Nurofen Sinus Pain Relief 200mg/5mg Tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: myHealthbox

active_ingredient:

Ibuprofen, Phenylephrine hydrochloride

MAH:

Reckitt Benckiser Healthcare (UK) Limited

ATC_code:

M01AE51

INN:

Ibuprofen, Phenylephrine hydrochloride

dosage:

200mg/5mg

pharmaceutical_form:

Film-coated Tablet

administration_route:

Oral use

units_in_package:

4, 6, 8, 10, 12, 14 and 16 tablets

prescription_type:

GSL - General Sales List

manufactured_by:

Reckitt Benckiser Healthcare International Ltd

therapeutic_indication:

It is indicated for the relief of symptoms of cold and ‘flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses.

authorization_status:

Authorised

authorization_date:

2014-12-11

SPC

Nurofen Sinus Pain Relief 200mg/5mg Tablets
Summary of Product Characteristics Updated 03­Jul­2015 | Reckitt Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen Sinus Pain Relief 200mg/5mg Tablets
2. Qualitative and quantitative composition
Active Ingredients
Ibuprofen
Phenylephrine hydrochloride
Quantity
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 short­term use only.
Adults, the elderly and children over 12 years:
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. 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 non­steroidal anti­inflammatory 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, renal failure or h