Benylin Children's Chesty Coughs

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GUAIFENESIN

Available from:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

ATC code:

R05CA03

INN (International Name):

GUAIFENESIN 50 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

GUAIFENESIN 50 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-08-10

Patient Information leaflet

3 HOW TO USE
THIS MEDICINE
CHECK THE TABLE BELOW TO SEE HOW
MUCH MEDICINE TO TAKE.
■
For oral use only.
■
Do not give more than the stated dose shown
below.
CHILDREN UNDER 6 YEARS OLD
This medicine is not recommended for children
under 6 years old.
CHILDREN 6 - 12 YEARS
IF ANYONE HAS TOO MUCH
If anyone has taken too much, contact a doctor
or your nearest Accident and Emergency
department (Casualty), taking this leaflet and
pack with you.
IF YOU FORGET TO GIVE THE MEDICINE
You should only give this medicine as required
following the dosage instructions above
carefully. If you forget to give a dose, give
the next dose when needed. DO NOT give a
double dose.
2 BEFORE GIVING THIS
MEDICINE TO YOUR CHILD
This medicine is suitable for most children but a few
children should not use it. If you are in any doubt, talk
to your doctor or pharmacist.
DO NOT USE THIS MEDICINE…
■
If your child has ever had a BAD REACTION to this
product or any of the ingredients. See section 6
for full list of ingredients.
■
If your child is taking ANY OTHER COUGH AND
COLD MEDICINE.
■
If your child is aged under 6 years.
If any of these apply, GET ADVICE FROM A DOCTOR OR
PHARMACIST WITHOUT USING BENYLIN CHILDREN’S
CHESTY COUGHS.
TALK TO YOUR DOCTOR OR PHARMACIST…
■
If your child suffers from LIVER or KIDNEY
PROBLEMS.
■
If your child has A PERSISTENT COUGH such as
occurs with asthma, has ASTHMA, is suffering
from an ASTHMA ATTACK or a COUGH THAT
PRODUCES A LOT OF MUCUS (PHLEGM).
If any of these apply now or in the past, TALK TO A
DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
The following advice is included in case an older
child or adult is taking the medicine.
■
If you are pregnant or breast-feeding, only use
this medicine on the advice of your doctor.
SOME OF THE INGREDIENTS
CAN CAUSE PROBLEMS
■
This medicine contains sorbitol liquid. This
should be taken into account in patients with
diabetes mellitus.
■
This medicinal product contains 14.88 mg
sodium per 5 ml. To be taken into consideration
by patient

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
BENYLIN Children's Chesty Coughs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BENYLIN Children's Chesty Coughs contains 50 mg guaifenesin in each 5
ml.
Each 5ml also contains:
Sorbitol liquid (non-crystallising)
Sodium Citrate
Sodium Saccharin
Sodium Benzoate
Carmellose Sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
BENYLIN Children's Chesty Coughs is an expectorant for the symptomatic
relief of
acute productive (chesty) coughs.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
Not applicable.
CHILDREN AGED 6 TO 12 YEARS:
10 ml syrup four times daily.
Page 2 of 7
Maximum daily dose: 40 ml syrup (400 mg guaifenesin)
Not to be used for more than 5 days without the advice of a doctor.
Parents and carers
should seek medical attention if the child’s condition deteriorates
during treatment.
CHILDREN UNDER 6 YEARS:
Benylin Children’s Chesty Coughs is contraindicated in children
under the age of 6 years
(see section 4.3).
METHOD OF ADMINISTRATION
For oral use
Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.3.
CONTRAINDICATIONS
BENYLIN Children's
Chesty Coughs is contraindicated in individuals with known
hypersensitivity to the product, or any of its components.
Not to be used in children under the age of 6 years.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ask a doctor before use if your child suffers from chronic cough, if
he/she has asthma or
is suffering from an acute asthma attack.
Stop use and ask a healthcare professional if your child’s cough
lasts for more than 5
days, comes back, or is accompanied by a fever, rash or persistent
headache.
Do not give with a cough suppressant.
Caution should be exercised in the presence of severe renal or severe
hepatic impairment.
Not more than 4 doses should be given in any 24 hours.
Do not exceed the stated dose