Beechams Powders oral powder sachets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Infovoldik Infovoldik (PIL)
08-06-2018
Toote omadused Toote omadused (SPC)
08-06-2018

Toimeaine:

Aspirin; Caffeine

Saadav alates:

Haleon UK Ltd

ATC kood:

N02BA51

INN (Rahvusvaheline Nimetus):

Aspirin; Caffeine

Annus:

600mg ; 50mg

Ravimvorm:

Oral powder

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Invalid to prescribe in NHS primary care

Toote kokkuvõte:

BNF: 04070100; GTIN: 5054563094087 0000050135059

Infovoldik

                                P7031/0218
TOTAL COLOURS & VARNISHES: 1
BLACK
TOTAL SPECIAL FINISHES: 0
1
HARMONY AMS
ARTWORK INFORMATION PANEL
MANUFACTURING SITE NUMBER:
P7031
MANUFACTURING SITE(S):
GSK_CAPE TOWN_SOUTH AFRICA
PRODUCT MARKET TRADE NAME:
Beechams Powders
APPROVING MARKET(S):
CFUN-UK Regulatory;United Kingdom-GBR
PRINT PROCESS:
Flexography
COLOUR STANDARD REFERENCE:
For colour, please refer to Industry Standard Pantone values
TECHNICAL DRAWING
(DO NOT INCLUDE VERSION NUMBER):
CT_L613D016_DWG
MATERIAL SPEC. (DO NOT INCLUDE VERSION NUMBER):
N/A
MATERIAL TYPE:
White Paper
SUBSTRATE
AIP_Production_V_INDD - 04_2017 - Harmony - Version 2
BODY TEXT SIZE:
8.0pt
SMALLEST TEXT SIZE:
7.0pt
LEADING:
8.2pt
HORIZONTAL SCALE:
100%
MICROTEXT:
N
ADDITIONAL INFO (1):
N/A
ADDITIONAL INFO (2):
N/A
ADDITIONAL INFO (3):
N/A
ARTWORK COPYRIGHT IS THE PROPERTY OF THE GSK GROUP OF COMPANIES. All
suppliers providing a service to GSK for printed components of any
description must ensure that they have a licence for all fonts /
software used in conjunction with GSK artwork.
The distribution and use of fonts / software without a licence
constitutes an intellectual property infringement. GSK will not accept
any liability for the breach of third party intellectual property
rights by printed component suppliers.
The GSK certification / audit process requires suppliers to declare
that they do not use unlicensed fonts / software and may require the
supplier to produce evidence of such licence to GSK.
200 MM MEASURING BAR
IF AN E-BANNER DOES NOT APPEAR ON THE TOP OF THIS DOCUMENT, THEN THIS
DOCUMENT HAS NOT BEEN PRINTED FROM THE HARMONY SYSTEM.
_ASPIRIN, CAFFEINE_
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE
YOU START USING THIS MEDICINE.
•
Keep this leaflet, you may need to read it
again.
•
If you have any questions, or if there is
anything you do not understand, ask your
pharmacist.
IN THIS LEAFLET:
1.
What Beechams Powders do
2.
Check before you take Beechams Powders
3.
How to take Beechams Powders
4.
Possible side effects
5.
How to store Beechams Powders
6
                                
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Toote omadused

                                OBJECT 1
BEECHAMS POWDERS
Summary of Product Characteristics Updated 09-Apr-2018 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Beechams Powders
2. Qualitative and quantitative composition
Each sachet contains:
ACTIVE CONSTITUENTS:
Aspirin 600 mg
Caffeine 50 mg.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose 67.45mg (as monohydrate)
Spice blend flavour 17.42.5890 (contains soya protein)
3. Pharmaceutical form
Powder
4. Clinical particulars
4.1 Therapeutic indications
The product may be recommended as an analgesic and antipyretic for:
a) The symptomatic relief of influenza, feverishness, chills and
colds, including feverish colds.
b) The relief of mild to moderate pain including headache, migraine,
neuralgia, toothache, sore throat,
period pains, aches and pains, rheumatic pain and muscular aches and
pains.
4.2 Posology and method of administration
_Directions for use: _Mix the powder with a little water and stir
before drinking.
_Adults and children aged 16 years and over:_
One powder to be taken every three to four hours as required. Do not
exceed six powders in any period of
24 hours.
Elderly: Use with particular caution in elderly patients who are more
prone to adverse events.
Children (under 16 years): Do not give to children aged under 16
years, unless specifically indicated (e.g.
for Kawasaki's disease).
Product should be discontinued if pain gets worse or lasts more than
10 days (or lasts more than 3 days
for fever).
4.3 Contraindications
Hypersensitivity to aspirin, other salicylates, caffeine or any of the
excipients. A history of
hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis,
urticaria, nasal polyps) in response to
aspirin or non-steroidal anti- inflammatory drugs.
Hypersensitivity to peanut or soya.
Patients with severe hepatic or renal failure. Aspirin is known to
cause sodium and water retention which
may exacerbate hypertension, congestive heart failure and renal
impairment.
Patients with active peptic ulceration or a history of peptic
ulceration. History of gastroin
                                
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