Nurofen Day & Night Cold & Flu 200mg/5mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Hent Indlægsseddel (PIL)
22-06-2018
Hent Produktets egenskaber (SPC)
22-06-2018

Aktiv bestanddel:

Phenylephrine hydrochloride; Ibuprofen

Tilgængelig fra:

Reckitt Benckiser Healthcare (UK) Ltd

INN (International Name):

Phenylephrine hydrochloride; Ibuprofen

Dosering:

5mg ; 200mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 03100000; GTIN: 5000158104334

Indlægsseddel

                                CUSTOMER INFO:
Minimum Point Size =
9.50pt
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RB Nottingham
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0000000
Nurofen
Adult
Cold & Flu
Ibuprofen & Phenylephrine
8/12/16Tablets
RB313112
PLEASE NOTE THAT ANY LOW RESOLUTION PAPER CANON COLOUR
COPIES ASSOCIATED WITH THIS JOB SHOULD BE REFERRED TO
FOR CONTENT, LAYOUT AND COLOUR SEPARATION ONLY.
STUDIO USE ONLY
V2.0
SM•ART CHECK RESULTS:
CUTTER
GUIDES
TECHNICAL & NON PRINTING ITEMS
CUTTER 2 (IF APPLICABLE)
GUIDES 2 (IF APPLICABLE)
Generic RB
N-Lft-FB-D0069114-296x192-Lge-Reel
TR1361251
Paper White
UK
01/05/18
C
JAMIE BROWN
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G=2; O=0; R=0;
- JB - 01/05/18 10:26:12
RB ARTWORK
AND PRINT SPECIFICATION
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100
D0069114
ARTWORK TYPE: IDM SUBMISSION
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1
LTH
PROCESS BLACK
COLOURS (LEAFLET)
RBH CONTACT:
Mathilde Capart
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INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for you. This medicine is available without
prescription. However, you still need to use Nurofen Day & Night
Cold & Flu carefully to get the best results from it.
Keep this leaflet. You may want to read it again.
If you have any further questions after you have read it, ask your
doctor or pharmacist.
YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT
IMPROVE AFTER 10 DAYS.
If any side effects get serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
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Produktets egenskaber

                                OBJECT 1
NUROFEN DAY & NIGHT COLD & FLU 200MG/5MG
TABLETS
Summary of Product Characteristics Updated 22-May-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Lemsip Max All Night Cold & Flu Tablets, or
Lemsip Max All Night Flu Relief Tablets, or
Nurofen Day & Night Cold & Flu 200mg/5mg Tablets
2. Qualitative and quantitative composition
ACTIVE INGREDIENTS
QUANTITY
Ibuprofen BP
Phenylephrine hydrochloride
200.0mg
5.0mg
For full list of excipients, see Section 6.1.
3. Pharmaceutical form
Yellow film coated tablet, printed with an identifying motif (IPE) in
black ink.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of symptoms of cold and 'flu with associated
congestion, including aches and pains,
headache, fever, sore throat, blocked nose and sinuses.
4.2 Posology and method of administration
For oral administration and short-term use only.
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
The patient should consult a doctor if symptoms persist or worsen, or
if the product is required for more
than 10 days.
Two tablets every 8 hours. Leave at least 4 hours between doses and do
not exceed six tablets in any 24
hour period.
NOT TO BE GIVEN TO CHILDREN UNDER 12 YEARS.
4.3 Contraindications
Hypersensitivity to ibuprofen, phenylephrine or any of the excipients
in the product. Hypertension and
severe coronary heart disease.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis, angioedema or
urticaria) in response to aspirin or other non-steroidal
anti-inflammatory drugs (NSAIDs).
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes or proven
ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure
(see Section 4.4).
Last trimester of pregnanc
                                
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