Skip to Content

DICLO-SR 75

Active substance(s): DICLOFENAC SODIUM

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Diclo-SR 75

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Diclofenac Sodium 75mg.
Excipient with known effect
Ethanol
61.1 mg Lactose monohydrate
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Prolonged release tablet

4.1.

Therapeutic indications
Adults:
Relief of all grades of pain and inflammation in a wide range of conditions including:
(i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis,
acute gout.
(ii) acute musculo-skeletal disorders such as periarthritis (for example frozen
shoulder), tendinitis, tenosynovitis, bursitis.
(iii) other painful conditions resulting from trauma, including fracture, low back pain,
sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

4.2.

Posology and method of administration
Posology

Adults: One tablet once or twice daily, taken whole with liquid, preferably with or
after food.
Elderly: Although the pharmacokinetics of Diclo-SR 75 are not impaired to any
clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs
should be used with particular caution in such patients who generally are more prone
to adverse reactions. If Diclo-SR 75 is considered necessary the lowest effective
dosage should be used in frail elderly patients or those with a low body weight (see
section 4.4 Special warnings and precautions for use) for the shortest possible
duration. The patient should be monitored regularly for GI bleeding during NSAID
therapy.
Renal impairment: Diclofenac is contraindicated in patients with severe renal
impairment (see section 4.3). No specific studies have been carried out in patients
with renal impairment, therefore, no specific dose adjustment recommendations can
be made. Caution is advised when administering diclofenac to patients with mild to
moderate renal impairment (see section 4.3 and 4.4).
Hepatic impairment: Diclofenac is contraindicated in patients with severe hepatic
impairment (see section 4.3). No specific studies have been carried out in patients
with hepatic impairment, therefore, no specific dose adjustment recommendations
can be made. Caution is advised when administering diclofenac to patients with mild
to moderate hepatic impairment (see section 4.3 and 4.4).
Paediatric population: Diclofenac sodium is not recommended for use in children as
dosage recommendations and indications for use in this group of patients have not
been established.
Undesirable effects may be minimized by using the lowest effective dose for the
shortest duration necessary to control symptoms (see section 4.4 special warnings and
precautions for use).
Method of administration
For oral use only.

4.3

Contraindications


Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.



Active, or gastric or intestinal ulcer, bleeding or perforation.

4.2.



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 NSAID
therapy.



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 failure, hepatic failure and renal failure (see section 4.4).



During the last trimester of pregnancy (see section 4.6).



Established congestive heart failure (NYHA II-IV), ischemic heart disease,
peripheral arterial disease and/or cerebrovascular disease.

Special warnings and precautions for use
General:
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 concomitant use of Diclofenac with systemic NSAIDs including
cyclooxygenase-2 selective inhibitors should be avoided due to the absence of
any evidence demonstrating synergistic benefits and the potential for additive
undesirable effects (see section 4.5).
Elderly:
Caution is indicated in the elderly on basic medical grounds. The elderly have
an increased frequency of adverse reactions to NSAIDs, especially
gastrointestinal bleeding and perforation, which may be fatal (see section 4.2).
It is recommended that the lowest effective dose be used in frail elderly
patients or those with a low body weight (see section 4.2).
As with other nonsteroidal anti-inflammatory drugs including diclofenac,
allergic reactions, including anaphylactic/anaphylactoid reactions, can also
occur without earlier exposure to the drug (see section 4.8).
Like other NSAIDs, diclofenac may mask the signs and symptoms of the
infection due to its pharmacodynamic properties.

