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SUDAFED SINUS PRESSURE & PAIN 200MG/30MG TABLETS

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Sudafed Sinus Pressure & Pain 200mg/30mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine
hydrochloride.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Yellow, round, film-coated tablets. Diameter: approx. 11 mm, height: approx. 5 mm.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Symptomatic treatment of nasal congestion associated with acute rhinosinusitis
suspected to be of viral origin with headache and/or fever.
This product is indicated in adults and adolescents aged 15 years and older.

4.2

Posology and method of administration
Posology
Adults and adolescents aged 15 years and older:
1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride)
every 6 hours if necessary.
For more intense symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg
pseudoephedrine hydrochloride) every 6 hours if necessary, to a maximum total daily
dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine
hydrochloride).
The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180
mg pseudoephedrine hydrochloride) must not be exceeded.

For short-term use.

The patient should consult a doctor if symptoms worsen. The maximum
duration of treatment is 4 days for adults and 3 days for adolescents aged 15
years and older.
In situations where the symptoms predominantly consist of either pain/fever or nasal
congestion, administration of single entity products is to be preferred.
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration
necessary to control symptoms (see section 4.4).
Paediatric population
This product is contraindicated in paediatric patients below 15 years of age (see
section 4.3).
Method of administration
For oral use.
The tablets should be swallowed whole without chewing with a large glass of water,
preferably during meals.

4.3

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in
section 6.1;


Patients aged under 15 years;



Pregnant women during the third trimester of pregnancy (see section 4.6);



Breast-feeding mothers (see section 4.6)


Patients who have previously shown hypersensitivity reactions (e.g.
bronchospasm, asthma, rhinitis, angioedema or urticaria) in response to
acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);

History of gastrointestinal bleeding or perforation related to previous
NSAIDs therapy;

Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct
episodes of proven ulceration or bleeding);


Cerebrovascular or other bleeding;



Unexplained haematopoietic abnormalities;



Severe hepatic insufficiency;



Severe renal failure;



Severe heart failure;


Severe cardiovascular disorders, coronary heart disease (heart disease,
hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes,
pheochromocytoma;

History of stroke or presence of risk factors for stroke (because of the α-sympathomimetic activity of pseudoephedrine hydrochloride);


Risk of closed-angle glaucoma;



Risk of urinary retention related to urethroprostatic disorders;



History of myocardial infarction;



History of seizures;



Systemic lupus erythematosus;


Concomitant use of other vasoconstrictor agents used as nasal decongestants,
whether administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and
ephedrine), and methylphenidate (see section 4.5);

Concomitant use of non-selective monoamine oxidase inhibitors (MAOIs)
(iproniazid) (see section 4.5) or use of monoamine oxidase inhibitors within the last
two weeks.

4.4

Special warnings and precautions for use
Concomitant use of this product with other NSAIDs including cyclo-oxygenase
(COX)-2 selective inhibitors should be avoided.
Undesirable effects may be reduced by using the minimum effective dose for the
shortest duration necessary to control symptoms (see "Gastro-intestinal effects" and
"Cardiovascular and cerebrovascular effects" below).
If symptoms persist beyond the recommended maximum duration of treatment with
this medicinal product (4 days for adults and 3 days for adolescents), measures to be
taken should be re-evaluated, in particular the possible usefulness of an antibiotic
treatment.
Acute rhinosinusitis, suspected to be of viral origin, is defined by moderate intensity,
bilateral rhinological symptoms dominated by nasal congestion with serous or
puriform rhinorrhea, occurring in an epidemic context. The puriform appearance of
rhinorrhea is common and does not systematically correspond to bacterial
superinfection.
Sinus pains, during the first days of the illness, are associated with congestion of the
sinus mucosa (acute congestive rhinosinusitis) and most often are resolved
spontaneously.
In the event of acute bacterial sinusitis, antiobiotic therapy is justified.

Special warnings related to pseudoephedrine hydrochloride:

The dosage, the recommended maximum duration of treatment (4 days for
adults and 3 days for adolescents) and the contraindications must be strictly adhered
to (see section 4.8).

