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DIFENE SPRAY GEL

Information leaflet

                                                         Irish Medicines Board




                                   Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Difene Spray Gel 4% w/w Cutaneous Spray, Solution

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each 1g of solution contains 40 mg of diclofenac sodium.
 Excipients: 150 mg propylene glycol (E1520) / gram solution

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Cutaneous spray, solution.
 A golden-yellow, transparent solution, which turns to a gel-like consistency after administration.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 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.

 4.2 Posology and method of administration

 For cutaneous use only.
 Adults
 Sufficient solution of Difene 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).
 Difene Spray Gel should be smoothed 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.
 Elderly
 The posology is the same as for adults.

 Children and adolescents:
 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.

 Patients with hepatic or renal insufficiency
 For the use of Difene Spray Gel in patients with hepatic or renal insufficiency see section 4.4.




______________________________________________________________________________________________________________________
Date Printed 30/09/2011                               CRN 2106126                                         page number: 1
                                                    Irish Medicines Board




 4.3 Contraindications

 o Hypersensitivity to the active substance or to any of the excipients.

 o Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)

  o 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.

 o The last trimester of pregnancy.

 o Application to the breast area of nursing mothers

 o Children and adolescents: the use in children and adolescents aged less than 14 years is contraindicated.



 4.4 Special warnings and precautions for use

 Contact with eyes and mucous membranes as well as oral use should be avoided.
 Difene Spray Gel should only be administered onto intact skin, not on open wounds or diseased skin areas.

 Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
 Discontinue if any rash develops. Not for use with occlusive dressings.

 The concomitant use of Difene Spray Gel with oral NSAIDs should be cautioned as the incidence of systemic side
 effects may increase (see section 4.5).

 Where Difene 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.

 Difene 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.

 Difene Spray Gel contains propylene glycol which may cause skin irritation.
 Difene Spray Gel contains peppermint oil which may cause allergic reactions.

 4.5 Interaction with other medicinal products and other forms of interaction

 The systemic availability of diclofenac from this pharmaceutical presentation is very low. Hence the risk of interactions
 with other medicinal products is small. Concurrent aspirin or other NSAIDs may result in an increased incidence of
 adverse reactions (see section 4.4).

 4.6 Fertility, pregnancy and lactation

 There are no adequate data from the use of Difene Spray Gel in pregnant and nursing women. Therefore the use is not
 recommended.

 Use in pregnancy:




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Date Printed 30/09/2011                               CRN 2106126                                         page number: 2
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