Active substance: IBUPROFEN

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Nurofen Back Pain 300mg Sustained Release Capsules


Ibuprofen 300 mg/capsule
Excipient(s) with known effect:
For the full list of excipients, see section 6.1


Sustained-release capsules
Size 0, hard gelatin capsules with transparent, colourless caps and transparent
colourless bodies, imprinted axially in red ink with "N 300", containing
spherical white granules.




Therapeutic indications
For the effective relief of backache, rheumatic pain and muscular pains.


Posology and method of administration
During short-term use, if symptoms persist or worsen the patient should be
advised to consult a doctor.
Adults, the elderly and children and adolescents between 12 and 18 years:
The minimum effective dose should be used for the shortest time necessary to
relieve symptoms.
If in children and adolescents this medicinal product is required for more than
3 days, or if symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the symptoms
worsen, the patient should consult a doctor.
For oral administration.
Children and Adolescents between 12 and 18 years: One or two capsules
taken twice daily.
Adults: One or two capsules taken twice daily.

The capsules should be taken together with water and swallowed whole. Do
not chew or suck the capsules.
Do not take more than 4 capsules in 24 hours.
There should be at least 8 hours between doses.


Patients with a known hypersensitivity to ibuprofen or any other constituent of
the medicinal product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma,
rhinitis, angiodema, 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.
Patients with severe hepatic failure, severe renal failure or severe heart failure.
See also Section 4.4
During the last trimester of pregnancy as there is a risk of premature closure of
the fetal ductus arteriosus with possible persistent pulmonary hypertension.
The onset of labour may be delayed and the duration increased with an
increased bleeding tendency in both mother and child (see Section 4.6)”.
Severe heart failure.


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 section 4.2, and 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.
Bronchospasm may be precipitated in patients suffering from, or with a history
of, bronchial asthma or allergic disease.
Other NSAIDs:
The use of Nurofen Back Pain SR Capsules 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 impairment as renal function may further deteriorate (see sections 4.3
and 4.8)
There is a risk of renal impairment in dehydrated children and adolescents
Hepatic dysfunction (see sections 4.3 and 4.8)
Cardiovascular and cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting
treatment in patients with a history of hypertension and/or heart failure as fluid
retention, hypertension and oedema have been reported in association with
NSAID therapy
Clinical trial and epidemiological data suggest that use of ibuprofen,
particularly at high doses (2400mg daily) and in long-term treatment 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 daily) is associated with an
increased risk of myocardial infarction.
Impaired female 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 on withdrawal of treatment.
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).
The elderly are at increased risk of the consequence of adverse reactions.
The risk of GI bleeding, ulceration or perforation is higher with increasing
NSAID doses, in patients with a history of ulcer, particularly if complicated
with haemorrhage or perforation (see section 4.3), and in the elderly. These
patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly the elderly, should report
any unusual abdominal symptoms (especially GI bleeding) particularly in the
initial stages of treatment.
Caution should be advised in patients receiving concomitant medications
which could increase the risk of ulceration or bleeding, such as corticosteroids,
or 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.
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. Nurofen back Pain SR Capsules should be
discontinued at the first appearance of skin rash, mucosal lesions, or any other
signs of hypersensitivity.
Advice for patients with sugar-related disorders:
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
The leaflet will include:
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
o have (or have had two or more episodes of) a stomach ulcer, perforation or
o are allergic to ibuprofen, to any of the ingredients, or to aspirin or other
o are taking other NSAID pain killers, or aspirin with a daily dose above
o or the patient is under 12 years of age.
Speak to your doctor or pharmacist before use if you
o Have or have had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems or are dehydrated
o Are a smoker
o Are pregnant
If symptoms persist or worsen, or if new symptoms occur, consult your doctor
or pharmacist.


Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be avoided in combination with:

Aspirin unless low-dose aspirin (not above 75mg daily) has been advised
by a doctor as this may increase the risk of adverse reactions (see Section
Experimental data suggest that ibuprofen may inhibit the effect of low
dose aspirin on platelet aggregation when they are dosed concomitantly.
However, the limitations of these data and the uncertainties regarding
extrapolation of ex vivo data to the clinical situation imply that no firm
conclusions can be made for regular ibuprofen use, and 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:
• Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding
(see section 4.4).

Antihypertensives and diuretics: since NSAIDs may diminish the effects
of these drugs. 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 or Angiotensin II antagonist and
agents that inhibit cyclo-oxygenase may result in further deterioration of
renal function, including possible acute renal failure, which is usually
reversible. These interactions should be considered in patients taking a
coxib concomitantly with ACE inhibitors or angiotensin II antagonists.
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. Diuretics can
increase the risk of nephrotoxicity of NSAIDs.

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such
as warfarin (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, reduced
GFR and increased plasma glycoside levels.

Lithium. There is evidence for potential increases in plasma levels of

Methotrexate: There is evidence for the potential increase in plasma
levels of 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

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


Fertility, pregnancy and lactation
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 embryfoetal 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,
Nurofen should not be given unless clearly necessary. If Nurofen 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,








the mother and the neonate, at the end of the 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, Nurofen is contraindicated during the third trimester of
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 regarding female fertility.

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


Undesirable effects

Adverse events which have been associated with Ibuprofen are given below, listed by
system organ class and frequency. Frequencies are defined as: very common ( 1/10),
common ( 1/100 to <1/10), uncommon ( 1/1000 to <1/100), rare ( 1/10,000 to
<1/1000), very rare (<1/10,000) and not known (cannot be estimated from the
available data). Within each frequency grouping, adverse events are presented in
order of decreasing seriousness.

