Approved by State Agency of Medicines (SAM) of Latvia
Registration No. 10222 - 250308
Translated from Latvian.
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
DIKLOFEROL® 50 mg coated tabletes
Diclofenacum kalicum
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE PRODUCT
Active substance: Diclofenac potassium (Diclofenacum kalicum).
Each coated tablet contains 50 mg of active ingredient Diclofenac potassium
Excipients: see p. 6.1.
3. PHARMACEUTICAL FORM
Coated tablets.
Appearance: tablets with dark pink coating, tablet coating section shows the dark-pink color and
the core of white to white with a yellowish tint.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Diseases for which treatment there is a need to decrease pain and inflammation.
• Acute musculoskeletal disorders:
pain, inflammation and swelling after an injury (such as ligament strain)
pain, inflammation and swelling after surgery, dental or orthopedic surgery
rheumatic diseases (rheumatoid arthritis, spondylarthritis, juvenile arthritis)
degenerative joint and spine diseases (arthrosis, spondiloze)
acutely painful and inflammatory conditions (such as periarthritis, bursitis, myositis, tendonitis,
synovitis)
acute gout attack
ear, nose and throat infections in the adjuvant therapy
• Migraine
• Dysmenorrhea.
4.2 Posology and method of administration
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A tablet is taken orally after meals with liquid.
Acute muscular-skeletal disorders:
Adults are indicated a dose of 50 mg 2-3 times a day. Treatment duration is usually several days
Children over 14 years of age: a dose of 50-100 mg is used a day.
Medicine Dikloferol® 50 mg Coated Tablets coated tablets are not suitable to use for children
younger than 14 years.
Migraine: therapy should be started as soon as the first symptoms of the disease occur. An initial
dose is 50 mg. In case the ache does not disappear during 2 hours, a further dose of 50 mg may be
used at intervals of 4-6 hours, not exceeding the total dose of 200 mg a day.
Dysmenorrhea: a dose is adjusted individually, usually 50-100 mg dose is used a day. If
necessary, the dose may be increased till maximal dose of 150 mg a day (maximal period of
therapy is 4 days).
4.3 Contraindications
Hypersensitivity to diclofenac potassium and/or any of the excipients, gastrointestinal (GI)
bleeding or perforation in the history associated with nonsteroidal anti-inflammatory drugs
(NSAID) therapy, active peptic ulcer / haemorrhage or the disturbance history (two or more
proven ulcers or bleeding episodes), severe heart failure, severe liver and/or renal insufficiency
(glomerular filtration rate <30 ml / min), severe bleeding disorders, porphyria (the history),
asthma, hives or allergic rhinitis caused by acetylsalicylic acid or other nonsteroidal antiinflammatory agents.
Contraindicated for use concomitantly with acetylsalicylic acid, other nonsteroidal antiinflammatory drugs, coumarin, ketorolac, lithium preparations.
The last three months of pregnancy. It is not recommended during other period of pregnancy. It is
not recommended to use during breast-feeding.
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
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4.4 Special warnings and special precautions for use
Concomitant use with NSAIDs including cyclooxygenase-2 selective inhibitors should be
avoided.
Undesirable effects may be minimized by using the lowest effective dose necessary to control
symptoms for a shorter period.
Elderly
NSAID use in elderly increases frequency of adverse side effects, particularly gastrointestinal
bleeding and perforation, which may be fatal. Gastrointestinal (GI) bleeding, ulceration and
perforation.
Reports of GI bleeding, ulceration or perforation (also with a fatal outcome) have been reported
regarding all NSAIDs. The reports show that these adverse reactions may occur regardless of the
duration of NSAID use. About adverse events may inform the manifistation of warning
symptoms, but they might not take place, as well as adverse reactions may occur in patients with
a history not having gastrointestinal disorders.
The risk of GI bleeding, ulceration or perforation is higher using the higher NSAID dose. Greater
the risk of adverse events are also in those patients with a history of ulcer, particularly if
complicated with haemorrhage or perforation, as well as in the elderly. These patients should
commence treatment at the possible low NSAID dose. In these, as well as in cases of low-dose
aspirin or other medicines with an increased gastrointestinal risk, careful consideration should be
given to combination of NSAID with gastroprotectors, such as misoprostol or proton pump
inhibitors.
