Benylin Phlegm Cough Menthol 100 mg/5 ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Guaifenesin

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

R05CA; R05CA03

INN (International Name):

Guaifenesin

Dosage:

100 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Expectorants; guaifenesin

Authorization status:

Marketed

Authorization date:

2011-10-07

Patient Information leaflet

BENYLIN PHLEGM COUGH MENTHOL
100MG/5ML ORAL SOLUTION
GUAIFENESIN
READ ALL OF THIS LEAFLET CAREFULLY 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
or nurse has 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 7 days.
WHAT IS IN THIS LEAFLET:
1. What Benylin Phlegm Cough Menthol is and what it is used for.
2. What you need to know before you take Benylin Phlegm Cough Menthol.
3. How to take Benylin Phlegm Cough Menthol.
4. Possible side effects.
5. How to store Benylin Phlegm Cough Menthol
6. Contents of the pack and other information
1.
WHAT THE BENYLIN PHLEGM COUGH MENTHOL IS AND WHAT IS IT USED FOR
Benylin Phlegm Cough Menthol contains guaifenesin which is a type of
medicine called an
expectorant. It helps to relieve chesty (productive) coughs by
loosening phlegm (mucus),
making it easier to cough up and the cough more productive.
The medicine is for use in adults and adolescents aged 12 years and
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENYLIN PHLEGM COUGH MENTHOL
X DO NOT TAKE THIS MEDICINE IF YOU
▪
If you are
ALLERGIC
to guaifenesin or 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
Menthol if you:
▪
have had a
COUGH
for more than 7 days or your cough recurs or is accompanied by a
FEVER
,
RASH
or
PERSISTENT HEADACHE.
▪
have a
PERSISTENT COUGH
that may be caused by
ASTHMA.
▪
have a cough which brings up a lot of
MUCUS
(phlegm).
▪
suffer from severe
LIVER
or
KIDNEY PROBLEMS.
▪
are taking
ALCOHOL.
CHILDREN:
The safety and efficacy

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2022
CRN00CDW4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Phlegm Cough Menthol 100 mg/5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
This product contains 20 mg guaifenesin in each ml (100mg in 5ml).
Excipient(s) with known effect:
Ethanol 39.7mg/ml
Ponceau 4R (E124) 0.05mg/ml
Macrogol glycerol hydroxystearate 40 3 mg/ml
Sodium benzoate (E211) 1 mg/ml
Propylene glycol (E1520) 200.35 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear to slightly opalescent red liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benylin Phlegm Cough Menthol is indicated to help loosen phlegm and
thin bronchial secretions associated with productive
cough, for use in adults and adolescents over 12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND ADOLESCENTS OVER 12 YEARS:
For oral administration: 10 ml (200mg guaifenesin) 4 times a day.
Maximum daily dose: 40ml (800mg guaifenesin)
PAEDIATRIC POPULATION
The safety and efficacy of Benylin Phlegm Cough Menthol in children
aged under 12 years have not yet been established.
No data are available
THE ELDERLY:
As per adults.
HEPATIC/RENAL IMPAIRMENT
Caution should be exercised in severe hepatic and severe renal
impairment (see Section 5.2).
If cough persists for more than 7 days, tends to recur, or is
accompanied by a fever, rash, or persistent headache, a physician
should be consulted.
Method ofadministration:
Health Products Regulatory Authority
01 February 2022
CRN00CDW4
Page 2 of 5
Oral
4.3 CONTRAINDICATIONS
Hypersensitivity to active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should not be used for persistent or chronic cough, such
as occurs with asthma, or where cough is accompanied
by excessive secretions, unless directed by a physician.
A persistent cough may be a sign of a serious condition. If cough
persists for more than 7 days