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BOOTS COLD & FLU RELIEF WITH IBUPROFEN

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
Boots Cold & Flu Relief with Ibuprofen

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

3

Ibuprofen BP

200.0mg

Pseudoephedrine Hydrochloride BP

30.0mg

PHARMACEUTICAL FORM
Tablets
An orange, round, biconvex, film coated tablet, debossed with ‘CF’ on one
face

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of the 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 7 days.
Initial dose two tablets, then if necessary one or two tablets up to three times a
day. Leave at least four hours between doses and do not take more than 6
tablets in any 24 hour period.

Children under 12 years:
Not suitable for children under 12 years.
4.3

Contraindications
Hypersensitivity to any of the ingredients in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma,
rhinitis, angioedema, urticaria), in response to ibuprofen, aspirin or other nonsteroidal anti-inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAID
therapy.
Severe renal failure or hepatic failure (See section 4.4).
Severe heart failure (NYHA Class IV).
During pregnancy (See section 4.6).
Children under 12 years.
Patients with serious cardiovascular disease, tachycardia, hypertension, severe
renal impairment, 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 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 ibuprofen 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:
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 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 cyclooxygense/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 anytime 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 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,
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 for 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. Ibuprofen 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, 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,
stroke,
heart, liver, kidney or bowel problems
- are a smoker
If symptoms persist for more than 7 days, or worsen, consult your doctor.
Warning: Do not exceed the stated dose.
Keep all medicines out of the sight and reach of children.

4.5

Interaction with other medicinal products and other forms of interaction
Pseudoephedrine:
Should not be given to patients receiving MAOI therapy or within 14 days of
ceasing such treatment.
May potentiate the effects of other sympathomimetic agents, such as
decongestants and appetite suppressants. May increase the risk of
vasoconstrictor effects of ergot alkaloids.

The effect of pseudoephedrine may be diminished by guanethidine, reserpine
and methyldopa and may be diminished or enhanced by tricyclic
antidepressants. Pseudoephedrine may also diminish the effects of
guanethidine and may increase the possibility of arrhythmias in digitalised
patients, or in those receiving quinidine or tricyclic antidepressants.
Ibuprofen:
Ibuprofen should be avoided in combination with:
Acetylsalicylic acid: Unless low-dose aspirin (not above 75mg daily) has been
advised by a doctor. Concomitant administration of ibuprofen and
acetylsalicylic acid is not generally recommended because of the potential of
increased adverse effects (See section 4.4).
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
this 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 cyclo-oxygenase-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 effect 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 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.
4.6

Pregnancy and lactation
In summary: This product is contraindicated in pregnancy.
Pregnancy
Pseudoephedrine
There is a possible association between the development of foetal
abnormalities and first trimester exposure to pseudoephedrine. Therefore the
use of pseudoephedrine during pregnancy should be avoided.
Ibuprofen
Whilst no teratogenic effects have been demonstrated in animal experiments,
the use of ibuprofen 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).
This medicine is contraindicated in pregnancy.
Lactation
In limited studies, ibuprofen and pseudoephedrine appear in the breast milk in
very low concentrations and are unlikely to affect the breast-fed infant
adversely.
Fertility
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
Ibuprofen
Hypersensitivity reactions have been reported and these may consist of:

(a) non-specific allergic reactions and anaphylaxis
(b) respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm,
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 and pseudoephedrine at OTC doses, for short-term use. In the
treatment of chronic conditions, under long-term treatment, additional adverse
effects may occur.
Hypersensitivity reactions:
Ibuprofen and pseudoephedrine
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:
Ibuprofen
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 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).
Pseudoephedrine
Dry mouth, thirst.
Nervous System:
Ibuprofen
Uncommon: Headache.
Very rare: Aseptic meningitis – single cases have been reported very rarely.
Pseudoephedrine
Less frequently: Anxiety, tremors and hallucinations (particularly in children).
Dizziness, restlessness, insomnia, anorexia.