Patients should be informed that treatment must be discontinued if they
develop hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any
neurological signs such as onset or worsening of headache.
Before using this medicinal product, patients should consult their doctor in case of:


Hypertension, heart disease, hyperthyroidism, psychosis or diabetes.


Concomitant administration of antimigraine agents, especially ergot alkaloid
vasoconstrictors (because of the α-sympathomimetic activity of pseudoephedrine).

Mixed connective tissue disease – increased risk of aseptic meningitis (see
section 4.8).

Neurological symptoms such as seizures, hallucinations, behavioural
disturbances, agitation and insomnia have been described after systemic
administration of vasoconstrictors, especially during febrile episodes or on overdose.
These symptoms have been more commonly reported in paediatric population.
As a result, it is advisable:

to avoid administration of this product either in combination with medicines
which can lower the epileptogenic threshold, such as terpene derivatives, clobutinol,
atropine-like substances and local anaesthetics, or where there is a history of seizures;

to adhere strictly to the recommended dosage in all cases and to inform the
patients about the risks of overdose if this product is taken concomitantly with other
medicines containing vasoconstrictors.
Patients with urethroprostatic disorders are more prone to develop symptoms like
dysuria and urinary retention.
Elderly patients may be more sensitive to the effects on the central nervous system
(CNS).

Precautions for use related to pseudoephedrine hydrochloride:


In patients undergoing scheduled surgery in which volatile halogenated
anaesthetics are to be used, it is preferable to discontinue treatment with this product
several days before surgery in view of the risk of acute hypertension (see section 4.5).

Athletes should be informed that treatment with pseudoephedrine
hydrochloride can lead to positive results in doping tests.

Interference with serological testing
Pseudoephedrine has the potential to reduce iobenguane i-131 uptake in
neuroendocrine tumors, thus interfering with scintigraphy.

Special warnings related to ibuprofen:
Bronchospasm may be precipitated in patients suffering from, or with a history of
bronchial asthma or allergic disease. The product should not be taken with cases of
asthma without prior consultation with a doctor (see section 4.3).
Patients who have asthma associated with chronic rhinitis, chronic sinusitis and/or
nasal polyposis have a higher risk of allergic reactions when taking acetylsalicylic
acid and/or NSAIDs. Administration of this product may precipitate an acute asthma
attack, particularly in some patients who are allergic to acetylsalicylic acid or an
NSAID (see section 4.3).
Prolonged use of any type of painkiller for headaches can make them worse. If this
situation is experienced or suspected, medical advice should be obtained and
treatment should be discontinued. The diagnosis of medication overuse headache
(MOH) should be suspected in patients who have frequent or daily headaches despite
(or because of) the regular use of headache medications.
Before using this medicinal product, patients should consult their doctor in case of a
blood clotting disorder.

Gastro-intestinal effects:
Gastro-intestinal 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 gastrointestinal events.
The risk of gastro-intestinal bleeding, ulceration or perforation, which can be fatal, is
higher with increasing NSAID doses, in patients with a history of ulcer, particularly if
complicated with bleeding or perforation (see section 4.3), and in the elderly. These
patients should commence treatment on the lowest dose available. Combination

therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be
considered for these patients and also for patients taking concomitant low-dose
acetylsalicylic acid or other medicinal products likely to increase gastro-intestinal risk
(see below and section 4.5).
Patients with a history of gastrointestinal toxicity, especially elderly patients, should
report any unusual abdominal symptoms (especially gastrointestinal bleeding)
particularly in the initial stages of treatment.
Particular caution is advised in patients receiving concomitant medications which
could increase the risk of ulceration or bleeding such as oral corticosteroids,
anticoagulants such as warfarin, SSRIs or antiplatelet agents such as acetylsalicylic
acid (see section 4.5).
Treatment with this product should be discontinued immediately if gastro-intestinal
bleeding or ulceration occurs.
NSAIDs should be given with care to patients with a history of gastro-intestinal
disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see
section 4.8).
Through concomitant consumption of alcohol, active substance-related undesirable
effects, particularly those that concern the gastrointestinal tract or the central nervous
system, may be increased on use of NSAIDs.
Cardiovascular and cerebrovascular effects:
Due to the pseudoephedrine hydrochloride component the following conditions are
contraindicated (see section 4.3): Severe cardiovascular disorders, coronary heart
disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism,
diabetes, pheochromocytoma, history of stroke or presence of risk factors for stroke,
history of myocardial infarction.
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
(e.g.

