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NUROFEN RECOVERY

Active substance: IBUPROFEN

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1.

TRADE NAME OF THE MEDICINAL PRODUCT
Nurofen Recovery

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg
Excipient(s) with known effect:
Aspartame
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.
The lowest effective dose should be used for the shortest duration necessary to relieve
symptoms. The patient 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, the elderly and children over 12 years:
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, 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).
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 trial and epidemiological data suggest that use of ibuprofen, particularly at high
doses (2400mg daily) and in long-term treatment may be associated with a small increased
risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall,
epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200mg daily) is
associated with an increased risk of myocardial infarction.
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 anytime 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 14 mg of phenylalanine.
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

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: unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this
may increase the risk of adverse reactions (see Section 4.4).
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. However, the limitations of these
data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation
imply that no firm conclusions can be made for regular ibuprofen use, and 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

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
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 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 trial and epidemiological data suggest that use of ibuprofen (particularly at high doses
2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial
thrombotic events (for example myocardial infarction or stroke), (see section 4.4).
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:

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.

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

Blood and Lymphatic
System Disorders

Immune System
Disorders

Nervous System
Disorders

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,

Renal and Urinary Disorders

especially in long-term use, associated with
increased serum urea and oedema.

Not Known
Investigations

Renal insufficiency

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).

4.9

Overdose
In children ingestion of more than 400 mg/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 antiinflammatory 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 inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. In one study, when a single dose of
ibuprofen 400mg was taken with 8 h before or within 30 min after immediate release aspirin
dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet
aggregation occurred. However, the limitations of these data and the uncertainties regarding
extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be
made for regular ibuprofen use, and no relevant effect is considered to be likely for
occasional ibuprofen use.
5.2

Pharmacokinetic properties
Nurofen Meltlets Mint consist 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 Meltlets Mint 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 25°C.

6.5

Nature and contents of container
The orodispersible tablets are packed in a cold formed blister pack. The blister pockets are
formed from 60 μm PVC/ 45 μm aluminium / 25 μm 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

Instructions for Use/Handling
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
20/03/2009

10

DATE OF REVISION OF THE TEXT
29/11/2013

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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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