NUROFEN 400 MG CAPSULE SOFT

Active substance: IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurofen 400 mg Capsule, soft

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Ibuprofen 400 mg
Excipient(s):
Sorbitol (E420) 16.27 mg/capsule
Ponceau 4R (E124) 0.79 mg/capsule
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Capsule, soft
A red, oval-shaped transparent soft gelatin capsule with a nurofen logo printed in
white.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
This medical product is indicated in adults and adolescents weighing from 40 kg (12
years of age and above) for the symptomatic treatment of mild to moderate pain such
as headache, period pain, dental pain and fever and pain associated with the common
cold.

4.2

Posology and method of administration
For oral use and short-term use only. Capsules should not be chewed.
Undesirable effects may be minimized by using the lowest effective dose for the
shortest possible duration necessary to control symptoms (see section 4.4)
Adults and adolescents weighing from 40 kg (12 years of age and above). Initial dose,
one capsule with water. Then, if necessary, one capsule every six hours. Do not
exceed three capsules (1200 mg) in any 24-hour period.

If the product is required for more than 3 days in the case of fever and 4 days for
treatment of pain, or if the symptoms worsen the patient is advised to consult a
doctor.
It is recommended that patients with a sensitive stomach take Nurofen with food.
If taken shortly after eating, the onset of action of Nurofen may be delayed. If this
happens do not take more Nurofen than recommended within section 4.2 (posology)
or until the correct re-dosing interval has passed.

Special patient groups
Elderly:
No special dose adjustment is required. Because of the possible undesirable-effect
profile (see section 4.4), the elderly should be monitored particularly carefully.
Renal insufficiency:
No dose reduction is required in patients with mild to moderate impairment to renal
function (patients with severe renal insufficiency, see section 4.3).
Hepatic insufficiency (see section 5.2):
No dose reduction is required in patients with mild to moderate impairment to hepatic
function (patients with severe hepatic dysfunction, see section 4.3).
Children and adolescents:
For use in children and adolescents, see section 4.3.

4.3

Contraindications




In patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma,
rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid
(ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs).



History of gastrointestinal bleeding or perforation, related to previous NSAIDs
therapy.



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



Patients with severe hepatic failure, severe renal failure, or severe heart failure. See
also section 4.4.



In patients with cerebrovascular or other active bleeding.



In patients with bleeding diathesis or coagulation disorders.



In patients with unclarified blood-formation disturbances.



In patients with severe dehydration (caused by vomiting, diarrhoea or insufficient
fluid intake).



During the last trimester of pregnancy (see Section 4.6).



4.4

Hypersensitivity to the active substance, ponceau 4R (E124) or to any of the other
excipients listed in section 6.1.

Adolescents weighing less than 40 kg or children under 12 years of age.

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the
shortest possible duration necessary to control symptoms (see gastrointestinal (GI)
and cardiovascular risks below).



Caution is required in patients with certain conditions, which may be made
worse:



systemic lupus erythematosus and mixed connective tissue disease –
increased risk of aseptic meningitis (see section 4.8).



congenital disorder of porphyrin metabolism (e.g. acute intermittent
porphyria).



gastrointestinal disorders and chronic inflammatory intestinal disease
(ulcerative colitis, Crohn’s disease) (see section 4.8).



hypertension and/or cardiac impairment (see section 4.3 and 4.8).



renal impairment as renal function may deteriorate (see sections 4.3 and 4.8).



hepatic dysfunction (see sections 4.3 and 4.8).



directly after major surgery.



in patients who show allergic reactions to other substances, as they are also at
a higher risk of hypersensitivity reactions when using Nurofen



in patients who suffer from hayfever, nasal poyps,chronic obstructive
respiratory disorders, or have a history of allergic disease, as an increased risk
exists for them of allergic reactions occurring. These may present as asthma
attacks (so-called analgesics asthma). Quincke’s oedema or urticaria.

Gastrointestinal (GI) safety
The use with concomitant NSAID’s, including cyclo-oxygenase-2 specific inhibitors,
increases risk of adverse reactions (see section 4.5) and should be avoided.
Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially
gastrointestinal (GI) bleeding and perforation which may be fatal. (see section 4.2)
Gastrointestinal (GI) bleeding, ulceration or perforation:
Gastrointestinal (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 GI events.
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment
should be withdrawn.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID
doses and 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 acetylsalicylic
acid, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

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 oral corticosteroids, anticoagulants
such as warfarin, selective serotonin-reuptake inhibitors (SSRI’s) or anti-platelet
agents such as aspirin (See section 4.5).
NSAID’s 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).
Skin reactions
Serious skin reactions, some of them fatal, including exfoliative dermatitis, StevensJohnson syndrome and toxic epidermal necrolysis, have been reported very rarely in
association with the use of NSAIDs (see section 4.8). Patients appear to be at highest
risk of these reactions early in the course of therapy: the onset of the reaction
occurring in the majority of cases within the first month of treatment. Nurofen 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 tissues
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 Nurofen
in case of varicella.
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 the use of ibuprofen, particularly
at high doses (2400 mg 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. 1200 mg daily) is associated with an increased risk of myocardial infarction.