≤ 1200 mg/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.
Skin reactions:
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 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.

Precautions for use related to ibuprofen:

Elderly: The pharmacokinetics of ibuprofen is not modified by age; no dose
adjustment is necessary in the elderly. However, elderly patients should be carefully
monitored as they have an increased frequency of NSAID-related undesirable effects,
particularly gastro-intestinal bleeding and perforation, which can be fatal.

Caution and special monitoring is required when administering ibuprofen to
patients with a history of gastro-intestinal disease (such as peptic ulcer, hiatus hernia
or gastrointestinal bleeding).

In the initial stages of treatment, careful monitoring of urine output and renal
function is required in patients with heart failure, patients with chronically impaired
renal or hepatic function, patients taking diuretics, patients who are hypovolaemic as
a result of major surgery and, in particular, elderly patients. There is a risk of renal
impairment in dehydrated adolescents.

If visual disturbances occur during the course of treatment, a full
ophthalmological examination should be carried out.

4.5

Interaction with other medicinal products and other forms of interaction

Combination of pseudoephedrine with:

Possible Reaction

Non-selective MAOIs (iproniazid):

Paroxysmal hypertension and hyperthermia, which
can be fatal. Because of the long duration of action
of MAOIs, this interaction can occur up to 15 days
after discontinuation of the MAOI.

Other indirectly-acting, orally or nasally
administered sympathomimetics or vasoconstrictor
agents, α-sympathomimetic drugs,
phenylpropanolamine, phenylephrine, ephedrine,
methylphenidate:
Reversible inhibitors of monoamine oxidase A
(RIMAs), linezolid, dopaminergic ergot alkaloids,
vasoconstrictor ergot alkaloids:
Volatile halogenated anaesthetics:

Guanethidine, reserpine and methyldopa:
Tricyclic antidepressants:

Risk of vasoconstriction and/or hypertensive crises.

Risk of vasoconstriction and/or hypertensive crises.

Perioperative acute hypertension. In scheduled
surgery, discontinue treatment with this product
several days before.
Effect of pseudoephedrine may be diminished.

Digitalis, chinidine or tricyclic antidepressants:

Effect of pseudoephedrine may be diminished or
enhanced.
Increased frequency of arrhythmia.

Concomitant use of ibuprofen with :

Possible Reaction

Other NSAIDs, including salicylates and COX-2
selective inhibitors:

The concomitant administration of several NSAIDs
may increase the risk of gastrointestinal ulcers and
bleeding due to a synergistic effect. The
concomitant use of ibuprofen with other NSAIDs
should therefore be avoided (see section 4.4).
The concomitant use of this product with digoxin
preparations may increase serum levels of these
medicinal products. A check of serum-digoxin is
not as a rule required on correct use (maximum
over 4 days).

Digoxin:

Corticosteroids:

Anti-platelet agents:
Acetylsalicylic acid:

Anticoagulants:
(e.g.: warfarin, ticlopidine, clopidogrel, tirofiban,

Corticosteriods as these may increase the risk of
adverse reactions, especially of the gastrointestinal
tract (gastrointestinal; ulceration or bleeding) (see
section 4.3).
Increased risk of gastrointestinal bleeding (see
section 4.4).
Concomitant administration of ibuprofen and
acetylsalicylic acid is not generally recommended
because of the potential of increased adverse
effects.
Experimental data suggest that ibuprofen may
competitively inhibit the effect of low dose
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).
NSAIDs as ibuprofen may enhance the effect of
anti-coagulants (see section 4.4).

eptifibatide, abciximab, iloprost)
Phenytoin:

