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NUROFEN EXPRESS PERIOD PAIN 200MG SOFT CAPSULES

Active substance(s): IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurofen Express Period Pain 200mg soft capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains Ibuprofen 200mg
Excipients with known effects:
Sorbitol
Ponceau 4R (E124)
Potassium hydroxide 50% solution (E525)

For a full list of excipients see 6.1.

3

PHARMACEUTICAL FORM
Capsule, soft
A clear red oval soft gelatin capsule printed with an identifying logo in white.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Adults and children over 12 years:
Nurofen Express Period Pain 200mg Soft Capsules are indicated for the symptomatic
relief from dysmenorrhoea and associated symptoms: muscular pain, backache,
headache and migraine pain.

4.2

Posology and method of administration
For oral administration and short-term use only.
Adults, the elderly and children and adolescents between 12 and 18 years:

Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see section 4.4).
If in children and adolescents between 12 and 18 years this medicinal product
is required for more than 3 days, or if symptoms worsen a doctor should be
consulted.
Adults should consult a doctor if symptoms persist or worsen, or if the product
is required for more than 10 days.
Children and Adolescents between 12 and 18 years: Take one or two
capsules, up to three times a day as required.
Adults: Take one or two capsules, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 6 capsules in any 24 hour period.

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 (NSAIDs).
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.)
Last trimester of pregnancy

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).
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 history
of, bronchial asthma or allergic disease.
Other NSAIDs:

The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2
selective inhibitors should be avoided (see section 4.5)
SLE and mixed connective tissue disease:
Systemic lupus erythematosus as well as mixed connective tissue disease –
increased risk of aseptic meningitis (see section 4.8).
Renal:
Renal impairment as renal function may further deteriorate (see sections 4.3
and 4.8)
There is a risk of renal impairment in dehydrated children and adolescents
Hepatic:
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 studies suggest that the 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 in an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA IIIII), established ischaemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease should only be treated with ibuprofen after careful
consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term
treatment of patients with risk factors for cardiovascular events (e.g.
hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if
high doses of ibuprofen (2400 mg/day) are required.
Impaired female fertility:
There is 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.
Gastrointestinal:
NSAIDs should be given with care to patients with a history of gastrointestinal
disease (ulcerative colitis, Crohn’s disease) as these conditions may be
exacerbated (see section 4.8).
GI bleeding, ulceration or perforation, which can be fatal has been reported
with all NSAIDs at any time during treatment, with or without warning
symptoms or a previous history of GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing
NSAID doses, in patients with a history of ulcer, particularly if complicated

with haemorrhage or perforation (see section 4.3), and in the elderly. These
patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly 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 or anti-platelet agents such as aspirin (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the
treatment should be withdrawn.
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis,
Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been
reported very rarely in association with the use of NSAIDs (see section 4.8).
Patients appear to be at highest risk for these reactions early in the course of
therapy: the onset of the reaction occurring in the majority of cases within the
first month of treatment. Ibuprofen should be discontinued at the first
appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
• have (or have had two or more episodes of) a stomach ulcer, perforation or
bleeding


are allergic to ibuprofen, to any of the ingredients, or to aspirin or other
painkillers



are taking other NSAID pain killers or aspirin with a daily dose above
75mg

Speak to a pharmacist or your doctor before taking if you:
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems


Are a smoker



Are pregnant

This medicine contains 14 mg potassium per capsule. To be taken into consideration
by patients with reduced kidney function or patients on a controlled potassium diet.

Contains Sorbitol. Patients with rare hereditary problems of fructose
intolerance should not take this medicine.
Also contains Ponceau 4R (E124) which may cause allergic reactions.
If symptoms persist or worsen, or if new symptoms occur, consult your doctor
or pharmacist.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be avoided in combination with:
• Aspirin (acetylsalicylic acid): Concomitant administration of ibuprofen and
acetylsalicylic acid is not generally recommended because of the potential of
increased adverse effects, unless low-dose aspirin (not above 75mg daily)

has been advised by a doctor (see Section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin (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).


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: as these may increase the risk of gastrointestinal
ulceration or bleeding (see Section 4.4)


Antihypertensives (ACE inhibitors and Angiotensin II Antagonists) 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, reduce GFR
and increase plasma glycoside levels.



