Benylin Dual Action Dry Syrup, Pseudoephedrine 30mg, Dextromethorphan 10mg, Triprolidine 1.25mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dextromethorphan hydrobromide; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

R01BA; R01BA52

INN (International Name):

Dextromethorphan hydrobromide; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Dosage:

30 mg/10 mg/1.25 mg/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics; pseudoephedrine, combinations

Authorization status:

Marketed

Authorization date:

2004-03-15

Patient Information leaflet

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. _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.
This medicine can lead to dependence. Therefore the treatment should
be of short duration.
X DO NOT USE THIS MEDICINE…
■ If you have ever had a BAD REACTION to pseudoephedrine,
dextromethorphan, triprolidine, or
any of the other ingredients.
■ If you suffer from LUNG DISEASE

Summary of Product characteristics

Health Products Regulatory Authority
10 July 2023
CRN00DM25
Page 1 of 10
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 with known effect:
Each 5 ml of Benylin Dual Action Dry Syrup also contains:
Sorbitol solution (70%) 1000.0mg
Sucrose 2835.0mg
Methylhydroxybenzoate (E218) 5.00mg
Ponceau 4R (E124) 0.8mg
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.
HEPATIC DYSFUNCTION
Caution should be exercised when administering Benylin Dual Action Dry
Syrup to patients with hepatic impairment.
Health Products Regulatory Authority
10 July 2023
CRN00DM25
Page 2 of 10
RENAL DYSFUNCTION
Caution should be exercised when administering Benylin Dual Action Dry
Syrup to patients with mild to moderate renal
impairment.
METHOD OF ADMINISTRATION
For oral use.
4.3 CONTRAINDICATIONS
Benylin Dual Action Dry Syrup is contraindicated in individuals with
hypersensitivity to dextromethorphan, pse