Patients (especially elderly ) with a history of gastrointestinal disorders, should report any
unusual abdominal symptoms (especially GI bleeding). Actually, an enhanced attention should be
given to the above mentioned symptoms at an early treatment.
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
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Caution should be given in patients receiving concomitant medications that may increase the risk
of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective
serotonin reversible inhibitors or anti-platelet agents (e.g. aspirin).
If a patient is diagnosed with GI bleeding or ulceration, NSAIDs should be stopped immediately.
Patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), NSAIDs
should be used with caution because of possible exacerbation of the disease.
Cardiovascular and cerebrovascular blood circulation disorders
The reports suggest that NSAID use is related to fluid retention and edema. Therefore, patients
with a history of hypertension and / or mild to moderate congestive heart failure need an adequate
monitoring and consultation.
Clinical trial and epidemiological data suggest that the use of diclofenac potassium salt,
particularly at high doses (150 mg daily) and long term treatment may be associated with an
increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease,
coronary disease, peripheral arterial and / or cerebrovascular disease may be prescribed
diclofenac potassium only after careful consideration of this drug administration. Similar
consideration should also be applied to a patient with cardiovascular disease risk factors (e.g.
hypertension, hyperlipidemia, diabetes mellitus, smoking) scheduled to start long-term therapy.
NSAIDs should be prescribed with caution in patients with asthma, hay fever or allergic rhinitis
in history. These patients are at increased risk of allergic reactions.
Very rarely the reports are received of severe skin reactions (some fatal) associated with the use
of NSAIDs: including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal
necrolysis. The reaction occurring in the early treatment: in most cases the first month of
treatment. Diclofenac potassium salt should be discontinued at the earliest mucosal lesions or any
other sign of hypersensitivityNSAIDs may raise one or more liver enzymes’ activity in patients
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
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with hepatic impairments. Using long-term it is necessary to perform regular checks of liver
functions. Preparation should be discontinued if the deterioration of liver function occurs or
manifestations of other liver dysfunction are observed (e.g. eosinophilia, rash). Asymptomatic
hepatitis can be developed.
In patients with renal impairment treated with diuretics, as well as the etiology of any significant
fall in extracellular fluid volume for other reasons (e.g. a surgical intervention in pre-or
postoperative period) during treatment is recommended to monitor renal function.
The preparation should be used with caution in patients with autoimmune diseases (systemic
lupus erythematodes, mixed collagenoses).
Patients with coagulation disorders or patients receiving concomitant use of anticoagulants,
diclofenac potassium salt can reversibly inhibit platelet aggregation, and enhance anticoagulant
effect.
Drug
administration
for
a
long
time,
require
blood
count
monitoring.
Diclofenac potassium salt, like other NSAIDs may mask symptoms of infection.
Patients with low body weight should use the lowest effective dose.
4.5 Interaction with other medicinal products and other forms of interactions
NSAIDs including diclofenac potassium salt, and
• ACE inhibitors and angiotensin II antagonists: antihypertensive activity decreases, increases
renal failure and hyperkalemia risk;
• anti-platelet agents and selective serotonin reversible inhibitors: increased risk of
gastrointestinal bleeding;
• acetylsalicylic acid: concomitant use contraindicated (increased risk of adverse reactions);
• baclofen: NSAIDs can reduce the excretion of baclofen (increased toxicity);
• beta-blockers: NSAIDs reduce the beta-blocker antihypertensive activity;
• calcium channel blockers: NSAIDs reduce the calcium channel blocker antihypertensive
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
JSC “Olainfarm”, Latvia
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activity (dihydropyridine derivatives: amlodipine, felodipine, isradipine, lacidipine, lercanidipine,
nicardipine, nifedipine, nimodipine, nisoldipine);
