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

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Guaifenesin

Доступна с:

JNTL Consumer Health I (Ireland) Limited

код АТС:

R05CA; R05CA03

ИНН (Международная Имя):

Guaifenesin

Фармацевтическая форма:

Syrup

Терапевтические области:

Expectorants; guaifenesin

Статус Авторизация:

Marketed

Дата Авторизация:

1998-07-27

тонкая брошюра

Package leaflet: Information for the user
Children’s Chesty
Coughs
_50 MG/5 ML SYRUP_
GUAIFENESIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take 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 gets 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 your child does not feel
better or feels worse after a few days.
WHAT IS IN THIS LEAFLET
1. What Benylin Children’s Chesty Coughs Syrup is and
what it is used for
2. What you need to know before you take Benylin
Children’s Chesty Coughs Syrup
3. How to use Benylin Children’s Chesty Coughs Syrup
4. Possible side-effects
5. How to store Benylin Children’s Chesty Coughs
Syrup
6. Contents of the pack and other information
1 WHAT BENYLIN CHILDREN’S
CHESTY COUGHS 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 TAKE BENYLIN
CHILDREN’S CHESTY COUGHS
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.
DO NOT USE BENYLIN CHILDREN'S CHESTY
COUGHS 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.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST
BEFORE USING BENYLIN CHILDREN'S CHESTY
COUGHS

Характеристики продукта

Health Products Regulatory Authority
28 March 2024
CRN00DGVJ
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
28 March 2024
CRN00DGVJ
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 t