BENYLIN CHILDREN'S DRY COUGHS SYRUP DIPHENHYDRAMI 7.0/0.55 MG/5ml Syrup

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL

可用日期:

McNeil Healthcare (Ireland) Ltd

ATC代码:

R06AA02

INN（国际名称）:

DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL

剂量:

7.0/0.55 MG/5ml

药物剂型:

Syrup

处方类型:

Product not subject to medical prescription

治疗领域:

Aminoalkyl ethers

授权状态:

Authorised

授权日期:

1992-08-24

资料单张

 IF YOU ARE PREGNANT OR BREAST-FEEDING
The following advice is included in case an older 
child or adult is taking the medicine:
■
 Ask your doctor or pharmacist for advice before 
taking this medicine if you are pregnant or 
breast-feeding.
 SPECIAL WARNINGS ABOUT THIS MEDICINE
■
 This product can make some people feel drowsy, 
dizzy or have blurred vision. Make sure that 
your child is not affected if he or she is going 
to do anything where they need to be alert. Be 
especially careful if the child is taking another 
medicine which may also cause drowsiness.
■
 If an older child or adult is taking the medicine 
remember that this product may cause 
drowsiness, dizziness or blurred vision. Do not 
drive or operate machinery if you are affected. 
Avoid alcoholic drink.
  SOME OF THE INGREDIENTS CAN CAUSE 
PROBLEMS

■
This medicine contains sorbitol 70% (non 
crystalline) which can cause stomach upset and 
diarrhoea when taken in large doses.
■
This medicinal product contains 5 vol % ethanol 
(alcohol), i.e. up to 200 mg per dose, equivalent 
to 5 ml beer, 2 ml wine per 5 ml. This can be 
harmful for those suffering from alcoholism.  
To be taken into account in pregnant or breast-
feeding women, children and high-risk groups 
such as patients with liver disease or epilepsy.
■
This medicinal product contains 16.47 mg sodium 
per 5 ml. To be taken in consideration by patients 
on a controlled sodium diet.
■
This medicinal product contains glycerol, which 
can cause headaches and may also upset the 
stomach when taken in large doses. It is important 
not to take more than the recommend dose.
■
  This medicinal product contains sodium 
benzoate, which may irritate the skin, eyes and 
mucosal surfaces.
2
  BEFORE GIVING YOUR CHILD 
  THIS MEDICINE 
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 GIVE YOUR CHILD THIS MEDICINE…
■
 If s/he has e

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Children’s Dry Coughs Syrup
Diphenhydramine Hydrochloride 7mg/5ml
Levomenthol 0.55mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Diphenhydramine Hydrochloride 7 mg and Levomenthol 0.55 mg in
each 5 ml.
Excipients
5ml contains:
Sorbitol 2.525 g
Sodium 17 mg
Ethanol 96% 0.260 ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup
Clear, colourless syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the symptomatic relief of non-productive cough and of allergic
conditions and reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHILDREN AGED 6 YEARS AND OVER:
Oral. 10 ml syrup 3 or 4 times a day.
Maximum daily dose: 40 ml syrup
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:
Benylin Children’s Dry Coughs is not suitable for administration to
children under 6 years of age. [See Section 4.3]
THE ELDERLY:
Not applicable
HEPATIC & RENAL DYSFUNCTION
It may be prudent to increase the dosage interval in subjects with
moderate to severe hepatic and/or renal dysfunction,
[See Pharmacokinetics].
4.3 CONTRAINDICATIONS
Benylin Children’s Dry Coughs is contraindicated in individuals with
known hypersensitivity to the product or any of
its components.
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