Nurofen Sinus Pressure & Headache Relief 200mg/30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen; Pseudoephedrine hydrochloride

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

M01AE51

INN (International Name):

Ibuprofen; Pseudoephedrine hydrochloride

Dosage:

200mg ; 30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5000158106246

Patient Information leaflet

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RB Nottingham
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00000000
Nurofen
Adult
Sinus
Pain Relief
24Tablets
RB313380
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-D0069118-190x295mm LST Flat
TR1361832
Paper White
UK
01/05/18
D
SAMANTHA KEYWORTH
0000000
G=2; O=0; R=0;
- SK - 01/05/18 12:42:02
RB ARTWORK
AND PRINT SPECIFICATION
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: [phone]
D0069118
ARTWORK TYPE: IDM SUBMISSION
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LTH
PROCESS BLACK
COLOURS (LEAFLET)
RBH CONTACT:
Mathilde Capart
CUSTOMER INFO:
Minimum Point Size =
_(Refers to the text within the_
_Nurofen bullet, main body copy is_
_at 11.5pt)._
9.05pt
Continued overleaf
Sinus Pressure & Headache
Relief 200mg/30mg tablets
Contains Ibuprofen and
Pseudoephedrine Hydrochloride
OTHER WARNINGS
• Nurofen Sinus Pressure and Headache Relief
200mg/30mg Tablets belong to a group of
medicines which may impair fertility in women.
This is reversible on stopping the medicine. It is
unlikely that Nurofen Sinus Pressure and Headache
Relief 200mg/30mg Tablets, used occasionally,
will affect your chances of becoming pregnant.
However, tell your doctor before taking this
medicine if you have problems becoming pregnant.
• Anti-inflammatory/pain-killer

Summary of Product characteristics

OBJECT 1
NUROFEN SINUS PRESSURE & HEADACHE RELIEF
200MG/30MG TABLETS
Summary of Product Characteristics Updated 22-May-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen Sinus Pressure & Headache Relief 200mg/30mg Tablets
2. Qualitative and quantitative composition
Active ingredients
Quantity
Ibuprofen BP
200mg
Pseudoephedrine Hydrochloride
30mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Yellow film coated tablet. Printed in black with an identifying motif.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of symptoms 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.
Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not to be given to children under 12 years.
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 history of recurrent peptic ulcer/hemorrhage (two or more
distinct episodes of 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 pregnancy (see section 4.6)
Patients with serious cardiovascular disease, tachycardia,
hypertension, angina pect