Lithium: There is evidence for potential increase in plasma levels of
lithium.



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



Ciclosporin: Increased risk of nephrotoxicity.

4.6



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
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.

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 pre- and post-implantation loss and embryofoetal 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, which may progress to renal failure with oligohydroamniosis;
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 pregnancy.

Lactation/Breastfeeding:
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.

4.7

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

4.8

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 effects relates to those experienced with
ibuprofen at OTC doses (maximum 1200mg per day), for short-term use. In
the treatment of chronic conditions, under long-term treatment, additional
adverse effects 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 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).
System Organ
Class
Blood and
Lymphatic
System Disorders

Immune System

Frequency

Adverse Event

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.
Hypersensitivity reactions

consisting of1:

Disorders
Uncommon

Urticaria and pruritus
Very rare
Severe hypersensitivity
reactions.

Not Known

Symptoms could be facial,
tongue and laryngeal swelling,
dyspnoea, tachycardia,
hypotension (anaphylaxis,
angioedema or severe shock).
Respiratory tract reactivity
comprising asthma, aggravated
asthma, bronchospasm or
dyspnoea.

Nervous System

Uncommon

Headache

Very rare

Aseptic meningitis2

Cardiac Disorders

Not Known

Cardiac failure and oedema

Vascular Disorders

Not Known

Hypertension

Gastrointestinal

Uncommon

Abdominal pain, nausea,
dyspepsia

Disorders

Disorders
Rare

Diarrhoea, flatulence,
constipation and
vomiting
Very rare

Not Known

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

Exacerbation of colitis and
Crohn's disease (section 4.4).
Hepatobiliary
Disorders

Very rare

Liver disorders

Skin and
Subcutaneous

Uncommon

Various skin rashes

Tissue Disorders

Very rare

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

Renal and Urinary
Disorders

Very rare

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

Not Known
Renal insufficiency
Investigations

Very rare

Decreased haemoglobin levels

Description of Selected Adverse Reactions
1

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).

2

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).

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
ATC Code: M01A E01 Propionic acid derivative.
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.
Clinical evidence demonstrates that when 400mg of ibuprofen is taken the
pain relieving effects can last for up to 8 hours.

Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are
dosed concomitantly. Some pharmacodynamics studies show that when single
doses of ibuprofen 400mg were taken within 8 h before or within 30 min after
immediate release aspirin (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 relevant effect is considered to be likely for
occasional ibuprofen use (see section 4.5).

5.2

Pharmacokinetic properties
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively
bound to plasma proteins.
Nurofen Express Period Pain 200mg soft capsules consist of ibuprofen 200mg
dissolved in a hydrophilic solvent inside a gelatin shell. On ingestion, the gelatin shell
disintegrates in the gastric juice releasing the solubilised ibuprofen immediately for
absorption. The median peak plasma concentration is achieved approximately 30
minutes after administration.
The median peak plasma concentration for Nurofen tablets is achieved 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.
No significant differences in pharmacokinetic profile are observed in the elderly.

5.3

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

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 600

Potassium hydroxide 50% solution (E525)
Gelatin
Sorbitol Liquid, Partially Dehydrated (E420)
Purified Water
Ponceau 4R (E124)
Lecithin (E322) or Phosphatidylcholine in Medium Chain Triglycerides
Triglycerides , medium chain
Ethanol
White ink*
The ink contains the following residual materials after application: Titanium
Dioxide (E171), Polyvinyl Acetate Phthalate, Macrogol 400, ammonium
hydroxide (E527), propylene glycol.

6.2

Incompatibilities
Not applicable

6.3

Shelf life
24 months

6.4

Special precautions for storage
Store below 25°C

6.5

Nature and contents of container
Blisters formed from Opaque Duplex PVC/PVdC 250µm/60gsm heat sealed to
20µm aluminium foil
or
opaque Tristar (Triplex) PVC/PE/PVdC 250µm/25µm/90gsm heat sealed to
20µm aluminium foil packed into cartons
Each carton may contain 10, 12, 16 in blister strips
Not all packs will be marketed.

6.6

Special precautions for disposal
Not applicable

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0646

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/01/2008

10

DATE OF REVISION OF THE TEXT
10/11/2015

11

DOSIMETRY (IF APPLICABLE)

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)

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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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