if necessary after 6 hours, without exceeding 4 suppositories per day.
Mode of administration
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 child,
∙ make it drink,
∙ Don’t leave your child in a place that’s too hot.
Frequency of administration
Systematic intake helps to avoid oscillations of pain or fever.
In children, they should be regularly spaced, including at night, preferably 6 hours, and 4 hours minimum.
In case of severe kidney disease (severe renal failure), the doses will be spaced at least 8 hours apart.
If you have the impression that the effect of COQUELUSEDAL PARACETAMOL 250 mg suppository is too strong or too weak, consult your doctor or pharmacist.
Duration of treatment
If pain persists for more than 5 days or fever for more than 3 days, or if insufficient efficacy or any other signs occur, do not continue treatment without your doctor’s advice.
If you use more COQUELUSEDAL PARACETAMOL 250 mg suppository than you should
The suppository form makes this eventuality unlikely.
If you forget to use COQUELUSEDAL PARACETAMOL 250 mg suppository
Do not take a double dose to make up for a forgotten dose.
If you stop using COQUELUSEDAL PARACETAMOL 250 mg suppository
Not applicable.
- WHAT ARE THE POSSIBLE UNDESIRABLE EFFECTS?
Like all medicines, this medicine can cause side effects, but not everyone gets them.
∙ In some rare cases, it is possible to develop a rash or skin redness or an allergic reaction that can manifest as a sudden swelling of the face and neck or by a sudden malaise with drop in blood pressure. Immediately stop treatment, tell your doctor and never resume medicines containing paracetamol,
∙ Exceptionally, biological changes requiring control of the blood test could be observed: liver dysfunction disorders, 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,
∙ risk of rectal or irritation (see section 2 ‘Posology and method of administration’).
Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not listed 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 Centres – Website: www.signalement-sante.gouv.fr
By reporting side effects, you help provide more information about the safety of the medicine.
- HOW TO STORE COQUELUSEDAL PARACETAMOL 250 mg suppository
Keep this medication out of the sight and reach 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.
Do not store above 30°C.
Do not dispose of any medication down the drain or with household waste. Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
- CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What COQUELUSEDAL PARACETAMOL 250 mg suppository contains
∙ The active substances are:
Paracetamol……………………………………………………………………………………………… 250.00 mg
Grindélia (Grindelia robusta Nutt.) (soft hydro-alcoholic extract (70% V/V)) (DER: 4:1) ……. 20 mg
Gelsemium (Gelsemium sempervirens (L.) Ait. f.) (soft hydro-alcoholic extract (60% V/V)) (DER:10:1)……………. 10 mg
For a suppository.
∙ The other components are:
Propylene glycol, solid hemi-synthetic glycerides.
What is COQUELUSEDAL PARACETAMOL 250 mg suppository and contents of the pack
This medication comes in suppository form.
Box of 10 suppositories.
Marketing authorisation holder
LABORATOIRE ELERTE
181-183, RUE ANDRE KARMAN
PO Box 101
93303 AUBERVILLIERS CEDEX
Marketing authorisation operator
ELERTE LABORATORY
181-183 ANDRE KARMAN STREET
PO Box 101
93303 AUBERVILLIERS CEDEX
Maker
ELERTE LABORATORY
181-183 ANDRE KARMAN STREET
PO Box 101
93303 AUBERVILLIERS CEDEX
