Benylin Mucus Cough Max Menthol 100mg/5ml oral solution

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Guaifenesin

から入手可能:

McNeil Products Ltd

ATCコード:

R05CA03

INN（国際名）:

Guaifenesin

投薬量:

20mg/1ml

医薬品形態:

Oral solution

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 03090200; GTIN: 3574660557091

情報リーフレット

should not be used during pregnancy unless
advised by a doctor.
■
Do not take this medicine if you are breast-
feeding until you speak with a doctor or
pharmacist.
DRIVING AND USING MACHINES
Benylin Mucus Cough Menthol flavour 100 mg/
5 ml oral solution is not expected to affect your
ability to drive or operate machinery. However, if
you do feel unwell, do not drive or use machinery. IMPORTANT INFORMATION ON SOME OF
THE OTHER INGREDIENTS IN THIS
MEDICINE
■
4.7 vol % ETHANOL
(alcohol), i.e. up to
400 mg per dose, equivalent
to approximately
10 ml beer, 4 ml wine per 10 ml
dose. This can
be harmful for those suffering from alcoholism.
The ethanol content should be taken into
account in pregnant or breast-feeding women,
children and high-risk groups such as patients
with liver or kidney disease or epilepsy.
■
PONCEAU 4R (E124) - red colouring - may
cause allergic reactions.
■
17.6 mg SODIUM per 10 ml dose. This should
be taken into consideration by those on a
controlled sodium diet.
■
GLUCOSE AND FRUCTOSE. If you have been told
by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.
3 HOW TO TAKE THIS
MEDICINE
Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you. You
should check with your doctor or pharmacist if you
are not sure.
■
This solution is for oral use only.
■
DO NOT USE MORE THAN THE STATED DOSE
SHOWN.
2 BEFORE YOU TAKE THIS
MEDICINE
DO NOT TAKE THIS MEDICINE IF YOU
■
are ALLERGIC (hypersensitive) to guaifenesin or
any of the other ingredients _(see Section 6 and _
_Section 2). _
TAKE SPECIAL CARE WITH THIS MEDICINE
Talk with your doctor or pharmacist before taking
this medicine 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 LIVER or KIDNEY PROBLEMS.
■
are taking ALCOHOL.
INTERFER

製品の特徴

OBJECT 1
BENYLIN MUCUS COUGH MENTHOL FLAVOUR
100MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 06-Jul-2015 | McNeil
Products Ltd
1. Name of the medicinal product
Benylin Mucus Cough Menthol flavour 100 mg/5 ml Oral Solution
2. Qualitative and quantitative composition
This product contains 20 mg guaifenesin in each ml (100mg in 5ml).
Each ml also contains:
Ethanol 39.7mg
Ponceau 4R (E124) 0.05mg
Sodium 1.8mg
Glucose
Fructose
For a 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
This product 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
ADULTS AND ADOLESCENTS OVER 12 YEARS:
For oral administration: 10 ml (200mg guaifenesin) 4 times a day.
Maximum daily dose: 40ml (800mg guaifenesin)
CHILDREN UNDER 12 YEARS:
Not recommended.
THE ELDERLY:
As for adults.
HEPATIC/RENAL DYSFUNCTION
Caution should be exercised in severe hepatic and severe renal
impairment.
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.
4.3 Contraindications
This product is contraindicated in individuals with known
hypersensitivity to the active substance or to
any of the excipients.
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, tends to
recur, or is accompanied by a fever, rash, or persistent headache, a
physician should be consulted.
Caution should be exercised when using the product in the presence of
severe renal or severe hepatic
impairment.
The concomitant use of cough suppressants is not recommended