Benylin Mucus Cough Night oral solution

国: イギリス

言語: 英語

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

即購入

ダウンロード 製品の特徴 (SPC)
16-06-2018

有効成分:

Guaifenesin; Levomenthol; Diphenhydramine hydrochloride

から入手可能:

McNeil Products Ltd

ATCコード:

R05FB

INN(国際名):

Guaifenesin; Levomenthol; Diphenhydramine hydrochloride

投薬量:

20mg/1ml ; 220microgram/1ml ; 2.8mg/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:

Never Valid To Prescribe As A VMP

製品概要:

BNF: 03090200; GTIN: 3574660496970

情報リーフレット

                                SPECIAL WARNINGS ABOUT THIS
MEDICINE
■
This medicine may cause drowsiness. If
affected, do not drive or operate machinery.
Avoid alcoholic drink.
SOME OF THE INGREDIENTS CAN CAUSE
PROBLEMS
This medicine contains sucrose and liquid glucose.
If you have been told by your doctor that you
have an intolerance to some sugars contact
your doctor before taking
this medicinal
product. Contains 1 g sucrose and 3.5 g glucose
per 5 ml. This should be taken into account in
patients with diabetes mellitus.
This medicinal product contains 5 vol %
ethanol (alcohol), i.e. up to 200 mg per 5 ml,
equivalent to 5 ml beer, 2 ml wine per 5 ml.
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 disease or epilepsy.
Ponceau 4R (E124) may cause allergic reactions.
This medicinal product contains 16.42 mg
sodium per 5 ml. This should be taken into
account by patients on a controlled sodium diet.
3 HOW TO TAKE THIS
MEDICINE
CHECK THE TABLE OVERLEAF TO SEE HOW
MUCH MEDICINE TO TAKE.
■
For oral use only.
■
Do not use more than the stated dose shown
overleaf.
CHILDREN UNDER 12 YEARS
Do not use in children under 12 years.
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.
■
If you are taking, or have taken in the last
two weeks, DRUGS FOR DEPRESSION known as
Monoamine Oxidase Inhibitors (MAOIs).
■
For a child under 12 years of age.
If any of these apply to you, GET ADVICE FROM A
DOCTOR OR PHARMACIST WITHOUT USING BENYLIN
MUCUS COUGH NIGHT.
TALK TO YOUR DOCTOR OR PHARMACIST…
■
If you suffer from LIVER or KIDNEY PROBLEMS.
■
If you have PROSTATE PROBLEMS (diffi culty with
passing water or needing to pass water often).
■
If you have NARROW-ANGLE GLAUCOMA (increased
pressure
                                
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製品の特徴

                                OBJECT 1
BENYLIN MUCUS COUGH NIGHT
Summary of Product Characteristics Updated 19-Jan-2012 | McNeil
Products Ltd
1. Name of the medicinal product
Benylin Dual Action Night Cough & Congestion
Benylin Mucus Cough Night
2. Qualitative and quantitative composition
Each 5 ml contains Diphenhydramine hydrochloride 14 mg, Guaifenesin
100 mg and Levomenthol 1.1
mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A clear red syrup with no insoluble matter.
4. Clinical particulars
4.1 Therapeutic indications
For the night time relief of cough, associated congestive symptoms and
aiding restful sleep.
4.2 Posology and method of administration
For oral use.
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
Patients may start with two 5 ml spoonfuls at bedtime followed by two
5 ml spoonfuls every 6 hours.
Or two 5 ml spoonfuls four times a day.
Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24
hours.
CHILDREN UNDER 12 YEARS:
This medicine is contraindicated in children under the age of 12 years
(see section 4.3).
ELDERLY (OVER 65 YEARS):
As for adults.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
Known hypersensitivity to the product or any of its constituents.
This product should not be administered to patients currently
receiving monoamine oxidase inhibitors
(MAOIs) or those patients who have received treatment with MAOIs
within the last two weeks.
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
This product 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.
Subjects with moderate to severe renal or hepatic dysfunction or
urinary retention should exercise caution
when using this product (see section 5.2).
This product contains diphenhydramine and should be used with caution
in patients with narrow-angle
glaucoma or symptomatic prostatic hypertrophy.
Avoid alcoholic drink.
The l
                                
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