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IBULAR TABLETS 200MG

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Ibular Tablets 200mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of Ibuprofen

3

PHARMACEUTICAL FORM
Coated Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Ibular is indicated for its anti-inflammatory and analgesic effect in the
treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or
still's disease), ankylosing spondylitis, osteoarthrosis and other nonrheumatoid (sero-negative) arthropathies. In treatment of non-articular
rheumatic conditions Ibular is indicated in periarticular conditions such as
capsulitis, bursitis tendinitis, tenosynovitis and low back pain: it can also be
used in soft tissue injuries such as sprains and strains. Ibular may be taken on
an empty stomach without gastric discomfort - a valuable aid to relieving early
morning stiffness.

4.2

Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see section 4.4).
Adults: Recommended initial dosage of Ibular is 1,200mg daily in divided
doses. Some patients can be maintained on 600 - 1200mg daily. In severe
conditions dosage can be increased to 1600mg daily in divided doses until the
acute phase is brought under control.
Children: 20mg ibuprofen per kg of body weight daily. Children weighing
less than 30kg - total dose of Ibular in 24 hours should not exceed 500mg.

4.3

Contraindications
Ibular is contraindicated in patients with hypersensitivity to the active
substance or to any of the excipients.
Ibular should not be used in patients who have previously shown
hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis)
after taking ibuprofen, aspirin or other NSAIDs.

Ibular is also contraindicated in patients with a history of gastrointestinal
bleeding or perforation, related to previous NSAID therapy. Ibular should
not be used in patients with active, or history of, recurrent peptic ulcer or
gastrointestinal haemorrhage (two or more distinct episodes of proven
ulceration or bleeding).
Ibular should not be given to patients with conditions involving an increased
tendency to bleeding.
Ibular is contraindicated in patients with severe heart failure (NYHA Class
IV), hepatic failure and renal failure (see section 4.4).
Ibular is contraindicated during the last trimester of pregnancy (see section
4.6).
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 section 4.2, and GI
and cardiovascular risks below).
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactose deficiency or glucose-galactose malabsorption should not take this
medication.
As with other NSAIDs, ibuprofen may mask the signs of
infection.
The use of Ibular with concomitant NSAIDs, including cyclooxygenase-2
selective inhibitors, should be avoided due to the increased risk of ulceration
or bleeding (see section 4.5).
Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs,
especially gastrointestinal bleeding and perforation, which may be fatal
(see section 4.2).
Paediatric population
There is a risk of renal impairment in dehydrated children and adolescents.
Gastrointestinal bleeding, ulceration and
perforation
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), 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 requiring concomitant low dose aspirin, or other drugs likely to
increase gastrointestinal risk (see below and section 4.5).

