Benylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100mg/5mlPseudoephedrine Hydrochloride 30mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE; Guaifenesin

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

R01BA; R01BA52

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE; Guaifenesin

Dosage:

30 mg/5ml + 100 mg/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics; pseudoephedrine, combinations

Authorization status:

Marketed

Authorization date:

1997-04-07

Patient Information leaflet

Package leaflet: Information for the user
BENYLIN PHLEGM COUGH PLUS DECONGESTANT SYRUP
GUAIFENESIN 100MG/5ML
PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML
.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after 5 days
WHAT IS IN THIS LEAFLET
1.
What Benylin Phlegm Cough plus Decongestant Syrup is and what it is
used for
2.
What you need to know before you use Benylin Phlegm Cough plus
Decongestant
Syrup
3.
How to use Benylin Phlegm Cough plus Decongestant Syrup
4.
Possible side effects
5.
How to store Benylin Phlegm Cough plus Decongestant Syrup
6.
Contents of the pack and other information
1. WHAT BENYLIN PHLEGM COUGH PLUS DECONGESTANT SYRUP IS AND WHAT IT IS
USED FOR
Benylin Phlegm Cough plus Decongestant is a medicine which is used to
relieve
chesty coughs, help clear the stuffy, blocked up feeling in your nose
and sinuses and reduce
catarrh. The syrup contains pseudoephedrine hydrochloride, which is a
decongestant that
relieves nasal and sinus congestion and guaifenesin, which is an
expectorant that helps to
loosen the mucus in your throat and chest.
This medicine is for use by adults and children aged 12 years and
over.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN PHLEGM COUGH PLUS
DECONGESTANT SYRUP
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
(
ALLERGIC REACTION
) to any of the ingredients (
_listed in _
_section 6_
).
■ If you have
HIG

Summary of Product characteristics

Health Products Regulatory Authority
21 September 2021
CRN00C1H7
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Phlegm Cough plus Decongestant Syrup
Guaifenesin 100mg/5ml
Pseudoephedrine Hydrochloride 30mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains 100 mg Guaifenesin and 30mg Pseudoephedrine
hydrochloride.
Excipients with known effect: Each 5ml contains:
Sucrose 3g
Sunset yellow (E110) 0.25mg
Ponceau 4R (E124) 0.25mg
Methyl hydroxybenzoate (E218) 5.0mg
Propyl hydroxybenzoate (E216) 0.5mg
Ethanol 188mg
Benzyl alcohol 0.02mg
3 PHARMACEUTICAL FORM
Syrup
A clear orange-red, cherry-flavoured syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benylin Phlegm Cough plus Decongestant Syrup is indicated for the
symptomatic relief of upper respiratory tract disorders
accompanied by productive cough which benefits from a combination of a
nasal decongestant and an expectorant.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN OVER 12 YEARS:
10 ml every 4-6 hours, up to four times a day
CHILDREN UNDER 12 YEARS:
This medicine is contra-indicated in children under 12 years of age
(see section 4.3)
OLDER PEOPLE:
There have been no specific studies of Benylin Phlegm Cough plus
Decongestant Syrup in the elderly. Experience has indicated
that normal adult dosage is appropriate.
HEPATIC DYSFUNCTION:
Caution should be exercised when administering Benylin Phlegm Cough
plus Decongestant to patients with severe hepatic
impairment.
RENAL DYSFUNCTION:
Caution should be exercised when administering Benylin Phlegm Cough
plus Decongestant to patients with mild to moderate
renal impairment.
Health Products Regulatory Authority
21 September 2021
CRN00C1H7
Page 2 of 9
METHOD OF ADMINISTRATION
For oral use
4.3 CONTRAINDICATIONS
Benylin Phlegm Cough plus Decongestant Syrup is contra-indicated in
individuals with known hypersensitivity to
Pseudoephedrine, Guaifenesin or to any of the excipients listed in
section 6.1.
Benylin Phlegm Cough plus Deconges