BENYLIN COUGH MEDICINE 14 / 1.1 MG/5ml Syrup

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL

Verfügbar ab:

McNeil Healthcare (Ireland) Ltd

ATC-Code:

R06AA02

INN (Internationale Bezeichnung):

DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL

Dosierung:

14 / 1.1 MG/5ml

Darreichungsform:

Syrup

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

Aminoalkyl ethers

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

1994-04-01

Gebrauchsinformation

■
 _antiemetics _(used to treat nausea and vomiting)
■
 _antipsychotics_
■
 _hypnotics_ 
If you are not sure about any of the medicines you are 
taking, show the bottle or pack to your pharmacist. 
If any of these bullet points apply to you now or in the 
past, TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
 Do not use this medicine if you are pregnant or 
breast-feeding.
SPECIAL WARNINGS ABOUT THIS MEDICINE
■
 This medicine may cause drowsiness. If affected, 
do not drive or operate machinery. Avoid 
alcoholic drink.
SOME OF THE INGREDIENTS CAN CAUSE 
PROBLEMS 
■
 This medicine contains sucrose and liquid glucose. 
If you have been told by your doctor that you 
have an intolerance to some sugars contact your 
doctor before taking this medicinal product. 
Contains 3.5 g glucose per 5 ml. This should 
be taken into account in patients with diabetes 
mellitus.
■
 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. 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.
■
 Ponceau 4R (E124) may cause allergic reactions. 
These reactions are more common in people who 
are allergic to aspirin.
■
 This medicinal product contains 16.61 mg  
sodium per 5 ml. To be taken in consideration by 
patients on a controlled sodium diet.
2
  BEFORE TAKING THIS  
 MEDICINE 
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 USE THIS MEDICINE…
■
 If you have ever had a BAD REACTION to any of the 
ingredients.
If any of these apply to you, GET ADVICE FROM A DOCTOR 
OR PHARMACIST WITHOUT USING BENYLIN COUGH 
MEDICINE. 
TALK TO YOUR DOCTOR OR PHARMACIST…
■
 If you suffer from LIVER or KIDNEY PROBLEMS
■
 If you suffer

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Cough Medicine Syrup
Diphenhydramine hydrochloride 14mg/5ml
Levomenthol 1.1mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains:
Each 5ml also contains:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Clear red syrup with a taste characteristic of menthol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
ADULTS AND CHILDREN OVER 12 YEARS:
One or two 5 ml spoonfuls three to four times daily.
Not recommended for children under 12 years. [see section 4.3]
4.3 CONTRAINDICATIONS
Benylin Cough Medicine is contra-indicated in individuals
hypersensitive to the active ingredients.
Diphenhydramine hydrochloride
14
mg
Levomenthol
1.1
mg
Glucose Syrup
3.49
g
Sucrose
1.0
g
Ethanol
0.26
ml
Ponceau 4R (E124)
0.25
mg
(a)
Properties
Fixed combination of anti-histamine with anti-tussive activity and
carminative.
(b)
Indications for use
In the symptomatic relief of non-productive cough and of allergic
conditions and reactions.
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Benylin cough Medicine should not be used in children under the age of
12 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use with any other product containing diphenhydramine, even one
used on skin (see Secti