Benylin Mucus Relief 250mg/5ml Syrup

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Carbocisteine

Fáanlegur frá:

McNeil Healthcare (Ireland) Ltd

ATC númer:

R05CB; R05CB03

INN (Alþjóðlegt nafn):

Carbocisteine

Skammtar:

250 mg/5ml

Lyfjaform:

Syrup

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Mucolytics; carbocisteine

Leyfisstaða:

Not marketed

Leyfisdagur:

2001-07-27

Upplýsingar fylgiseðill

■
This medicine is used to help treat conditions where the
lungs produce too much mucus (phlegm) or the mucus is
too thick.
■
This medicine is for use by adults and children aged 2
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.
1 WHAT THE MEDICINE IS FOR
Benylin Mucus Relief is a medicine which is used to help
treat conditions where the lungs produce too much mucus
(phlegm) or the mucus is too thick. It contains
Carbocisteine (a mucolytic) to help thin the mucus when it
has become too thick or sticky to cough up.
The medicine is for use in adults and children aged 2 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 USE THIS MEDICINE…
■
If you have ever had a BAD REACTION to any of the
ingredients.
■
For a child under 4 years of age.
If any of these apply to you, GET ADVICE FROM A DOCTOR OR
PHARMACIST WITHOUT USING BENYLIN MUCUS RELIEF.
TALK TO YOUR DOCTOR OR PHARMACIST…
■
If you suffer from LIVER or KIDNEY PROBLEMS.
■
If you have, or have ever had a stomach ulcer.
■
If you are taking other medicines including pholcodine
linctus.
If you are not sure about any of the medicines you are
taking, show the bottle or pack to your pharmacist.
If any of these bullet points apply to you now or in the past,
TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
Ask your doctor or pharmacist f

Vara einkenni

Health Products Regulatory Authority
26 October 2021
CRN00CGYW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Mucus Relief 250mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 250 mg carbocisteine (50mg/ml).
Excipients: Each 5ml also contains 7.5 mg methyl parahydroxybenzoate,
47.1 mg sodium and 0.03 mg sunset yellow (E110).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Clear, light yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mucolytic agent for use in disorders of the lower respiratory tract in
which an increase in the amount and viscosity of mucus is
a prominent feature.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration:
ADULTS AND CHILDREN OVER 12 YEARS
Three 5 ml spoonfuls three times a day initially; after a satisfactory
response, this may be reduced to two 5 ml spoonfuls three
times daily.
CHILDREN OVER 4 YEARS
(6-12 years): One 5 ml spoonful three times a day
(4-5 years): Half to one 5 ml spoonful twice a day (5-10ml).
Not recommended for children under 4 years.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Carbocisteine is contra-indicated in cases of active peptic ulcer.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used with caution in patients with a history of
peptic ulceration, because of the possible effect on the
mucous glands of the stomach.
If symptoms persist or get worse, or if new symptoms occur, patients
should stop use and consult a physician.
Health Products Regulatory Authority
26 October 2021
CRN00CGYW
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known, but see Section 6.2 below.
4.6 FERTILITY, PREGNANCY AND LACTATION
There are insufficient adequate and well controlled studies in
pregnant women. Therefore, Benylin Mucus Relief action should
not be used during pregnancy or by nursing mothers.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not r