Acuflam Spray

Acuflam Spray

diclofenac

Manufacturer:

Unison

Distributor:

JustRight Healthcare
Full Prescribing Info
Contents
Diclofenac sodium.
Description
Each 100 g contains: Diclofenac diethylammonium eq. to Diclofenac sodium, BP 1 g (1 % w/w).
Action
Pharmacology: Diclofenac Spray is an anti-inflammatory and analgesic preparation designed for external application.
Pharmacokinetics: When Diclofenac Spray 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 Spray. Synovial fluid and tissue levels of Diclofenac are higher than those detected in plasma.
Indications/Uses
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.
Dosage/Direction for Use
Adults and children aged 14 years and over: Diclofenac Spray should be sprayed into the skin. Depending on the size of the affected site to be treated, should be applied 3-4 times a day. After application, the hands should be washed unless they are the site being treated. A period of at least 4 hours should be left between applications. The dose should not be applied more than 4 times in a 24 hour period. If symptoms persist after 7 days or get worse at any time, medical advice should be sought. Not to be used for more than 7 days unless recommended by a doctor.
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. 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.
Overdosage
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 hemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
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 spray.
Concomitant use of oral NSAIDs.
Diclofenac Spray should not be co-administered with other products containing Diclofenac.
The use in children and adolescents aged less than 14 years is contraindicated.
Special Precautions
Diclofenac Spray 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 asthma or allergic disease.
Discontinue if rash develops.
Adverse Reactions
Local reactions: Diclofenac Spray is usually well tolerated.
Occasional: allergic or non-allergic contact dermatitis (with symptoms and signs such as itching, reddening, edema, papules, vesicles, bullae or scaling of skin).
Systemic reactions: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnea or (c) assorted skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema, and less commonly, bullous dermatoses (including epidermal necrolysis, erythema multiforme and exfoliative dermatitis.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
General: Systemic absorption of Diclofenac Spray 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 Spray 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.
Gastro-intestinal: Abdominal pain, dyspepsia.
Bronchospasms may be precipitated in patients suffering from or with a previous history of asthma or allergic disease.
Drug Interactions
Systemic absorption of Diclofenac Spray is low and hence the risk of an interaction is small. There are no known interactions with Diclofenac Spray but for a list of interactions known with oral Diclofenac the Summary of Product Characteristics for oral dosage forms should be consulted.
Concurrent use of Aspirin or other NSAIDs may result in an increased incidence of adverse reactions.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Presentation/Packing
Topical spray 10 mg/g (1% w/w) x 60 mL x 1's.
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