Voltarol Active 4% spray

Summary of Product characteristics

                                OBJECT 1
VOLTAROL ACTIVE 4% CUTANEOUS SPRAY
Summary of Product Characteristics Updated 21-Jun-2012 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Voltarol
®
Active 4% cutaneous spray
2. Qualitative and quantitative composition
1g of Voltarol Active 4% cutaneous spray contains 40 mg of diclofenac
sodium.
Each pump stroke delivers 8 mg of diclofenac sodium.
Excipients:
Propylene glycol 150 mg/g
Soy bean lecithin 100 mg/g
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous spray, solution.
A golden-yellow, transparent solution (pH value: 6.5–7.6), 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 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_
There are insufficient data on efficacy and safety available for
chil
                                
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