Patients with a history of gastrointestinal disease, particularly when elderly,
should report any unusual abdominal symptoms (especially gastrointestinal
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 Ibular, the
treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of ulcerative
colitis or Crohn's disease as these conditions may be exacerbated (see
section
4.
8).
Respiratory
disorders
Caution is required if Ibular is administered to patients suffering from, or with
a history of, bronchial asthma, chronic rhinitis or allergic diseases since
NSAIDs have been reported to precipitate bronchospasm, urticaria or
angioedema in such patients.
Cardiac, renal and hepatic impairment
The administration of an NSAID may cause a dose dependent reduction in
prostaglandin formation and precipitate renal failure. The habitual
concomitant intake of various similar painkillers further increases this risk.
Patients at greatest risk of this reaction are those with impaired renal
function, cardiac impairment, liver dysfunction, those taking diuretics and
the elderly. For these patients, use the lowest effective dose, for the shortest
possible duration and monitor renal function especially in long-term treated
patients (see also section 4.3).
Ibular should be given with care to patients with a history of heart failure or
hypertension since oedema has been reported in association with ibuprofen
administration.
Cardiovascular
and
cerebrovascular
effects
Appropriate monitoring and advice are required for patients with a history of
hypertension and/or mild to moderate congestive heart failure as fluid
retention and oedema have been reported in association with NSAID
therapy.
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 such as 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.
Renal
effects
Caution should be used when initiating treatment with ibuprofen in patients
with considerable dehydration.
As with other NSAIDs, long-term administration of ibuprofen has resulted in
renal papillary necrosis and other renal pathologic changes. Renal toxicity
has also been seen in patients in whom renal prostaglandins have a
compensatory role in the maintenance of renal perfusion. In these patients,
administration of an NSAID may cause a dose-dependant reduction in
prostaglandin formation and, secondarily, in renal blood flow, which may
precipitate overt renal decompensation. Patients at greatest risk of this
reaction are those with impaired renal function, heart failure, liver
dysfunction, those taking diuretics and ACE inhibitors and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the
pre-treatment state.
SLE and mixed connective tissue
disease
In patients with systemic lupus erythematosus (SLE) and mixed connective
tissue disorders there may be an increased risk of aseptic meningitis
(see below and section 4.8).
Dermatological effects
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 of these reactions early in the course of
therapy, the onset of the reaction occurring within the first month of
treatment in the majority of cases. Ibular should be discontinued at the first
appearance of skin rash, mucosal lesions, or any other sign of
hypersensitivity.
Haematological
effects
Ibuprofen, like other NSAIDs, can interfere with platelet aggregation and
has been shown to prolong bleeding time in normal subjects.
Aseptic
meningitis
Aseptic meningitis has been observed on rare occasions in patients
on ibuprofen therapy. Although it is probably more likely to occur in
patients with systematic lupus erythematosus and related connective tissue

diseases, it has been reported in patients who do not have an underlying
chronic disease.
Impaired
female
fertility
The use of Ibular may impair female fertility and is not recommended in
women attempting to conceive. In women who have difficulties conceiving
or who are undergoing investigation of infertility, withdrawal of Ibular
should be considered.
4.5

Interaction with other medicinal products and other forms of interaction
Care should be taken in patients treated with any of the following drugs as
interactions have been reported in some patients.

Anti-hypertensives, beta-blockers and diuretics: NSAIDs may reduce the
effect of anti-hypertensives, such as ACE inhibitors, beta blockers and
diuretics. Diuretics can also increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma cardiac glycoside levels.
Cholestyramine: The concomitant administration of ibuprofen and
cholestyramine may reduce the absorption of ibuprofen in the gastrointestinal
tract. However, the clinical significance is unknown
Lithium: Decreased elimination of lithium.
Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and
reduce clearance of methotrexate.
Ciclosporin:
nephrotoxicity.

Increased

risk

of

Mifepristone: A decrease in the efficacy of the medicinal product can
theoretically occur due to the antiprostaglandin properties of NSAIDs. Limited
evidence suggests that coadministration of NSAIDs on the day of
prostaglandin administration does not adversely influence the effects of
mifepristone or the prostaglandin on cervical ripening or uterine contractility
and does not reduce the clinical efficacy of medicinal termination of
pregnancy.
Other analgesics and cyclooxygenase-2 selective inhibitors: Avoid
concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this
may increase the risk of adverse effects (see section 4.4).
Aspirin (Acetylsalicylic acid): As with other products containing NSAIDs,
concomitant administration of ibuprofen and aspirin 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 aspirin 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 use (see section 5.1).
Corticosteroids: Increased risk of gastro-intestinal ulceration or bleeding with
NSAIDs (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as
warfarin (see section 4.4).
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.
Sulfonylureas: NSAIDs may potentiate the effects of sulfonylurea
medications. There have been rare reports of hypoglycaemia in patients on
sulfonylurea medications receiving ibuprofen.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding with NSAIDs (see section 4.4).
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.
Aminoglycosides: NSAIDs may decrease the excretion of
aminoglycosides.
Herbal extracts: Ginkgo biloba may potentiate the risk of bleeding with
NSAIDs.
CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9
inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a
study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased
S(+)- ibuprofen exposure by approximately 80 to 100% has been shown.
Reduction of the ibuprofen dose should be considered when potent CYP2C9
inhibitors are administered concomitantly, particularly when high-dose
ibuprofen is administered with either voriconazole or fluconazole.

