Nurofen Sinus and Pain Film-Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

200 mg/ 30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

2014-06-20

Patient Information leaflet

NUROFEN SINUS & PAIN FILM COATED TABLETS
Ibuprofen 200mg
Pseudoephedrine Hydrochloride 30mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you will
still need to take Nurofen Sinus
and Pain Film-Coated Tablets carefully to get the best result from
them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve
after 3 days.
- If any of the side-effects gets serious, or if you notice any
side-effect not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nurofen Sinus and Pain Film-Coated Tablets are and what they
are used for
2. Before you take Nurofen Sinus and Pain Film-Coated Tablets
3. How to take Nurofen Sinus and Pain Film-Coated Tablets
4. Possible side-effects
5. How to store Nurofen Sinus and Pain Film-Coated Tablets
6. Further information
WHAT NUROFEN SINUS AND PAIN FILM-COATED TABLETS ARE ANDWHAT ARE THEY
USED FOR?
Nurofen Sinus and Pain Film-Coated Tablets contain two active
ingredients which work together to
relieve the major symptoms of sinus and pain: ibuprofen relieves pain,
reduces inflammation and
lowers temperature, whilst Pseudoephedrine Hydrochloride is an
effective decongestant to ease
nasal and sinus congestion. Nurofen Sinus and Pain Film-Coated Tablets
rapidly relieves the
headaches, aches and the pain and fever commonly associated with colds
and flu and eases blocked
noses, sinuses and the pain of sore throats.
2. BEFORE YOU TAKE NUROFEN SINUS AND PAIN FILM-COATED TABLETS:
Do not take Nurofen Sinus and Pain Film-Coated Tablets if you:
• are allergic to ibuprofen, pseudoephedrine hydrochloride, or any
of the ingredients of Nurofen
Sinus and Pain Film-Coated Tablets listed in Section 6.
• have experienced shortness of breath, worsening of asthma,
allergic rash or an itchy, runny nose
or swelling of the lips, face, tongue or throat

Summary of Product characteristics

Health Products Regulatory Authority
10 September 2021
CRN00925X
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Sinus and Pain Film-Coated Tablets
Ibuprofen 200mg
Pseudoephedrine Hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients Quantity
Ibuprofen 200mg
Pseudoephedrine Hydrochloride 30mg
Excipients: Sunset Yellow (E110), up to 16.8 micrograms per tablets.
Sodium 6mg (0.26 mmol) per tablet. Total maximum daily dose (MDD) is
36mg (1.56mmol).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, circular, biconvex, tablets printed in black with an
identifying motif.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of head colds and influenza, including
nasal congestion and to ease the pain of sore throats.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve 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 3 days.
POSOLOGY
Adults: Initial dose two tablets, then if necessary two tablets every
four hours. Do not exceed six tablets in any 24 hour period.
PAEDIATRIC POPULATION:
CHILDREN OVER 12 YEARS OF AGE: As above
CHILDREN UNDER 12 YEARS OF AGE: Ibuprofen and pseudoephedrine
combination solid dose strength products are
contraindicated in children aged less than 12 years of age.
ELDERLY POPULATION: There is no indication that dosage needs to be
modified in the elderly. However, it may be advisable to
monitor renal and hepatic function and, if there is serious
impairment, caution should be exercised.
HEPATIC IMPAIRMENT: It may be advisable to monitor hepatic function.
The product should not be used in severe hepatic
failure (see section 4.3 and 4.4).
RENAL IMPAIRMENT: It may be advisable to monitor renal function. The
product should not be used in severe renal failure (see
section 4.3 and