Respiratory disorders:
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa
(i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic
infections of the respiratory tract (especially if linked to allergic rhinitis like
symptoms), reactions on NSAIDs like asthma exacerbations (so called
intolerance to analgesics / analgesics asthma), Quincke's oedema or urticaria
are more frequent than in other patients. Therefore, special precaution is
recommended in such patients (readiness for emergency). This is applicable as
well for patients who are allergic to other substances, e.g. with skin reactions,
pruritus or urticaria.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac
sodium and other NSAIDs can precipitate bronchospasm if administered to
patients suffering from, or with a previous history of bronchial asthma.
Renal effects:
As fluid retention and oedema have been reported in association with NSAID
therapy, including diclofenac, particular caution is called for in patients with
impaired cardiac or renal function, history of hypertension, the elderly,
patients receiving concomitant treatment with diuretics or medicinal products
that can significantly impact renal function, and those patients with substantial
extracellular volume depletion from any cause, e.g. before or after major
surgery (see section 4.3). Monitoring of renal function is recommended as a
precautionary measure when using diclofenac in such cases. Discontinuation
therapy is usually followed by recovery to the pre-treatment state.
Hepatic effects:
Close medical surveillance is required when prescribing diclofenac to patients
with impairment of hepatic function as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, values of one or more liver
enzymes may increase. During prolonged treatment with Diclofenac, regular
monitoring of hepatic function is indicated as a precautionary measure. If
abnormal liver function tests persist or worsen, clinical signs or symptoms
consistent with liver disease develop or if other manifestations occur
(eosinophilia, rash), diclofenac should be discontinued.
Hepatitis may occur with diclofenac without prodromal symptoms. Caution is
called for when using diclofenac in patients with hepatic porphyria, since it
may trigger an attack.
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
including diclofenac.
Clinical trial and epidemiological data consistently point towards increased
risk of arterial thrombotic events (for example myocardial infarction or stroke)
associated with the use of diclofenac, particularly at high dose (l50mg daily)
and in long term treatment.
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.
Patients with significant risk factors for cardiovascular events (e.g.
hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be
treated with diclofenac after careful consideration.
As the cardiovascular risks of diclofenac may increase with dose and duration
of exposure, the shortest duration possible and the lowest effective daily dose
should be used. The patient’s need for symptomatic relief and response to
therapy should be re-evaluated periodically.
Gastrointestinal effects:
Gastrointestinal bleeding (haematemesis, melena), ulceration or perforation,
which can be fatal, has been reported with all NSAIDs including diclofenac
and may occur at any time during treatment, with or without warning
symptoms or a previous history of serious gastrointestinal events. They
generally have more serious consequences in the elderly. If gastrointestinal
bleeding or ulceration occurs in patients receiving diclofenac, the drug should
be withdrawn.
As with all NSAIDs, including diclofenac, close medical surveillance is
imperative and particular caution should be exercised when prescribing
diclofenac in patients with symptoms indicative of gastrointestinal disorders,
or with a history suggestive of gastric or intestinal ulceration, bleeding or
perforation (see section 4.8). The risk of gastrointestinal bleeding, ulceration
or perforation is higher with increasing NSAID doses, and in patients with a
history of ulcer, particularly if complicated with haemorrhage or perforation
(see section 4.3).
The elderly have increased frequency of adverse reactions to NSAIDs
especially gastro intestinal bleeding and perforation which may be fatal (see
section 4.2). To reduce the risk of gastrointestinal toxicity in patients with a
history of ulcer, particularly if complicated with haemorrhage or perforation,
and in the elderly, the treatment should be initiated and maintained at the
lowest effective dose.
These patients should commence treatment and be maintained on the lowest
dose available. Combination therapy with protective agents (e.g. misoprostol
or proton pump inhibitors) should be considered for these patients, and also for

patients requiring concomitant use of medicinal products containing low dose
aspirin or other drugs likely to increase gastrointestinal risk (see below and
section 4.5).
Patients with a history of gastrointestinal toxicity, particularly when elderly,
should report any unusual abdominal symptoms (especially gastrointestinal
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 systemic
corticosteroids, anti-coagulants such as warfarin, selective serotonin-reuptake
inhibitors (SSRIs) or anti-platelet agents such as aspirin (see section 4.5).

Close medical surveillance and caution should be exercised in patients with
ulcerative colitis, or with Crohn’s disease as these conditions may be
exacerbated (see section 4.8).
An increased risk of anastomotic dehiscence has been noted in patients
receiving oral diclofenac for analgesia after colon resection surgery.
Haematological effects:
During prolonged treatment with diclofenac, as with other NSAIDs,
monitoring of the blood count is recommended. Diclofenac may reversibly
inhibit platelet aggregation (see section 4.5). Patients with defects of
haemostasis, bleeding diathesis or haematological abnormalities should be
carefully monitored.
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).