4.6

Fertility, pregnancy and lactation
Pregnan
cy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy
and/or embryo/foetal development. Data from epidemiological studies suggest
an increased risk of miscarriage and of cardiac malformation and gastroschisis
after the use of a prostaglandin synthesis inhibitor in early pregnancy. In
animals, the administration of a prostaglandin synthesis inhibitor has been
shown to result in increased pre- and post-implantation losses 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, Ibular should not be given
unless clearly necessary. If Ibular is used by a woman attempting to conceive,
or during the first or 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 the following:
• Cardiopulmonary toxicity (with premature closure of the ductus arteriosus
and pulmonary hypertension)
• Renal dysfunction, which may progress to renal failure with
oligohydramnios.
At the end of pregnancy, prostaglandin synthesis inhibitors may expose the
mother and the neonate to the following:
• Possible prolongation of bleeding time
• Inhibition of uterine contractions, which may result in delayed or prolonged
labour.
Consequently, Ibular is contraindicated during the third trimester of
pregnancy.
Lactation
In the limited studies so far available, NSAIDs can appear in the breast milk in
very low concentrations . NSAIDs should, if possible, be avoided when
breastfeeding.
See section 4.4 Special warnings and precautions for use, regarding female
fertility

4.7

4.8

Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual
disturbances are possible after taking NSAIDs. If affected, patients should not
drive or operate machinery.
Undesirable effects

Gastrointestinal disorders: The most commonly observed adverse events 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, gastrointestinal haemorrhage,
exacerbation of colitis and Crohn's disease (see section 4.4) have been
reported following ibuprofen administration. Less frequently, gastritis,
duodenal ulcer, gastric ulcer and gastrointestinal perforation have been
observed.
Immune system disorders: Hypersensitivity reactions have been reported
following treatment with NSAIDs. These may consist of (a) non-specific
allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising
asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin
disorders, including rashes of various types, pruritus, urticaria, purpura,
angioedema and, very rarely, erythema multiforme, exfoliative and bullous
dermatoses (including Stevens- Johnson syndrome and toxic epidermal
necrolysis).
Cardiac disorders and vascular disorders: Oedema, hypertension and cardiac
failure have been reported in association with NSAID treatment. Clinical
studies suggest that use of ibuprofen, particularly at high dose (2400 mg/
daily), may be associated with a small increased risk of arterial thrombotic
events such as myocardial infarction or stroke (see section 4.4).
Infections and infestations: Rhinitis and aseptic meningitis (especially in
patients with existing autoimmune disorders, such as systemic lupus
erythematosus and mixed connective tissue disease) with symptoms of stiff
neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Exacerbation of infection-related inflammations coinciding with the use of
NSAIDs has been described. 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.
Skin and subcutaneous tissue disorders: In exceptional cases, severe skin
infections and soft-tissue complications may occur during a varicella infection
(see also "Infections and infestations")
The following adverse reactions possibly related to ibuprofen and displayed
by MedDRA frequency convention and system organ classification.
Frequency groupings are classified according to the subsequent conventions:
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) and Not known
(cannot be estimated from the available data).

System organ class
Infections and infestations

Frequency Adverse reaction
Uncommon Rhinitis
Rare
Meningitis aseptic (see section 4.4)

Blood and lymphatic system
disorders

Rare

Immune system disorders
Psychiatric disorders

Rare
Uncommon
Rare
Common
Uncommon
Rare
Uncommon
Rare
Uncommon
Uncommon

Nervous system disorders

Eye disorders
Ear and labyrinth disorders
Respiratory, thoracic and
mediastinal disorders
Gastrointestinal disorders

Hepatobiliary disorders

Skin and subcutaneous tissue
disorders

Renal and urinary disorders

General disorders and
administration site conditions

Leukopenia, thrombocytopenia,
neutropenia, agranulocytosis, aplastic
anaemia , haemolytic anaemia
Anaphylactic reaction
Insomnia, anxiety
Depression, confusional state
Headache, dizziness
Paraesthesia, somnolence
Optic neuritis
Visual impairment
Toxic optic neuropathy
Hearing impaired , tinnitus, vertigo
Asthma, bronchospasm, dyspnoea

