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BOOTS IBUPROFEN 3 MONTHS PLUS 100MG/5ML SUSPENSION STRAWBERRY FLAVOUR

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Boots Ibuprofen 3 Months Plus 100mg/5ml Oral Suspension Strawberry
Flavour or Almus Ibuprofen 100mg/5ml Oral Suspension Strawberry Flavour

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient:
Ibuprofen 100mg/5ml (equivalent to 2.0% w/v).
Excipients:
Maltitol liquid (E965) 2.1g/5ml
Sodium content 11mg/5ml
See section 4.4 Special warnings and precautions for use for further
information.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension
An off-white, strawberry-flavoured, syrupy suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the fast and effective reduction of fever, including post immunisation
pyrexia and the fast and effective relief of the symptoms of cold and influenza
and mild to moderate pain, such as a sore throat, teething pain, toothache,
dental pain, headache, minor aches and sprains, rheumatic and muscular pain.

4.2

Posology and method of administration
For oral administration.
Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see section 4.4).
For post immunisation pyrexia: One 2.5ml dose followed by one further 2.5ml
dose 6 hours later if necessary. No more than two 2.5ml doses in 24 hours. If
the fever is not reduced, consult your doctor. Not suitable for children under 3
months of age.
For pain and fever: For children weighing 5kg or more: 20mg/kg bodyweight
daily in divided doses.

Using the spoon or dosing syringe device provided this can be achieved as
follows:
Infants 3 - 6 months weighing more than 5kg: One 2.5ml dose may be taken 3
times in 24 hours.
Infants 6 - 12 months: One 2.5ml dose may be taken 3 to 4 times in 24 hours.
Children 1 - 3 years: One 5ml dose may be taken 3 times in 24 hours.
Children 4 - 6 years: 7.5ml (5ml + 2.5ml) may be taken 3 times in 24 hours.
Children 7 - 9 years: Two 5ml doses may be taken 3 times in 24 hours.
Doses should be given approximately every 6 to 8 hours, (or with a minimum
of 4 hours between each dose if required).
Not suitable for children under 3 months of age.
For short term use only.
For infants aged 3-5 months: Medical advice should be sought if symptoms
worsen or not later than 24 hours if symptoms persist.
For children aged from 6 months: If this medicinal product is required for
more than 3 days, or symptoms worsen a doctor should be consulted.

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
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 NSAIDs
therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see
section 4.4, Special warnings and precautions for use).
Last trimester of pregnancy (see section 4.6, Pregnancy and lactation).

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 Interaction with other
medicinal products and other forms of interaction).
SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease - increased
risk of aseptic meningitis (see section 4.8 Undesirable effects)
Renal:
Renal impairment as renal function may further deteriorate (see sections 4.3
Contraindications and 4.8 Undesirable effects)
There is a risk of renal impairment in dehydrated children and adolescents.
Hepatic:
Hepatic dysfunction (see sections 4.3 Contraindications and 4.8 Undesirable
effects)
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
(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 IIIII), established ischaemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease should only be treated with ibuprofen after careful
consideration and high doses (2400mg/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 (2400mg/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 Undesirable effects).
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 Contraindications), 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 Interaction
with other medicinal products and other forms of interaction).
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
Undesirable effects). 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.
Exceptionally, varicella can be at the origin of serious cutaneous and soft
tissue infectious complications. To date, the contributing role of NSAIDs in
the worsening of these infections cannot be ruled out. Thus, it is advisable to
avoid use of Ibuprofen in case of varicella (see section 4.8).
This product contains maltitol liquid (E965): patients with rare hereditary
problems of fructose intolerance should not take this medicine.
Each 5ml of this product contains 11mg sodium (a maximum daily dose of
30ml will provide 66mg of sodium). This should be taken into consideration
by patients on a controlled sodium diet.
The label will state:
Read the enclosed leaflet before taking this product.
Do not give this product if your baby or child:
• Is under 3 months old
• has (or has had two or more episodes of) a stomach ulcer, perforation or
bleeding
• is allergic to ibuprofen or any other ingredient of the product, aspirin or
other related painkillers
• is taking other NSAID painkillers, or aspirin with a daily dose above 75mg
Speak to your doctor or pharmacist before giving this product if baby or child:
• has or has had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems
This product is intended for children aged between 3 months and 10 years.

