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NUROFEN SINUS PRESSURE AND HEADACHE RELIEF 200MG/30MG TABLETS

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurofen Sinus Pressure & Headache Relief 200mg/30mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Ibuprofen BP
Pseudoephedrine
Hydrochloride

Quantity
200mg
30mg

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Yellow film coated tablet. Printed in black with an identifying motif.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of symptoms 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.
Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not to be given to children under 12 years.

4.3

Contraindications
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis,
angioedema, or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs.
Active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes
of 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 (see section 4.6)
Patients with serious cardiovascular disease, tachycardia, hypertension, angina
pectoris, hyperthyroidism, diabetes, phaeochromocytoma, closed angle glaucoma,
prostatic enlargement.

4.4

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the
shortest possible duration necessary to control symptoms (see GI and cardiovascular
risks below).
The elderly have an increased frequency 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 Nurofen Sinus pressure & Headache Relief 200mg/30mg Tablets with
concomitant NSAIDs including cyclooxygenase-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 associated with NSAID therapy.
Clinical studies suggest that the use of ibuprofen, particularly at a high dose
(2400mg/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 (e.g. ≤1200mg/day) is associated with an
increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III),
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 upon 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 hemorrhage
or perforation (see section 4.3), and the elderly. These patients should commence
treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when 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 anti-platelet 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 exfoliative dermatitis, StevensJohnson 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 for these reactions early in the course of therapy: the onset of the reaction
occurring in the majority of cases with the first month of treatment. Nurofen Sinus
Pressure & Headache Relief 200mg/30mg Tablets should be discontinued at the first
appearance of a skin rash, mucosal lesions, or any other signs 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, or aspirin with a daily dose above 75mg

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, consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be avoided 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 75mg 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 occasional
ibuprofen use (see section 5.1).

Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant
use of two or more NSAIDs as this may increase the risk of adverse effects (see
section 4.4.).
Ibuprofen should be used with caution in combination with:
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin
(see section 4.4).
Antihypertensives and diuretics: NSAIDS may diminish the effects of these drugs.
Diuretics can increase the risk of nephrotoxicity of NSAIDs.
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 increases in plasma levels of lithium.
Methotrexate: There is a 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 effects 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.
-Pseudoephedrine may potentiate the effects of other sympathomimetic agents, such
as decongestants and appetite suppressants.
-Pseudoephedrine should not be given to patients receiving MAOI therapy or within
14 days of ceasing such treatment.
-The effect of Pseudoephedrine may be diminished by guanethidine, reserpine and
methyldopa
-The effect of pseudoephedrine may be diminished/enhanced by tricyclic
antidepressants.

4.6

Fertility, pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use
of Nurofen Sinus Pressure & Headache Relief 200mg/30mg Tablets should, if
possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature
closure of the foetal 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).
Although ibuprofen appears in breast milk in very low concentrations, significant
amounts of Pseudoephedrine are secreted into breast milk and the use of Nurofen
Sinus Pressure & Headache Relief 200mg/30mg Tablets during lactation should be
avoided.
See section 4.4 regarding female fertility.

4.7

Effects on ability to drive and use machines
None expected at recommended doses and duration of therapy.

4.8

Undesirable effects
Hypersensitivity reactions have been reported following treatment with ibuprofen.
These may consist of (a) non-specific allergic reaction and anaphylaxis, (b)
respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm
or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis,
urticaria, purpura, angioedema and, more rarely, 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 longterm treatment, additional adverse effects may occur.
Hypersensitivity Reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and
larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or
severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal Disorders:
The most commonly-observed adverse events are gastrointestinal in nature.
Uncommon: Abdominal pain, dyspepsia and nausea.
Rare: Diarrhoea, flatulence, constipation and vomiting
Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis,
gastritis.
Exacerbation of ulcerative colitis and Crohn’s disease (See section 4.4)
Nervous System:
Uncommon: Headache
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, especially in long-term treatment.
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.
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 doses
(2400mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke), (see section 4.4).
Side effects of Pseudoephedrine include:
May give rise to dyspepsia, gastro-intestinal intolerance and bleeding, skin rashes,
nausea, vomiting, sweating, giddiness, thirst, tachycardia, percorial pain, palpitations,
restlessness and insomnia. Less frequently Nurofen Sinus Pressure & Headache
Relief 200mg/30mg Tablets may cause difficulty in micturition, muscle weakness,
tremors, anxiety, hallucinations and thrombocytopenia.
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
In children ingestion of more than 400 mg/kg ibuprofen may cause symptoms. In
adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3
hours.
Symptoms
Most 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 the 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.

5.1

Pharmacodynamic properties
Pharmacotherapeutic Group: Anti-inflammatory and antirheumatic
propionic acid derivatives. Ibuprofen combinations.
ATC Code:

products,

M01AE51

Ibuprofen is a propionic acid derivative, having analgesic, anti-pyretic and antiinflammatory activity. The drug's therapeutic effects as a non-steroidal antiinflammatory drug are thought to result from inhibitory activity on prostaglandin
synthesis. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
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 pharmacodynamics studies show that when single doses of
ibuprofen 400mg were taken with 8 h before or within 30 min after immediate release
aspirin (acetylsalicylic acid) dosing (81mg), a decreased effect of (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
relevant effect is considered to be likely for occasional use (see section 4.5).
Pseudoephedrine hydrochloride is used as a nasal and bronchial decongestant
which acts by vasoconstriction to reduce oedema and nasal swelling. It is a
stereoisomer of Ephedrine and has a similar action. It is a sympathomimetic
agent with direct and indirect effects on adrenergic receptors. It has alpha- and
beta-adrenergic activities and has stimulating effects on the central nervous
system. It has a more prolonged, though less potent action than adrenaline.
However, pseudoephedrine has been stated to have less pressor activity and
central nervous system effects than ephedrine.

5.2

Pharmacokinetic properties

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum
concentrations occurring 1-2 hours after administration. The elimination half- life is
approximately two hours.
Ibuprofen is metabolised in the liver to two major inactive metabolites and these
together with unchanged ibuprofen are excreted by the kidney either as such or as
conjugates. Excretion by the kidney is both rapid and complete.
Ibuprofen is extensively bound to plasma proteins.
Pseudoephedrine is absorbed from the gastrointestinal tract and is largely excreted in
the urine unchanged, together with small amounts of a hepatic metabolite. It has an
elimination half-life of several hours, which may be reduced by acidifying the urine.

5.3

Preclinical safety data
No data is available which is of relevance to the consumer.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tricalcium phosphate 118,
microcrystalline cellulose,
polyvidone,
croscarmellose sodium,
magnesium stearate,
methylhydroxypropyl cellulose,
talc,
Opaspray Yellow M-1F-6168 or Mastercote Yellow FA 0156,
black printing ink (contains shellac, iron oxide black and propylene glycol).

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Store in a dry place.

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 12 tablets.
One or two trays packed in a cardboard carton (12 or 24 tablets).

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0718

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/10/2015

10

DATE OF REVISION OF THE TEXT
02/02/2016

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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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