Common

Dyspepsia, diarrhoea, nausea,
vomiting,
abdominal pain, flatulence,
constipation,
melaena, haematemesis,
gastrointestinal
haemorrhage
Uncommon Gastritis, duodenal ulcer, gastric ulcer,
mouth
ulceration, gastrointestinal perforation
Very rare
Pancreatitis
Not known Exacerbation of Colitis and Crohn´s
disease
Uncommon Hepatitis, jaundice, hepatic function
abnormal
Very rare
Hepatic failure
Common
Rash
Uncommon Urticaria, pruritus, purpura,
angioedema,
photosensitivity reaction
Very rare
Severe forms of skin reactions ( e.g.
Erythema
multiforme, bullous reactions,
including StevensJohnson syndrome,and toxic epidermal
necrolysis)
Uncommon Nephrotoxity in various forms
e.g.Tubulointerstitial nephritis,
nephrotic
syndrome and renal failure
Common
Fatigue

Cardiac disorders

Rare
Very rare

Vascular disorders

Very rare

Oedema
Cardiac failure, myocardial infarction
(also see
section 4.4)
Hypertension

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
Toxicity
Signs and symptoms of toxicity have generally not been observed at doses
below 100 mg/kg in children or adults. However, supportive care may be
needed in some cases. Children have been observed to manifest signs and
symptoms of toxicity after ingestion of more than 400mg/kg or greater
Symptoms
Most patients who have ingested clinically important amounts of NSAIDs will
manifest symptoms within 4 to 6 hours.
The most frequently reported symptoms of overdose include nausea,
vomiting, abdominal pain, lethargy and drowsiness. Central nervous
system (CNS) effects include tinnitus, headache, dizziness, convulsion, and
loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal
effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression
of the CNS and respiratory system have also been rarely reported.
Disorientation, excitation, fainting and cardiovascular toxicity, including
hypotension, bradycardia and tachycardia have been reported. In cases of
significant overdose, renal failure and liver damage are possible. Large
overdoses are generally well tolerated when no other drugs are being taken.
Therapeutic measures
Patients should be treated symptomatically as required. Within 1 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
Frequent or prolonged convulsions should be treated with intravenous
diazepam. Other measures may be indicated by the patient’s clinical
condition.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic classification: Anti-inflammatory and antirheumatic
products, nonsteroidal; propionic acid derivatives.
ATC code: M01AE01
Ibuprofen is a propionic acid derivative with analgesic, antiinflammatory and anti-pyretic activity. The drug's therapeutic effects as
an NSAID is thought to result from its inhibitory effect on the enzyme
cyclo-oxygenase, which results in a marked reduction in prostaglandin
synthesis.
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin on platelet aggregation when they are dosed
concomitantly. Some pharmacodynamic studies show that when single doses
of ibuprofen 400mg were taken within 8 hours before or within 30 minutes
after immediate release aspirin dosing (81mg), a decreased effect of aspirin 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 from the gastrointestinal tract, peak serum
concentrations occurring 1-2 hours after administration. The elimination halflife is approximately 2 hours.
Ibuprofen is metabolised in the liver to two inactive metabolites and these,
together with unchanged ibuprofen, are excreted by the kidney either as such
or as conjugates. Excretion by the kidney is both rapid and complete.
Ibuprofen is extensively bound to plasma proteins.
5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Povidone
Maize starch

Purified talc
Magnesium stearate
Colloidal sodium
Coat:
Povidone
Gelatin
Macrogol 1540
Calcium carbonate
Purified talc
Sucrose
Erythrosine BS

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store in a cool, dry place

6.5

Nature and contents of container
Securitainer containing 14, 28, 30, 56, 60, 84, 90, 100 and 500 tablets.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Ennogen Pharma Limited
Unit G4,
Riverside Industrial Estate,
Riverside Way,
Dartford
DA1 5BS
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 40147/0048

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/10/1984

10

DATE OF REVISION OF THE TEXT
19/08/2016

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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