In this manual :
1. WHAT IS FERVEX CHILDREN, granulated in a sachet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING FERVEX CHILDREN, granulated sachet
3. HOW DO I TAKE FERVEX CHILDREN, granulated sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE FERVEX CHILDREN, granulated sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS FERVEX CHILDREN, granulated sachet and WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
This medicine is indicated for the treatment of colds and rhinopharyngitis in children (6 years and older):
- of clear nasal discharge and watery eyes,
- sneezing,
- headaches and/or fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING FERVEX CHILDREN, granulated sachet
List of information needed before taking the medicine
Not applicable.
Do not take FERVEX CHILDREN, granules in a sachet in the following cases
- children under 6 years of age,
- if you have a history of allergy to any of the product's ingredients,
- in case of certain forms of glaucoma (increased pressure in the eye),
- in case of difficulties in urinating of prostatic or other origin,
- in case of severe liver disease due to the presence of paracetamol,
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam,
- in people with fructose intolerance, glucose/galactose malabsorption syndrome or sucrase-isomaltase deficiency, due to the presence of glucose.
You should not generally use this medicine unless your doctor tells you to do so during pregnancy and breastfeeding.
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Be careful with FERVEX CHILDREN, granulated sachet:
Special warnings
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN
- it is imperative that the dosage, the 3-day treatment period, and the contraindications be strictly observed.
- The consumption of alcoholic beverages, medicines containing alcohol or sedative drugs is not recommended during treatment.
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In case of overdose or if you have taken too much by mistake, consult your doctor immediately. This medicine contains paracetamol and pheniramine. Other medicines contain them. Do not combine them, so that you do not exceed the recommended daily dose (see section "Dosage").
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- Each sachet contains 2.41 g of sucrose: take this into account in the daily ration in the event of a low sugar diet or diabetes.
- Tell your pharmacist or doctor if you are taking any other medicine during the same period.
If you have:
- severe liver or kidney disease,
- predisposition to constipation, dizziness and urinary disorders, this medicine should only be used on the advice of your doctor.
Precautions for use
- In case of: purulent nasal discharge, persistent fever, lack of improvement after 3 days of treatment, CONSULT YOUR DOCTOR.
Interactions with other medicines
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To avoid the adverse effects of an overdose, DO NOT COMBINE without MEDICAL ADVICE other drugs containing antihistamines or paracetamol. IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
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This medicine may cause drowsiness increased by alcohol: it is preferable to start the treatment in the evening and to abstain from alcoholic beverages during the treatment.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
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Ask your doctor or pharmacist for advice before taking any medicine.
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Pregnancy
This medicine should not be taken during pregnancy.
Breastfeeding
This medicine should not be taken during breastfeeding.
Not applicable.
Effects on the ability to drive vehicles or use machines
Attention is drawn, particularly in drivers of vehicles and users of machines, to the possibility of drowsiness or reduced vigilance associated with the use of this medicine.
This phenomenon is accentuated by the use of alcoholic beverages, medicines containing alcohol or sedative drugs.
List of excipients with a notable effect
List of excipients with a notorious effect:
Sucrose.
Aspartam (source of phenylalanine) (E951).
3. HOW TO TAKE FERVEX CHILDREN, granulated sachet?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
This presentation is reserved for children (from 6 years of age).
- Children from 6 to 10 years: 1 sachet twice a day.
- Children aged 10 to 12 years: 1 sachet 3 times a day.
- Children aged 12 to 15: 1 sachet 4 times a day.
The sachets should be renewed if necessary after at least 4 hours
IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR'S PRESCRIPTION.
Mode and way of administration
Take by mouth.
The sachets must be taken in a sufficient quantity of water, cold or hot.
Frequency of administration
In case of renal insufficiency (creatinine clearance less than 10 ml/min), the interval between two doses should be at least 8 hours.
Duration of treatment
The maximum duration of treatment is 3 days.
Symptoms and instructions in case of overdose
If you have taken more FERVEX CHILDREN, granules in a sachet than you should have: STOP THE TREATMENT AND SEEK A MEDICINE IMMEDIATELY.
Instructions in case of missed doses
If you forget to take FERVEX CHILDREN, granulated sachet: DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE DOSE YOU MISSED.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, FERVEX CHILDREN, granulated sachet is likely to have side effects, although not everyone is susceptible.
- The onset of acute glaucoma in susceptible individuals.
- Urinary disorders (significant decrease in urination, difficulty in urinating).
- Dry mouth, visual disturbances, constipation.
- Memory or concentration problems, confusion, dizziness (more frequent in the elderly).
- Motor incoordination, tremors.
- Drowsiness, decreased alertness, more pronounced at the beginning of treatment.
- A drop in blood pressure when moving to a standing position, which may be accompanied by dizziness.
- In rare cases, a rash or redness of the skin or an allergic reaction may occur, which may be manifested by sudden swelling of the face and neck or a sudden feeling of malaise with a fall in blood pressure. Treatment must be stopped immediately, your doctor must be informed and you must not take any other medication containing paracetamol or pheniramine.
- In exceptional cases, biological changes requiring a blood test 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 bleeds. In this case, consult a doctor.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE FERVEX CHILDREN, granulated sachet
Keep out of the reach and sight of children.
Do not use FERVEX CHILDREN, granulated sachet after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What FERVEX CHILDREN, granulated sachet contains and what is in the outer packaging?
The active ingredients are
Pheniramine maleate .................................................................................................................. 0.0100 g
Paracetamol .................................................................................................................................. 0.2800 g
Ascorbic acid ............................................................................................................................ 0.1000 g
For a 3 g sachet.
Other components are:
Sucrose, 5 ' riboflavin phosphate (sodium salt), magnesium citrate anhydrous, aspartam, banana-caramel flavor (coffee extract, foenugreek extract, isoamyl acetate, caramel, isoamyl isovalerianate, ethyl butyrate, geranyl formate, acetic aldehyde, citral, vanillin, ethylvanillin, heliotropin, butyric acid, diacetyl, ethyl acetate, butylbutyryl lactate, dihydrocoumarin, sorbitol, maltodextrin, gum arabic).
Pharmaceutical form and content
What is FERVEX CHILDREN, granules in a sachet and what does it contain?
This medicine is presented as a granulated sachet.
Box of 8, 12 or 16 sachets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
UPSA CONSEIL
3, rue Joseph Monier
92500 RUEIL-MALMAISON
Operator
UPSA CONSEIL
3, rue Joseph Monier
BP 325
92506 RUEIL-MALMAISON CEDEX
Manufacturer
BRISTOL-MYERS SQUIBB
304, avenue du Docteur Jean Bru
47000 AGEN
or
BRISTOL-MYERS SQUIBB
979, avenue des Pyrenees
47520 LE PASSAGE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps (France) website.
Information for health professionals only
Not applicable.
Not applicable.
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