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NUROFEN SINUS PAIN RELIEF 200MG/5MG TABLETS

Active substance(s): IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE / IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE / IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE

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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

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).
Hyperthyroidism.
Contraindicated in patients currently receiving or within two weeks of
stopping therapy with monoamine oxidase inhibitors.

4.4

Special warnings and precautions for use
Ibuprofen
Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see gastrointestinal and
cardiovascular risks below).
The elderly are at increased risk of consequence of adverse reactions to
NSAIDs, especially gastrointestinal bleeding and perforation which may be
fatal.
Respiratory: Bronchospasm may be precipitated in patients suffering from or
with a previous history of bronchial asthma or allergic disease.
Other NSAIDs: The use of this product with concomitant NSAIDs, including
cyclo-oxygenase-2 selective inhibitors, should be avoided (see Section 4.5).

SLE and mixed connective tissue disease: Systemic lupus erythematosus and
mixed connective tissue disease - increased risk of aseptic meningitis (see
Section
4.8).
Renal: Renal impairment as renal function may further deteriorate (see
Sections
4.3 and 4.8).
Hepatic: Hepatic dysfunction (see Sections 4.3 and 4.8).

Cardiovascular and cerebrovascular effects: Caution (discussion with doctor
or pharmacist) is required prior to starting treatment in patients with a history
of hypertension and/or heart failure as fluid retention, hypertension and
oedema have been reported in association with NSAID therapy.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example, myocardial infarction or stroke). Overall, epidemiological
studies do not suggest that low dose ibuprofen (≤1200 mg/day) is associated
with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA IIIII), established ischaemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease should only be treated with ibuprofen after careful
consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term
treatment of patients with risk factors for cardiovascular events (e.g.
hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if
high doses of ibuprofen (2400 mg/day) are required.
Impaired female fertility: There is limited evidence that drugs which inhibit
cyclo-oxygenase/prostaglandin synthesis may cause impairment of female
fertility by an effect on ovulation. This is reversible on withdrawal of
treatment.
Gastrointestinal: NSAIDs should be given with care to patients with a history
of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these
conditions may be exacerbated (see Section 4.8).
GI bleeding, ulceration or perforation, which can be fatal, has been reported
with all NSAIDs at any time during treatment, with or without warning
symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing
NSAID doses, in patients with a history of ulcer, particularly if complicated
with haemorrhage or perforation (see Section 4.3), and in the elderly. These
patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report
any unusual abdominal symptoms (especially GI bleeding), particularly in the
initial stages of treatment.
Caution should be advised in patients receiving concomitant medications
which could increase the risk of ulceration or bleeding, such as oral
corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake
inhibitors or antiplatelets agents such as aspirin (see Section 4.5).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the
treatment should be withdrawn.
Dermatological: Serious skin reactions, some of them fatal, including
exfoliating dermatitis, Stevens-Johnson Syndrome, and toxic epidermal
necrolysis, have been reported very rarely in association with the use of
NSAIDs (see Section 4.8).
Patients appear to be at highest risk of these reactions early in the course of
therapy: the onset of the reaction occurring in the majority of cases within the
first month of treatment. This product should be discontinued at the first
appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
The label will include:
Read the enclosed leaflet before taking this product.
Do not take if you:




Have (or have had two or more episodes of) a stomach ulcer, perforation
or bleeding.
Are allergic to ibuprofen or any other ingredient of the product, aspirin or
other related painkillers.
Are taking other NSAID painkillers, other products containing
phenylephrine or aspirin with a daily dose above 75 mg.

Speak to a pharmacist or your doctor before taking if you:




Have or have had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems.
Are a smoker.
Are pregnant.

If symptoms persist or worsen, consult your doctor.
Phenylephrine
Phenylephrine should be used with care in patients with cardiovascular
disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and
hypertension.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen
Ibuprofen should not be used in combination with:
Aspirin (acetylsalicylic acid): Concomitant administration of ibuprofen and
acetylsalicylic acid is not generally recommended because of the potential of
increased adverse effects, unless low-dose aspirin (not above 75 mg daily) has
been advised by a doctor (see Section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are
dosed concomitantly. Although there are uncertainties regarding extrapolation
of these data to the clinical situation, the possibility that regular, long-term use
of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic
acid cannot be excluded. No clinically relevant effect is considered to be likely
for the occasional ibuprofen use (see section 5.1).
Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid
concomitant use of two or more NSAIDs as this may increase the risk of
adverse reactions (see Section 4.4).
Ibuprofen should be used with caution in combination with:
Anti-coagulants: NSAIDs may enhance the effects of anticoagulants such as
warfarin
(see Section 4.4).
Antihypertensives and diuretics: NSAIDs may diminish the effect of these
drugs.
Diuretics can increase the risk of nephrotoxicity.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see
Section
4.4).
Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding (see Section 4.4).
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma glycoside levels.
Lithium: There is evidence for potential increase in plasma levels of lithium.
Methotrexate: There is potential for an increase in plasma methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given
with
tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given
with
zidovudine. There is evidence of an increased risk of haemarthroses and
haematoma in HIV(+) haemophiliacs receiving concurrent treatment with
zidovudine and ibuprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk
of convulsions associated with quinolone antibiotics. Patients taking NSAIDs
and quinolones may have an increased risk of developing convulsions.
Phenylephrine
Monoamine oxidase inhibitors (including moclobemide): hypertensive
interactions occur between sympathomimetic amines such as phenylephrine
and monoamine oxidase inhibitors (see section 4.3).
Sympathomimetic amines: concomitant use of phenylephrine with other
sympathomimetic amines can increase the risk of cardiovascular side effects.
Beta-blockers and other antihypertensives (including debrisoquine,
guanethidine, reserpine, methyldopa): phenylephrine may reduce the efficacy
of beta-blockers and
antihypertensives. The risk of hypertension and other cardiovascular side
effects may be increased (see section 4.3).
Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of
cardiovascular side effects with phenylephrine (see section 4.3).
Digoxin and cardiac glycosides: concomitant use of phenylephrine may
increase the risk of irregular heartbeat or heart attack.

