Nurofen Pain Relief 200mg capsules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download 환자 정보 전단 (PIL)
03-07-2018
Download 제품 특성 요약 (SPC)
03-07-2018

유효 성분:

Ibuprofen

제공처:

Reckitt Benckiser Healthcare (UK) Ltd

ATC 코드:

M01AE01

INN (국제 이름):

Ibuprofen

복용량:

200mg

약제 형태:

Oral capsule

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 10010100; GTIN: 5000158106505

환자 정보 전단

                                CUSTOMER INFO:
Minimum Point Size =
9.00pt
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BARCODE INFO
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(2D IF APPLICABLE)
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RB Nottingham
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0000000
Nurofen
Adult
Indication Specific Pain
Joint and Back Pain Relief
16Capsule
RB307366
UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
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
TR1346417
Paper White
UK
10/05/18
D
RYAN REILLY
000000
G=2; O=0; R=0;
- RR - 10/05/18 12:41:02
RB ARTWORK
AND PRINT SPECIFICATION
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100
APPROVED BY SONOCO TRIDENT ON BEHALF OF RECKITT BENCKISER
SIGNED:
DATE:
NOT APPROVED FOR COLOUR
ARTWORK APPROVAL
D0069114
ARTWORK TYPE: IDM SUBMISSION
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1
LTH
PROCESS BLACK
COLOURS (LEAFLET)
RBH CONTACT:
Mathilde Capart
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N/A
INFORMATION FOR THE USER:
IN CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS:
If in children and adolescents this medicinal product is required for
more than 3 days, or if symptoms worsen a doctor should be
consulted.
IF YOU HAVE TAKEN MORE NUROFEN PAIN RELIEF 200MG SOFT CAPSULES
THAN YOU SHOULD, OR IF CHILDREN HAVE TAKEN THIS MEDICINE BY
ACCIDENT ALWAYS CONTACT A DOCTOR OR NEAREST HOSPITAL TO GET AN
O
                                
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제품 특성 요약

                                OBJECT 1
NUROFEN PAIN RELIEF 200MG SOFT CAPSULES
Summary of Product Characteristics Updated 14-Jun-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen Pain Relief 200mg Soft Capsules
2. Qualitative and quantitative composition
Ibuprofen 200 mg per capsule, soft.
Excipient(s) with known effect:
Sorbitol (E420)
Potassium hydroxide 50% solution (E525)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, soft
Oval clear capsules printed with a logo in white.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of rheumatic or muscular pain, backache, neuralgia,
migraine, headache, dental pain,
dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2 Posology and method of administration
For oral administration and short-term use only. Do not chew.
Adults, the elderly and children and adolescents between 12 and 18
years:
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
If in children and adolescents between 12 and 18 years this medicinal
product is required for more than 3
days, or if symptoms worsen a doctor should be consulted.
Adults should consult a doctor if symptoms persist or worsen, or if
the product is required for more than
10 days.
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: Take one or two
capsules (200 mg – 400 mg), up
to three times a day as required (maximum dose 400 mg).
ADULTS: Take one or two capsules (200 mg – 400 mg), up to three
times a day as required (maximum dose
400 mg).
Leave at least four hours between doses and do not take more than 6
capsules (1200 mg) in any 24 hour
period.
Children under 12 years:
Not recommended.
4.3 Contraindications
Hypersensitivity to ibuprofen or any of the excipients in the product.
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.
Active or his
                                
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