The list of the following adverse events relates to those experienced with ibuprofen at
OTC doses, for short-term use. In the treatment of chronic conditions, under longterm treatment, additional adverse events may occur.
The adverse events observed most often are gastrointestinal in nature. Adverse events
are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal
bleeding is dependent on the dosage range and duration of treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at
high doses 2400mg daily) and in long-term treatment may be associated with a small
increased risk of arterial thrombotic events (for example myocardial infarction or
stroke), (see section 4.4).
System Organ Class

Very rare:

Adverse Event
pancytopenia, agranulocytosis).
First signs are: fever, sore throat, superficial
mouth ulcers, flu-like symptoms, severe
exhaustion, unexplained bleeding and
Hypersensitivity reactions consisting of1:


Urticaria and pruritus

Very rare

Severe hypersensitivity reactions.
Symptoms could be facial, tongue and
larynx swelling, dyspnoea, tachycardia,
hypotension (anaphylaxis, angioedema or
severe shock).

Not Known

Respiratory tract reactivity comprising
asthma, aggravated asthma, bronchospasm
or dyspnoea.



Very rare

Aseptic meningitis2

Cardiac Disorders

Not Known

Cardiac failure and oedema

Vascular Disorders

Not Known




Abdominal pain, nausea, dyspepsia

Blood and Lymphatic
System Disorders

Immune System

Nervous System


Diarrhoea, flatulence, constipation and

Very rare

Peptic ulcer, perforation or gastrointestinal
haemorrhage, melaena, haematemesis,
sometimes fatal, particularly in the elderly.
Ulcerative stomatitis, gastritis

Not Known

Exacerbation of ulcerative colitis and
Crohn's disease (section 4.4).
Liver disorders, especially in long-term

Hepatobiliary Disorders

Very rare

Skin and Subcutaneous
Tissue Disorders


Various skin rashes

Very rare

Severe forms of skin reactions such as
bullous reactions including StevensJohnson syndrome, erythema multiforme
and toxic epidermal necrolysis can occur.

Very rare

Acute renal failure, papillary necrosis,
especially in long-term use, associated with
increased serum urea and oedema.

Not Known

Renal insufficiency

Very rare

Decreased haemoglobin levels

Renal and Urinary Disorders


Description of Selected Adverse Reactions

Hypersensitivity reactions have been reported following treatment with ibuprofen.
These may consist of (a) non-specific allergic reactions and anaphylaxis, (b)
respiratory tract activity comprising asthma, aggravated asthma, bronchospasm,
dyspnoea or (c) assorted skin disorders, including rashes of various types pruritus,
urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses
(including epidermal necrolysis and erythema multiforme).


The pathogenic mechanism of drug-Induced aseptic meningitis is not fully
understood. However, the available data on NSAID-related aseptic meningitis points
to a hypersensitivity reaction (due to a temporal relationship with drug intake, and
disappearance of symptoms after drug discontinuation). Of note, single cases of
symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever
or disorientation) have been observed during treatment with ibuprofen, in patients
with existing auto-immune disorders (such as systemic lupus erythematosus, mixed
connective tissue disease).


In children ingestion of more than 400mg/kg may cause symptoms. In adults
the dose response effect is less clear cut. This product, sustained release
capsules, has a half life of approximately 8 hours.
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 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.




Pharmacodynamic properties
ATC Code: M01AE01
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 suggests that ibuprofen may inhibit the effect of low dose
aspirin on platelet aggregation when they are dosed concomitantly. In one
study, when a single dose of ibuprofen 400mg was taken within 8 h before or
within 30 min after immediate release dosing (81mg), a decreased effect of
acetylsalicylic acid on the formation of thromboxane of platelet aggregation
occurred. However, the limitations of these data and the uncertainties
regarding extrapolation of ex vivo data to the clinical situation imply that no
firm conclusion can be made for regular ibuprofen use, and no clinically
relevant effect is considered to be likely for occasional ibuprofen use.
The analgesic effects of a 2 capsule-dose (600mg) of sustained release
ibuprofen last for up to 12 hours


Pharmacokinetic properties
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is
extensively bound to plasma proteins.
Peak serum concentration occurs approximately 1-2 hours after administration.
Ibuprofen is metabolised in the liver to two major metabolites with primary
excretion via the kidneys, either as such or as major conjugates, together with
a negligible amount of unchanged ibuprofen. Excretion by the kidney is both
rapid and complete.
Elimination half-life is approximately 2 hours.
T½ with this formulation is prolonged from 2 to 8 hours.
No significant differences in pharmacokinetic profile are observed in the


Preclinical safety data
No relevant information, additional to that contained elsewhere in the SPC.




List of excipients
Sucrose and maize starch microgranules, polymers of methacrylic acid esters,
povidone, polymers of acrylic and methacrylic acid esters, talc, colloidal
Capsule Shells:
Gelatine, iron oxide ink (E172)




Shelf life
36 months


Special precautions for storage
Do not store above 25°C


Nature and contents of container
Blister packs composed of aluminium and opaque or clear PVC

Boxes of 12, 24, 28, 30, 36, 56 and 60 capsules


Special precautions for disposal
None stated


Reckitt Benckiser Healthcare (UK) Ltd


PL 00063/0378





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Source: Medicines and Healthcare Products Regulatory Agency

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