4.6

Fertility, pregnancy and lactation
Ibuprofen
Whilst no teratogenic effects have been demonstrated in animal experiments,
the use of this product should, if possible, be avoided during the first six
months of pregnancy.

During the third trimester, ibuprofen is contraindicated as there is a risk of
premature closure of the fetal ductus arteriosus with possible persistent
pulmonary hypertension. The onset of labour may be delayed and the duration
increased with an increased bleeding tendency in both mother and child (see
Section 4.3).
In limited studies, ibuprofen appears in the breast milk in very low
concentrations and is unlikely to affect the breast-fed infant adversely.
See Section 4.4 regarding female fertility.
Phenylephrine
The safety of this medicine during pregnancy and lactation has not been
established but in view of a possible association of foetal abnormalities with
first trimester exposure to phenylephrine, the use of the product during
pregnancy should be avoided. In addition, because phenylephrine may reduce
placental perfusion, the product should not be used in patients with a history of
preeclampsia. In view of the lack of data on the use of phenylephrine during
lactation, this medicine should not be used during breast feeding.
4.7

Effects on ability to drive and use machines
No adverse effects known

4.8

Undesirable effects
Ibuprofen
Hypersensitivity reactions have been reported following treatment with
ibuprofen and these may consist of:
(a) Non-specific allergic reaction and anaphylaxis.

(b) Respiratory tract reactivity, e.g. asthma, aggravated asthma,
bronchospasm or dyspnoea.
(c) Various skin reactions, e.g. pruritus, urticaria, angioedema and, more
rarely,
exfoliative and bullous dermatoses (including epidermal necrolysis and
erythema multiforme).
The following list of adverse effects relates to those experienced with
ibuprofen at
OTC doses, for short-term use. In the treatment of chronic conditions, under
long-term treatment, additional effects may occur.
Hypersensitivity reactions
Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could be: facial,
tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension
(anaphylaxis, angioedema or severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal
The most commonly-observed adverse events are gastrointestinal in nature.
Uncommon: Abdominal pain, nausea and dyspepsia.
Rare: Diarrhoea, flatulence, constipation and vomiting.
Very rare: Peptic ulcer, perforation and gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal, particularly in the elderly. Ulcerative
stomatitis, gastritis and mouth ulceration.
Exacerbation of colitis and Crohn's disease (see Section 4.4).
Nervous System
Uncommon: Headache, dizziness and tinnitus.
Very rare: Aseptic meningitis - single cases have been reported very rarely.
Renal
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.
Hepatic
Very rare: Liver disorders.
Haematological
Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia,
pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial
mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and
bruising.
Dermatological
Uncommon: Various skin rashes.
Very rare: Severe forms of skin reactions such as bullous reactions, including
Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal
necrolysis, can occur.
Immune System
In patients with existing auto-immune disorders (such as systemic lupus
erythematosus, mixed connective tissue disease) during treatment with
ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck,
headache, nausea, vomiting, fever or disorientation, have been observed (see
Section 4.4).
Cardiovascular and Cerebrovascular
Oedema, hypertension and cardiac failure have been reported in association
with NSAID treatment.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example, myocardial infarction or stroke) (see Section 4.4).
Phenylephrine
High blood pressure with headache and vomiting, probably only in overdose.
Rarely, palpitations.
Also, rare reports of allergic reactions and occasionally urinary retention in
males.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Ibuprofen
In children, ingestion of more than 400mg/kg may cause symptoms. In adults,
the dose response rate effect is less clear cut. The half-life in overdose is 1.5-3
hours.
Symptoms
Patients who have ingested clinically important amounts of NSAIDs will
develop no more than nausea, vomiting, epigastric pain, or more rarely
diarrhoea.
Tinnitus, headache and gastrointestinal bleeding are also possible. In more
serious poisoning, toxicity is seen in the central nervous system, manifesting
as drowsiness, occasionally excitation and disorientation or coma.
Occasionally patients develop convulsions. In serious poisoning metabolic
acidosis may occur and prothrombin time/INR may be prolonged, probably
due to interference with the actions of circulating clotting factors. Acute renal
failure and liver damage may occur. Exacerbation of asthma is possible in
asthmatics.
Management
Management should be symptomatic and supportive and include the
maintenance of a clear airway and monitoring of cardiac and vital signs until
stable. Consider oral administration of activated charcoal if the patient
presents within 1 hour of ingestion of a potentially toxic amount. If frequent or