• cardiac glycosides: NSAIDs may increase glycoside concentration in blood plasma, may
exacerbate heart failure and impair renal function;
• cyclosporin: cyclosporin increases the plasma concentration of diclofenac (diclofenac dose
should be reduced by half);
• clonidine: NSAIDs reduce the hypotensive effects of clonidine;
• clopidogrel: increased risk of bleeding;
• corticosteroids: increased gastrointestinal bleeding and ulceration risk of interactions not
observed with topical corticosteroids preparations (including preparations for inhalation);
• anticoagulants: diclofenac may enhance the anticoagulant activity of coumarin
(concomitant use is contraindicated), in combination with heparin increases risk of bleeding;
• diazoxide: NSAIDs reduce the hypotensive effect of diazoxide;
• diuretics, potassium-sparing diuretics and aldosterone antagonists: may increase risk of
hyperkalemia when NSAIDs are taken concomitantly with potassium-sparing diuretics and
aldosterone antagonists;
• drospirenone: a risk of hyperkalemia (potassium concentration in blood plasma should be
monitored);
• erlotinib: increased risk of bleeding;
• hydralazine: NPL reduce hydralazine hypotensive effects;
• iloprost: increased risk of bleeding;
• ketorolac: the concomitant use is contraindicated (increase of side effects and
haemorrhage);
• lithium preparations: diclofenac decreases lithium excretion (increased risk of toxicity,
concomitant use is contraindicated);
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
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• methotrexate: diclofenac reduces the excretion of methotrexate (increased methotrexate
toxicity);
• methyldopa: NSAIDs reduce the hypotensive effect of methyldopa;
• mifepristone: mifepristone is not recommended by its manufacturer to be co-administered with
NSAIDs;
• minoxidil: NSAIDs reduce the hypotensive effect of minoxidil;
• moxonidine: NPL reduce moxonidine hypotensive effect;
• nitrates: NSAIDs reduce the hypotensive effects of nitrates;
• nitroprusside: NSAIDs reduce the hypotensive effect of nitroprusside;
• NPL: contraindicated for concomitant administration of several NSAIDs (reinforcing
effects);
• penicillamine: may increase risk of nephrotoxicity;
• pentoxifyilline (oxpentifylline): may increase risk of bleeding;
• fenindione: diclofenac reinforces fenindione anticoagulant activity;
• phenytoin: NSAIDs may enhance the activity of phenytoin;
• quinolone antibacterials: may increase risk of convulsions;
• ritonavir: NSAIDs may increase the plasma concentration of ritonavir;
• sibutramine: increases the risk of bleeding;
• antidiabetic sulphonylurea: NSAIDs may enhance the activity of this preparation;
• tacrolimus: may increase risk of nephrotoxicity;
• venlafaxine: increased risk of bleeding;
• zidovudine: increased haematological toxicity.
Concomitant use with alcohol, increases stomach irritation (if not bleeding).
Pregnancy and lactation
Pregnancy. During the first six months of therapy the usefulness of treatment for the mother and
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
JSC “Olainfarm”, Latvia
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the potential risk to the infant should be carefully evaluated, the last three months - are
contraindicated. Prostaglandin inhibitors can cause premature closure of the ductus arteriosus,
uterine inertia, increased bleeding in mother and child, maternal edema.
Lactation. Diclofenac potassium salt is excreted in breast milk. It is not recommended during
breast-feeding.
4.7 Effects on ability to drive and use machines
Preparation does not affect the ability to drive or operate machinery. One must not drive, if
during treatment occur headache, dizziness, fatigue or blurred vision.
4.8 Undesirable effects
Like all medicines, Dikloferol ® 50 mg tablets can cause side effects, although not everybody gets
them. Side effects are mainly dependent on the dose and different patients may have various side
effects.
Very
common
≥ 1/10
Common
> 1/100, < 1/10
Uncommon
> 1/1 000, < 1/100
Rare
> 1/10 000,< 1/1 000
Very rare
< 1/10 000
Classification of side effects frequency is given in the table.
Blood and lymphatic system disorders: rare - thrombocytopenia, leukopenia, agranulocytosis,
very rare - hemolytic anemia, aplastic anemia. The initial symptoms of these adverse effects may
be fever, sore throat, flu-like syndrome, bleeding from the nose, dermatorrhagia, fatigue.
Immune system disorders: very rare - a systemic anaphylactic and anaphylactoid reactions
(including hypotension), hypersensitivity reactions (angioedema, bronchospasm).
Metabolism and nutrition disorders: rare - weight gain.