Other notes
Severe acute hypersensitivity reactions (for example anaphylactic shock) are
observed very rarely. At the first signs of a hypersensitivity reaction after
taking/administering Nurofen therapy must be stopped. Medically required measures,
in line with the symptoms, must be initiated by specialist personnel.
Ibuprofen, the active substance of Nurofen may temporarily inhibit the blood-platelet
function (thrombocyte aggregation). Therefore, it is recommended to monitor patients
with coagulation disturbances carefully.

In prolonged administration of Nurofen regular checking of the liver values, the
kidney function, as well as of the blood count, is required.
Prolonged use of any type of painkiller for headaches can make them worse. If this
situation is experienced or suspected, medical advice should be obtained and
treatment should be discontinued. The diagnosis of medication overuse headache
(MOH) should be suspected in patients who have frequent or daily headaches despite
(or because of) the regular use of headache medications.
The habitual intake of painkillers, particularly the combination of several painkillers,
may lead to permanent renal damage with the risk of renal failure (analgesic
nephropathy). This risk may be increased by salt loss and dehydration.
Through concomitant consumption of alcohol, active substance-related undesirable
effects, particularly those that concern the gastrointestinal tract or the central nervous
system, may be increased on use of NSAID’s.
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 (see section 4.6).
The medicinal product contains sorbitol. Patients with rare hereditary problems of
fructose intolerance should not take this medicine.
This medicinal product contains Ponceau 4R(E124). It may cause allergic reactions.

4.5

Interaction with other medicinal products and other forms of interaction
Acetylsalicylic acid (low dose):
Ibuprofen should be avoided in combination with acetylsalicylic acid unless low dose
acetylsalicylic acid (not above 75mg daily) has been advised by a doctor, as this may
increase the risk of adverse reactions (see section 4.4). Experimental data suggest that
ibuprofen may inhibit the effect of low dose acetylsalicylic acid on platelet
aggregation when they are dosed concomitantly. However, the limitation 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 clinical
relevant effect is considered to be likely for occasional ibuprofen use (see section
5.1).
Other NSAIDs, including cyclooxygenase-2 selective inhibitors:
The concomitant administration of several NSAIDs may increase the risk of
gastrointestinal ulcers and bleeding due to a synergistic effect. The concomitant use
of ibuprofen with other NSAIDs should therefore be avoided (see section 4.4).

Digoxin, phenytoin, lithium:
The concomitant use of Nurofen with digoxin, phenytoin or lithium preparations may
increase serum levels of these medicinal products. A check of serum-lithium, serumdigoxin and serum-phenytoin levels is not as a rule required on correct use (maximum
over 4 days).
Corticosteroids:
Corticosteriods as these may increase the risk of adverse reactions, especially of the
gastrointestinal tract (gastrointestinal ulceration or bleeding). (see Section 4.3)
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding. (See section 4.4).

Anticoagulants:
NSAIDs may enhance the effect of anti-coagulants, such as warfarin (see section 4.4).
Probenecid and sulfinpyrazone:
Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion
of ibuprofen.
Diuretics, ACE inhibitors, betareceptor-blocker and angiotensin-II antagonists:
NSAIDs may reduce the effect of diuretics and other antihypertensive 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,
betareceptor-blocker or angiotensin-II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible
acute renal failure, which is usually reversible. Therefore, the combination should be
administered with caution, especially in the elderly. Patients should be adequately
hydrated and consideration should be given to monitoring of renal function after
initiation of concomitant therapy, and periodically thereafter.
Potassium sparing diuretics:
The concomitant administration of Nurofen and potassium-sparing diuretics may lead
to hyperkalaemia (check of serum potassium is recommended).
Methotrexate:
The administration of Nurofen within 24 hours before or after administration of
methotrexate may lead to elevated concentrations of methotrexate and an increase in
its toxic effect.

