Benylin Phlegm Cough Syrup Guaifenesin 100 mg/5ml Levomenthol 1.1 mg/ 5ml Syrup

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Levomenthol; Guaifenesin

Dostupné z:

Johnson & Johnson (Ireland) Limited

ATC kód:

R05CA; R05CA03

INN (Medzinárodný Name):

Levomenthol; Guaifenesin

Dávkovanie:

100 mg/5ml + 1.1 mg/5ml

Forma lieku:

Syrup

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Expectorants; guaifenesin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2011-09-09

Príbalový leták

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take 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 3 days.
WHAT IS IN THIS LEAFLET
1. What Benylin Phlegm Cough Syrup is and what it is used for
2. What you need to know before you take Benylin Phlegm Cough
Syrup
3. How to use Benylin Phlegm Cough Syrup
4. Possible side-effects
5. How to store Benylin Phlegm Cough Syrup
6. Contents of the pack and other information
1 WHAT BENYLIN PHLEGM COUGH SYRUP IS AND WHAT IT
IS USED FOR
Benylin Phlegm Cough Syrup
is a medicine which is used to help
relieve chesty coughs.
It contains Guaifenesin (an expectorant) to help loosen
mucus (phlegm) from the lungs and make it easier to
cough up, and Levomenthol to help you breathe more
easily by easing congestion.
The medicine is for use in adults and children aged
12 years and over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN
PHLEGM COUGH 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 BENYLIN PHLEGM COUGH SYRUP …
■
If you are allergic to guaifenesin or levomenthol
or to any of the other ingredients of this
medicine (listed in section 6).
! WARNINGS AND PRECAUTIONS
! TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING BENYLIN
PHLEGM COUGH SYRUP...
■
If you suffer from
LIVER
or
KIDNEY PROBLEMS
.
■
If you have been told by your doctor that you
have an intolerance to some sugars.
■
If you have had a
COUGH
for a few weeks that
may be caused by
ASTHMA
, or a cough which brings up a lot of
mucus (phlegm

Súhrn charakteristických

Health Products Regulatory Authority
11 January 2022
CRN00CQXJ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Phlegm Cough Syrup
Guaifenesin 100mg/5ml
Levomenthol 1.1mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mls contains 100 mg guaifenesin and 1.1 mg levomenthol
Excipients with known effect: Each 5ml contains
Glucose liquid 3.5g
Sucrose 1g
Ponceau 4R (E124) 0.25mg
Sodium benzoate (E211) 10mg
Sodium 16.4mg
Ethanol 197mg
Propylene glycol (E1520) 1.07mg
Invert sugar 6.75mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup.
Clear, red syrup having a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benylin Phlegm Cough Syrup is indicated for the symptomatic relief of
productive cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS:
Oral.
Two 5 ml spoonfuls every 4 to 6 hours.
Do not give more than 4 doses in 24 hours.
Maximum daily dose 40ml.
CHILDREN UNDER 12 YEARS:
Not recommended. [See section 4.3].
THE ELDERLY:
As for adults.
HEPATIC/RENAL DYSFUNCTION
Experience with the use of this product suggests that normal adult
dosage is appropriate for mild to moderate dysfunction.
Caution should be exercised in severe hepatic and severe renal
impairment. [See section 4.4].
4.3 CONTRAINDICATIONS
This product is contraindicated in individuals with known
hypersensitivity to the active substance or to any of the excipients.
Health Products Regulatory Authority
11 January 2022
CRN00CQXJ
Page 2 of 6
Benylin Phlegm Cough Syrup should not be used in children under the
age of 12 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benylin Phlegm Cough Syrup should be not used for persistent or
chronic cough, such as occurs with asthma, or where cough
is accompanied by excessive secretions, unless directed by a
physician.
Caution should be exercised when using the product in the presence of
severe renal or severe hepatic impairment. [See section
4.2].
This medicinal product contains 3.5g glucose