- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Gel formulation of diclofenac.
Osteoarthritis of superficial joints
Relief of pain and inflammation due to trauma
Soft tissue injuries
Soft tissue rheumatism
POM and GSL and P products
Depending on the size of the affected site to be treated, 2 to 4 g of gel (a circular shaped mass approximately 2 to 2.5 cm in diameter) should be applied three to four times daily, with four hours between applications (maximum 4 doses in 24 hours).
12 hour P Product
Depending on the size of the affected site to be treated, 2 to 4 g of gel (a circular shaped mass approximately 2 to 2.5 cm in diameter) should be applied twice daily (preferably morning and evening).
It is recommended that treatment should be limited to 14 days for the 'Pharmacy Only' products and 7 days for the 'GSL' products unless otherwise advised by a doctor, and treatment should be reviewed after 14 days when prescribed by a doctor. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.
(See Dosage; Adult)
Children 14 years and over
(See Dosage; Adult)
Children under 14 years
Third trimester of pregnancy
Precautions and Warnings
First trimester of pregnancy
History of gastrointestinal bleeding
History of peptic ulcer
Second trimester of pregnancy
May mask symptoms or signs of infections
Not all available brands are licensed for all indications
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with diseased or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Breastfeeding: Do not treat the breast area if patient breastfeeding
Not for use in open wounds
Not to be applied to infected skin
Prolonged use over a large area may cause systemic absorption
Discontinue if signs of gastro-intestinal ulceration occur
Discontinue if irritation or sensitisation occur
Discontinue if patient is attempting to conceive
Advise patient residue on clothing/bedding may cause fire hazard
Avoid excessive exposure to sunlight
Fire hazard: Keep away from naked flames and potential sources of ignition
Serious skin reactions, including exfoliative dermatitis, Stevens Johnson syndrome and epidermal necrolysis have been associated with the administration of NSAIDs. The risk of occurrence is highest during the first month of treatment. Concomitant use of oral NSAID's should be cautioned.
Pregnancy and Lactation
Diclofenac sodium is contraindicated during pregnancy.
The manufacturer does not recommend using diclofenac sodium during the first and second trimesters of pregnancy unless clearly necessary. The dose should be low and the duration as short as possible.
Use of diclofenac sodium during the third trimester of pregnancy is contraindicated by the manufacturer. There is an increased risk of developmental effects including cardiopulmonary toxicity and renal dysfunction.
Use diclofenac sodium with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst using diclofenac sodium unless advised by a healthcare professional. Avoid application to the breast area.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: May 2013
Summary of Product Characteristics: Voltarol 1.16% Emulgel, gel. Novartis Consumer Health UK. Revised November 2012.
Summary of Product Characteristics: Voltarol 12 Hour Emulgel P. Novartis Consumer Health. Revised April 2013.
Summary of Product Characteristics: Voltarol Emulgel P. Novartis Consumer Health. Revised November 2012.
Summary of Product Characteristics: Voltarol Pain-eze Emulgel. Novartis Consumer Health. Revised November 2012.
The Drug Database for Acute Porphyria (NAPOS)
Available at: www.drugs-porphyria.com
Diclofenac. Last revised: 1st October 2004
Last accessed: May 13, 2013
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Diclofenac. Last revised: March 1, 2012
Last accessed: May 13, 2013
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.