Selective serotonin reuptake inhibitors (SSRIs):
Lithium:

Probenecid and sulfinpyrazone:

Diuretics, ACE inhibitors, betareceptorblockers and angiotensin-II antagonists:

Potassium sparing diuretics:

Methotrexate:

Ciclosporin:

Tacrolimus:
Zidovudine:

The concomitant use of this product with phenytoin
preparations may increase serum levels of these
medicinal products. A check of serum-phenytoin
levels is not as a rule required on correct use
(maximum over 4 days).
Increased risk of gastrointestinal bleeding (see
section 4.4).
The concomitant use of this product with lithium
preparations may increase serum levels of these
medicinal products. A check of serum-lithium is not
as a rule required on correct use (maximum over 4
days).
Medicinal products that contain probenecid or
sulfinpyrazone may delay the excretion of
ibuprofen.
NSAIDs may reduce the effect of diuretics and
other antihypertensive medicinal products. In some
patients with compromised renal function (e.g.
dehydrated patients or elderly patients with
compromised renal function) the co-administration
of an ACE inhibitor, betareceptor-blockers or
angiotensin-II antagonists and agents that inhibit
cyclo-oxygenase may result in further deterioration
of renal function, including possible acute renal
failure, which is usually reversible. Therefore, the
combination should be administered with caution,
especially in the elderly. Patients should be
adequately hydrated and consideration should be
given to monitoring of renal function after initiation
of concomitant therapy, and periodically thereafter.
The concomitant administration of this product and
potassium-sparing diuretics may lead to
hyperkalaemia (check of serum potassium is
recommended).
The administration of this product within 24 hours
before or after administration of methotrexate may
lead to elevated concentrations of methotrexate and
an increase in its toxic effect.
The risk of a kidney-damaging effect due to
ciclosporin is increased through the concomitant
administration of certain nonsteroidal antiinflammatory drugs. This effect also cannot be
ruled out for a combination of ciclosporin with
ibuprofen.
The risk of nephrotoxicity is increased if the two
medicinal products are administered concomitantly.
There is evidence of an increased risk of
haemarthroses and haematoma in HIV (+)
haemophiliacs receiving concurrent treatment with
zidovudine and ibuprofen.

Sulphonylureas:

Quinolone antibiotics:

Heparins; Gingko biloba:

4.6

Clinical investigations have shown interactions
between nonsteroidal anti-inflammatory drugs and
antidiabetics (sulphonylureas). Although
interactions between ibuprofen and sulphonylureas
have not been described to date, a check of bloodglucose values is recommended as a precaution on
concomitant intake.
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.
Increased risk of bleeding.

Fertility, pregnancy and lactation
Pregnancy
Pseudoephedrine hydrochloride:
Studies in animals have shown reproductive toxicity (see section 5.3). The use of
pseudoephedrine hydrochloride decreases maternal uterine blood flow but clinical
data are insufficient with respect to effects on pregnancy.
Ibuprofen:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the
embryo/foetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and of
cardiac malformation and gastroschisis after use of prostaglandin synthesis inhibitors
in early pregnancy. The risk is believed to increase with dose and duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to
result in increased pre- and post-implantation loss and embryo-foetal lethality. In
addition, increased incidences of various malformations, including cardiovascular,
have been reported in animals given a prostaglandin synthesis inhibitor during the
organogenetic period.
During the first and second trimester of pregnancy, ibuprofen should not be given
unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or
during the first and second trimester of pregnancy, the dose should be kept as low and
duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may
expose the foetus to:

-cardiopulmonary toxicity (with premature closure of the ductus arteriosus and
pulmonary hypertension);
-renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
the mother and the child, at the end of pregnancy, to:
-possible prolongation of bleeding time, an anti-aggregating effect which may occur
even at very low doses
-inhibition of uterine contractions resulting in delayed or prolonged labour
Consequently, the use of this medicinal product is:
Contra-indicated during the third trimester of pregnancy and should only be given if
clearly necessary during the first and second trimester.
Breast-feeding
Measures which must be taken during lactation result from the presence of
pseudoephedrine hydrochloride in the medicinal product formulation:
pseudoephedrine hydrochloride is excreted in human breast milk. Considering the
potential cardiovascular and neurological effects of vasoconstrictors, ingestion of this
medicinal product is contra-indicated during lactation.
Fertility:
There is some 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.