Psychiatric disorders: very rare - depression, anxiety, nightmares, psychotic reactions.
Nervous system disorders: rare - headache, dizziness, very rare - sensory disturbances including
paresthesia, taste disturbance, memory and orientation problems, insomnia or drowsiness,
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
JSC “Olainfarm”, Latvia
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anxiety, seizures, tremor, aseptic meningitis.
Eye disorders: very rarely - visual disturbances (blurred vision, diplopia).
Ear and labyrinth disorders: very rare - a temporary hearing loss, tinnitus.
Cardiovascular disorders: very rare - palpitations, chest pain, vasculitis. In association with
NSAID reported oedema, hypertension, and heart failure. Clinical trial and epidemiological data
suggest that the use of diclofenac potassium salt, particularly at high doses (150 mg daily) and
long term treatment may be associated with an increased risk of arterial thrombotic events (e.g.
myocardial infarction and stroke).
Respiratory, thoracic and mediastinal disorders: rare - alveolitis, pulmonary eosinophilia, very
rare - pneumonitis.
Gastrointestinal disorders are the most common adverse events. Peptic ulcers, perforation or GI
bleeding, sometimes fatal are possible, particularly in the elderly. Reported the following adverse
reactions: nausea, vomiting, diarrhea, flatulence, dyspepsia, constipation, abdominal pain, blood
in the stool (melena), vomiting blood (haematemesis), ulcerative stomatitis, colitis or Crohn's
disease exacerbation. Gastritis is seen rarely.
Hepatobiliary disorders: uncommon - aminotransferase activity in blood serum; rarely - hepatitis
with or without jaundice, very rare - fulminant hepatitis developments.
Skin and subcutaneous tissue disorders: rare - hives, rash, very rare - eczema, erythema
multiforme, exfoliative dermatitis, alopecia, photosensitivity, purpura, bullous skin reactions,
including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Renal and urinary disorders: rare – swelling; very rare - acute renal failure, hematuria,
proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis (particularly in
predisposed patients).4.9 Overdose
Symptoms. There is no specific clinical picture. Diclofenac potassium salt overdose symptoms
include headache, dizziness, gastrointestinal disturbances: nausea, vomiting, abdominal pain,
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
JSC “Olainfarm”, Latvia
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diarrhea. It is also possible gastrointestinal bleeding, liver and kidney problems, skin reactions,
changes in blood count.
Procedures. As soon as possible, to prevent absorption it is necessary to make gastric lavage and
administer activated charcoal. In case of complications (hypotension, renal failure, convulsions,
gastrointestinal irritation, respiratory depression) symptomatic treatment is performed. Due to
NPL expressed connection to plasma proteins forced diuresis and hemodialysis are ineffective.
There is no specific antidote.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Non-steroidal anti-inflammatory agent (phenylacetic acid
derivative. ATC code: M01A B05.
Diclofenac potassium has a pronounced anti-inflammatory and analgesic, and also antipyretic
effects. A rapid effect of diclofenac potassium salt is suitable for the treatment of acute pain.
Diclofenac potassium salt works on the prostaglandin biosynthesis inhibition, almost irreversibly
inhibiting cyclo-oxygenase, key enzyme of arachidonic acid metabolism Prostaglandins are
mediators of inflammatory reactions (local capillary enlargement, edema, exudation) as sensitiser
receptors for pain mediators (histamine, bradykinin), lowers the pain threshold, increases the
hypothalamic thermoregulatory centre response to the pyrogenic effects that occur in the body in
response to infectious agents and toxins effects. Diclofenac potassium salt calms moderate and
severe pain. In post-traumatic and postoperative inflammatory cases, it quickly reduces both
spontaneous pain and pain associated with movements and inflammation, as well as wound
edema, effectively reduces the headache of migraine attacks and pain in case of dysmenorrhoea.
5.2 Phamacokinetics
Absorption. Diclofenac potassium salt is rapidly and completely absorbed from the
gastrointestinal tract. Absorption is a little slower if the preparation is taken with food. There is a
Written by
Chief pharmacist
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Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
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18.02.2008
JSC “Olainfarm”, Latvia
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linear dependence between dose and the absorbed active substance. The pharmacokinetics of
repeated doses does not change. After a single 50 mg oral dose of the active substance, peak
plasma concentration is reached within 20-60 min.
