In this manual :
1. WHAT IS FERVEX, granules in a sachet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING FERVEX, granules in a sachet
3. HOW DO I TAKE FERVEX, granules in a sachet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE FERVEX, granules in a sachet?
6. ADDITIONAL INFORMATION
1. WHAT IS FERVEX, granules in a sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is indicated for the treatment of colds, rhinitis, rhinopharyngitis and influenza in adults (15 years and older):
- of clear nasal discharge and watery eyes,
- sneezing,
- headaches and/or fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING FERVEX, granules in sachet
List of information needed before taking the medicine
Not applicable.
This medicine should NEVER BE USED in the following cases:
- children under 15 years of age,
- in case of previous allergy to the constituents of the product,
- 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 fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases), because of the presence of sucrose.
You should not generally use this medicine unless your doctor tells you to during pregnancy and breastfeeding.
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Special warnings
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN
- it is imperative that the dosage, the 5-day treatment period and the contraindications are strictly observed.
- The consumption of alcoholic beverages, medicines containing alcohol or sedative drugs is not recommended during treatment
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In the event of an overdose or if you take 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 11.5 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 5 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 beverages
Food and Beverage
Do not consume alcoholic beverages during treatment.
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 medicines.
List of excipients with a known effect
Sucrose.
3. HOW TO TAKE FERVEX, granules in a sachet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults only (from 15 years of age)
1 sachet to be repeated if necessary after at least 4 hours, without exceeding 3 sachets per day.
Mode and route of administration
Oral use.
The sachets should be taken in a sufficient quantity of water, cold or hot.
During flu-like conditions it is better to take this medicine in warm water in the evening.
How often and when to take the medicine
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 5 days.
Symptoms and instructions in case of overdose
If you have taken more FERVEX granules in a sachet than you should have: STOP THE TREATMENT AND SEEK MEDICAL ADVICE IMMEDIATELY.
Instructions in case of missed doses
If you forget to take FERVEX, granules in a sachet: DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE SINGLE DOSE YOU MISSED.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
AS WITH ANY ACTIVE SUBSTANCE, THIS MEDICINE MAY CAUSE VARYING DEGREES OF ADVERSE REACTIONS IN SOME PEOPLE:
- The onset of an acute glaucoma attack in predisposed subjects.
- Urinary disorders (significant decrease in urine output, 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. Stop taking the medication immediately, tell your doctor and never take any medication containing paracetamol or pheniramine again.
- 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 nosebleeds or bleeding from the gums. In this case, consult a doctor.
TELL YOUR DOCTOR OR PHARMACIST ABOUT ANY UNWANTED AND TROUBLESOME EFFECTS NOT MENTIONED IN THIS LEAFLET.
5. HOW TO STORE FERVEX, granules in a sachet
Keep out of the reach and sight of children.
Do not use FERVEX, granules in a sachet after the expiry date stated on the box.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does FERVEX granules in a sachet contain?
The active substance is:
Per unit of administration
Paracetamol .................................................................................................................................... 0.500 g
Ascorbic acid ............................................................................................................................. 0.200 g
Pheniramine maleate .................................................................................................................... 0.025 g
For one sachet.
Other components are:
Gum Arabic, citric acid, sodium saccharinate, natural West Indian flavour(1), sucrose.
(1)Composition of the natural West Indian flavour
Essential oil of lemon
Cinnamon essential oil
Clove essential oil
Natural extract of rum and vanilla
Peruvian balm
Caramel
Pharmaceutical form and contents
What is FERVEX, granules in a sachet and what does it contain?
This medicine comes in sachets. Boxes of 6 and 8.
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 medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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