NOTICE
ANSM - Last updated: 09/07/2014
Name of the medicinal product
ACTIFED GRIPPAL STATES, powder for oral solution in sachet-dose
framed
Read all of this leaflet carefully before you start taking this medicine. It contains important information about your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist or worsen, seek advice from your pharmacist or doctor.
· This leaflet is designed to help you use the medicine properly, keep it, you may need to read it again.
Review summary
In this notice :
1. WHAT IS ACTIFED GRIPPAL STATES, powder for oral solution in sachet-dose AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE ACTIFED GRINDER STATES, powder for oral solution in sachet-dose?
3. HOW TO TAKE ACTIFED BLACK STATES, powder for oral solution in a sachet-dose?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ACTIFED FLAKED STATES, powder for oral solution in a sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS ACTIFED GRIPPAL STATES, powder for oral solution in sachet-dose AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
ANTALGIC PERIPHERAL / ANTIPYRETIC
ANTIHISTAMINIC INHIBITORS OF RECEPTORS H 1
(R: respiratory system)
(N: Central Nervous System).
This medication contains paracetamol, an antihistamine, chlorphenamine and vitamin C.
Therapeutic indications
This medication is indicated for the treatment of colds, rhinitis, nasopharyngitis and influenza conditions in adults and children over 15 years of age:
· clear nasal discharge and tears,
· sneezing,
· headache and / or fever.
2. BEFORE YOU TAKE ACTIFED GRINDER STATES, powder for oral solution in sachet-dose?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take ACTIFED STREAMS, powder for oral solution in sachet-dose:
In case of known allergic reaction to paracetamol or to any of the components of the sachet-dose.
· in case of severe liver disease.
· if there is a risk of glaucoma (increased pressure in the eye),
· in case of difficulty urinating of prostatic or other origin.
This medication should not be used, unless otherwise advised by your doctor, in case of breast-feeding.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with ACTIFED FLAME STATES, powder for oral solution in sachet-dose:
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
In case of overdosage or mistakenly taking too high a dose, immediately notify a doctor.
This medicine contains paracetamol, chlorphenamine maleate and ascorbic acid. Other medicines contain it. Do not combine them to avoid exceeding the recommended maximum doses ( see DOSAGE AND ADMINISTRATION ). |
In case:
· purulent nasal discharge,
· persistence of fever,
· lack of improvement after 5 days of treatment,
Consult your doctor.
This medication is not recommended for breast-feeding.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
This medicine contains 1.19 g of sucrose per sachet-dose which must be taken into account in the daily diet in the case of a low-sugar diet or diabetes.
Precautions for use
If fever or pain persists, take the advice of your doctor or pharmacist.
Precautions are necessary in elderly people with prostate problems, predisposed to chronic constipation, dizziness or drowsiness.
If you have severe liver or kidney disease, tell your doctor to adjust the dosage.
This medication may cause drowsiness, increased by alcohol:
· it may be best to start treatment one night,
· and avoid drugs containing alcohol during the course of treatment.
IN CASE OF DOUBT, DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
Tell your doctor or pharmacist of all prescription and nonprescription / herbal products you may use before using this medication.
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER PROCESSING IN PROGRESS TO YOUR DOCTOR OR TO YOUR PHARMACIST, including medicines obtained without a prescription.
Interactions with food and beverages
Food and drinks
The consumption of alcoholic beverages should be avoided during the treatment period.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
This medication, under normal conditions of use, may be used during pregnancy, provided that this is for a short time (a few days) and recommended doses.
However, at the end of pregnancy, abuse of this drug can cause neurological effects in the newborn. Therefore, always seek the advice of your doctor before using it and never exceed the recommended dose.
feeding
This drug most likely passes into breast milk. Given its sedative properties that could affect your child (lethargy, decreased tone) or on the contrary exciting (insomnia), this drug is not recommended in case of breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Attention is drawn, especially to vehicle drivers and machine users, on the risks of drowsiness associated with the use of this drug, especially at the beginning of treatment.
This is exacerbated by the use of alcoholic beverages or alcohol-containing medications. It is best to start this treatment at night.
