Nurofen Sinus 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

Patient Information leaflet

CUSTOMER INFO:
Minimum Point Size =
9.50pt
RB00000
RB00000
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 Sinus &
Blocked Nose 200mg/5mg Tablets 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:
1-
What is this medicine and what is it used for?
2-
Before taking this medicine
3-
How to take this medicine
4-
Possible side-effects
5-
How to store
6-
Further information
1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Nurofen Sinus & Blocked Nose 200mg/5mg Tablets contains
ibuprofen and phenylephrine hydrochloride, which are effective
in relieving the symptoms associated with colds and flu,
including relief of aches and pains, sore throats, headache,
nasal congestion (blocked nose) and lowering of temperature.
Ibuprofen belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs) and is effective
against aches and pains (including headache), swelling and
can also reduce a fever. Phenylephrine hydrochloride (nasal
decongestant) reduces swelling in the passages of the nose,
relieving nasal congestion and reducing the pressure which may
cause a headache.
2. BEFORE TAKING THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF YOU:
•
are allergic to ibuprofen, phenylephrine hydrochloride or any
other ingredients of this medicine (see section 6) or to
aspirin or other painkillers
•
have ever had a stomach ulcer, perforation or bleeding
•
have had a worsening of asthma, skin rash, itchy runny
nose or facial swelling when previously taking ibuprofen,
aspirin or similar medicines
•
have had gast

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Sinus Pain Relief 200mg/5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Quantity
Ibuprofen
200.0mg
Phenylephrine hydrochloride 5.0mg
For full list of excipients, see Section 6.1
Excipients with known effect:
Sunset Yellow E 110.
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 up to 3 times a day. Leave at least four hours between
doses and
do not take more than 6 tablets in any 24hour 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).
Hyperthyroidism.
Contraindicated in patients currently