Voltarol emugel Direct relief from pain and inflammation to the affected area.
Voltarol Gel
Therapeutic indications
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
- localised forms of soft tissue rheumatism
It is recommended that treatment be reviewed after 14 days in these indications.
For the treatment of osteoarthritis of superficial joints such as the knee.
In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.
Posology and method of administration
Adults: Voltarol Emulgel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3 - 4 times a daily. After application, the hands should be washed unless they are the site being treated.
Use in the elderly: The usual adult dosage may be used.
Children: Voltarol Emulgel is not recommended for use in children as dosage recommendations and indications for use in this group of patients have not been established.
Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently.
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 (NSAIDs).
' Hypersensitivity to the active substance or any of the excipients ,
' Hypersensitivity to propylene glycol, isopropanol or other components of the gel base.
Special warnings and precautions for use
Warnings
The likelihood of systemic side effects with topical diclofenac is small compared to the frequency of side effects in patients using oral diclofenac. However when Voltarol Emulgel is applied to relatively large areas of skin over a prolonged period of time, as described in the product information on systemic forms the possibility of systemic side effects cannot be excluded.
Voltarol Emulgel contains propylene glycol, which may cause mild, localised skin irritation in some people.
Precautions
Concomitant use of oral NSAID's should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase. (See also 'Interactions')
Voltarol Emulgel should not be co-administered with other products containing diclofenac.
Voltarol Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should be 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.
Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
Interaction with other medicinal products and other forms of interaction
Systemic absorption of Voltarol Emulgel is low and hence the risk of an interaction is small. There are no known interactions with Voltarol Emulgel but for a list of interactions known with oral diclofenac the data sheet for oral dosage forms should be consulted.
Pregnancy and lactation
Pregnancy
Since no experience has been acquired with Voltarol Emulgel in pregnancy or lactation, it is not recommended for use in these circumstances.
During the last trimester of pregnancy the use of prostaglandin synthetase inhibitors may result in premature closure of the ductus arteriosus, or in uterine inertia.
Animal data has shown an increased incidence of dystonia and delayed parturition when drug administration is continued into late pregnancy (see section 5.3 Preclinical safety data).
Lactation
It is not known whether topical diclofenac is excreted in human milk, and Voltarol Emulgel is therefore not recommended during breast-feeding, if there are compelling reasons for using Voltarol Emugel during breast feeding it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
