EFFERVESCENT POWDER FOR AN ORAL SO TON IN SACHET
IDENTIFICATION OF THE MEDICINE
Paracetamol : 80 mg. Excipients: Anhydrous cc acid, sodium hydrogen carbonate, sorb to) anhydrous sodium carbonate, povidone, docusate sodium, sodium benzoate, orange flavouring*, aspartame, sq. for one 0.52 sachet.
* Composition of orange flavouring: Concentrated orange juice ; essential orange oil ; acetaldehyde ethyl butyrate ; ethyl acetate ; isoamyl acetate ; citral ; eucalyptol octanal ; alpha tarp ; linalol ; hexanal ; carvone butylhydroxyanisole ; on a support of gum arabic and maltodextrin.
Effervescent powder for oral solution in sachets. Box of 12 sachets.
OTHER ANALGESICS and ANTIPYRETICS
CASE(S) IN WHICH THIS MEDICINE IS TO BE USED
This medicine contains paracetamol. It is intended for the treatment of pain and/or fever, such as headaches, influenza-like conditions, dental pain muscular pain.
This presentation is restricted to children weighing from 5 to 16 kg about 6 months. Read the section "Dosage" carefully Other paracetamol presentations are available for children with different weights : ask your doctor or pharmacist for advice.
This medicine MUST NOT BE USED in the following cases
- known allergy to paracetamol or to the other ingredients,
- severe liver disease,
- phenylketonuria (a hereditary disease detected at birth), because of the presence of aspartame. WHEN IN DOUBT ALWAYS CONSULT YOUR DOCTOR OR PHARMACIST
Consult your doctOr immediately in the event M overdose or accidental administration of an excessively high dose.
This medicine contains paracetamol. Other medicines also contain this substance. Do not combine such medicines in order not to exceed the recommended daily dosage (see the section on Dosage).
This medicine contains sorbitol and must not be used in cases of intolerance to fructose (a hereditary metabolic disease( This medicine contains maltodextrin and consequently must not be used in cases of glucose and galac-tose malabsorption syndrome.
- if pain pemists for more than 5 days or fever for more than 3 days or if the medicine is insufficientW effective, or if any other symptom develops, do no continue the treatment without consulting your doctor.
- In cases of severe liver or kidney disease, you must consult your doctor before taking paracetamol or giving paracetamol to your child to take.
- This medicine contains 66 mg sodium per sachet which must be taken into account in cases of low- salt diets.
WHEN IN DOUBT DO NOT HESITATE TO CONSULT YOUR DOCTOR OR PHARMACIST
If the doctor prescribes an assay of blood uric acid or sugar levels, you should inform him that your child is taking this medicine.
IN ORDER TO AVOID POTENTIAL INTERACTIONS BETWEEN DIFFERENT MEDICINES YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST IF OTHER MEDICINES ARE BEING TAKEN.
Under normal conditions of use, paracetamol can be taken during pregnancy and when breast-feeding.
AS A GENERAL RULE, IT IS ALWAYS ADVISABLE TO CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINE DURING PREGNANCY OR WHEN BREAST-FEEDING.
Aspartame (source of phenylalanine) (E951), sodium benzoate, sodium (93 mg per sachet), sorbitol, maltodextrin (glucose)
HOW TO USE THIS MEDICINE
This presentation is restricted to children weighing from 5 to 16 kg (about 2 months to 15 years of age).
The paracetamol dosage depends on the child's weight ; ages are given as guidance only.
If you do not know the child's weight, you should weigh the child in order to administer the most suitable dose.
Paracetamol is available at many different strengths and consequently the treatment can be adapted to the weight of each child.
The recommended daily dose of paracetamol is about 60 mg/kg/day, to be divided into 4 or 6 administrations, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
The usual dosage is
- Children weighing from 5 to 6 kg (about 2 to 4 months), the dosage is one sachet per administration, to be repeated if necessary after an interval of 6 hours, without exceeding 4 sachets per day.
- Children weighing from 7 to 8 kg (about 3 to 9 months), the dosage is one sachet per administration, to be repeated it necessary after an interval of 4 hours, without exceeding 6 sachets per day.
- Children weighing from 9 to 12 kg (about 9 to 24 months), the dosage is two sachets per administration, to be repealed if necessary after an interval of 6 hours, without exceeding 8 sachets per day.
- Children weighing from 13 to 16 Kg (about 2 to 5 years), the dosage is two sachets per administration, to be repeated if necessary after an interval of 4 hours, without exceeding 12 sachets per day.
WHEN IN DOUBT, CONSULT YOUR DOCTOR LA PHARMACIST.
Pour the contents of the sachet into a glass and then add a small quantity of liquid (for example water, milk, fruit juice). Dissolve completely and drink immediately.
In addition, if the child's temperature exceeds 38.5C, the following steps will
improve the efficaciousness of the medicine treatment:
- undress the child,
- give the child liquids to drink,
- do not leave the child in an excessively warm place.
FREQUENCY AND TIMING OF ADMINISTRATION OF THE MEDICINE
Regular administrations avoM fluctuations in pain levels or fever.
In children, there must Sea regular interval between administrations, during both day and night, preferably of 6 hours and at least 4 hours.
In cases of serious kidney disease (severe renal fa lard, the inferno l between administrations must be at least 8 hours.
If the pain persists for more than 5 days,or fever for more than 3 days ,if they become more severe, or if any other symptom develops, do not continue the treatment without consulting your doctor or pharmacist.
Inform a doctor immedfately in cases of overdose or accidental poisoning.
UNWANTED AND UNPLEASANT EFFECTS
LIKE ALL ACTIVE PRODUCTS, THIS MEDICINE CAN, IN CERTAIN INDIVIDUALS, BRING ABOUT EFFECTS OF GREATER OR LESSER SEVERITY
DO NOT HESITATE TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST AND REPORT TO THEM ANY UNWANTED OR UNPLEASANT EFFECT WHICH MAY NOT BE REFERRED TO IN THIS PACKAGE LEAFLET
Do not store above 25sC Store in no dry place