Distribution. 99.7 % of diclofenac binds to plasma proteins. Volume of distribution is 1.4 l / kg.
Diclofenac potassium salt penetrates the synovial fluid, where the maximum concentration is
reached 2-4 hours after the maximum concentration in plasma. Plasma elimination half-life of
diclofenac potassium salt lasts for 1-2 hours. After 3-6 hours concentration of active substance
and its metabolites in synovial fluid is higher than the concentration in blood plasma. Diclofenac
potassium salt is released more slowly from the synovial fluid than from blood plasma. The
elimination half-life from synovial fluid is 3-6 hours.
Metabolism. Practically diclofenac potassium salt is completely metabolized in the liver; about
50 % of active substance is metabolized, for the first time excreting in the liver (the first-pass
metabolism), glucuronidation, but mainly hydroxylation and metoxylation process creating a
number of metabolites. Two metabolites have biological activity, but in comparison with
diclofenac potassium salt of activity their activity is low.
Excretion. 60-65 % of the dose is excreted in the urine as metabolites, less than 1% - unchanged.
Doses residue is excreted in faeces as metabolites.
Patients with hepatic dysfunction (chronic hepatitis, compensated cirrhosis) kinetics of diclofenac
potassium salt does not differ from patients, who have no liver function abnormalities, kinetics.
In patients with impaired renal function diclofenac potassium salt’s accumulation was not
observed, but patients with severe impairment (creatinine clearance <10 ml / min) can
accumulate metabolites, which concentrations in blood plasma compared to concentrations in
patients without renal dysfunction, is about 4 times higher.
In patients of different age a significant difference in the absorption, metabolism and excretion
was not observed.
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
JSC “Olainfarm”, Latvia
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5.3 Preclinical safety data
Carcinogenicity: Long-term carcinogenicity studies in rats treated with diclofenac for up to
20 mg / kg / day did not show a significant increase in cancer incidence. Female rats slightly,
but statistically significant increase in benign mammary fibroadenoma’s development rate.
Mutagenicity: A standard has not been established in various mutagenicity.
Teratogenicity: rats and mice diclofenac crosses the placenta. Studies in mice treated with
diclofenac for up to 20 mg / kg / body weight per day, and rats that received up to 10 mg / kg /
body weight per day have shown no teratogenicity, although the dose was toxic to mate rats and
foetuses. Toxic doses caused birth disorders in mate rats, reduced foetus mass and growth, as
well as foetus survival.
Effects on fertility: diclofenac potassium salt did not affect fertility in male and female rats at a
dose of 4 mg/kg/body weight a day.
6. PHARMACEITICAL INFORMATION
6.1 List of excipients
Calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized maize starch, povidone,
sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, hydroxypropyl
methylcellulose, dyes: titanium dioxide (E 171), iron oxides (E 172).
6.2 Incompatibilities: Not applicable.
6.3 Shelf life: 4 years.
6.4 Special precautions for storage
Do not store above 25 °C. Protect from light and moisture.
6.5 Nature and contents of container: 10 tablets in blister from PVC film and lacquered
aluminium foil, 1-2 blisters with patient’s leaflet in the carton pack.
6. Instructions for use and handling: No special requirements.
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008
JSC “Olainfarm”, Latvia
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7. MARKETING AUTHORISATION HOLDER
Joint-Stock Company “Olainfarm”.
Address: 5 Rupnicu St., Olaine, LV-2114, Latvia.
Phone +371 67013701 • Fax +371 67013777 • e-mail: olainfarm@olainfarm.lv
8. REGISTRATION NUMBER
01-0263.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11.07.2001/ 24.01.2007.
10. DATE OF REVISION OF THE TEXT
15.02.2008
Translated from Latvian into English by Larisa Zelnina,
Senior Regulatory Affairs specialist.
Translation corresponds to the original text.
/Larisa Zelnina/30.12.2010.
Written by
Chief pharmacist
Approved by
Head of Pharmacovigilance Group,
QPPV JSC Olainfarm
/signature/
R. Luse
15.02.2008
/signature/
U. Armanis
18.02.2008