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NUROFEN MELTLETS 200MG ORODISPERSIBLE TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurofen Recovery
Nurofen Meltlets 200mg Orodispersible Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Excipient(s) with known effect:
Aspartame
Sorbitol (E421)
For the full list of excipients, section see 6.1.

3

PHARMACEUTICAL FORM
Orodispersible tablet
White to off-white tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of headache and migraine.

4.2

Posology and method of administration
For oral administration and short-term use only.
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.
Place a tablet on the tongue, allow it to dissolve and then swallow; no water is
required.
Adults: Initial dose, two tablets, then if necessary, one or two tablets every
four hours.

Children and Adolescents between 12 and 18 years:
Initial dose, two tablets, then if necessary, one or two tablets every four hours.
The Elderly:
Initial dose, two tablets, then if necessary, one or two tablets every four hours.
Do not exceed six tablets in any 24 hours.
Not for use by children under 12 years.

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 (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 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 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 high doses
(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 IIIII), established ischaemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease should only be treated with ibuprofen after careful
consideration and high doses (2400mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term
treatment of patients with risk factors for cardiovascular events (e.g.
hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if
high doses of ibuprofen (2400mg/day) are required.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclooxygenase/
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.
Caution is required in patients with phenylketonuria or who are intolerant to
phenylalanine. The product contains aspartame which is a source of
phenylalanine. Each orodispersible tablet contains a source equivalent to 14mg
of phenylalanine.
This product contains sorbitol. Patients with rare hereditary problems of
fructose intolerance should not take this medicine.
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 or are dehydrated
• Are a smoker
• Are pregnant
If symptoms persist or worsen, consult your doctor or pharmacist.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be used with caution 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).
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.
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

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 preand 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 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 high doses
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

Blood and Lymphatic
System Disorders

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.

Immune System
Disorders

Hypersensitivity reactions consisting of1:
Uncommon Urticaria and pruritus.
Very rare

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

Not Known 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

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 Exacerbation of colitis and Crohn's disease (section

4.4).
Hepatobiliary
Disorders

Very rare

Skin and
Subcutaneous Tissue
Disorders

Uncommon Various skin rashes
Very rare

Liver disorders

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

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

4.9

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).

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, having analgesic, anti-pyretic and
anti-inflammatory activity. The drug's therapeutic effects as a non-steroidal
anti-inflammatory drug are thought to result from inhibitory activity on
prostaglandin synthesis. 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 pharmacodynamic studies show that when single
doses of ibuprofen 400mg were taken with 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 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
Nurofen Recovery consists of taste masked ibuprofen granules incorporated
into a compressed tablet. When the tablet is placed on the tongue it rapidly
dissolves to release the ibuprofen granules. The ibuprofen granules can then be
swallowed without the need for water.
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is
extensively bound to plasma proteins. Ibuprofen diffuses into the synovial
fluid.
Peak plasma concentrations from Nurofen Recovery occur approximately 1
hour 50 minutes after administration. When taken with food, peak plasma
levels may be delayed.

Ibuprofen is metabolised in the liver to two major inactive metabolites and
these together with unchanged ibuprofen are excreted by the kidney either as
such or as conjugates. Excretion by the kidney is both rapid and complete.
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 elsewhere in the Summary of
Product Characteristics.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ethylcellulose (E462)
Silicon Dioxide (E551)
Hypromellose (E464)
Mannitol (E420)
Aspartame (E951)
Croscarmellose Sodium (E468)
Magnesium Stearate (E572)
Flavour (mint flavours, maltodextrin, acacia gum (E414), sorbitol (E421))

6.2

Incompatibilities
Not applicable

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25ºC.

6.5

Nature and contents of container
The orodispersible tablets are packed in a cold formed blister pack. The blister
pockets are formed from 60µm PVC/ 45µm aluminium/ 25µm polyamide film
heat sealed to the 20µm aluminium foil blister lid.

The blister trays are packed into cardboard cartons containing 4, 6, 10, 12, 14,
16, 18, 20, 22, 24, 30, 36, 40 or 48 orodispersible tablets. Not all pack sizes
may be marketed.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Crookes Healthcare Limited
1 Thane Road West
Nottingham
NG2 3AA
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00327/0130

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/03/2002

10

/

20/03/2009

DATE OF REVISION OF THE TEXT
06/05/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

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