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DICLOFENAC SODIUM EC TABLETS 25 MG

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Diclofenac Sodium EC Tablets 25 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of the active ingredient Diclofenac Sodium PhEur.

3

PHARMACEUTICAL FORM
Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
ADULTS
It is indicated for treatment of osteoarthritis and rheumatoid arthritis, and for
treatment of musculoskeletal disorders such as pain in the lower back,
periarthritis, tendinitis, tenosynovitis, bursitis, as well as for dislocation,
sprains and strains. Also it is indicated for the treatment of ankylosing
spondylitis and acute gout and for pain relief and for its anti-inflammatory
effect in minor surgery – such as orthopaedic and dental surgery.
CHILDREN
It is indicated for the treatment of juvenile chronic arthritis.
ELDERLY
Indications are as described under Adults above.

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
A daily dose of 75 – 150 mg given in 2 or 3 divided doses is recommended for
all indications.
CHILDREN (1 year and over)
For the treatment of juvenile chronic arthritis, a dose of 1-3 mg/kg/day in
divided doses is recommended.
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.

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 heart, hepatic and renal 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).

4.4

Special warnings and precautions for use
In all patients:
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.)
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 Diclofenac, the
treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal
disease (ulcerative colitis, Crohn’s disease) or with a history of haematological
abnormalities (bleeding diathesis, melaena, or haematemesis) as those
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).
Hepatic porphyria
Use of Diclofenac in patients with hepatic porphyria may trigger an attack.
Female fertility:
The use of Diclofenac 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 Diclofenac
should be considered.
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 and epidemiological data suggest that use of diclofenac,
particularly at high dose (150mg daily) and in long term treatment may be
associated with a small increased risk of arterial thrombotic events (for
example myocardial infarction or stroke).
Patients with uncontrolled hypertension, congestive heart failure, established
ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular
disease should only be treated with diclofenac 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
• Care should be taken in patients treated with any of the following
drugs as interactions have been reported in some patients.

Anti-hypertensives: Reduced anti-hypertensive effect.
Cardiac Glycosides and Lithium: The plasma concentration of digoxin and
lithium may be increased. NSAIDs may exacerbate cardiac failure, reduce
GFR and increase plasma glycoside levels.
Anti-coagulants: Although clinical investigations do not appear to indicate that
Diclofenac has an influence on the effect of anticoagulants, there are isolated
reports of an increased risk of haemorrhage with the combined use of
Diclofenac and anticoagulant therapy. Therefore, to be certain that no change
in anticoagulant dosage is required, close monitoring of such patients is
necessary. As with other non-steroidal anti-inflammatory agents, Diclofenac
can reversibly inhibit platelet aggregation.
Hypoglycaemics: Diclofenac does not appear to potentiate the effect of oral
hypoglycaemics. However, caution is advised in patients receiving such
combinations of treatment and close monitoring of such patients is required.
Cyclosporin: Cyclosporin nephrotoxicity may be increased by the effect of
non-steroidal anti-inflammatory drugs on renal prostaglandins.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Other NSAIDs and Methotrexate: Caution should be exercised if NSAIDs and
methotrexate are administered within 24 hours of each other, since NSAIDs
may increase methotrexate plasma levels, resulting in increased toxicity.
Concomitant therapy with other systemic NSAIDs may increase the frequency
of side effects.
Co-administration of Diclofenac with steroids and other NSAIDs may increase
the frequency of unwanted side effects.
Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics.
Diuretics can increase the risk of nephrotoxicity of NSAIDs. Concomitant
treatment with potassium-sparing diuretics may be associated with increased
serum potassium levels, hence serum potassium should be monitored.

Quinolone anti-microbials: Concomitant therapy with quinolone antimicrobials, may cause convulsions. This may occur in patients with or
without a previous history of epilepsy or convulsions. Thus caution is needed
if introducing a quinolone anti-microbial to a patient already taking an
NSAID.
Use of Diclofenac in patients with hepatic porphyria may trigger an attack.

4.6

Pregnancy and lactation
Diclofenac is not recommended for use during pregnancy. If used in the third
term of pregnancy prostaglandin synthetase inhibitors can cause the premature
closing of the ductus artheriosus or uterine inertia. Traces of Diclofenac have
been found in breast milk following 150 mg daily oral doses, but in quantities
so small that no undesirable effects on the infant are to be expected.
Whilst no teratogenic effects have been demonstrated in animal toxicity
studies, the use of NSAIDs during pregnancy should if possible be avoided.
Congenital abnormalities have been reported in association with NSAID
administration in man; however these are low in frequency and do not appear
to follow any discernible pattern.

4.7

Effects on ability to drive and use machines
Patients who experience dizziness or other central nervous system
disturbances while taking Diclofenac should refrain from driving or operating
machinery.

