Indications comply with the anti-inflammatory activity of diclofenac, they depend on the
gravity of the onset of intolerability manifestations caused by the drug and its position in the
range of anti-inflammatory products currently available.
Use of the product is restricted to adults (over 15 years of age) for the short-term symptomatic
in regard to the short duration symptomatic treatment of acute attacks of:
 articular rheumatisms such as shoulder periarthritis, tendinitis, bursitis,
 microcrystalline arthritis,
 osteoarthritis,
 back pain,
 radiculitis.
 

 

4.2 Dosage and method of administration
Method of administration
Oral route.
The granules must be dissolved in a glass of water, preferably during meals.

Dosage
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration
necessary to control symtpoms (see section 4.4 Special warnings and precaution fro use).
150mg of diclofenac sodium for a maximum period of 7 days, that is to say, 1 sachet of 50mg, 3
times per day for 7 days.
In cases of acute crisis, it is recommended that the granules be taken before meals.

This drug is contra-indicated: - starting from the 6th month of pregnancy (see chapter Pregnancy and Breast feeding), past history of allergy or asthma that began with taking diclofenac or similar substances such as other NSAID drugs, aspirin, - hypersensitivity to one of the excipients, - gastroduodenal ulcer in development, - severe hepatocellular insufficiency, - severe kidney insufficiency, - established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, - in case of phenylketonuria (due to the presence of aspartame), - children less than 15 years old. It is generally contraindicated to take this drug in association with: - oral anticoagulants, - other NSAID drugs (including heavy doses of salicylates), - heparins (parenteral administration), - lithium, - methotrexate (administered in doses higher than 15mg/week), - ticlopidine.

Special warning:
This drug is contra-indicated in case of intolerance to fructose (because of the presence of sorbitol).
Patients with asthma associated with chronic rhinitis, or suffering chronic sinusitis and/or a nasal
polyposis, have a higher risk of allergic manifestations when taking aspirin and/or non-steroidal
anti-inflammatory drugs than the rest of the population. The administration of this medicine can
provoke an asthma attack.
Gastrointestinal bleeding or ulcers/perforations can occur at any time during the course of treatment
without having necessarily any symptoms or warning signs. The relative risk increases with elderly,
fragile, underweight subjects and if the patient is undergoing anticoagulant treatment.
In the event of gastro-intestinal bleeding or ulcer, stop the treatment immediately.

Precautions for use:
Diclofenac exists in other dosage forms, which may be more appropriate;
The occurrence of an asthma attack in certain patients may be related to allergy to aspirin or to an
NSAID drug (see contra-indications);
Diclofenac should be administered with caution, and under surveillance particularly to patients
who have a history of digestive disorders (gastroduodenal ulcer, ulcerous colitis, Crohn’s disease),
hepatic function disorders, antecedents of haematological disorders or coagulation problems.
At the beginning of treatment, careful monitoring of the volume of the diuresis and renal function
is necessary for patients suffering from cardiac, hepatic and chronic renal insufficiency, and for
patients taking diuretic drugs, those recovering after a major surgical operation involving
hypovolemy and in particular elderly subjects;
As with the majority of NSAID drugs, an increase in the rate of one or more hepatic enzymes may
be observed. Interrupt the treatment in case of persistent anomalies or worsening of the hepatic
function in cases of clinical indications of hepatopathies or other manifestations (eosinophily, skin
eruptions...).
During prolonged treatments, it is recommended that the blood status as well as hepatic and renal
functions are checked.

Certain drugs or therapeutic classes are likely to cause hyperkaliaemia: potassium salts,
hyperkaliaemia diuretic drugs, inhibitors of the converting enzymes, inhibitors of angiotensin II,
non-steroidal anti-inflammatory drugs, heparins (with low molecular weights or non fractioned),
ciclosporin and tacrolimus, trimethoprim. The occurrence of hyperkaliaemia can depend upon a
combination of factors.
The risk is greater in case of association with the above-mentioned drugs.
The concomitant administration of diclofenac with the following products needs a rigorous
surveillance of the clinical and biological state of the patient.

