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

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Levomenthol; Guaifenesin

Dostopno od:

JNTL Consumer Health I (Ireland) Limited

Koda artikla:

R05CA; R05CA03

INN (mednarodno ime):

Levomenthol; Guaifenesin

Farmacevtska oblika:

Syrup

Terapevtsko območje:

Expectorants; guaifenesin

Status dovoljenje:

Marketed

Datum dovoljenje:

2011-09-09

Navodilo za uporabo

turn over
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHLEGM
Guaifenesin 100mg/5ml
Levomenthol 1.1mg/5ml
Read all of this leaflet carefully before you start taking
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
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 take 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 IS IT USED FOR
Benylin Phlegm Cough 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 TAKE 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. DO NOT TAKE 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

Lastnosti izdelka

Health Products Regulatory Authority
28 March 2024
CRN00DHHF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Phlegm Cough Syrup Guaifenesin 100 mg/5ml Levomenthol 1.1 mg/
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.
Benylin Phlegm Cough Syrup should not be used in children under the
age of 12 years.
Health Products Regulatory Authority
28 March 2024
CRN00DHHF
Page 2 of 6
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