prolonged, convulsions should be treated with intravenous diazepam or
lorazepam. Give bronchodilators for asthma.
Phenylephrine
Features of severe overdose of phenylephrine include haemodynamic changes
and cardiovascular collapse with respiratory depression.
Treatment includes early gastric lavage and symptomatic and supportive
measures. Hypertensive effects may be treated with an intravenous alphareceptor blocking agent.
Phenylephrine overdose is likely to result in: nervousness, headache,
dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis,
acute angle closure glaucoma (most likely to occur in those with closed angle
glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria,
allergic dermatitis), dysuria, urinary retention (most likely to occur in those
with bladder outlet obstruction, such as prostatic hypertrophy).
Additional symptoms may include hypertension, and possibly reflex
bradycardia.
In severe cases confusion, hallucinations, seizures and arrhythmias may occur.
Treatment should be as clinically appropriate. Severe hypertension may need
to be treated with alpha blocking medicinal products such as phentolamine.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
M01AE51 - Ibuprofen, combinations.
Ibuprofen
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its
efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces
inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly
inhibits platelet aggregation.
The therapeutic effect of ibuprofen in symptoms relating to the common cold
and influenza has a duration of up to 8 hours.
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are
dosed concomitantly. Some pharmacodynamic studies show that when single
doses of ibuprofen 400mg were taken within 8 hours before or within 30
minutes after immediate release aspirin (acetylsalicylic acid) (81 mg), a
decreased effect of aspirin (acetylsalicylic acid) on the formation of
thromboxane or platelet aggregation occurred. Although there are uncertainties

regarding extrapolation of these data to the clinical situation, the possibility
that regular, long-term use of ibuprofen may reduce the cardioprotective effect
of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant
effect is considered to be likely for occasional ibuprofen use (see section 4.5).

Phenylephrine

Phenylephrine is a post-synaptic alpha-receptor agonist with low
cardioselective betareceptor affinity and minimal central stimulant activity. It
is a recognised decongestant and acts by vasoconstriction to reduce oedema
and nasal swelling.

5.2

Pharmacokinetic properties
Ibuprofen
Ibuprofen is rapidly absorbed following administration and is rapidly
distributed throughout the whole body. The excretion is rapid and complete
via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if
taken on an empty stomach. When taken with food, peak levels are observed
after 1-2 hours. These times may vary with different dosage forms.
The half-life of ibuprofen is about 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low
concentrations.
Phenylephrine
Phenylephrine is absorbed from the gastrointestinal tract, but has reduced
bioavailability by the oral route due to first-pass metabolism.
It retains activity as a nasal decongestant when given orally, the drug
distributing through the systemic circulation to the vascular bed of the nasal
mucosa.
When taken by mouth as a nasal decongestant, phenylephrine is usually given
at intervals of 4-6 hours.
Ibuprofen and Phenylephrine Combination
The ibuprofen component of this fixed combination (ibuprofen 200mg plus
phenylephrine hydrochloride 5mg) is absorbed faster than standard ibuprofen

200mg tablets, with therapeutic levels being reached in 26.4 minutes (from the
fixed combination) as opposed to 55.2 minutes (for standard ibuprofen).
5.3

Preclinical safety data
There are no findings of relevance to the prescriber other than those already
mentioned elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Microcrystalline cellulose
Sodium starch glycolate Type A
Hypromellose
Magnesium stearate
Talc
Mastercote yellow FA 0156
Black printing ink (The ink contains the following residual materials after
application: shellac (E904), iron oxide black (E172), propylene glycol
(E1520)).

6.2

Incompatibilities
Not applicable

6.3

Shelf life
Two years

6.4

Special precautions for storage
Store in a dry place
Store in the original package
Store below 25ºC
Keep out of reach and sight of children

6.5

Nature and contents of container
A strip pack consisting of a blister tray of white pigmented 250 μm PVC/40
gsm

PVDC laminate heat-sealed to lacquered 20 μm aluminium foil containing 2, 4
or 8 tablets. One or two trays packed in a cardboard carton (i.e. 4, 6, 8, 10, 12,
14 or 16 tablets).
6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0688

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/12/2014

10

DATE OF REVISION OF THE TEXT
21/01/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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