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NUROFEN 200 MG TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Nurofen 200 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Excipient(s) with known effect:
Sucrose
Sodium
For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Coated Tablet
A white to off-white, biconvex, round, sugar coated tablet printed ‘Nurofen’ in
black on one face.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of migraine-headaches, backache, dental pain, neuralgia and
period pains as well as rheumatic and muscular pains.
Nurofen relieves pain and reduces inflammation and temperature as well as
relieving headaches and other types of pain. It also relieves cold and flu
symptoms.

4.2

Posology and method of administration
For oral administration and short-term use only.
During short-term use, if symptoms persist or worsen the patient should be
advised to consult a doctor.
Adults 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 this medicinal product is required for more than
3 days, or if symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the symptoms
worsen the patient should consult a doctor.

Children and Adolescents between 12 and 18 years: Take 1 or 2 tablets with

water, up to three times a day as required.
Adults: Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least four hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not for use by children under 12 years of age.

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.
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
previous 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 those with 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 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.
Advice for patients with sugar-related disorders:
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
Advice for patients on a controlled sodium diet:
This medicinal product contains 1.1 mmol (or 25.3 mg) of sodium per 2 doses
(2 tablets). To be taken into consideration by patients on a controlled sodium
diet.
The leaflet will include:
The quantity of sodium contained in 2 tablets is approximately 1.1mmol, i.e.
about 25.3 mg. This quantity is to be taken into consideration by patients on a
controlled sodium diet.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
• 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
related 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

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 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).
Ant-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.
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.
4.6

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 preand post-implantation loss and embryfoetal lethality. In addition, increased
incidences of various malformations, including cardiovascular, have been
reported in animals given a prostaglandin synthesis inhibitor during the
organogenetic period. During the first and second trimester of pregnancy,
Nurofen should not be given unless clearly necessary. If Nurofen is used by a
woman attempting to conceive, or during the first and second trimester of
pregnancy, the dose should be kept as low and duration of treatment as short
as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors
may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus
and pulmonary hypertension);
- renal dysfunction, 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 events relates to those experienced with ibuprofen at
OTC doses for short-term use. In the treatment of chronic conditions, under long-term
treatment, additional adverse events may occur.
The adverse events observed most often are gastrointestinal in nature. Adverse events
are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal
bleeding is dependent on the dosage range and duration of treatment.
Clinical 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
Very rare:

Adverse Event
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:

Uncommon

Urticaria and pruritus

Very rare

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

Not Known

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

Uncommon

Headache

Blood and Lymphatic
System Disorders

Immune System
Disorders

Nervous System
Disorders

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

Diarrhoea, flatulence, constipation and
vomiting

Very rare

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

Not Known
Hepatobiliary Disorders

Very rare

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

Skin and Subcutaneous
Tissue 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.

Very rare

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

Not Known

Renal insufficiency

Very rare

Decreased haemoglobin levels

Renal and Urinary Disorders

Investigations

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: M01AE01
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its
efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen
reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen
reversibly inhibits platelet aggregation.
Experimental data 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 was 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 clinically relevant effect is considered to be likely for

occasional ibuprofen use (see section 4.5).

5.2

Pharmacokinetic properties
Ibuprofen is rabidly 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.
Elimination half-life is approximately 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low
concentrations.

5.3

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

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tablet Core
Croscarmellose Sodium
Sodium Laurilsulfate
Sodium Citrate
Stearic Acid
Colloidal Anhydrous Silica
Sugar coat ingredients
Carmellose Sodium
French Chalk for Tablets (Talc)
Acacia Spray Dried
Sucrose
Titanium Dioxide
Macrogol 6000
Tablet printing
Black Printing Ink (solids)1

1

Black Printing Ink contains shellac, Iron oxide black (E172) and propylene
glycol

6.2

Incompatibilities
Not applicable

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25ºC
Store in the original pack

6.5

Nature and contents of container
The tablets will be packed in blisters consisting of:
Push through laminate consisting of opaque, white 250 micron PVC heatsealed to 20 micron aluminium foil
or
Push through laminate consisting of opaque, white 250 micron PVC with 40
gsm PVdC, heat-sealed to 20 micron aluminium foil.
The blisters are contained in a cardboard or plastic carton
2, 3, 4, 5, 6, 8, 10, 12, 15, 16 tablets
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 00063/0385

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/07/2003

10

DATE OF REVISION OF THE TEXT
09/11/2015

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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