BENYLIN PHLEGM COUGH PLUS DECONGESTANT 100mg/5ml 30mg/5ml %v/v Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

R01BA52

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN

Dosage:

100mg/5ml 30mg/5ml %v/v

Pharmaceutical form:

Syrup

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics

Authorization status:

Authorised

Authorization date:

1997-03-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHLEGM
GUAIFENESIN 100 MG/5 ML
PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG/5 ML
READ ALL OF THIS LEAFLET CAREFUL
LY 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.
DO NOT USE THIS MEDICINE…
n
If you have ever had a BAD REACTION
(ALLERGIC REACTION) to any of the ingredients _(listed in _
_section 6)_.
n
If you have HIGH BLOOD PRESSURE or HEART DISEASE.
n
If you ha

Summary of Product characteristics

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 5 ml of syrup contains 100 mg of Guaifenesin and 30 mg of
Pseudoephedrine Hydrochloride.
Excipients:
Also includes sucrose 3g per 5ml; Sunset Yellow (E110) 0.25mg per 5ml;
Ponceau 4R (E124) 0.25mg per 5ml; Methyl
hydroxybenzoate (E218) 5.0mg per 5ml, Propyl hydroxybenzoate (E216)
0.5mg per 5ml and ethanol (96%) 0.25ml per
5ml.
_For a full list of excipients, see section 6.1_
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
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