Diclofenac

Registered South African indications:

• Symptomatic treatment of localised inflammatory diseases associated with pain of the oropharyngeal cavity which may be caused by conditions such as but not limited to
  - Pharyngitis
  - Pharyngotonsillitis
  - Tonsillitis
  - Gingivitis
  - Mucositis
  - Mouth ulcers
• Pain and inflammation resulting from minor dental treatment or dental extraction
• Oral mucositis resulting from radiotherapy treatment in oncology patients

Registered South African contraindications

• Hypersensitivity to diclofenac, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the excipients

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Manifestations of DRESS

• If any manifestations of drug reaction with eosinophilia and systemic symptoms (DRESS) occur, the agent should be discontinued

Prolonged use

• The use of topical preparations, especially if prolonged, can cause the development of sensitisation phenomena
• In case of sensitisation, the treatment should be suspended and appropriate therapy undertaken, if necessary

Excipient cautions

• Diclofenac spray and mouth wash contains sorbitol and therefore it may have a laxative effect
• Patients with the rare hereditary condition of sorbitol intolerance should not take this product
• This product also contains sodium benzoate, which is mildly irritant to the skin, eyes, and mucous membranes

Effects on ability to drive and use machines

• Diclofenac is not known to affect cognitive ability. Diclofenac has no or negligible influence on the ability to drive and use machines. Patients should be advised to exercise caution until they know how diclofenac affects them

Forms avail. in SA and covered in this monograph: mow, spo

South African registered indications and dosages

Symptomatic treatment of localised inflammatory diseases associated with pain of the oropharyngeal cavity which may be caused by conditions such as but not limited to:
- Pharyngitis
- Pharyngotonsillitis
- Tonsillitis
- Gingivitis
- Mucositis
- Mouth ulcers

• Oral (mow): Rinse or gargle with 15ml of solution for 30 seconds twice a day
• Oral (spo): 2 sprays directly to the affected area 3 times a day; If symptoms worsen or do not improve after 7 days further medical assessment may be necessary

Pain and inflammation resulting from minor dental treatment or dental extraction

• Oral (mow): Rinse or gargle with 15ml of solution for 1 minute twice a day
• Oral (spo): 2 sprays directly to the affected area 3 times a day; If symptoms worsen or do not improve after 14 days further medical assessment may be necessary

Oral mucositis resulting from radiotherapy treatment in oncology patients

• Oral (mow): Rinse or gargle with 15ml of solution for 2 minutes 3 times a day

Method of administration
Mouthwash: The required quantity of solution (undiluted or diluted in a small amount of water) should be rinsed around the mouth or used as a gargle and then spat out. The solution should not be swallowed. Unless treating oral mucositis resulting from radiotherapy treatment, if symptoms worsen or do not improve after 7 days, further medical assessment may be necessary
Oral spray: External (oral) use. This product is not intended to be swallowed

Safety and efficacy in children has not been established

Pregnancy

South African recommendations

• Caution; not recommended
• Adequate and well controlled studies in pregnant women have not been performed thus the safety in pregnancy has not been established. Use of diclofenac mouth wash and spray in pregnant women is not recommended

Breastfeeding

South African recommendations

• Caution; not recommended
• It is unknown if diclofenac is excreted in human milk thus the safety of its use in lactation has not been established. Use of diclofenac mouth wash and spray during breastfeeding is not recommended

Fertility

South African recommendations

• No clinical data is currently available

South African recommendations

• Caution; no dose adjustment recommended
  Safety and efficacy in patients with renal impairment has not been established

South African recommendations

• Caution; no dose adjustment recommended
  Safety and efficacy in patients with hepatic impairment has not been established

South African recommendations

• Caution; no dose adjustment recommended
  Safety and efficacy in the elderly has not been established

Respiratory, Thoracic and Mediastinal Disorders

Less frequent

• Cough

General Disorders and Administration Site Conditions

Less frequent

• Mild irritation of the oral cavity

None known

None routine

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). Systemically administered diclofenac has analgesic, antipyretic and anti-inflammatory properties. When used topically diclofenac possesses analgesic and anti-inflammatory properties.