4.8

Undesirable effects
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature.
Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the
elderly, may occur (see section 4.4). Anorexia, nausea, vomiting, glossitis,
oesophageal lesions, diarrhoea, flatulence, constipation, dyspepsia, abdominal
pain, melaena, haematemesis, pancreatitis, epigastric pain, ulcerative
stomatitis, lower gut disorders (e.g. non-specific haemorrhagic colitis and
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 or skin eruptions, palpitation, chest pain, pruritus,
urticaria, purpura, angiodema, and more rarely eczema and bullous
dermatoses (including epidermal necrolysis, erythema multiforme, exfoliative
dermatitis and Steven-Johnson Syndrome).
There have been isolated reports of loss of hair.
Cardiovascular: Oedema, hypertension, and cardiac failure, have been
reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of diclofenac,
particularly at high doses (150 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).
Other adverse events reported less commonly include:
Isolated cases of impotence were reported, although the association with
Diclofenac intake is doubtful.
Renal:
Nephrotoxicity in various forms, including urinary abnormalities (e.g.
proteinuria), interstitial nephritis, nephrotic syndrome and renal failure.
Hepatic: Occasionally, liver function tests have shown raised serum
aminotransferase enzymes (ALT, AST) and more rarely, hepatitis (in isolated
cases fulminate) with or without jaundice.
Neurological and special senses:
Visual disturbance, optic neuritis, headaches, paraesthesia, reports of aseptic
meningitis (especially in patients with existing auto-immune disorders, such as
systemic lupus erythematosus, mixed connective tissue disease), with
symptoms such as stiff neck, headache, nausea, vomiting, fever, or memory
disturbance, disorientation (see section 4.4), irritability, convulsions,
depression, nightmares, tremor, confusion, hallucinations, tinnitus, vertigo,
dizziness, malaise, fatigue and drowsiness.
Haematological:
Thrombocytopenia, leucopenia, neutropenia, agranulocytosis, aplastic anaemia
and haemolytic anaemia,

Dermatological: photosensitivity.

4.9

Overdose
Absorption should be prevented as soon as possible after overdosage by means
of gastric lavage and treatment with activated charcoal. Supportive and
symptomatic treatment should be given for complication such as hypotension,
respiratory depression, convulsions, renal failure.
Forced diuresis, dialysis or haemoperfusion are probably of little help due to
Diclofenac’s high rate of protein binding and extensive metabolism.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Diclofenac sodium is a phenylacetic acid derivative which has analgesic,
antipyretic, and anti-inflammatory actions. It is an inhibitor of cyclooxygenase.

5.2

Pharmacokinetic properties
Diclofenac is absorbed more slowly when given as enteric-coated tablets,
especially when this dosage form is given with food. Although orally
administered Diclofenac is almost completely absorbed, it is subject to firstpass metabolism so that only 50 to 60 % of the drug reaches the systemic
circulation in the unchanged form. At therapeutic concentrations it is more
than 99 % bound to plasma proteins. Diclofenac penetrates synovial fluid and
has been detected in breast milk. The terminal plasma half-life is about 1 to 2
hours.
Diclofenac is metabolised to 4’-hydroxydiclofenac, 5’hydroxydiclofenac, 3’-hydroxydiclofenac and 4’,5-dihydroxydiclofenac. It is
then excreted in the form of glucuronide and sulphate conjugates, mainly in
the urine but also in the bile.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the prescriber which are
additional to those already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
The tablets contain microcrystalline cellulose BP, lactose BP, maize starch BP,
Povidone BP, magnesium stearate BP, colloidal silicon dioxide USNF and
pregelatinised maize starch BP. The enteric film coating contains cellacephate
BP and diethyl phthalate BP. The film coating contains diethylphthalate BP,
hydroxypropyl methylcellulose USP, hydroxypropylcellulose, titanium
dioxide BP, quinoline yellow aluminium lake (E104), erythrosine aluminium
lake (E127) and iron oxide yellow (E172) and carnauba wax BP.

6.2

Incompatibilities
None known.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Store in a dry place below 25°C.

6.5

Nature and contents of container
Polypropylene containers with polyethylene caps (with optional polyethylene
ullage filler) in packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100,
112, 120, 168, 180, 200, 250 or 500 tablets.
PVC/Aluminium foil blister packs of 30, 50 or 100 tablets.

6.6

Special precautions for disposal
Not Applicable.

Administrative Data
7.

Marketing Authorisation Holder

Generics [UK] Limited
T/A Mylan
Station Close
Potters Bar
Hertfordshire
EN6 1TL

8

MARKETING AUTHORISATION NUMBER(S)
PL 04569/0182

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/07/1988 / 11/03/2009

10

DATE OF REVISION OF THE TEXT
27/01/2010

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