Skin effects:
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, including
diclofenac (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. Diclofenac should be
discontinued at the first appearance of skin rash, mucosal lesions or other signs
of hypersensitivity.
Porphyria
Diclofenac should only be used with extreme caution in patients with
porphyria where no suitable alternative is available.

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 (see section 4.6).

Excipients
Contains lactose. Patients with rare hereditary problems of galactose
intolerance, total lactase deficiency or glucose-galactose malabsorption should
not take this medicine.
This medicinal product contains small amounts of ethanol (alcohol), less that
100mg per dose.

4.5

Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with diclofenac gastro-resistant
tablets and/or other pharmaceutical forms of diclofenac.
Diclofenac is bound practically completely to plasma albumin (99.7%) and
consequently displacement reactions with high protein binding affinity must be borne
in mind.
Care should be taken in patients treated with any of the following drugs as
interactions have been reported in some patients.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of
diclofenac with diuretics and antihypertensive agents (e.g. beta-blockers, angiotensin
converting enzyme (ACE) inhibitors may cause a decrease in their antihypertensive
effect via inhibition of vasodilatory prostaglandin synthesis.
Therefore, the combination should be administered with caution and patients,
especially the elderly, should have their blood pressure periodically monitored.
Patients should be adequately hydrated and consideration should be given to
monitoring of renal function after initiation of concomitant therapy periodically
thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of
nephrotoxicity.
Cardiac glycosides: Concomitant use of cardiac glycosides and NSAIDs in patients
may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of
digoxin. Monitoring of the serum digoxin level is recommended.
Lithium: If used concomitantly, diclofenac may increase plasma concentrations of
lithium. Monitoring of the serum lithium level is recommended.
Methotrexate: Diclofenac can inhibit the tubular renal clearance of methotrexate
hereby increasing methotrexate levels. Caution is recommended when NSAIDs,
including diclofenac, are administered less than 24 hours before treatment with
methotrexate, since blood concentrations of methotrexate may rise and the toxicity of
this substance be increase Cases of serious toxicity have been reported when
methotrexate and NSAIDs including diclofenac are given within 24 hours of each
other. This interaction is mediated through accumulation of methotrexate resulting
from impairment of renal excretion in the presence of the NSAID.
Ciclosporin: Diclofenac, like other NSAIDs, may increase the risk of nephrotoxicity
of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given
at doses lower than those that would be used in patients not receiving ciclosporin.
Mifepristone: NSAIDs should not be used 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:
Co-administration of diclofenac with other systemic NSAIDs or corticosteroids may
increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of
two or more NSAIDs (including aspirin) as this may increase the risk of adverse
effects (see section 4.4).
Anticoagulants and anti-platelet agents: Caution is recommended since concomitant
administration could increase the risk of bleeding (see section 4.4). Although clinical
investigations do not appear to indicate that diclofenac has an influence on the effect
of anticoagulants, there are reports of an increased risk of haemorrhage in patients
receiving diclofenac and anticoagulant concomitantly (see section 4.4). Therefore, to
be certain that no change in anticoagulant dosage is required, close monitoring of
such patients is required. As with other nonsteroidal anti-inflammatory agents,
diclofenac in a high dose can reversibly inhibit platelet aggregation.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of
SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4).
Quinolone antibiotics: Convulsions may occur due to an interaction between
quinolones and NSAIDs. This may occur in patients with or without a previous
history of epilepsy or convulsions. Therefore, caution should be exercised when
considering the use of a quinolone in patients who are already receiving an NSAID.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with
tacrolimus. This might be mediated through renal antiprostaglandin effects of both
NSAID and calcineurin inhibitor.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with
zidovudine. There is evidence of an increased risk of haemarthroses and haematoma
in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and
ibuprofen.
Drugs known to cause hyperkalaemia: Concomitant treatment with
potassium sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be
associated with increased serum potassium levels, which should therefore be
monitored frequently.
Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of
phenytoin plasma concentrations is recommended due to an expected increase in
exposure to phenytoin.
Antidiabetics: Clinical studies have shown that diclofenac can be given together with
oral antidiabetic agents without influencing their clinical effect. However, there have
been isolated reports of hypoglycaemic and hyperglycaemic effects necessitating
changes in the dosage of the antidiabetic agents during treatment with diclofenac. For
this reason, monitoring of the blood glucose level is recommended as a precautionary
measure during concomitant therapy.
Colestipol and cholestyramine: These agents can induce a delay or decrease in
absorption of diclofenac. Therefore, it is recommended to administer diclofenac at
least one hour before or 4 to 6 hours after administration of colestipol/
cholestyramine.
Potent CYP2C9 inhibitors: Caution is recommended when co prescribing diclofenac
with potent CYP2C9 inhibitors (such as voriconazole), which could result in a
significant increase in peak plasma concentrations and exposure to diclofenac due to
inhibition of diclofenac metabolism.

