For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints, eg. due to sprains, strains and bruises
- localised forms of soft tissue rheumatism
It is recommended that the treatment be reviewed after 14 days in these indications. For the
treatment of osteoarthritis of superficial joints such as the knee. In the treatment of osteoarthritis,
therapy should be reviewed after 4 weeks.

Adults: Diclon Emulgel should be rubbed gently into the skin. Depending on the size of the
affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter)
should be applied 3 - 4 times a daily.
After application, the hands should be washed unless they are the site being treated.
Use in the elderly: The usual adult dosage may be used.
Children and adolescents: There are insufficient data on efficacy and safety available for the
children and adolescents below 14 years of age (see also contraindications section 4.3).

In children aged 14 years and over, if this product is required for more than 7 days for pain relief
or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
Diclon Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in
combination with ultrasound therapy. If large areas of the body are covered with gel, systemic
absorption will be greater and the risk of side-effects increased, especially if the therapy is used
frequently.

Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). •Hypersensitivity to diclofenac or any of the excipients •Third trimester of pregnancy. •The use in children and adolescents aged less than 14 years is contraindicated.

The possibility of systemic adverse events from application of Diclon Emulgel cannot be excluded
if the preparation is used on large areas of skin and over a prolonged period (see the product
information on systemic forms of diclofenac).
Diclon Emulgel contains propylene glycol, which may cause mild, localised skin irritation in some
people. Concomitant use of oral NSAID's should be cautioned as the incidence of untoward
effects, particularly systemic side effects, may increase. (See also 'Interactions')
Diclon Emulgel should not be co-administered with other products containing diclofenac. Diclon
Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open
injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and
should not be ingested. Discontinue the treatment if a skin rash develops after applying the
product.

Diclon Emulgel can be used with non-occlusive bandages but should not be used with an airtight
occlusive dressing. Some possibility of gastro-intestinal bleeding in those with a significant history
of this condition has been reported in isolated cases.

Since systemic absorption of diclofenac from a topical application is very low such interactions are
very unlikely. There are no known interactions with Diclon Emulgel but for a list of interactions
known with oral diclofenac the data sheet for oral dosage forms should be consulted

Pregnancy
The systemic concentration of diclofenac is lower after topical administration, compared to oral
formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the
following is recommended: Inhibition of prostaglandin synthesis may adversely affect the
pregnancy and/or the embryo/fetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and of 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 been shown to result in increased pre- and post-implantation
loss and embryo-fetal lethality. In addition, increased incidences of various malformations,
including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor
during the organogenetic period.
During the first and second trimester of pregnancy, diclofenac should not be given unless clearly
necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second
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 fetus
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 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.

Lactation
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic
doses of Diclon Emulgel no effects on the suckling child are anticipated.
Because of a lack of controlled studies in lactating women, the product should only be used during
lactation under advice from a healthcare professional. Under this circumstance, Diclon Emulgel
should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for
a prolonged period of time (see section 4.4).

Cutaneous application of Diclon Emulgel has no influence on the ability to drive and use
machines.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using
the following convention: 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), not known: cannot be
estimated from the available data.

Immune system disorder:
Very rare: Hypersensitivity (including urticaria),
angioneurotic oedema
Infections and infestations:
Very rare: Rash pustular.
Respiratory, thoracic and mediastinal disorders
Very rare: Asthma.
Skin and subcutaneous tissue disorders
Common: Rash, eczema, erythema, dermatitis
(including dermatitis contact), pruritus
Rare: Dermatitis bullous
Very rare: Photosensitivity reaction

Although less likely with the topical administration some side effects normally associated with
systemically administered diclofenac may also occur.
Reporting of suspected reactions:
Saudi Arabia
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
Other GCC States:
 Please contact the relevant competent authority.

Signs and symptoms
The low systemic absorption of Diclon Emulgel renders overdose very unlikely. However,
undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be
expected if Diclon Emulgel is inadvertently ingested (1 tube of 100g contains the equivalent of
1000mg of diclofenac sodium). In the event of accidental ingestion, resulting in significant
systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with
nonsteroidal anti-inflammatory medicines should be used. Gastric decontamination and the use of
activated charcoal should be considered, especially within a short time of ingestion
Treatment
Management of overdosage with NSAIDs essentially consists of supportive and symptomatic
measures. There is no typical clinical picture resulting from Diclon overdosage. Supportive and
symptomatic treatment should be given for complications such as hypotension, renal failure,
convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as
forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to
their high rate of protein binding and extensive metabolism. Further management should be as
clinically indicated or as recommended by the national poisons centre, where available.

Pharmacotherapeutic group: Topical products for joint and muscular pain, anti-inflammatory
preparations, non-steroids for topical use

ATC code M02A A15
Diclofenac is a non-steroidal anti-inflammatory (NSAID) and analgesic, Diclon Emulgel
preparation designed for external application. Due to an aqueous-alcoholic base the gel exerts a
soothing and cooling effect.

When Diclon Emulgel is applied locally, the active substance is absorbed through the skin. In
healthy volunteers approximately 6% of the dose applied is absorbed, as determined by urinary
excretion of diclofenac and its hydroxylated metabolites. Findings in patients confirm that
diclofenac penetrates inflamed areas following local application of the Emulgel. After topical
administration of Diclon Emulgel to hand and knee joints diclofenac can be measured in plasma,
synovial tissue and synovial fluid. Maximum plasma concentrations of diclofenac are about 100
times lower than after oral administration of Diclofenac.

None known.

6.1.List of Exipients
Benzyl Alcohol
Isopropanol
Propylene Glycol
Tefose 63 (PEG-6 Stearate, Glycol Stearate & PEG-32 Stearate)
Labrafil M 1944 CS
(Oleoyl Macrogol-6 Glycerides & Oleoyl Polyoxyl-6 Glycerides)
Butylated Hydroxyanisole
Carbomer 940
Camphor Crystals
Triethanolamine
Purified Water

None Known.

36 Months

Store below 25° C.

Diclon Emulgel is white to off white homogenous smooth translucent emulgel with characteristic
odour free from undispersed particle or extraneous matter, 45 gm packed in collapsible aluminum
tube coated internally by epoxide resin with screw cap, packed in a carton box along with a leaflet.

No special instructions.