Benylin Children’s Coughs and Colds 5mg/0.625mg per 5ml Syrup

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

TRIPROLIDINE HYDROCHLORIDE; Dextromethorphan hydrobromide

Disponível em:

McNeil Healthcare (Ireland) Ltd

Código ATC:

R05X

DCI (Denominação Comum Internacional):

TRIPROLIDINE HYDROCHLORIDE; Dextromethorphan hydrobromide

Dosagem:

5 mg/0.625 mg/5ml

Forma farmacêutica:

Syrup

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

OTHER COLD PREPARATIONS

Status de autorização:

Marketed

Data de autorização:

1998-03-20

Folheto informativo - Bula

BENYLIN
CHILDREN'S COUGHS &
COLDS
_5MG/0.625MG PER 5ML _
_SYRUP_
DEXTROMETHORPHAN,
TRIPROLIDINE
■ This medicine is used to help relieve children’s dry cough and
cold
symptoms.
■ This medicine is for use by children aged 6 to 12
years.
■
DO NOT USE THIS
MEDICINE:
■ There are some people who should not use this medicine.
_To find out if your child is one _
_of _
_them see section _
_2>_
■ If your child has ever had a
BAD REACTION
to any of the ingredients.
_See section _
_6>_
■
SPEAK TO YOUR
DOCTOR:
■ If your child suffers from any of the conditions mentioned in
section 2.
_See section _
_2>_
■ If your child is taking any
OTHER MEDICINES
.
_See section _
_2>_
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _See section _
_3>_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leaflet:
you
might need it
again.
Ask your pharmacist if you need more information or
advice.
Go to see your doctor if your child's symptoms worsen or do not
improve after a few
days.
1 WHAT THE MEDICINE IS
FOR
Benylin Children's Coughs & Colds Syrup is a medicine which is used to
help relieve
the
symptoms of colds and dry coughs. The liquid contains dextromethorphan
(an antitussive)
to
help stop coughing and triprolidine (an antihistamine) to help stop
sneezing, runny
nose
and watery
eyes.
The medicine is for use in children aged 6 to 12
years.
2 BEFORE GIVING THE MEDICINE TO YOUR
CHILD
This medicine is suitable for most children but a few people should
not use it. If you are
in
any doubt, talk to your doctor or
pharmacist.
X DO NOT GIVE THIS
MEDICINE…
■
If your child has ever had a
BAD REACTION
to any of the
ingredients.
■
If your child is taking, or has taken in the last two weeks,
DRUGS FOR DEPRESSION
known
as
Monoamine Oxidase Inhibitors
(MAOIs).
■
If your child is taking
_selective serotonin reuptake inhibitors _
(used to treat
DEPRESSION
and
ANXIETY
) such as fluoxetine, paroxetine and
sertraline).
■
If your child is taking
ANY OTHER COUGH AND COLD
MEDICINE.
■
If your child has serio

Características técnicas

Health Products Regulatory Authority
12 December 2018
CRN008K16
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Children’s Coughs and Colds 5mg/0.625mg per 5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 5 mg Dextromethorphan hydrobromide and 0.625 mg
Triprolidine
hydrochloride.
Excipients: Each 5ml contains liquid maltitol 4080mg and methyl
hydroxybenzoate
(E218) 5mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup
Clear colourless syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benylin Children’s Coughs & Colds is indicated for the symptomatic
relief of dry
unproductive cough and rhinorrhoea associated with the common cold and
influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 YEARS AND OVER:
Not appropriate.
CHILDREN AGED 6 TO 12 YEARS:
10 ml three or four times daily. Leave at least 4 hours between doses.
Maximum daily dose: 40 ml (4 doses).
Use only when simple measures have failed to provide adequate relief.
Use for more than five consecutive days is not recommended.
Health Products Regulatory Authority
12 December 2018
CRN008K16
Page 2 of 12
CHILDREN UNDER 6 YEARS:
Benylin Children's Coughs and Colds Syrup is contraindicated in
children under the
age of 6 years. [See Section 4.3]
HEPATIC DYSFUNCTION
Caution should be exercised when administering this product to
patients with
hepatic impairment.
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
Benylin Children's Coughs and Colds Syrup is contraindicated in
individuals with
hypersensitivity to dextromethorphan, triprolidine or to any of the
excipients listed in
section 6.1.
Benylin Children's Coughs and Colds Syrup is contraindicated in
patients who are
receiving monoamine oxidase inhibitors (MAOIs) or who have received
these within
the previous 14 days. There is a risk of serotonin syndrome with the
concomitant use
of dextromethorphan and MAOIs, and the concomitant use of this product
and
MAOIs may cause a r