List of excipients with known effect
List of excipients with known effect:
Sucrose.
3. HOW TO TAKE ACTIFED BLACK STATES, powder for oral solution in sachet-dose?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine
Dosage
Reserved for adults and children over 15 years of age.
The usual dosage is 1 sachet to be renewed if necessary, after 4 hours minimum, without exceeding 4 sachets per day.
Method and route of administration
Oral use.
Dissolve the contents of the sachet in a large glass of water. Take the sachet preferably 1/4 of an hour before meals.
Given the sedative effect, it is preferable to start treatment at night.
Frequency of Administration
The intake of this medication should be spaced at least 4 hours apart.
In case of severe kidney disease (severe kidney failure), space the catch for at least 8 hours.
Duration of treatment
The duration of use is limited to 5 days. If the fever does not decrease after 3 days or if the clinical signs worsen, do not continue your treatment without the advice of your doctor.
Symptoms and Instructions for Overdose
If you have taken more ACTIFED STREAMS, powder for oral solution in sachet-dose than you should:
In case of overdose or accidental poisoning, STOP TREATMENT AND IMMEDIATELY CONSULT A DOCTOR.
Instructions for omission of one or more doses
If you forget to take ACTIFED STREAMS, powder for oral solution in sachet-dose:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, ACTIFED CONTAINER STATES, powder for oral solution in sachet-dose is likely to have undesirable effects, although not everyone is subject to it.
Some effects require stopping the treatment immediately and notifying a doctor.
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.
Exceptionally, biological changes requiring blood check have been observed: liver function 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.
Other side effects may include:
· Drowsiness, decreased vigilance more marked at the beginning of treatment.
· Drops in blood pressure when standing up, which may be accompanied by dizziness.
· Dryness of the mouth, visual disturbances, urinary disorders, constipation, palpitations.
· Disorders of memory or concentration, confusion, dizziness, hallucinations.
· Difficulty in coordinating movements, tremors.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE ACTIFED FLAKED STATES, powder for oral solution in a sachet-dose?
Keep out of the reach and sight of children.
Expiration date
Do not use ACTIFED STREAMS, powder for oral solution in a sachet-dose after the expiry date stated on the carton.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does ACTIFED GRIPPAL STATES contain, powder for oral solution in sachet-dose?
The active substances are:
Paracetamol ................................................. .................................................. ............................. 500.00 mg
Chlorphenamine Maleate ............................................... .................................................. ............. 4.00 mg
Ascorbic acid ................................................ .................................................. ....................... 100.00 mg
For a sachet-dose.
The other components are:
Sucrose, anhydrous colloidal silica, Gesweet flavor, verbena-honey flavor, lemon flavor, caramel color (E150).
Pharmaceutical form and content
What is ACTIFED STREAMS, powder for oral solution in sachet-doses and contents of the pack?
This medication is in the form of a powder for oral solution in a sachet-dose. Box of 10 sachets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
exploiting
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
FAMAR ORLEANS
5 AVENUE DE CONCYR
45071 ORLEANS CEDEX 2
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
ADVICE / HEALTH EDUCATION
WHAT TO DO IN THE EVENT OF FEVER:
Normal body temperature varies from person to person and ranges from 36 ° C to 37 ° C. A temperature rise above 38 ° C may be considered a fever.
This medication is for adults and children over 15 years of age.
If the disorders that the fever causes are too troublesome, you can take this drug that contains paracetamol in accordance with the indicated dosages.
To avoid any risk of dehydration, consider drinking frequently.
With this medication, the fever should drop rapidly. However:
· if other unusual signs appear
· if the fever persists for more than 3 days or if it worsens,
· if the headache becomes violent, or in case of vomiting.
CONSULT YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IF PAIN:
The intensity of the perception of pain and the ability to resist it vary from person to person.
· If there is no improvement after 5 days of treatment,
· If the pain is violent, unexpected, and occurs abruptly (including severe pain in the chest) and / or reverses regularly,
· If it is accompanied by other signs such as a state of general malaise, fever, unusual swelling of the painful area, decreased strength in a limb,
· If she wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY.