BENYLIN DUAL ACTION DRY - PSEUDOEPHEDRINE/DEXTROMETHORPHAN/TRIPROLIDINE

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

PSEUDOEPHEDRINE HYDROCHLORIDE ; DEXTROMETHORPHAN HYDROBROMIDE ; TRIPROLIDINE HYDROCHLORIDE

Dostupné z:

Johnson & Johnson (Ireland) Limited

ATC kód:

R01BA52

INN (Medzinárodný Name):

PSEUDOEPHEDRINE HYDROCHLORIDE ; DEXTROMETHORPHAN HYDROBROMIDE ; TRIPROLIDINE HYDROCHLORIDE

Dávkovanie:

30/10/1.25 Milligram

Forma lieku:

Syrup

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

pseudoephedrine, combinations

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1984-03-15

Príbalový leták

PACKAGE LEAFLET
BENYLIN
DUAL ACTION DRY SYRUP
Pseudoephedrine 30 mg, Dextromethorphan
10 mg, triprolidine 1.25 mg
_Cough & Congestion_
■ This medicine is used to help relieve symptoms of cold and flu
including irritating dry
cough and related congestion symptoms.
■ This medicine is for use by adults and children aged 12 years and
over.
■ DO NOT USE THIS MEDICINE:
■ There are some people who should not use this medicine. _To find
out if you are one _
_of them See Section 2>_
■ If you have ever had a BAD REACTION to any of the ingredients.
_For the list of _
_ingredients See Section 6>_
■ SPEAK TO YOUR DOCTOR:
■ If you suffer from any of the conditions mentioned in Section 2.
_See Section 2>_
■ If you are taking any OTHER MEDICINES. _See Section 2>_
■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the
tables. _See Section 3>_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leaflet: you
might need it again.
Ask your pharmacist if you need more information or advice. Go to see
your doctor if your
symptoms worsen or do not improve after a few days.
1 WHAT THE MEDICINE IS FOR
Benylin Dual Action Dry is a medicine which is used to help relieve
dry coughs and related
congestion symptoms. The liquid contains triprolidine hydrochloride
which is an
antihistamine that helps stop sneezing, runny nose and watery eyes,
pseudoephedrine
hydrochloride which is a decongestant that unblocks stuffy noses and
dextromethorphan
hydrobromide which is an antitussive to help stop coughing.
The medicine is for use in adults and children aged 12 years and over.
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.
X DO NOT USE THIS MEDICINE…
■ If you have ever had a BAD REACTION to any of the ingredients.
■ If you have HIGH BLOOD PRESSURE or HEART DISEASE.
■ If you are taking beta blockers (used to treat HIGH BLOOD
PRESSURE).
■ If you are taking, or have taken

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Dual Action Dry Syrup
Pseudoephedrine 30mg
Dextromethorphan 10mg
Triprolidine 1.25mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of Benylin Dual Action Dry Syrup contains
Pseudoephedrine Hydrochloride 30 mg
Dextromethorphan Hydrobromide 10 mg
Triprolidine Hydrochloride 1.25 mg
Excipients: contains Sorbitol Solution (70%) 1000.0mg, Sucrose
2835.0mg, sodium Benzoate (E211) 5.0mg, Ponceau
4R (E124) 0.8mg and Ethanol (96% v/v) 201.5mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup
A clear, bright red, blackberry-flavoured syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BENYLIN Dual Action Dry Syrup is indicated for the relief of dry cough
and upper respiratory tract congestion such as
is associated with the common cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN 12 YEARS AND OVER:
10 ml every 4-6 hours, up to four times a day
Maximum daily dose: 40ml (80mg dextromethorphan, 240mg pseudoephedrine
and 10mg triprolidine).
CHILDREN UNDER 12 YEARS:
This medicine is contraindicated in children under the age of 12
years. [See section 4.3]
USE IN THE ELDERLY
There have been no specific studies of Benylin Dual Action Dry Syrup
in the elderly. Experience has indicated that
normal adult dosage is appropriate.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_3_
_/_
_0_
_7_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_8_
_4_
_8_