Voltarol

Voltarol^® Active 4% cutaneous spray

Cutaneous spray, solution.

A golden-yellow, transparent solution (pH value: 6.5-7.6), which turns to a gel-like consistency after administration.

For the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures.

For cutaneous use only.

Adults and adolescents aged 14 years and over

Sufficient solution of Voltarol Active 4% cutaneous spray should be sprayed onto the skin of the affected site. Depending on the size to be treated, 4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times a day at regular intervals. The maximum single dose of 1.0 g of the product should not be exceeded. The maximum daily dose is 15 pump strokes (3.0 g of spray containing 120 mg of diclofenac sodium).

Voltarol Active 4% cutaneous spray should be massaged gently into the skin. After this the hands should be washed unless they are the site to be treated. After application some minutes for drying should be allowed before dressing or binding the treated area.

The treatment may be discontinued when the symptoms (pain and swelling) have subsided. Treatment should not be continued beyond 7 days without review. The patient is requested to consult the doctor if no improvement is seen after 3 days.

Children and adolescents

In adolescents 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.

Elderly

The posology is the same as for adults.

Patients with hepatic or renal insufficiency

- Hypersensitivity to diclofenac, peanut, soya or to any of the excipients. Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)

- Patients with or without asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

- During the third trimester of pregnancy.

- Application to the breast area of breast-feeding mothers

- Use in children and adolescents less than 14 years is contraindicated.

The possibility of systemic adverse events from application of Voltarol Active 4% cutaneous spray 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).

Voltarol Active 4% cutaneous spray 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.

Voltarol Active 4% cutaneous spray can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.

Discontinue the treatment if a skin rash develops after applying the product.

The concomitant use of Voltarol Active 4% cutaneous spray with oral NSAIDs should be cautioned as the incidence of systemic undesirable effects may increase.

Where Voltarol Active 4% cutaneous spray is applied to a relatively large area of skin (i.e. more than 600 square centimetres of the body surface) and over a prolonged period (i.e. more than 4 weeks), the possibility of systemic undesirable effects from application of Voltarol Active 4% cutaneous spray cannot be excluded (for example, there is the potential for hypersensitivity, asthmatic and renal adverse reactions). Bronchospasm may be precipitated in patients suffering from or with previous history of bronchial asthma or allergenic disease.

Voltarol Active 4% cutaneous spray should only be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, or bleeding diathesis, or inflammatory bowel disease, as isolated cases with topical diclofenac have been reported.

Information concerning excipients

Voltarol Active 4% cutaneous spray contains:

propylene glycol which may cause skin irritation in some people.

peppermint oil which may cause allergic reactions.

Cutaneous application of Voltarol Active 4% cutaneous spray has no influence on the ability to drive and use machines.

Skin disorders are commonly reported.

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 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1

* Pruritus has been reported at a frequency of 0.9% in a clinical trial, 236 patients with ankle distortions were treated with 4-5 pump strokes of Voltarol Active 4% cutaneous spray t.i.d. (120 patients) or placebo (116 patients) for 14 days.

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. The total single dose of product should not exceed 1.0 g (equivalent to 5 pump strokes) of spray.

Nevertheless during long term treatment (> three weeks) and/or when treating large areas (i.e. more than 600 square centimetres of the body surface) there is a possibility of systemic adverse reactions. Reactions like abdominal pain, dyspepsia, gastric and renal disorders may occur.

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 Voltarol Active 4% cutaneous spray is inadvertently ingested (i.e. a 15 ml spray bottle containing 500 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.

Pharmacotherapeutic group: Antiinflammatory preparations, non-steroids for topical use.

ATC code: M02AA 15

Sodium diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which has also analgesic properties. The inhibition of prostaglandin synthesis is considered to be an essential part of its mode of action.

After cutaneous application of 1.5 g Voltarol Active 4% cutaneous spray a rapid onset of diclofenac absorption can be observed leading to measurable plasma levels of about 1 ng/ml as early as 30 minutes and to maximum levels of about 3 ng/ml at about 24 hours after application.

The achieved systemic concentrations of diclofenac are about 50 times lower than those achieved following oral administration of equivalent amounts of diclofenac. Systemic plasma levels are not supposed to contribute to the efficacy of Voltarol Active 4% cutaneous spray.

Diclofenac is extensively bound to plasma proteins (about 99 %).

In rabbit skin, Voltarol Active 4% cutaneous spray is classified as non-irritant.

Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential of diclofenac reveal no special hazard for humans beyond those already outlined in other sections of the SPC. In animal studies, chronic toxicity of diclofenac following systemic administration mainly took the form of gastrointestinal lesions and ulcers. In a 2-year toxicity study, rats treated with diclofenac showed a dose-dependent increase in thrombotic occlusion of the cardiac vessels.

In rats and rabbits oral doses of diclofenac were not teratogenic but caused embryotoxicity at maternally toxic doses.

Diclofenac did not affect fertility in rats but inhibited ovulation in rabbits and reduced implantation in rats.

In rats, diclofenac resulted in dose-dependent constriction of the fetal ductus arteriosus, dystocia and delayed parturition. Doses below the materno-toxic threshold had no influence on the postnatal development of the progeny.

Isopropyl alcohol

Soybean lecithin

Ethanol

Disodium phosphate dodecahydrate

Sodium dihydrogen phosphate dihydrate

Disodium edetate

Propylene glycol

Peppermint oil (contains menthol and cineole)

Ascorbyl palmitate

Hydrochloric acid 10% (w/w) for pH adjustment

Sodium hydroxide 10% (w/w) for pH adjustment

Purified water.

Not applicable.

3 years

After first opening: 6 months

Store in the original package.

Glass bottle (Type III Ph.Eur.) with metering pump and protection cap.

Pack sizes of 12.5 g solution (15 ml bottle) and 25 g solution (30 ml bottle).

Not all pack sizes may be marketed.

No special requirements.

Novartis Consumer Health UK Limited

Wimblehurst Road, Horsham

West Sussex - RH12 5AB

United Kingdom

PL 00030/0445

Date of first authorisation: 29/08/2008

18/05/2012