Benylin Dry & Tickly Cough syrup

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Vara einkenni (SPC)
24-03-2023

Virkt innihaldsefni:

Sucrose; Glycerol

Fáanlegur frá:

McNeil Products Ltd

ATC númer:

n/a

INN (Alþjóðlegt nafn):

Sucrose; Glycerol

Skammtar:

340mg/1ml ; 150microlitre/1ml

Lyfjaform:

Oral solution

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 03090200; GTIN: 3574660411379 3574661366258

Upplýsingar fylgiseðill

                                TYPE
BARCODES
NUMBER
DATAMATRIX
TBC
EAN-13
3574661370194
CTE
10.04.19
401385617_V1R0
Carton
900210D
900210C
N/A
9214400
UK
900210D
57 x 57 x 130 MM
McNeil Iberica
N/A
N/A
N/A
Frutiger-BoldCn
Frutiger-Cn
Frutiger-Roman
GillSans-Bold
Humanist521BT-RomanCondensed
ZapfDingbatsITC
7.0pt
PANTONE
2735 C
PANTONE
877 C
PANTONE
485 C
PANTONE
137 C
PANTONE
7406 C
BRAILLE
VARNISH
FREE
N/A
N/A
Benylin Dry & Tickly Cough 150ml (Rubicon + Carton size reduction +
variable data position)
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• Give the dose 3 or 4 times within 24 hours, if needed.
• If symptoms persist, contact your pharmacist or doctor.
CHILDREN 1 – 5 YEARS
ONE 5 ML SPOONFUL
ADULTS (INCLUDING THE ELDERLY)
AND CHILDREN OVER 5 YEARS
TWO 5 ML SPOONFULS
AGE
DOSE
WHAT THIS MEDICINE IS FOR
Benylin Dry & Tickly Cough Syrup is a soothing cough syrup which
relieves irritating tickly, dry coughs and sore throats.
BEFORE TAKING THIS MEDICINE
This product is suitable for most people, but a few people should
not use it. If you are in any doubt you should contact your doctor
or pharmacist.
DO NOT USE THIS MEDICINE…
Q
If you are allergic to any of the ingredients
Q
Do not give this medicine to your child if s/he is under 1 year old.
TALK TO YOUR DOCTOR OR PHARMACIST
Q
If you have an intolerance to some sugars.
Q
If this applies to you now or in the past, talk to a doctor or
pharmacist.
SOME OF THE INGREDIENTS CAN CAUSE PROBLEMS
Q
This product contains 1.85 g glucose and 1.707 g sucrose in each
5 ml, which may be harmful to the teeth. If you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before using this medicine.This should be taken into
account in patients with diabetes.
Q
Carbohydrate content of this medicine is 3.85 g per 5 ml.
Q
This product contains small amounts of ethanol (alcohol), less
than 100 mg per 5 ml dose.
Q
You can take this medicine if you are pregnant or breastfeedi
                                
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Vara einkenni

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benylin Dry & Tickly Coughs Syrup
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
per 5 ml
Glycerol
0.75 ml
Sucrose
1.71g
Excipients with known effect:
Liquid Glucose
2.342g
Propylene glycol (E1520)
24mg
Sodium benzoate (E211)
10mg
Ethanol
5mg
Sodium
1.62mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of irritating, tickling dry coughs and sore throats.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults and children over 5 years: 10 ml
Children 1 – 5 years: 5 ml
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
_Elderly_:
There is no need for dosage reduction in the elderly.
Method of administration:
For oral use.
_4.3 _
_CONTRAINDICATIONS _
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
Do not give to children under one year.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Diabetics should take note that sucrose and glycerol may affect blood
sugar levels.
Information relating specifically to excipients in the formulation.
This medicine contains sucrose and glucose. Patients with rare
hereditary problems of
fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase
insufficiency should not take this medicine.
This medicine contains 24 mg propylene glycol in each 5 ml which is
equivalent to
4.8mg/ml.
This medicine contains 10 mg sodium benzoate (E211) in each 5ml.
This medicine contains 5 mg of alcohol (ethanol) in each 5 ml dose.
The amount in 5
ml of this medicine is equivalent to less than 1 ml beer or wine. The
small amount of
alcohol in this medicine will not have any noticeable effects.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that
is to say
essentially ‘sodium-free’.
If symptoms persist for more than 3 days or get worse, patients should
stop use and
consult a doct
                                
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