Swiss Relief Spray Gel

/ Perrigo

Adults: Sufficient solution of Swiss relief Spray Gel should be sprayed onto the skin of the affected site.
Depending on the size of area 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 daily in regular intervals. A 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).
Swiss relief Spray Gel 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 7-8 days without review. The patient is requested to consult the doctor if no improvement is seen after 3 days.
Older people: The posology is the same as for adults.
Paediatric population: There are insufficient data on efficacy and safety available for the children and adolescents below 15 years of age.
In children aged 15 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 hepatic or renal impairment: For the use of Swiss relief Spray Gel in patients with hepatic or renal insufficiency.
Method of administration: For cutaneous use only.

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.

– 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 aspirin or other non-steroidal anti-inflammatory agents (NSAIDs).
– During the third trimester of pregnancy.

The possibility of systemic adverse events from application of Swiss relief Spray Gel cannot be excluded if the preparation is used on large areas of skin and over a prolonged period.
Swiss relief Spray Gel 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.
Swiss relief Spray Gel 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 Swiss relief Spray Gel with oral NSAIDs should be cautioned as the incidence of systemic side effects may increase.
Where Swiss relief Spray Gel 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 side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on diclofenac oral dosage forms should be consulted (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.
Swiss relief Spray Gel should only be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, bleeding diathesis or inflammatory bowel disease as isolated cases with topical diclofenac have been reported.
Swiss relief Spray Gel contains propylene glycol which may cause skin irritation in some people.
Swiss relief Spray Gel contains peppermint oil which may cause allergic reactions.

Common: Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus.
See prescribing information for full details.

Since systemic absorption of diclofenac from a topical application of Swiss relief Spray Gel is very low such interactions are very unlikely. Concurrent acetylsalicylic acid or other NSAIDs may result in an increased incidence of adverse reactions.

Pregnancy: During the first and second trimester of pregnancy, Swiss relief Spray Gel should not be given unless clearly necessary. If Swiss relief Spray Gel 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 foetus 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 Swiss relief Spray Gel 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, Swiss relief Spray Gel 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 prescribing information for full details.

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 Swiss relief Spray Gel 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.