Renal:
Ibuprofen
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.
Pseudoephedrine
Less frequently: Difficulty in micturition.
Hepatic:
Ibuprofen
Very rare: Liver disorders.
Haematological:
Ibuprofen
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:
Ibuprofen
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:
Ibuprofen
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:
Ibuprofen
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).
Pseudoephedrine
Cardiac arrhythmias, precordial pain, palpitations, hypertension.
Musculoskeletal:

Pseudoephedrine:
Less frequently: Muscle weakness.
Ear and Labyrinth Disorders:
Pseudoephedrine
Hearing disturbance.
Endocrine Disorders:
Pseudoephedrine:
Sweating.
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 400mg/kg ibuprofen may cause symptoms.
In adults, the dose response is less clear cut. The half-life in overdose is 1.5 –
3 hours.
Symptoms
Symptoms include headache, nausea, vomiting, epigastric pain,
gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation,
drowsiness, tinnitus. In cases of significant poisoning acute renal failure and
liver damage are possible. In serious poisoning metabolic acidosis may occur
and prothrombin time/INR may be prolonged, probably due to interference
with the actions of circulatory clotting factors. Acute renal failure and liver
damage may occur. Exacerbation of asthma is possible in asthmatics.
Other symptoms of overdosage which may be associated with
pseudoephedrine include anxiety, restlessness, irritability, fever, sinus
tachycardia, sweating, insomnia, dilated pupils, blurred vision, delusions and
hallucinations, muscular weakness, difficulty in micturition, tremors,
respiratory depression, hypertension, supraventricular and ventricular
arrhythmias.
Symptoms associated with severe poisoning from either ibuprofen or
pseudoephedrine overdose include convulsions and coma.
Therapeutic measures
Patients should be treated symptomatically as required. Within one hour of
ingestion of a potentially toxic amount, activated charcoal should be

considered. Alternatively, in adults, gastric lavage should be considered
within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially
toxic amounts. A clear airway should be maintained and monitoring of
cardiac and vital signs should continue until stable.
Frequent or prolonged convulsions should be treated with intravenous
diazepam or lorazepam.
Bronchodilators should be given for asthma.
Other measures may be indicated by the patient's clinical condition.
Chlorpromazine may be used to control marked excitement and hallucinations.
Severe hypertension may need to be treated with an alpha-receptor blocking
drug such as phentolamine. A beta-receptor blocking drug may be required to
control cardiac arrhythmias.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.
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 400mg were taken within 8 h before or within 30 min after
immediate release 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 this 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).
Pseudoephedrine is a sympathomimetic agent with direct and indirect effects
on adrenergic receptors. It has alpha and beta stimulant adrenergic activity
and some stimulant effect on the central nervous system. The
sympathomimetic effect of pseudoephedrine produced vasoconstriction which
in turn relieves nasal congestion.

5.2.

Pharmacokinetic properties

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 to 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.
Pseudoephedrine is readily and completely 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 about 5-8
hours, but its urinary elimination and hence half-life is pH dependent.
Pseudoephedrine is rapidly distributed throughout the body, its volume of
distribution being 2 to 3 l/kg.

5.3.

Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tricalcium phosphate 118
Microcrystalline cellulose
Povidone K29-32
Croscarmellose sodium
Magnesium stearate
Purified water Ph Eur
Isopropyl alcohol
Hydroxypropylmethylcellulose
Talc
Mastercote orange FA1202A (solids)

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
36 months

6.4.

Special Precautions for Storage
Do not store above 25°C.
Store in original package.

6.5.

Nature and Contents of Container
Blister trays of white pigmented 250µm PVC/40G GSM PVDC laminate heatsealed to lacquered 20µm hard-temper aluminium foil, containing 12 tablets.
One or two trays contained in a cardboard carton.

6.6.

Instruction for Use/Handling
None.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company Plc
1 Thane Road West
Nottingham
NG2 3AA

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0600

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/03/2009

10

DATE OF REVISION OF THE TEXT
04/05/2016

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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