Voltarol Emulgel P

1. Name Of The Medicinal Product

Voltarol Emulgel^® P

2. Qualitative And Quantitative Composition

Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.

100g of Voltarol Emulgel P contains 1.16g of the active substance diclofenac diethylammonium, which corresponds to 1g diclofenac sodium.

For excipients, see section 6.1

3. Pharmaceutical Form

Gel for topical administration.

White to practically white, soft, homogeneous, cream-like.

4. Clinical Particulars

4.1 Therapeutic Indications

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

- localised forms of soft tissue rheumatism

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

4.2 Posology And Method Of Administration

Adults and children 14 years and over: Voltarol Emulgel P 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 day. The maximum daily dose is 16g. Therefore the maximum weekly dose is 112g.

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 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.

4.3 Contraindications

Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents.

Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

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.

4.4 Special Warnings And Precautions For Use

Voltarol Emulgel P should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth.

Patients with a history of, or active, peptic ulceration.Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.

Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of, bronchial asthma.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

Lithium and digoxin: Voltarol may increase plasma concentrations of lithium and digoxin.

Anticoagulants: Although clinical investigations do not appear to indicate that Voltarol has an influence on the effect of anticoagulants, there are isolated reports of an increased risk of haemorrhage 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 Voltarol can be given together with oral antidiabetic agents without influencing their clinical effect. However there have been isolated reports of hypoglycaemic and hyperglycaemic effects which have required adjustment to the dosage of hypoglycaemic 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 Voltarol 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 8-12 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.

4.6 Pregnancy And Lactation

Since no experience has been acquired with Voltarol Emulgel P in pregnancy or lactation, it is not recommended for use in these circumstances.

During the last trimester of pregnancy the use of prostaglandin synthetase inhibitors may result in premature closure of the ductus arteriosus, or in uterine inertia.

Animal data has shown an increased incidence of dystonia and delayed parturition when drug administration is continued into late pregnancy.

Following oral doses of 50mg diclofenac administered every 8 hours, diclofenac passes into breast milk in quantities so small that no undesirable effects on the infant are to be expected.

4.7 Effects On Ability To Drive And Use Machines

Voltarol Emulgel P has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Local:

Voltarol Emulgel P is usually well tolerated. Local irritation, erythema, pruritus or dermatitis may occasionally occur. Skin photosensitivity, desquamation, discoloration 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.

General:

Systemic absorption of Voltarol Emulgel P is low compared with plasma levels obtained following oral forms of diclofenac. However, where Voltarol Emulgel P is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side effects cannot be completely excluded.

Asthma has been rarely reported in patients using topical NSAID preparations.

The following additional side-effects have been observed with oral forms of diclofenac.

Gastro-intestinal tract

Occasional: Epigastric pain, other gastro-intestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, anorexia).

Rare: Gastro-intestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea.

In isolated cases: Lower gut disorders (e.g. non-specific haemorrhagic colitis and exacerbations of ulcerative colitis or Crohn's proctocolitis, colonic damage and stricture formation), pancreatitis, aphthous stomatitis, glossitis, oesophageal lesions, constipation.

Central Nervous System:

Occasional: Headache, dizziness, or vertigo.

Rare: Drowsiness, tiredness.

In isolated cases: Disturbances of sensation, paraesthesia, memory disturbance, disorientation, disturbance of vision (blurred vision, diplopia), impaired hearing. Tinnitus, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions. Taste alteration disorders.

Skin:

Occasional: Rashes or skin eruptions.

Rare: Urticaria.

In isolated cases: Eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, (acute toxic epidermolysis), photosensitivity reactions, erythroderma (exfoliative dermatitis), loss of hair, purpura including allergic purpura.

Kidney:

In isolated cases: Acute renal failure, urinary abnormalities (e.g. haematuria, proteinuria), interstitial nephritis, nephrotic syndrome, papillary necrosis.

Liver:

Occasional: Elevation of serum aminotransferase enzymes (ALT, AST).

Rare: Liver function disorders including hepatitis (in isolated cases fulminant) with or without jaundice.

Blood:

In isolated cases: Thrombocytopenia, leucopenia, agranulocytosis, haemolytic anaemia, aplastic anaemia.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of rare cases of anaphylactic/anaphylactoid systemic reactions including hypotension, and respiratory tract reactivity comprising

asthma, aggravated asthma, bronchospasm or dyspnoea. (See also “Skin”).

Other organ systems:

Rare: Oedema

Isolated cases: Impotence (association with diclofenac is doubtful), palpitation, chest pain, hypertension.

4.9 Overdose

Signs and symptoms

The low systemic absorption of topical diclofenac renders overdosage extremely unlikely. In the event of accidental ingestion, resulting in significant systemic side-effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be used.

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Voltarol Emulgel P 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.

5.2 Pharmacokinetic Properties

When Voltarol Emulgel P 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 Emulgel P.

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

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol, purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

All presentations: Do not store above 30°C.

Pump dispenser presentation: The pump dispenser is a pressurised container. It should be protected from direct sunlight and must not be pierced or burned even when empty.

Voltarol Emulgel P should be kept out of reach of children.

6.5 Nature And Contents Of Container

Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap, available in packs of 10g, 30g, 50g and 100g.

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 30g, 50g and 100g.

Pump dispenser with aluminium can, valve (high density polyethylene, reinforced with titanium dioxide) with multi-layer pouch (low density polyethylene), mounted with a protective cap. Available in packs of 75ml.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd.

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UK

8. Marketing Authorisation Number(S)

PL 00030/0174

9. Date Of First Authorisation/Renewal Of The Authorisation

1 April 2000

10. Date Of Revision Of The Text

17 March 2011.

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