SOLUBLE CUFEN EF IBUPROFEN EFFERVESCENT TABLETS 400MG

Active substance: IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400mg.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 400mg/tablet.
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Effervescent tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Ibuprofen is a non steroidal anti-inflammatory and analgesic drug that is used in the
treatment of Rheumatoid Arthritis (including juvenile Rheumatoid Arthritis or Still’s
Disease), osteoarthritis, ankylosing spondylitis and other non-Rheumatoid
Arthropathies and in the treatment of non-articular rheumatic conditions.
It is also indicated in periarticular disorders such as bursitis, frozen shoulder,
tendinitis, tensosynivitis and low back pain. It may also be used in soft tissue injuries
such as sprains and strains.
It may be used for the relief of mild to moderate pain such as period pains, dental and
post-operative pain and in the relief of migraine.

4.2

Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see section 4.4).

For oral administration.
Adults and children aged over 12 years
The recommended dose is one tablet to be taken three or four times daily.
Some patients can be maintained on one tablet two or three times daily.
In severe or acute conditions it can be advantageous to increase the dose until
the acute phase is brought under control provided the daily dose does not
exceed six tablets per day in divided doses.
Children
Not suitable for children under 12 years.
The Elderly The elderly are at increased risk of the serious consequences of adverse
reactions. If an NSAID is considered necessary, the lowest effective dose should be
used and for the shortest possible duration. The patient should be monitored regularly
for GI bleeding during NSAID therapy.
Directions The tablets must be dissolved in half a glass of water (100ml). The tablets
dissolve more quickly in warm water, or if stirred. To be taken preferably with or
after food.

4.3

Contraindications
Hypersensitivity to any of the constituents.
NSAIDs are contraindicated in patients who have previously shown hypersensitivity
reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen,
aspirin, or other non-steroidal anti-inflammatory drugs.
Severe hepatic, renal or cardiac failure (See section 4.4 – Special warnings and
precautions for use).
During the last trimester of pregnancy (See section 4.6 – Pregnancy and lactation).
Active or previous peptic ulcer.
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs
therapy.
Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors (See
section 4.5 Interactions).
Severe heart failure.
Each tablet contains 995mg or 43.3 mmols of Na+. This should be taken into account
when prescribing for patients on a sodium restricted diet.

4.4

Special warnings and precautions for use
In all patients:

Undesirable effects may be minimised by using the maximum effective dose for the
shortest possible duration.
Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially
gastrointestinal bleeding and perforation which may be fatal (See section 4.2 –
Posology and administration).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous
history of, bronchial asthma since NSAIDs have been reported to precipitate
bronchospasm in such patients.
Cardiovascular, Renal and Hepatic Impairment:
The administration of an NSAID may cause a dose dependent reduction in
prostaglandin formation and precipitate renal failure. Patients at greatest risk of this
reaction are those with impaired renal function, cardiac impairment, liver
dysfunction, those taking diuretics and the elderly. Renal function should be
monitored in these patients (See also section 4.3 – Contraindications).
Caution in patients with a history of hypertension and/or heart failure as fluid
retention and oedema have been reported in association with NSAID therapy.
Gastrointestinal bleeding, ulceration and perforation: 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.
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 gastrotoxicity or bleeding, such as corticosteroids, or
anticoagulants such as warfarin or anti-platelet agents such as aspirin (see section 4.5
– Interactions).
When GI bleeding or ulceration occurs in patients receiving Soluble Cufen EF
Ibuprofen Effervescent Tablets 400mg, the treatment should be withdrawn.
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 – Undesirable effects).
SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue
disorders there may be an increased risk of aseptic meningitis (See section 4.8 –
Undesirable effects).
Female fertility:
The use of Soluble Cufen EF Ibuprofen Effervescent Tablets 400mg may impair
female fertility and is not recommended in women attempting to conceive. In women
who have difficulties conceiving or who are undergoing investigation of infertility,
withdrawal of Soluble Cufen EF Ibuprofen Effervescent Tablets 400mg should be
considered.
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).

Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of
hypertension and/or mild to moderate congestive heart failure as fluid retention and
oedema have been reported in association with NSAID therapy.
Clinical trial data suggest that use of ibuprofen, particularly at a high dose (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.



Patients with uncontrolled hypertension, congestive heart failure, established
ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
should only be treated with ibuprofen after careful consideration. Similar
consideration should be made before initiating longer-term treatment of patients with
risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes
mellitus, smoking).

4.5

Interaction with other medicinal products and other forms of interaction
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 analgesics: Avoid concomitant use of two or more NSAIDs (including aspirin)
as this may increase the risk of adverse effects (See section 4.3 – Contraindications).
Anti-hypertensives: Reduced anti-hypertensive effect.
Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity
of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma glycoside levels.
Lithium: Decreased elimination of lithium.
Methotrexate: Decreased elimination of methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.
Mifespristone: NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Corticosteroids: Increased risk of GI bleeding (See section 4.4 – Special warnings
and precautions for use).
Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as
warfarin (See section 4.4 – Special warnings and precautions for use).
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.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given
tacrolimus.
Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma
in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and
ibuprofen.

4.6

Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use
of Soluble Cufen Ef Ibuprofen Effervescent Tablets should, if possible, be avoided
during the first 6 months of pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature
closure of the foetal ductus arteriosus with possible persistant pulmonary
hypertension. The onset of labour may be delayed and the duration increased with an
increased bleeding tendency in both mother and child (See section 4.3
Contraindications).
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
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are
possible after taking NSAIDs. If affected, patients should not drive or operate
machinery

4.8

Undesirable effects
Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in
nature. Peptic ulcers, perforations or GI bleeding, sometimes fatal, particularly in the
elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence,
constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative
stomatitis, exacerbation of colitis and Crohn’s disease (See section 4.4 Special
warnings and precautions for use) have been reported following administration. Less
frequently, gastritis has been observed.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment
with NSAIDs. These may consist of (a) non-specific allergic reactions and
anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma,
bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various
types of various types, pruritus, urticaria, purpura, angiodema and, more rarely
exfoliative and bullous dermatoses (including epidermal necrolysis and erythema
multiforme).

Cardiovascular: Oedema has been reported in association with NSAID treatment.
Other adverse events reported less commonly include:
Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephritic
syndrome and renal failure.
Hepatic: Abnormal liver function, hepatitis and jaundice.
Neurological and special senses: Visual disturbances, optic neuritis, headaches,
paraesthesia, reports of aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue
disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or
disorientation (See section 4.4), depression, confusion, hallucinations, tinnitus,
vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia
and haemolytic anaemia.
Dermatological: photosensitivity.
Oedema, hypertension, and cardiac failure, have been reported in association with
NSAID treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at
high dose (2400 mg 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).

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
Pharmacotherapeutic group: Ibuprofen, ATC code: M01AE01.
Analgesic/anti-inflammatory.
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 within 8 hours before or within 30 minutes after
immediate release aspirin dosing (81mg), a decreased effect of aspirin 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 clinically relevant effect is considered to be likely for occasional
ibuprofen use.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium bicarbonate
Sodium carbonate (anhydrous)
Sodium cyclamate
Sodium saccharin
Citric acid anhydrous
Docusate sodium
Polyethylene glycol powder 6000
Povidone

Orange mint flavour 611160E
IMS

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months unopened.

6.4

Special precautions for storage
Store in a cool dry place.

6.5

Nature and contents of container
Strip pack using PPFP laminate, constructed of: 40gsm MGBK paper/l2gsm
LDPE/8µ aluminium foil/23gsm LDPE. Strips are packed into a carton containing
either 12, 24, 48, 96, 112 or 144 tablets

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Limited,
North Way,
Walworth Industrial Estate,
Andover,

SP10 5AZ
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0092

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27 June 1991 / 09 December 1998

10

DATE OF REVISION OF THE TEXT
17/02/2009

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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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