Benylin Mucus Cough Plus Decongestant syrup

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pseudoephedrine hydrochloride; Guaifenesin

Available from:

McNeil Products Ltd

ATC code:

R01BA52

INN (International Name):

Pseudoephedrine hydrochloride; Guaifenesin

Dosage:

6mg/1ml ; 20mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03090200; GTIN: 3574660572971

Patient Information leaflet

Guaifenesin & Pseudoephedrine
n
This medicine is used to relieve chesty coughs and help
clear the stuffy, blocked up feeling in your nose and
sinuses and reduce catarrh.
n
This medicine is for use by adults and children aged
12 years and over.
n
DO NOT TAKE THIS MEDICINE:
n
There are some people who should not take this
medicine. _To find out if you are one of them_ _see section 2_
n
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6 _
n
SPEAK TO YOUR DOCTOR:
n
If you suffer from any of the conditions mentioned in
section 2. _See section 2 _
n
If you are taking any OTHER MEDICINES. _See section 2 _
n
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are
shown in the table. _See section 3_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet you might need it again.
1
WHAT THE MEDICINE IS FOR
Benylin Mucus Cough plus Decongestant Syrup 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 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 TAKE THIS MEDICINE…
n
If you have ever had a BAD REACTION to any of the
ingredients of this medicine (listed in section 6).
n
If you have HIGH BLOOD PRESSURE or HEART DISEASE.
n
If you are taking _beta blockers_ (used to treat HIGH BLOOD
PRESSURE).
n
If you have DIABETES.
n
If you have an OVERACTIVE THYROID GLAND.
n
If you have GLAUCOMA (increased pressure in the eye).
n
If you have PHAEOCHROMOCYTOMA (a rare tumour which
affects your heart rate and blood pressure).
n
If you have SEVERE KIDNEY PROBLEMS.
n
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benylin MUCUS Cough plus Decongestant Syrup
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Pseudoephedrine hydrochloride
30 mg
Guaifenesin
100 mg
Each 5ml also contains:
Sucrose
3 g
Methyl Hydroxybenzoate (E 218)
5 mg
Propyl Hydroxybenzoate (E 216)
0.5 mg
Ethanol 96 %v/v
190 mg
Ponceau 4R (E 124)
0.25 mg
Sunset Yellow (E 110)
0.25 mg
Benzyl alcohol
0.02 mg
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
A clear orange-red syrup.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product is indicated for the symptomatic relief of upper
respiratory tract
disorders accompanied by productive cough, which are benefited by the
combination of a decongestant of the mucous membranes of the upper
respiratory tract, especially the nasal mucosa and sinuses, and an
expectorant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
10 ml syrup every 4 - 6 hours up to 4 times a day.
Maximum daily dose: 40 ml
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY:
Normal adult dosage is appropriate, [See Pharmacokinetics in the
elderly, section
5.2].
HEPATIC DYSFUNCTION:
Experience with the use of the product suggests normal adult dosage is
appropriate,
although it may be prudent to exercise caution in the presence of
severe hepatic
impairment, [See Pharmacokinetics in the elderly, section 5.2].
RENAL DYSFUNCTION:
Caution should be exercised when administering this product to
patients with
moderate to severe renal impairment, particularly if accompanied by
cardiovascular
disease, [See Pharmacokinetics in Renal Impairment, section 5.2].
Do not exceed the stated dose.
METHOD OF ADMINISTRATION
For oral use
4.3
CONTRAINDICATIONS
This product is contraindicated in individuals with known
hypersensitivity to
guaifenesin or pseudoephedrine, or to any of the excipients listed in
section 6.1.
This product is contraindic