• For the local symptomatic relief of pain and inflammation in:

- Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises;
- Localized forms of soft tissue rheumatism

• For the relief of pain of non-serious arthritic conditions.

(See Section 5.2 Pharmacokinetic properties-Special patient population)
 

Adults and children 14 years and over
Diclomax Emulgel should be rubbed gently into the skin. Depending on the size of the affected site to be treated, 2 to 4 g (a circular shaped mass approximately 2.0 to 2.5 cm in diameter) should be applied 3 to 4 times a day. The maximum daily dose is 16 g. Therefore the maximum weekly dose is 112 g.

For arthritis pain it may be necessary to apply the gel for up to 7 days (to allow its effect to build up on the joint) before an improvement in pain is noticed. The gel can be used for up to 14 days under pharmacy supervision.

After application, the hands should be washed unless they are the site being treated.

If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Consultation with a doctor is recommended if more than two major joints in the body are affected. Do not use for more than 14 days unless recommended by a doctor. 

Use in the elderly
The usual adult dosage may be used.

Children
There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (See Section 4.3. Contraindications). 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.

- 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, acetylsalicylic acid, other non-steroidal anti- inflammatory drugs or any of the excipients. - Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. - Third trimester of pregnancy. - Hypersensitivity to any other ingredient of the gel. - Concomitant use of other products containing diclofenac. - Concomitant use of oral NSAIDS. - The use in children and adolescents aged less than 14 years is contraindicated.

The posibility of systemic adverse events from application of Diclomax 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).

Diclomax 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')

Diclomax Emulgel should not be co-administered with other products containing diclofenac.

Diclomax 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.

Diclomax 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 topical application is very low, such interactions are very unlikely.

No drug interactions during treatment with diclofenac diethylammonium have been reported, but the following have been observed with oral forms of diclofenac or other NSAIDs.

Lithium and digoxin
Diclomax may increase plasma concentrations of lithium and digoxin.

Anticoagulants
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 hemorrhage 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 required. As with other non-steroidal anti-inflammatory agents, diclofenac in a high dose can reversibly inhibit platelet aggregation.

Antidiabetic agents
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 hypoglycemic and hyperglycemic effects which have required adjustment to the dosage of hypoglycemic agents.

Ciclosporin
Cases of nephrotoxicity have been reported in patients receiving concomitant cyclosporin and NSAIDs, including diclofenac. This might be mediated through combined renal antiprostaglandin effects of both the NSAID and cyclosporin. 

Methotrexate
Cases of serious toxicity have been reported when methotrexate and NSAIDs 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.

Quinolone antimicrobials
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.

Other NSAIDs and steroids
Co-administration of diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. Concomitant therapy with aspirin lowers the plasma levels of each, although no clinical significance is known.

Diuretics
Various NSAIDs are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, hence serum potassium should be monitored.

Mifepristone
NSAIDs should not be used for 8 to 12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.

Anti-hypertensives
Concomitant use of NSAIDs with antihypertensive drugs (i.e. beta-blockers, angiotensin converting enzyme (ACE) inhibitors, diuretics) may cause a decrease in their antihypertensive effect via inhibition of vasodilatory prostaglandin synthesis.

Pregnancy: Pregnancy Category B
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 diclofenac diethylammonium 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, Diclomax 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. Special warnings and precautions for use).

Cutaneous application of diclofenac diethylammonium emulgel has no or negligible influence on the ability to drive and use machines.

Local: diclofenac diethylammonium emulgel is usually well tolerated. Local irritation, erythema, pruritus or dermatitis may occasionally occur. Skin photosensitivity, desquamation, discolouration and bullous or vesicular eruptions have been reported in isolated cases. Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity. 

The following categories were used for the classification of undesirable effects: very common (≥1/10), common (1-10/100), uncommon (1-10/1000), rare (1-10/10,000), very rare (≤1/10,000), not known (cannot be estimated from the available data). 

Immune system disorders
Very rare	Hypersensitivity (including urticaria), angioneurotic edema.
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.

General: Systemic absorption of diclofenac diethylammonium emulgel is low compared with plasma levels obtained following administration of oral forms of diclofenac and the likelihood of systemic side-effects occurring with topical diclofenac is small compared with the frequency of side-effects associated with oral diclofenac. However, where diclofenac diethylammonium emulgel is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on diclofenac oral dosage forms should be consulted. 

Reporting of suspected adverse reactions

• Saudi Arabia:

The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

• Other GCC States: Please contact the relevant competent authority.

Signs and symptoms
The low systemic absorption of topical diclofenac renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if diclofenac diethylammonium emulgel is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 mg of diclofenac sodium). In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non- steroidal 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 diclofenac 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.

Pharmacotherapeutic group: Nonsteroidal anti-inflammatory drugs (NSAIDs).

ATC code: M01AB05.

Diclomax Emulgel is an anti-inflammatory and analgesic preparation designed for external application. Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.

When diclofenac diethylammonium emulgel is applied locally, the active substance is absorbed through the skin. In healthy volunteers approximately 6% of the dose applied is absorbed when determined by urinary excretion of diclofenac and its hydroxylated metabolites. Findings in patients confirm that diclofenac penetrates inflamed areas following local application of diclofenac diethylammonium emulgel.

Synovial fluid and tissue levels of diclofenac are higher than those detected in plasma.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

• Diethlamine;
• Carbomer 934P;
• Volpo CS 20 (Ethoxy 20 Cetostearyl);
• Propylene Glycol;
• Cetiol LC;
• Liquid paraffin (Mineral Oil);
• Isoparopyl Alcohol;
• Benzyl Alcohol;
• Fragranc Hay 46552 Lavender;
• Purefied water.

Not stated.

3 years Shelf-life after first opening is one month.

Store below 30° C.

Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap, available in packs of 50 g
Aluminium laminated tube (low density polyethylene/aluminium/high density polyethylene (internal layer)) fitted with a high density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap in white or blue, with two alternate shapes of cap and thread, incorporating a moulded feature used to insert, twist and remove the seal before first use. Available in packs of 50.

No special requirements.