NOTICE
ANSM - Last updated: 23/11/2016
Name of the medicinal product
FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, pellets for oral solution in sachets
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor, or your pharmacist. 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.
Do not use this medication for children.
What is in this leaflet?
In this notice :
1. What is FERVEX RHEUME PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets and in which cases it is used?
2. What should I know before taking FERVEX RHEUME PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets?
3. How to take FERVEX CHEMISTRY PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets?
4. What are the possible side effects?
5. How to store FERVEX CHEMISTRY PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, pellets for oral solution in sachets?
6. Package contents and other information
1. WHAT IS FERVEX COLUMN PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets AND WHAT CASES IS IT USED FOR?
Other common cold medications, ATC code: R05X
This medication is indicated for the treatment of colds and nasopharyngitis in children (from 6 years of age):
· clear nasal discharge and tears,
· sneezing, headache and / or fever.
You should contact your doctor if you experience no improvement or feel less well after 3 days.
2. BEFORE YOU TAKE FERVEX PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets?
Never take FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets in the following cases:
· child under 6 years of age,
· if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6,
· if you have some forms of glaucoma (increased eye pressure),
· if you have trouble urinating with prostatic or other causes,
· if you have severe liver disease due to the presence of paracetamol.
You should not use this medication unless you are advised to do so by your doctor during pregnancy and breast-feeding.
in case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking FERVEX RHEUME PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets
Warning
DO NOT LEAVE THIS MEDICINE FOR CHILDREN
· it is imperative to strictly observe the dosage, the duration of treatment of 3 days, and the contraindications.
· the absorption of alcoholic beverages, medicines containing alcohol or sedative drugs is discouraged during treatment.
In case of overdosage or mistake of too high a dose, consult your doctor immediately . This medicine contains paracetamol and pheniramine. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose (see section "Dosage").
· Tell your doctor or pharmacist if you are taking any other medicines for the same period.
· This medication contains an azo dye (E110) and may cause allergic reactions.
If you suffer :
· severe liver or kidney disease,
· predisposition to constipation, dizziness and urinary problems, this medication should only be used after consulting your doctor.
Precautions
· In case of : purulent nasal discharge, persistent fever, no improvement after 3 days of treatment, CONSULT YOUR DOCTOR.
Children and Youth
Not applicable.
Other medicines and FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
To avoid the adverse effects of overdosage, DO NOT ASSOCIATE WITHOUT MEDICAL ADVICE other medicines containing antihistamines or paracetamol. IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets with food, drinks and alcohol
This medication may cause drowsiness, increased by alcohol: it is preferable to start the treatment at night and to refrain from alcoholic beverages during the treatment.
Pregnancy, breast-feeding and fertility
Taking this medication is not recommended during pregnancy.
Taking this medication is not recommended during breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Sport
Not applicable.
Driving and using machines
Attention is drawn to the possibilities of drowsiness or decreased vigilance associated with the use of this drug, especially among vehicle drivers and machine users.
This is exacerbated by the use of alcoholic beverages, medicines containing alcohol or sedative drugs.
FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets contains orange-yellow S.
3. HOW TO TAKE FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is:
· Children from 6 to 10 years: 1 sachet 2 times per 24 hours.
· Children from 10 to 12 years: 1 sachet 3 times per 24 hours.
· Children from 12 to 15 years: 1 sachet 4 times per 24 hours.
The sachets are to be renewed if necessary after 4 hours minimum.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Method and route of administration
Oral use.
The bags should 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 2 catches will be at least 8 hours.
Duration of treatment
The maximum duration of treatment is 3 days.
Use in children and adolescents
This presentation is reserved for the child (from 6 years).
If you take more FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachet you should:
Stop treatment and seek immediate medical attention.
If you forget to take FERVEX CHEMISTRY PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachet:
Do not take a double dose to make up for the single dose that you have forgotten to take.
If you stop taking FERVEX PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, granules for oral solution in sachets:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· The onset of an acute glaucoma crisis in predisposed subjects.
· Urinary problems (significant decrease in urine, difficulty urinating).
· Dry mouth, visual disturbances, constipation.
· Memory or concentration disorders, confusion, dizziness (more common in the elderly).
· A motor incoordination, trembling.
· Drowsiness, decreased alertness, more marked at the beginning of treatment.
· A drop in blood pressure when standing up may be accompanied by dizziness.
· 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 or pheniramine,
· Exceptionally, biological changes requiring control of the blood balance have been observed: 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.
Additional Adverse Events in Children and Adolescents
Not applicable.
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 FERVEX PARACETAMOL CHEMISTRY / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN, pellets for oral solution in sachets?
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 carton. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medication into drains or household waste. 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 FERVEX RHEUME PARACETAMOL / VITAMIN C / PHENIRAMINE SUGAR-FREE CHILDREN contain granules for oral solution in sachets
The active substances are:
Maleate of Pheniramine ............................................... .................................................. ...... 0.0100 g
Paracetamol................................................. .................................................. ..................... 0.2800 g
Ascorbic acid................................................ .................................................. ............... 0.1000 g
For a bag of 3 g.
The other components are:
Mannitol, anhydrous citric acid, povidone, anhydrous magnesium citrate, acesulfame potassium raspberry aroma containing orange yellow S (E110).
What is FERVEX RHEUME PARACETAMOL / VITAMIN C / PHENIRAMINE CHILDREN, granules for oral solution in sachets and contents of the pack
This medicinal product is in the form of granules in sachets.
Box of 8, 12 or 16 sachets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing Authorization Operator
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Maker
UPSA SAS
304, AVENUE OF DOCTOR 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}.
Other
Detailed information on the medication is available on the ANSM website (France).