Ciclosporin:
The risk of a kidney-damaging effect due to ciclosporin is increased through the
concomitant administration of certain nonsteroidal antiinflammatory drugs. This
effect also cannot be ruled out for a combination of ciclosporin with ibuprofen.
Tacrolimus:
The risk of nephrotoxicity is increased if the two medicinal products are administered
concomitantly
Zidovudine:
There is evidence of an increased risk of haemarthroses and haematoma in HIV (+)
haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Increased risk of haematological toxicity when NSAIDs are given with zidovudine.
Sulfonylureas:
Clinical investigations have shown interactions between nonsteroidal antiinflammatory drugs and antidiabetics (sulphonylureas). Although interactions
between ibuprofen and sulphonylureas have not been described to date, a check of
blood-glucose values is recommended as a precaution on concomitant intake.
Quinolone antibiotics:
Animal data indicate that NSAID’s can increase the risk of convulsions associated
with quinolone antibiotics. Patients taking NSAID’s and quinolones may have an
increased risk of developing convulsions.
Mifepristone:
NSAIDs should not be used for 8-12 days after mifepristone administration as
NSAIDs can reduce the effect of mifepristone.

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 raise concern about 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 pre- and post-implantation loss and embryo-foetal lethality. In

addition, increased incidences of various malformations, including cardiovascular,
have been reported in animals given a prostaglandin synthesis inhibitor during the
organogenetic period.
During the first and second trimester of pregnancy, ibuprofen should not be given
unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or
during the first and second trimester of pregnancy, the dose should be kept as low and
duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may
expose

the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and
pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the 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.
Lactation:
Ibuprofen and its metabolites can pass in low concentrations into the breast milk. No
harmful effects to infants are known to date, so for short-term treatment with the
recommended dose for pain and fever interruption of breast-feeding would generally
not be necessary.

Fertility:
The use of ibuprofen may affect female fertility. This effect is reversible on
withdrawal of treatment.
Therefore use of ibuprofen is not recommended in women having difficulties
becoming pregnant (see
section 4.4.).

4.7

Effects on ability to drive and use machines
Patients who experience dizziness, drowsiness, vertigo or visual disturbances while
they are taking ibuprofen, should avoid driving or using machinery. Single
administration or short term use of ibuprofen does not usually warrant the adoption of
any special precautions. This applies to a greater extent in combination with alcohol.

4.8

Undesirable effects
The list of the following undesirable effects comprises all undesirable effects that
have become known under treatment with ibuprofen, also those under high-dose long-

term therapy in rheumatism patients. The stated frequencies, which extend beyond
very rare reports, refer to the short-term use of daily doses up to a maximum of 1200
mg ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.
With the following adverse drug reactions, it must be accounted for that they are
predominantly dose-dependent and vary interindividually.
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,
exacerbation of colitis and Crohn's disease (see section 4.4) have been reported
following administration. Less frequently, gastritis has been observed. Particularly the
risk of gastrointestinal bleeding occurring is dependent on the dose range and the
duration of use.
Oedema, hypertension and cardiac failure have been reported in association with
NSAID treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at
high dose (2400 mg 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).
Hypersensitivity reactions have been reported and these may consist of:
(a)

non-specific allergic reactions and anaphylaxis

(b)

respiratory tract reactivity, eg 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 patient is to be instructed to inform a doctor at once and to stop taking Nurofen
Express if they experience any of the above.
Please note that within each frequency grouping, undesirable effects are presented in
order of decreasing seriousness.

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 nonsteroidal anti-inflammatory drugs
has been described. This is possibly associated with the mechanism of action of the
nonsteroidal anti-inflammatory drugs.
If signs of an infection occur or get worse during use of Nurofen, the patient is
therefore recommended to go to a doctor without delay. It is to be investigated
whether there is an indication for an anti-infective/antibiotic therapy.
The symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting,
fever or consciousness clouding have been observed under ibuprofen. Patients with
autoimmune disorders (SLE, mixed connective-tissue disease) appear to be
predisposed.
Blood and Lymphatic System Disorders:
Very rare: Disturbances to blood formation (anaemia, leukopenia, thrombocytopenia,
pancytopenia, agranuloctosis). The first signs may be fever, sore throat, superficial
wounds in the mouth, influenza-like complaints, severe lassitude, nosebleeds and skin
bleeding. In such cases the patient should be advised to discontinue the medicine
immediately, to avoid any self-medication with analgesics or antipyretics and to
consult a physician.
The blood count should be checked regularly in long-term therapy

Immune system disorders (Hypersensitivity):
Uncommon: Hypersensitivity reactions with urticaria and pruritus, as well as asthma
attacks (possibly with drop in blood pressure).
Very rare: severe general hypersensitivity reactions. Symptoms could be: facial,
tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis,
angioedema or severe shock).
Exacerbation of asthma and bronchospasm.