Associations advised against :
Other NSAID (inclusive of heavy doses of salicylates): increase of the ulcerogenic and
haemorrhagic digestive risk (additive synergy).
Oral anticoagulants: increase of the risk of haemorrhagic of the oral anticoagulant (inhibition of
the platelet function and stress of the gastroduodenal mucous membrane by the NSAID drugs).
If the association cannot be avoided, strict clinical and biological surveillance is necessary.
Héparins (parenteral administration): increase of the haemorrhagic risk (inhibition of the platelet
function and stress of the gastroduodenal mucous membrane by the NSAID drugs).
If the association cannot be avoided, strict clinical (and biological for the non fractioned heparins) is
necessary.
Lithium (described with diclofenac, ketoprofen, indomethacin, phenylbutazone, piroxicam): the
increase of lithemia could reach toxic values (reduction of the lithium elimination in the kidneys).
If the association cannot be avoided, strict observation and monitoring of the lithemia is necessary
and adapt the lithium posology during the association and after ceasing NSAID drugs;
Methotrexate (administered in doses higher than 15 mg/week):
increase of the haematological toxicity of methotrexate (reduced renal clearance of methotrexate by
the anti-inflammatory drugs).

Ticlopidine: increase of the haemorrhagic risk (synergy of the platelet anti-aggregation activities).
If the association cannot be avoided, strict clinical and biological surveillance is necessary
(inclusive of the bleeding time).
Associations subject to precautions for use:
Diuretics, inhibitors of the converting enzyme (IEC), inhibitors of angiotensin II: acute renal
insufficiency with the dehydrated patient (reduction of the glomerulose filtration by reduction of the
renal prostaglandin synthesis).
Furthermore, a reduction of the antihypertensive effect for the IEC and the inhibitors of angiotensin
II. Hydrate the patient and monitor the renal function at the beginning of the treatment;
Methotrexate, used at low doses (less than 15mg/week):
increase of the haematological toxicity of methotrexate (reduced renal clearance of methotrexate by
the anti-inflammatory drugs).
Control the haemogramm weekly during the first weeks of the association. Increase surveillance in
the event of deterioration (even light) of the renal function, the same as with an elderly subject.
Pentoxifylline: increase of the haemorrhagic risk.
Reinforce the clinical surveillance and check the bleeding times more frequently;
Associations to be taken into account:
Beta-blockers (by extrapolation starting from the indomethacin): reduction of the antihypertensive
effect (inhibition of the vasodilator prostaglandins by the NSAID drugs);
Ciclosporin: risk of addition of the nephrotoxic effects, in particular with elderly subjects;
Intra-uterine device: controversial risk of reduction of the efficiency of the intra-uterine device;
Thrombolytics: increase of the haemorrhagic risk.

Pregnancy
No particular malformative effect has been reported for the human species. However,
complementary epidemiologic studies are necessary in order to confirm the absence of risks.
During the third quarter, all the inhibitors of prostaglandins synthesis can:
Expose the foetus to:
cardio-pulmonary toxicity (pulmonary arterial hypertension - premature closing of the arterial
channel),
renal dysfunction that can become renal insufficiency with oligohydramnios,
Expose the mother and the child to a possible lengthening of the time of bleeding at the end of the
pregnancy.
As a consequence the prescription of NSAID drugs must only be considered, if necessary, during
the 5 first months of pregnancy.
Apart from extremely limited obstetrical uses, and those which justify specialist surveillance, the
prescription of NSAID drugs is advised against after the 6th month.
Lactation
NSAID drugs are excreted into the mother’s milk, therefore as a precaution it is recommended that
a breast feeding woman avoids taking them.

Patients with a possible appearance of vertigo, somnolence and sight troubles should avoid driving
and using machinery.

Due to diclofenac:
Gastro-intestinal effects:
Infrequent: at the beginning of treatment, nausea, vomiting, diarrhoea, abdominal cramps, epigastric
pains, dyspepsia, anorexia, eructations.
Rare: gastroduodenal ulcer, perforation or digestive haemorrhages. These are more frequent with
frequent posology.
Isolated cases: low abdominal ailments such as non specific hemorrhagic colitis, exacerbation of
ulcerous colitis. Pancreatitis and cases of constipation have been reported.
Skin Effects:
Isolated cases: alopecia, photoallergy reactions.
Very rare: occurrence of bullosis (Stevens-Johnson syndrome, Lyell's Syndrome) and
erythrodermia.
Hypersensitivity reactions:
dermatological: cutaneous eruption, urticaria, eczema.
respiratory: bronchospasm, hypersensibility pneumonitis.
other: isolated cases of vasculitis including Debré-Lamy purpura, and hypotension.
general: very rare anaphylactic/anaphylactoid reactions in particular with the subjects presenting
allergy to aspirin.

Effects on the Central Nervous System:
Infrequent: migraines, dizzy spells or vertigo.
Rarely: somnolence.
Isolated cases: convulsions, aseptic meningitis. Disorders of the insomnia, irritability, asthenia,
tremors were reported.
Isolated cases of sensorial troubles: parestheses, sight problems (visual blur, diplopia), ear buzzing.
Effects on the kidneys:
Rare peripheral edemas.
Isolated cases: acute renal insufficiency, urinary anomalies (haematuria, proteinuria), interstitial
nephritis, nephrotic syndrome, papillary necrosis, hyperkaliaemia by hyporeninism.