4.7

Effects on ability to drive and use machines
This product has minor or moderate influence on the ability to drive and use
machines. Patients who experience dizziness, hallucinations, unusual headaches and
visual or hearing disturbances should avoid driving or using machinery. Single
administration or short-term use of this medicine does not usually warrant the
adoption of any special precautions.

4.8

Undesirable effects
The most commonly-observed adverse reactions related to ibuprofen are
gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal,
particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea,
flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis,
ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (See section 4.4

Special warnings and precautions for use) have been reported following
administration. Less frequently, gastritis has been observed. In general, the risk of
development of adverse reactions (in particular the risk of development of serious
gastrointestinal complications) increases with increasing dose and with increasing
duration of treatment administration.
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
(c) Assorted skin disorders, including rashes of various types, pruritis, urticaria,
purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including
epidermal necrolysis and erythema multiforme).
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.
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).
The following list of adverse reactions relates to those experienced with ibuprofen
and pseudoephedrine hydrochloride at OTC doses, for short-term use. In the
treatment of chronic conditions, under long-term treatment, additional adverse
reactions may occur.
Patients should be informed that they should stop taking this product immediately and
consult a doctor if they experience a serious adverse drug reaction.







the available data)>

Infections and

Ibuprofen

Very rare

infectious inflammations
(e.g. necrotizing fasciitis),
Aseptic meningitis (stiffness
of the neck, headache,
nausea, vomiting, fever or
disorientation in patients with
preexistent autoimmune
diseases (Systemic Lupus
Erythematosus (SLE), mixed
connective tissue disease)

infestations

Blood and

Exacerbation of

Ibuprofen

Very rare

Haematopoietic

lymphatic system

disorders (anaemia,

disorders

leucopenia,
thrombocytopenia,
pancytopenia,
agranulocytosis)

Immune system
disorders

Ibuprofen

Uncommon

Hypersensitivity reactions
with urticaria, pruritus and
asthma attacks (with drop in
blood pressure)

Psychiatric disorders

Nervous system
disorders

Ibuprofen and
pseudoephedrine
hydrochloride

Very rare

Severe generalised
hypersensitivity reactions,
signs may be facial oedema,
angioedema, dyspnoea,
tachycardia, drop in blood
pressure, anaphylactic shock

Ibuprofen

Very rare

Psychotic reactions,
depression

Pseudoephedrine
hydrochloride

Not known

Agitation, hallucination,
anxiety, abnormal behaviour,
insomnia

Ibuprofen

Uncommon

Central nervous disturbances
such as headache, dizziness,
sleeplessness, agitation,
irritability or tiredness

Pseudoephedrine
hydrochloride

Rare

Insomnia, nervousness,
anxiety, restlessness, tremor,
hallucinations

Pseudoephedrine
hydrochloride

Not known

Haemorhagic stroke,
ischemic stroke, convulsion,
headache

Eye disorders

Ibuprofen

Uncommon

Visual disturbances

Ear and labyrinth
disorders

Ibuprofen

Rare

Tinnitus

Cardiac disorders

Ibuprofen

Very rare

Palpitations, heart failure,
myocardial infarction

Pseudoephedrine
hydrochloride

Not known

Palpitations, tachycardia,
chest pain, arrythmia

Ibuprofen

Very rare

Arterial hypertension

Pseudoephedrine
hydrochloride

Not known

Hypertension

Pseudoephedrine
hydrochloride

Rare

Exacerbation of asthma or
hypersensitivity reaction with
bronchospasm

Ibuprofen

Common

Gastrointestinal discomfort,
dyspepsia, abdominal pain,
nausea, vomiting, flatulence,
diarrhoea, constipation,
minor gastrointestinal blood
loss in rare cases leading to
anaemia

