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NUROFEN PAIN RELIEF 200MG SOFT CAPSULES

Active substance(s): IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT
Nurofen Pain Relief 200mg Soft Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg per capsule, soft.
Excipient(s) with known effect:
Sorbitol (E420)
Potassium hydroxide 50% solution (E525)
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Capsule, soft
Oval clear capsules printed with a logo in white.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache,
dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.

4.2

Posology and method of administration
For oral administration and short-term use only. Do not chew.
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 (200
mg – 400 mg), up to three times a day as required (maximum dose 400 mg).
Adults: Take one or two capsules (200 mg – 400 mg), up to three times a day as
required (maximum dose 400 mg).
Leave at least four hours between doses and do not take more than 6 capsules (1200
mg) in any 24 hour period.
Children under 12 years:
Not recommended.

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 antiinflammatory drugs.
Active or history of recurrent peptic ulcer / haemorrhage (two or more distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs
therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure (See section
4.4).
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).
The elderly have an increased frequency of adverse reactions to NSAIDs, especially
GI bleeding and perforation which may be fatal.
Respiratory:
Bronchospasm may be precipitated in patients suffering from or with a previous
history of bronchial asthma or allergic disease.
Other NSAIDs:
The use of Nurofen Pain Relief 200mg Soft Capsules with concomitant NSAIDs
including cyclooxygenase-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:
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 use of ibuprofen, particularly at a high dose
(2400mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke). Overall, epidemiological studies
do not suggest that low dose ibuprofen (e.g. ≤ 1200mg/day) is associated with an
increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III),
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 limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin
synthesis may cause impairment of female fertility by an effect on ovulation. This is
reversible upon withdrawal of treatment.
Gastrointestinal:
NSAIDs should be given with care to patients with a history of gastrointestinal
disease (ulcerative colitis, Crohn’s disease) – as these conditions may be exacerbated
(See section 4.8).
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.
Patients with a history of GI toxicity, particularly when elderly, should report any
unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages
of treatment.
Caution should be advised in patients receiving concomitant medications which could
increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants
such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as
aspirin (See section 4.5).
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, 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 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 Pain Relief 200mg Soft Capsules should be discontinued at the first
appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Patients with rare hereditary problems of fructose intolerance should not take this
medicine because of the presence of sorbitol.
This medicine contains 18 mg potassium per capsule. To be taken into consideration
by patients with reduced kidney function or patients on a controlled potassium diet.

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 or any other ingredient of the product, aspirin or
other related painkillers


are taking other NSAID painkillers, or aspirin with a daily dose above 75mg



are in the last 3 months of pregnancy

Speak to a pharmacist or your doctor before taking this product if you

have or have had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems or are dehydrated


are a smoker



are in the first 6 months of pregnancy

If symptoms persist or worsen, consult your doctor.

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: Increased risk of gastrointestinal ulceration or bleeding (See section
4.4).
Antihypertensives (ACE inhibitors and Angiotensin II Antagonists) and diuretics:
since NSAIDs may diminish the effect 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 increases in plasma levels of lithium.
Methotrexate: There is evidence for the 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 mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with
tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with
zidovudine. There is evidence of an increased risk of haemarthroses and haematoma
in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and
ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of
convulsions associated with quinolone antibiotics. Patients taking NSAIDs and
quinolones may have an increased risk of developing convulsions.

4.6

Fertility, pregnancy and lactation
Pregnancy:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the
embryo/foetal development. Data from epidemiological studies suggest an increased
risk of miscarriage and of cardiac malformation and gastroschisis after use of a
prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for
cardiovascular malformation was increased from less than 1%, up to approximately
1.5%. The risk is believed to increase with dose and duration of therapy. In animals,
administration of a prostaglandin synthesis inhibitor has been shown to result in
increased 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 doses 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 following list of 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 most commonly observed adverse events 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

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:

Blood and
Lymphatic
System Disorders

Immune System
Disorders
Uncommon

Urticaria and pruritus
Very rare

Not Known

Severe hypersensitivity
reactions.
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
Disorders

Uncommon

Headache

Very rare

Aseptic meningitis2

Cardiac Disorders

Not Known

Cardiac failure and oedema

Vascular Disorders

Not Known

Hypertension

Gastrointestinal
Disorders

Uncommon

Abdominal pain, nausea,
dyspepsia

Rare

Very rare

Not Known

Diarrhoea, flatulence,
constipation and
vomiting
Peptic ulcer, perforation or
gastrointestinal haemorrhage,
melaena, haematemesis,
sometimes fatal, particularly in
the elderly. Ulcerative
stomatitis, gastritis

Hepatobiliary
Disorders
Skin and
Subcutaneous
Tissue Disorders

Very rare

Exacerbation of colitis and
Crohn's disease (section 4.4).
Liver disorders

Uncommon

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.

Renal and Urinary
Disorders

Very rare

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

Not Known
Renal insufficiency
Investigations

Very rare

Description of Selected Adverse Reactions

Decreased haemoglobin levels

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 400 mg/kg ibuprofen 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
Pharmacotherapeutic group: anti-inflammatory and antirheumatic products,
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.
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 ASA (acetylsalicylic acid) on the formation of thromboxane or
platelet aggregation occurred. Although there are uncertainties regarding
extrapolation of these data to the clinical situation, the possibility that regular,
long-term use of ibuprofen may reduce the cardioprotective effect of low-dose
acetylsalicylic acid cannot be excluded. No clinically relevant effect is
considered to be likely for occasional ibuprofen use (see section 4.5).

5.2

Pharmacokinetic properties

Ibuprofen is rapidly absorbed following administration and is rapidly distributed
throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on
an empty stomach. When taken with food, peak levels are observed after 1 to 2
hours. These times may vary with different dosage forms.
The half-life of ibuprofen is about 2 hours.

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3

Preclinical safety data
There are no preclinical safety data of relevance additional to that contained
elsewhere in the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Capsule contents
Macrogol 600
Potassium hydroxide
Purified water
Capsule shell
Gelatin
Sorbitol
Purified water
Opacode WB white NS-78-18011 (titanium dioxide (E171), hypromellose, propylene
glycol)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 25°C. Store in the original package.

6.5

Nature and contents of container
A blister pack consisting of opaque, white polyvinyl chloride (PVC)/polyethylene
(PE)/polyvinylidene chloride (PVDC), heat sealed to aluminium foil. The blisters are
packed into cardboard cartons.
Package size(s): 4, 10 or 16 capsules per carton. Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
103-105 Bath Road
Slough
SL1 3UH

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0651

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/06/2010

10

DATE OF REVISION OF THE TEXT
06/10/2017

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