Benylin Children’s Chesty Cough 50mg/5ml Syrup

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Guaifenesin

Disponível em:

Johnson & Johnson (Ireland) Limited

Código ATC:

R05CA; R05CA03

DCI (Denominação Comum Internacional):

Guaifenesin

Dosagem:

50 mg/5ml

Forma farmacêutica:

Syrup

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

Expectorants; guaifenesin

Status de autorização:

Marketed

Data de autorização:

1998-07-27

Folheto informativo - Bula

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or
as your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If your child get any side-effects, talk to your doctor or
pharmacist. This includes any possible side-effects not listed in this
leaflet.
_See section 4_
.
- You must talk to a doctor if you do not feel better or if you
feel worse after a few days.
WHAT IS IN THIS LEAFLET
1. What Benylin Children’s Cough Syrup is and what it is used for
2. What you need to know before you take Benylin Children’s
Cough Syrup
3. How to use Benylin Children’s Cough Syrup
4. Possible side-effects
5. How to store Benylin Children’s Cough Syrup
6. Contents of the pack and other information
1 WHAT BENYLIN CHILDREN’S COUGH SYRUP IS AND
WHAT IT IS USED FOR
Benylin Children's Chesty Coughs Syrup is a medicine which is
used to help relieve chesty coughs in children.
It contains guaifenesin (an expectorant) to help loosen mucus
(phlegm) from the lungs and make it easier to cough up.
The medicine is for use in children aged 6-12 years.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN
CHILDREN’S COUGH SYRUP
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.
X DO NOT USE BENYLIN CHILDREN’S COUGH SYRUP …
■
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 applies,
GET ADVICE FROM A DOCTOR OR
PHARMACIST WITHOUT USING BENYLIN CHILDREN’S COUGH SYRUP.
! WARNINGS AND PRECAUTIONS
! TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BENYLIN
CHILDREN’S ...
■
If your child suffers from
LIVER
or
KIDNEY PROBLEM

Características técnicas

Health Products Regulatory Authority
03 August 2022
CRN00D11F
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Children’s Chesty Cough 50mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 50 mg guaifenesin.
Excipients with known effect:
Sorbitol liquid (E420) 2.525g per 5ml.
Benzyl alcohol 0.05mg per 5ml
Sodium benzoate (E211) 15mg per 5 ml
Sodium 14.9mg per 5ml
Propylene glycol (E1520) 0.1mg per 5ml
Ethanol 0.00025mg per 5ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A colourless to slightly yellow, clear syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benylin Children's Chesty Coughis indicated for the symptomatic relief
of productive coughs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
Not appropriate.
CHILDREN AGED 6 TO 12 YEARS:
Oral. 10 ml three or four times daily
Maximum daily dose: 40 ml
Use only when simple measures have failed to provide adequate relief.
Use for more than five consecutive days is not recommended.
CHILDREN UNDER 6 YEARS:
Not recommended. [See Section 4.3]
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the active ingredients.
Use in patients at risk of developing respiratory failure.
Use in children under 6 years of age is contraindicated.
Health Products Regulatory Authority
03 August 2022
CRN00D11F
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
BENYLIN Children's Chesty Coughs should be not used for persistent or
chronic cough, such as occurs with asthma, or where
cough is accompanied by excessive secretions, unless directed by a
physician.
If cough tends to recur or is accompanied by a fever, rash or
persistent headache, a physician should be consulted.
Caution should be exercised in the presence of severe renal or severe
hepatic impairment.
Patients with rare hereditary problems of fructose intolerance should
not take this medicine.
Not more than 4 doses should be given in any 24 hours. Do not exceed
the stated dose.
Do not