Ibuprofen

Uncommon

Gastrointestinal ulcers
sometimes with bleeding
and/or perforation, gastritis,
ulcerative stomatitis,
exacerbation of colitis and
Crohn’s disease (see section
4.4)

Ibuprofen

Very rare

Oesophagitis, pancreatitis,
intestinal diaphragm-like
stricture

Pseudoephedrine
hydrochloride

Not known

Dry mouth, thirst, nausea,
vomiting

Hepatobiliary disorders

Ibuprofen

Very rare

Hepatic dysfunction, hepatic
damage, particularly in longterm therapy, hepatic failure,
acute hepatitis

Skin and subcutaneous
tissue disorders

Ibuprofen

Uncommon

Various skin rashes

Ibuprofen

Very rare

Bullous reactions including
Stevens-Johnson syndrome
and toxic epidermal
necrolysis (Lyell syndrome),
alopecia, severe skin
infections and soft-tissue
complications in a varicella
infection

Vascular disorders

Respiratory, thoracic
and mediastinal
disorders

Gastrointestinal
disorders

Renal and Urinary
disorders

Pseudoephedrine
hydrochloride

Not known

Rash, urticaria, pruritus,
hyperhidrosis

Ibuprofen

Rare

Kidney-tissue damage
(papillary necrosis)
and elevated uric acid
concentrations in the blood

Ibuprofen

Very rare

Increase in serum creatinine,
oedemas (particularly in
patients with arterial
hypertension or renal
insufficiency), nephrotic
syndrome, interstitial
nephritis, acute renal
insufficiency

Pseudoephedrine
hydrochloride

Not known

Difficulty in micturition

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
The clinical effects of overdose are more likely to be due to the pseudoephedrine
hydrochloride rather than ibuprofen in this medicinal product. The effects do not
correlate well with the dose taken due to inter-individual sensitivity to
sympathomimetic properties.
Symptoms of sympathomimetic effect
CNS depression: e.g. sedation, apnea, cyanosis, coma
CNS stimulation (which is more likely in children): e.g. insomnia, hallucinations,
convulsions, tremor
Besides the symptoms already mentioned as undesirable effects, the following
symptoms can occur: hypertensive crisis, cardiac arrhythmias, muscle weakness and
tenseness, euphoria, excitement, thirst, chest pain, dizziness, tinnitus, ataxia, blurred
vision, hypotension

Ibuprofen-related symptoms (in addition to the gastro-intestinal and neurological
symptoms already mentioned as undesirable effects)
Drowsiness, nystagmus; tinnitus, hypotension, metabolic acidosis, loss of
consciousness
Therapeutic measures
No specific antidote is available.
Consider oral administration of activated charcoal if the patient presents within one
hour of ingestion of a potentially toxic amount.
Electrolytes should be checked and ECG performed. In case of cardiovascular
instability and/or symptomatic electrolyte imbalance, symptomatic treatment should
be initiated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Cough and cold preparations; other cold preparations.
ATC code: R05X

Pseudoephedrine hydrochloride is a sympathomimetic agent which, when
administered systemically, acts as a nasal decongestant.
Ibuprofen is an NSAID belonging to the propionic acid class of drugs. It is an
arylcarboxylic acid derivative which has analgesic, antipyretic and anti-inflammatory
properties as well as a short-acting inhibitory effect on platelet function. All of these
properties are related to its ability to inhibit prostaglandin synthesis.
This product is a combination of a vasoconstrictor (pseudoephedrine hydrochloride)
with an analgesic dose of an NSAID (ibuprofen).
Experimental data suggest that ibuprofen may competitively inhibit the effect of low
dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly.

Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg
were taken within 8 h before or within 30 min after immediate release acetylsalicylic
acid dosing (81 mg), 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 lowdose acetylsalicylic acid cannot be excluded. No clinically relevant effect is
considered to be likely for occasional ibuprofen use (see section 4.5).