Effect on the liver:
Infrequent: increase of the serum transaminases.
Rare hepatitis with or without icterus.
Isolated cases: fulminant hepatitis.
Effects on the blood:
Very rarely: leucopenia, agranulocytosis, thrombopenia with or without purpura, medullary aplasia,
weak haemolytic activity.
Due to sorbitol:
Possibility of digestion troubles and diarrhoeas.
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.
To report any side effects:

Symptoms:
migraines, behavioural agitation, muscle contraction, increased irritability, ataxia, vertigo;
convulsions especially in the child;
epigastric pains, nausea, vomiting, haematemesis, diarrhoea, gastroduodenal ulcer;
problems with the hepatic function;
oliguria.
Action to be taken:
Immediate transfer to a specialized hospital;
Rapid evacuation of the product ingested by gastric washing;

Suppressive therapy: acceleration of the elimination, dialysis in case of severe intoxication
accompanied by renal insufficiency, diazepam or phenobarbital in cases of convulsions.

5.1 Pharmacodynamic properties:
ATC Code: M01A B05
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(M: Muscle and Skeleton).
Diclofenac epolamine is a new diclofenac salt.
Diclofenac is a non-steroidal anti-inflammatory drug derived from the phenylacetic acid of the
group of the aryl carboxylic acids. It has the following properties:
analgesic activity,
anti-pyretic activity,
anti-inflammatory activity,
short-term inhibition of the platelet function.
The totality of these properties is related to the inhibition of the prostaglandin synthesis.
A study found that the clinical effect of FLECTOR begins 15 minutes after its ingestion.

Absorption
Administered in the form of epolamine, diclofenac is rapidly and totally absorbed. The
maximum plasmatic concentrations of the diclofenac are reached approximately 40
minutes after administration and are around 2.3 mg/i for a sachet of 50mg.
Repeated doses do not lead to any accumulation of diclofenac, nor of epolamine in plasma.
Distribution
Diclofenac is strongly bound to plasmatic proteins (> 99%) whereas epolamine is only slightly
bound (<6%).
Diclofenac spreads in the synovial liquid where the maximum concentrations are measured from 2
to 4 hours after the plasmatic peak. The apparent elimination half-life from synovial liquid is from 3
to 6 hours-
In mother's milk, the diclofenac is excreted in small quantity but there are no data concerning the
epolamine.
Metabolism
Diclofenac is metabolized quickly and almost entirely, essentially in the liver. The main
metabolization methods are hydroxylation and glycuro-conjugation. The metabolites obtained do
not have any pharmacological activity.
Epolamine is strongly metabolized as N-oxyde epolamine.

Excretion
The excretion of diclofenac is both urinary and faecal. Less than 1% of the active principle is
eliminated unchanged in urine. Approximately 60% of the administered quantity are eliminated in
the form of metabolites in urine, the remainder is eliminated in faeces.
The plasmatic elimination half-life of the unchanged diclofenac is around 1 to 2 hours. The total
plasmatic clearance is approximately 263 ml/minute.
Epolamine is primarily eliminated in the form of metabolites (93% of the amount) in urine. The
half-life N-oxyde epolamine elimination is 6 to 8 hours.
Physio-pathologic variations
Diclofenac’s kinetics is linear in the interval of doses from 25 to 150mg. The pharmacokinetic
parameters are not modified by age.

Physio-pathologic variations
Diclofenac’s kinetics is linear in the interval of doses from 25 to 150mg. The pharmacokinetic
parameters are not modified by age.
5.3 Preclinical security data
The studies of toxicity by repeated administration of FLECTOR were carried out on rats and dogs.
They highlighted digestive reactions and haematological attenuation with a NSAID drug.
No mutagen effect was highlighted on a traditional array of in vitro and in vivo tests.

Sorbitol, aspartame, potassic acesulfame, povidone, Colloidal anhydrous silica, peach flavour
(furaneol, hexyl alcohol, beta caryophyllene, gamma decalactone, hexanoic acid, hexyl hexanoate,
cis-3-hexenol, citral, delta decalactone, linalol, acetic acid, nerol, methyl cyclopentenolone, essential
orange oil (propylene glycol, Arabic gum, maltodextrine), mint flavour (essential peppermint oil,
menthol, butylhydroxyanisole, Arabic gum, maltodextrine).

No object

4 years

Store below 30°C; keep safe from moisture.

2g sachet-dose (Paper/Aluminium/PE); box of 10.
2g sachet-dose (Paper/Aluminium/PE); box of 20.

No specific requirements.