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 or 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 shown to result in increased
pre and post implantation loss and embryo foetal lethality.
In addition, increased incidences of various malformations, including cardiovascular,
have been reported in animals given a prostaglandin synthesis inhibitor during
organogenetic period.
Diclofenac should not be used during the first two trimesters of pregnancy or labour
unless the potential benefit to the patient outweighs the potential risk to the foetus.
If diclofenac is used by a woman attempting to conceive, or during the 1st 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 oligo-hydroamniosis
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, diclofenac is contraindicated during the third trimester of pregnancy.
Breast-feeding
In the limited studies so far available, NSAIDs can appear in the breast milk in very
low concentrations. NSAIDs should, if possible, be avoided in breastfeeding
in order to avoid undesirable effects in the infant (see section 5.2).
Female fertility
As with other NSAIDs, the use of diclofenac may impair female fertility and is not
recommended in women attempting to conceive. In women who may have difficulties
conceiving or who are undergoing investigation of infertility, withdrawal of
diclofenac should be considered (see section 4.4).

4.7

Effects on ability to drive and use machines
Patients who experience visual disturbances, dizziness, vertigo, somnolence, central
nervous system disturbances, drowsiness or fatigue while taking NSAIDs should
refrain from driving or operating machinery.

4.8

Undesirable effects

Adverse reactions are ranked under the heading of frequency, the most frequent first, using
the following convention: very common: (>1/10); common (≥ 1/100 to <1/10); uncommon (≥
1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known: cannot be
estimated from the available data.
The following undesirable effects include those reported with other short-term or long-term
use.
Blood and lymphatic system disorders
Very rare

Thrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic anaemia),
agranulocytosis

Immune system disorders
Rare

Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and
shock).

Very rare

Angioneurotic oedema (including face oedema).

Psychiatric disorders
Very rare

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders
Common

Headache, dizziness.

Rare

Somnolence, tiredness.

Very rare

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste
disturbances, cerebrovascular accident.

Unknown

Confusion, hallucinations, disturbances of sensation, malaise.

Eye disorders
Very rare

Visual disturbance, vision blurred, diplopia.

Unknown

Optic neuritis.

Ear and labyrinth disorders
Common

Vertigo.

Very rare

Tinnitus, hearing impaired.

Cardiac disorders
Uncommon*

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders
Very rare

Hypertension, hypotension, vasculitis.

Respiratory, thoracic and mediastinal disorders
Rare

Asthma (including dyspnoea).

Very rare

Pneumonitis.

Gastrointestinal disorders
Common

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

Rare

Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena
gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularl
the elderly).

Very rare

Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's
disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal
disorder, diaphragm-like intestinal strictures, pancreatitis.

Unknown

Ischaemic colitis

Hepatobiliary disorders
Common

Transaminases increased.

Rare

Hepatitis, jaundice, liver disorder.

Very rare

Fulminant hepatitis, hepatic necrosis, hepatic failure.

Skin and subcutaneous tissue disorders
Common

Rash.

Rare

Urticaria.

Very rare

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome,
toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair,
photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders
Very rare

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, re
papillary necrosis.

General disorders and administration site conditions
Rare

Oedema

Reproductive system and breast disorders
Very rare

Impotence.

*The frequency reflects data from long-term treatment with a high dose (150 mg/day).