Psychiatric disorders:
Very rare: Psychotic reactions, depression

Nervous System Disorders:
Uncommon: Central nervous disturbances such as headache, dizziness, sleeplessness,
agitation, irritability or tiredness

Eye disorders:
Uncommon: Visual disturbances

Ear and labyrinth disorders:
Rare: Tinnitus

Cardiac Disorders:
Very rare: palpitations, heart failure, myocardial infarction
Vascular disorders:
Very rare: Arterial hypertension

Gastrointestinal Disorders:
Common: Gastro-intestinal complaints such as dyspepsia, pyrosis, abdominal pain,
nausea, vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood
losses that may cause anaemia in exceptional cases
Uncommon: Gastrointestinal ulcers, potentially with bleeding and perforation.
Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4),
gastritis
Very rare: Oesophagitis, pancreatitis, formation of intestinal diaphragm-like
strictures.
The patient is to be instructed to withdraw the medicinal product and to go to a doctor
immediately if severe pain in the upper abdomen or melaena or haematemesis occurs.

Hepatobiliary Disorders:
Very rare: Hepatic dysfunction, hepatic damage, particularly in long-term therapy,
hepatic failure, acute hepatitis
Skin and Subcutaneous Tissue Disorders:
Very rare: Bullous reactions including Stevens-Johnson syndrome and toxic
epidermal necrolysis, alopecia. In exceptional cases, severe skin infections and softtissue complications may occur during a varicella infection (see also "Infections and
infestations").
Renal and Urinary Disorders :

Rare: Kidney-tissue damage (papillary necrosis) and elevated uric acid concentrations
in the blood may also occur rarely
Very rare: Formation of oedemas, particularly in patients with arterial hypertension or
renal insufficiency, nephrotic syndrome, interstitial nephritis that may be
accompanied by acute renal insufficiency. Renal function should therefore be
checked regularly.

4.9

Overdose
In adolescents and adults the dose response effect is not 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 dizziness,
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
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, nonsteroids; propionic acid derivative
ATC Code: M01A E01

Nurofen is a nonsteroidal anti-inflammatory drug (NSAID) that in the conventional
animal-experiment inflammation models has proven to be effective via prostaglandinsynthesis inhibition. In humans, ibuprofen reduces inflammatory-related pain,
swellings and fever. Furthermore, ibuprofen reversibly inhibits ADP – and collagen –
induced platelet aggregation
Experimental data suggests that ibuprofen may inhibit the effect of low dose ASA 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 ASA dosing (81 mg), a decreased effect of ASA 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.

5.2

Pharmacokinetic properties
On oral administration, ibuprofen is partly absorbed in the stomach and then
completely in the small intestine.
Following hepatic metabolism (hydroxylation, carboxylation, conjugation), the
pharmacologically inactive metabolites are completely eliminated, mainly renally
(90 %), but also with the bile. The elimination half-life in healthy individuals and
those with liver and kidney diseases is 1.8 - 3.5 hours. Plasma-protein binding is
about 99 %.
Peak plasma levels following oral administration of a normal-release pharmaceutical
form (tablet) are reached after 1 - 2 hours. Ibuprofen is absorbed rapidly from the
gastrointestinal tract following oral administration. In a pharmacokinetic study (R071009), the time to peak plasma levels (median Tmax) in fasted state, for normalrelease pharmaceutical form ibuprofen acid tablets (Nurofen tablets) was 90 min
compared with 40 min for Nurofen Capsules, soft. Ibuprofen is detected in the plasma
for more than 8 hours after administration of Nurofen .

5.3

Preclinical safety data
The subchronic and chronic toxicity of ibuprofen in animal experiments was observed
principally as lesions and ulcerations in the gastro-intestinal tract. In vitro and in vivo
studies gave no clinically relevant evidence of a mutagenic potential of ibuprofen. In
studies in rats and mice no evidence of carcinogenic effects of ibuprofen was found.
Ibuprofen led to inhibition of ovulation in rabbits as well as disturbance of
implantation in various animal species (rabbit, rat, mouse). Experimental studies have
demonstrated that ibuprofen crosses the placenta, for maternally toxic doses, an
increased incidence of malformations (e.g. ventricular septal defects) was observed.

In animal studies it has been observed that the use of NSAIDs, known to inhibit
prostaglandin synthesis, may increase the incidence of dystocia and delayed
parturition.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Fill
Macrogol 600
Potassium hydroxide
Purified water
Capsule Shell:
Gelatin
Sorbitol Liquid (E420)
Ponceau 4R (E124)
Ink:
Titanium Dioxide (E171),
Propylene Glycol,
Hypromellose (E464).
Processing Aids:
Triglycerides (medium chain)
Lecithin (E322)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life

2 years

6.4

Special precautions for storage
Do not store above 25°C. Store in the original package to protect from moisture.
Do not refrigerate or freeze.

6.5

Nature and contents of container
Blister, white opaque PVC/ PVDC aluminium. Each blister tray contains 2, 4, 6, 8,
10, 12, 16, 20, 24, 30, 40 or 50 capsules, soft. The blisters are packed in a cardboard
carton. Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0615

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/02/2012

10

DATE OF REVISION OF THE TEXT
01/02/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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