If you are an adult taking this product:
Speak to a pharmacist or your doctor before taking if:
• You are pregnant
• You are trying to get pregnant
• Are elderly
• Are a smoker
Do not exceed the stated dose.
Keep out of the reach and sight of children.
For short term use.
For infants aged 3-5 months, if symptoms worsen or do not go away, talk to
your doctor within 24 hours.
For a child of 6 months of age and over, if this medicinal product is required
for more than 3 days or if symptoms worsen talk to your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen should be avoided in combination with:
Acetylsalicylic acid (aspirin): 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 Special warnings and precautions for
use).
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 Pharmacodynamic properties).
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 Special warnings and precautions for use)
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 Special warnings and precautions for use).
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 Special warnings and precautions for use).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings
and precautions for use).
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

Fertility, pregnancy and lactation
Pregnancy
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 a prostaglandin synthesis inhibitor in early
pregnancy. The absolute risk for cardiovascular malformation was increased
from less than 1%, up to approximately 1.5%. 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 preand 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 oligohydroamniosis;
the mother and the neonate, 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, Ibuprofen is contraindicated during the third trimester of
pregnancy.
In limited studies, ibuprofen appears in the breast milk in very low
concentration and is unlikely to affect the breast-fed infant adversely.
See section 4.4 Special warnings and precautions for use, 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
The following frequencies are taken as a basis when evaluating undesirable
effects:
Very common:
≥1/10
Common:
≥1/100 to <1/10
Uncommon:
≥1/1,000 to <1/100
Rare:
≥1/10,000 to <1/1,000
Very rare:
≥1/10,000
Not known:
cannot be estimated from the available data
Infections and infestations:
Very rare: Exacerbation of infection-related inflammations (e.g. development
of necrotising fasciitis) coinciding with the use of non-steroidal antiinflammatory drugs has been described. This is possibly associated with the
mechanism of action of the non-steroidal anti-inflammatory drugs. If signs of
an infection occur or get worse during use of Ibuprofen the patient is therefore
recommended to go to a doctor without delay. It is to be investigated whether
there is an indication for anti-infective/antibiotic therapy.
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.
Immune System:
Not known: 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 Special warnings and precautions for use).
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).

Not known: Respiratory tract reactivity, e.g. asthma, aggravated asthma,
bronchospasm, dyspnoea. Exfoliative and bullous dermatoses (including
epidermal necrolysis and erythema multiforme).
Nervous System:
Uncommon: Headache.
Very rare: Aseptic meningitis - single cases have been reported very rarely.
Cardiovascular and Cerebrovascular:
Not known: 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
(2400mg/day) may be associated with a small increased risk of arterial
thrombotic events (for example myocardial infarction or stroke) (see section
4.4 Special warnings and precautions for use).
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature.
Uncommon: abdominal pain, nausea, 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 Special warnings and precautions for use).
Hepatic:
Very rare: liver disorders.
Skin and subcutaneous tissue disorders:
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.
Not known: In exceptional cases, severe skin infections and soft-tissue
complications may occur during a varicella infection (see also "Infections and
infestations").
Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.
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 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

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.
Ibuprofen has been shown to have an onset of both analgesic and antipyretic
action within 30 minutes.
ATC Code, M01A E01
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 was taken within 8 hours before or within 30 minutes
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 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).

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.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the consumer.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Citric acid
Sodium citrate
Sodium chloride
Sodium saccharin
Domiphen bromide
Purified water
Polysorbate 80
Maltitol liquid
Xanthan gum
Strawberry flavour
Glycerol

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
100ml, 150ml - 3 years.
30ml, 50ml - 2 years.

6.4

Special precautions for storage
Do not store above 25ºC.

6.5

Nature and contents of container
Amber coloured polyethylene terephthalate (PET) bottle with a child-resistant
closure fitted with a low density polyethylene liner. The bottle contains 50ml,
100ml or 150ml of product. A double ended spoon with measures of 2.5ml
and 5ml will be provided.
OR
Amber coloured polyethylene terephthalate (PET) bottle with a child-resistant
closure fitted with a low density polyethylene liner or polyethylene plug. The
bottle contains 50ml, 100ml or 150ml of product. Syringe composed of a
natural polypropylene barrel and a polyethylene pigmented white plunger.
OR
A 30ml amber glass bottle with a polypropylene child-resistant closure and
tamper evident band. A double ended spoon with measures of 2.5ml and 5ml
will be provided.
Not all pack sizes will be marketed.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
Trading as: BCM

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0652

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/10/2004

10

/

09/04/2009

DATE OF REVISION OF THE TEXT
15/01/2016

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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