5.2

Pharmacokinetic properties
Ibuprofen:
At therapeutic doses, pharmacokinetics of ibuprofen is linear.
Absorption:
Peak serum levels are reached approximately 90 minutes after oral dosing.
With single oral dose administration, peak serum levels in adults, are proportional to
the dose (Cmax 17 ± 3.5 μg/ml for a 200 mg dose and 30.3 ± 4.7 μg/ml for a 400 mg
dose). Absorption of ibuprofen is delayed by food ingestion.
Distribution:
Ibuprofen does not accumulate. It is 99% bound to plasma proteins.
In the synovial fluid, ibuprofen is recovered at steady concentrations two to eight
hours after dosing, with Cmax in the synovial fluid being about one third of plasma
Cmax. After administration of a 400 mg ibuprofen dose every 6 hours in breast-feeding
women, the amount of ibuprofen recovered in breast milk is less than 1 mg per 24
hours.
Biotransformation:
Ibuprofen does not have any enzyme-inducing effect. It is 90% metabolized and
converted into inactive metabolites.
Elimination:
Ibuprofen is mainly excreted via the urine. Ibuprofen is completely excreted within
24 hours, with 10% eliminated unchanged and 90% in the form of inactive
metabolites, mainly glucurono-conjugates.
Elimination half-life is approximately 2 hours.
The pharmacokinetic parameters of ibuprofen are only slightly modified in the
elderly, in renal failure patients and in patients with hepatic insufficiency. The
alterations observed do not require dosage adjustment.

Pseudoephedrine hydrochloride:
When administered by oral route, pseudoephedrine is excreted mainly via the kidney
in unchanged form (70 to 90 %).
Elimination half-life depends on urinary pH.
Urine alcalinazation results in an enhanced increase in tubular reabsorption, and
consequently the prolongation of the elimination half-life of pseudoephedrine.

5.3

Preclinical safety data
The LD50 values for the combination of ibuprofen and pseudoephedrine
hydrochloride in acute oral toxicity studies were: 2.40 g/kg for mice and 1.45 g/kg for
rats.
No repeated dose toxicity studies on the combination of ibuprofen and
pseudoephedrine hydrochloride have been performed.
No mutagenicity was observed with ibuprofen and pseudoephedrine hydrochloride /
ibuprofen in combination using the Ames test.
The subchronic and chronic toxicity of ibuprofen in animal experiments showed up
mainly in the form of lesions and ulcerations in the gastro-intestinal tract. In studies
in rats and mice, no evidence of carcinogenic effects of ibuprofen was found.
Reprotoxicity studies in mice and rats with individual ingredients (~ 100 mg/kg
ibuprofen; ~15 mg/kg pseudoephedrine hydrochloride) nor a combination of these
revealed no indication of maternal or foetal toxicity or teratogenicity.
At a maternally toxic dose, pseudoephedrine hydrochloride induced foetotoxicity
(reduced foetal weight and delayed ossification) in rats. Fertility studies or peripostnatal studies have not been performed for pseudoephedrine hydrochloride.
Published reproductive toxicity studies on ibuprofen demonstrated an inhibition of
ovulation in rabbits and impaired implantation in different animal species (rabbit, rat,
and mouse). Studies in rats and rabbits have demonstrated that ibuprofen passes the
placenta; for maternally toxic doses, an increased incidence of malformations (e.g.
ventricular septal defects) was observed.
The active substance ibuprofen may show an environmental risk for the aquatic
environment, especially for fish.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tablet Core
Microcrystalline cellulose
Calcium hydrogen phosphate anhydrous
Croscarmellose sodium
Maize starch
Silica, colloidal anhydrous
Magnesium stearate
Tablet Coat
Hypromellose
Macrogol 400
Talc
Titanium dioxide (E171)
Iron oxide yellow (E 172)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
30 months.

6.4

Special precautions for storage
Do not store above 30ºC.

6.5

Nature and contents of container
Child-resistant PVC/PVDC/aluminium foil blister.

Pack sizes: 10, 12, 20, 24 film-coated tablets
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0396

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/06/2017

10

DATE OF REVISION OF THE TEXT
15/06/2017

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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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