Clinical trial and epidemiological data consistently point towards an increased
risk of arterial thrombotic events (for example myocardial infarction or
stroke) associated with the use of diclofenac, particularly at high dose (150mg
daily) and in long term treatment. (see section 4.3 and 4.4 for
Contraindications and Special warnings and special precautions for use).
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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.

4.9

Overdose
a) Symptoms
There is no typical clinical picture resulting from diclofenac over dosage. Symptoms
include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely
diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting
and occasionally convulsions. In cases of significant poisoning acute renal failure
and liver damage are possible.
B) Therapeutic measures
Management of acute poisoning with NSAIDs, including diclofenac, essentially
consists of supportive measures and symptomatic treatment. Supportive measures and
symptomatic treatment should be given for complications such as hypotension, renal
failure, convulsions, gastrointestinal disorder, and respiratory depression.
Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of
no help in eliminating NSAIDs, including diclofenac, due to high protein binding and
extensive metabolism.
Activated charcoal may be considered after ingestion of potentially toxic overdose,
and gastric decontamination (e.g vomiting, gastric lavage) should be considered
within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured. Renal and liver function should be closely
monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic
amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated by the patient’s clinical condition.

5.1.

Pharmacodynamic properties
Pharmacotherapeutic group: Acetic acid derivatives and related substances, ATC
code: M01AB05.
Mechanism of action
Diclofenac is a non-steroidal agent with marked analgesic/anti-inflammatory
properties. It is an inhibitor of prostaglandin synthetase, (cyclo-oxygenase).
Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in cartilage at
concentrations equivalent to the concentrations reached in human beings.

5.2

Pharmacokinetic properties
Diclofenac sodium is rapidly absorbed from the gut and is subject to first-pass
metabolism.
The active substance is 99.7% protein bound and plasma half-life for the terminal
elimination phase is 1-2 hours.
Diclofenac enters the synovial fluid, where maximum concentrations are measured 24 hours after the peak plasma values have been obtained. The apparent half-life for
elimination from the synovial fluid is 3-6 hours, two hours after reaching the peak
plasma values, concentrations of the active substance are already higher in the
synovial fluid than they are in the plasma, and they remain higher for up to 12 hours.
Approximately 60% of the administered dose is excreted via the kidneys in the form
of metabolites and less than 1% in unchanged form. The remainder of the dose is
excreted via the bile in metabolised form. In patients with impaired renal function, no
accumulation of diclofenac has been reported.

5.3

Preclinical safety data
Dog: Oral LD50: 59mg/kg No toxic effects noted
Mouse: Oral LD50: 125mg/kg No toxic effects noted
Rat: Oral LD50: 53mg/kg Behavioural (altered sleep time, ataxia), lungs, thorax or
respiration (respiratory stimulation)
Rabbit: Oral LD50: 157mg/kg No toxic effects noted
(Registry of toxic effects of chemical substances 1985-6)

6.1.

List of excipients

Ethanol
Lactose Monohydrate
Magnesium stearate
Methylhydroxypropylcellulose
Microcrystalline Cellulose
Povidone
Talc
Pigment Blend (PB24916 Pink) containing
Lactose Monohydrate and
Iron Oxide Red (E172)
*Not present in the final product

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
PP-container with PE lids Pack sizes: 28, 56, 100 tablets
HDPE-container with PE lids: Pack sizes 28, 56, 100 tablets
Aluminium foil/PVDC blister strips: Pack sizes 10, 20, 28, 30, 50, 56, 60, 90 and 100
tablets
Blister strips consisting of push through 20 µm aluminium foil with a formpacking
bottom strip of 45 µm aluminium foil: Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90 and
100 tablets

6.6.

Special precautions for disposal

No special requirements.

7.

MARKETING AUTHORISATION HOLDER
Strides Pharma UK Ltd
Unit 4 Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD18 9SS
Trading as: Co-pharma

8

MARKETING AUTHORISATION NUMBER(S)
PL 13606/0145

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/01/2003 / 24/02/2009

10

DATE OF REVISION OF THE TEXT
11/01/2018

+ 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.

Hide