Benylin Children's Night Coughs

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

LEVOMENTHOL

Beszerezhető a:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

ATC-kód:

R06AA52

INN (nemzetközi neve):

LEVOMENTHOL 0.55 mg/5ml

Gyógyszerészeti forma:

SYRUP

Összetétel:

LEVOMENTHOL 0.55 mg/5ml

Recept típusa:

OTC

Terápiás terület:

ANTIHISTAMINES FOR SYSTEMIC USE

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2006-08-10

Betegtájékoztató

■
 _opioid analgesics_ (drugs used to RELIEVE 
PAIN e.g. codeine, tramadol, morphine).
■
 _antipsychotics_ (drugs used to treat MOOD 
DISORDERS).  
If you are not sure about any of the medicines your 
child is taking, show the bottle or pack to your 
pharmacist. 
If any of these bullet points apply now or in the 
past, TALK TO A DOCTOR OR PHARMACIST.
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). If you have been told by your 
doctor that your child has an intolerance to 
some sugars contact your doctor before taking 
this medicinal product.
■ 
This medicinal product contains 5 vol % 
ethanol (alcohol), i.e. up to 200 mg per 
5 ml, 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.
2
  BEFORE GIVING YOUR CHILD
   THIS MEDICINE 
This medicine is suitable for most children but a few 
children s

Termékjellemzők

 
1 

SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
NAME OF THE MEDICINAL PRODUCT 

BENYLIN CHILDREN’S NIGHT COUGHS 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

BENYLIN CHILDREN’S NIGHT COUGHS contains - 

ACTIVE INGREDIENT 
MG/5 ML 
Diphenhydramine Hydrochloride 
7.0 mg 
Levomenthol 
0.55 mg 

3. 
PHARMACEUTICAL FORM 

A clear colourless syrup with no insoluble matter. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

BENYLIN CHILDREN’S NIGHT COUGHS is indicated for the relief of 
cough and its congestive symptoms, runny nose and sneezing, and in the 
treatment of hay fever and other allergic conditions affecting the upper 
respiratory tract.  It is specially formulated for children and contains no 
artificial dyes or sucrose. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Route of Administration: Oral 

CHILDREN UNDER 6 YEARS: 

BENYLIN CHILDREN’S NIGHT COUGHS is contraindicated in children 
under the age of 6 years (see section 4.3). 

CHILDREN 6 TO 12 YEARS: 

Two 5 ml spoonfuls every 6 hours 

No more than four doses should be given in any 24 hours. 

2 

Not to be used for more than five days without the advice of a doctor.  Parents 
or carers should seek medical attention if the child’s condition deteriorates 
during treatment. 

Do not exceed the stated dose. 

Keep out of the reach and sight of children. 

4.3 
CONTRAINDICATIONS 

BENYLIN CHILDREN’S NIGHT COUGHS is contraindicated in individuals 
with known hypersensitivity to the product or any of its constituents. 

BENYLIN CHILDREN’S NIGHT COUGHS should not be administered to 
patients currently receiving monoamine oxidase inhibitors (MAOI) or those 
patients who have received treatmen