Nurofen Sinus Pain Relief 200mg/5mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Phenylephrine hydrochloride; Ibuprofen

Disponible des:

Reckitt Benckiser Healthcare (UK) Ltd

Designació comuna internacional (DCI):

Phenylephrine hydrochloride; Ibuprofen

Dosis:

5mg ; 200mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 03100000; GTIN: 5000158106260

Fitxa tècnica

OBJECT 1
NUROFEN SINUS PAIN RELIEF 200MG/5MG TABLETS
Summary of Product Characteristics Updated 02-Feb-2016 | 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 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 pregnancy.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific
inhibitors (see Section 4.5).
Hyper