BENYLIN PHLEGM COUGH 100 / 1.1 MG/5ml Syrup

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

GUAIFENESIN, LEVOMENTHOL

可用日期:

McNeil Healthcare (Ireland) Ltd

ATC代码:

R05CA03

INN（国际名称）:

GUAIFENESIN, LEVOMENTHOL

剂量:

100 / 1.1 MG/5ml

药物剂型:

Syrup

处方类型:

Product not subject to medical prescription

治疗领域:

Expectorants

授权状态:

Authorised

授权日期:

2011-09-09

资料单张

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PHLEGM
Guaifenesin 100mg/5ml
Levomenthol 1.1mg/5ml
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 you 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 
feel worse after 3 days.
WHAT IS IN THIS LEAFLET
1.  What Benylin Phlegm Cough Syrup is and what it is 
used for
2.  What you need to know before you take Benylin 
Phlegm Cough Syrup
3. How to take Benylin Phlegm Cough Syrup
4. Possible side-effects
5. How to store Benylin Phlegm Cough Syrup
6. Contents of the pack and other information
1
  WHAT BENYLIN PHLEGM 
COUGH SYRUP IS AND  
WHAT IS IT USED FOR
Benylin Phlegm Cough is a medicine which is used  
to help relieve chesty coughs. It contains Guaifenesin  
(an expectorant) to help loosen mucus (phlegm) 
from the lungs and make it easier to cough up, and 
Levomenthol to help you breathe more easily by  
easing congestion.
The medicine is for use in adults and children aged  
12 years and over.
2  
WHAT YOU NEED TO KNOW 
BEFORE YOU TAKE BENYLIN 
PHLEGM COUGH SYRUP 
This medicine is suitable for most people but a few 
people should not use it. If you are in any doubt, talk to 
your doctor or pharmacist. 
  DO NOT TAKE BENYLIN PHLEGM COUGH 
SYRUP
■
 If you are allergic to guaifenesin or levomenthol 
or to any of the other ingredients of this 
medicine (listed in section 6). 

WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Benylin 
Phlegm Cough Syrup
■
 If you suffer from LIVER or KIDNEY PROBLEMS.
■
 If you have been

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Phlegm Cough Syrup
Guaifenesin 100 mg/5ml
Levomenthol 1.1 mg/ 5 ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 100 mg guaifenesin and 1.1 mg levomenthol,
Excipients with known effect:
Glucose Liquid 3.49g per 5ml, Sucrose 1g per 5ml, Ponceau 4R (E124)
0.25mg per 5ml, Sodium 16.4mg per 5ml and
5%w/v ethanol i.e. up to 200 mg per dose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup.
Clear, red syrup having a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benylin Phlegm Cough Syrup is indicated for the symptomatic relief of
productive cough
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS:
Oral.
Two 5 ml spoonfuls every 4 to 6 hours.
Do not give more than 4 doses in 24 hours.
Maximum daily dose 40ml.
CHILDREN UNDER 12 YEARS:
Not recommended. [See section 4.3].
THE ELDERLY:
As for adults.
HEPATIC/RENAL DYSFUNCTION
Experience with the use of this product suggests that normal adult
dosage is appropriate for mild to moderate
dysfunction. Caution should be exercised in severe hepatic and severe
renal impairment. [See section 4.4].
4.3 CONTRAINDICATIONS
This product is contraindicated in individuals with known
hypersensitivity to the active substance or to any of the
excipients.
Benylin Phlegm Cough Syrup should not be used in children under the
age of 12 years.
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