INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ELMETACIN Solution

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ELMETACIN Solution

COMPOSITION
Elmetacin solution contains 10 mg
indomethacin per g

PHARMACOLOGICAL CLASSIFICATION
Category A 3.1 Antirheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION
Elmetacin solution has antirheumatic properties (Annexure 15B). When the solution is used externally on the affected areas, indomethacin is absorbed through the skin and acts locally, inhibiting inflammation, alleviating pain, and reducing swelling. In this way rheumatic symptoms are specifically treated while the total exposure to indomethacin is low. Pain and local stiffness are alleviated and mobility is improved.
Elmetacin solution is easy to apply, has a pleasant cooling affect and is suitable for long-term treatment.

INDICATIONS
For the local relief of pain, inflammation and swelling associated with
- degenerative disorders of the joints (osteoarthritis of the knee and smaller joints)
- periarticular rheumatic disorders (tendonitis, tenovaginitis, synovitis, painful shoulder stiffness)
- sports and accidental injuries (sprains, strains and contusions)

CONTRA-INDICATIONS
Hypersensitivity to indomethacin. During pregnancy and lactation Elmetacin solution should not be used on large skin areas over a long period of time.

WARNINGS
The solution contains isopropyl alcohol and should not be brought into contact with open wounds, mucous membranes or the eyes.

DOSAGE AND DIRECTIONS FOR USE
Unless otherwise prescribed, spray sufficient solution onto the skin, to cover the affected area, 3 to 5 times daily.
The maximum of Elmetacin solution to be used per day is 25 mL, and corresponds to 200 mg indomethacin. This quantity should not be exceeded.
If other indomethacin preparations are used simultaneously the total daily dose should not exceed 200 mg of indomethacin.
Paediatric dosage has not been established.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Irritation of the skin, e.g. reddening, itching and burning may occur in rare cases in patients with hypersensitivity, but disappears when medication is discontinued.
Provided that the recommended dosage is not exceeded. It is unlikely that adverse reactions will occur as they do follow systemic administration of indomethacin.
Side-effects experienced with systemically administered indomethacin are the following:
Headache and dizziness occur frequently at the commencement of treatment. Anorexia, nausea and vomiting, dyspepsia, and diarrhea may occur. Peptic ulceration, possibly with gastro-intestinal haemorrhage, may also occur and is not always preceded by dyspepsia; there may be oesophageal ulceration. Other reported toxic effects include blood dyscrasias, haematuria, oedema and hypertension, angioneurotic oedema, skin rashes, alopecia, drowsiness, confusion, psychotic reactions, convulsions, dyspnoea, tinnitus, and retinal and corneal effects. Regular ophthalmological examinations are recommended in patients on long-term treatment.
Indomethacin should be administered with caution to patients with impaired hepatic or renal function, and to those with epilepsy, parkinsonism, or psychiatric disorders. Elderly patients may be specially susceptible to the toxic effects of indomethacin. It should not be given to patients with a history of peptic ulcer or to those who are sensitive to aspirin. It should not be administered during pregnancy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Due to the mode of application overdoses are not to be expected.

CONDITIONS OF REGISTRATION
To be imposed by the Council

IDENTIFICATION
Transparent, yellow-green solution with a typical odour.

PRESENTATION
Elmetacin is available in 50 mL and 100 mL bottles.

STORAGE INSTRUCTIONS
Store below 25ºC.
Keep out of reach of children.

REGISTRATION NUMBER
T/3.1/173

NAME AND BUSINESS ADDRESS OF APPLICANT
PHARMAFRICA (PTY) LTD
33 Hulbert Road
New Centre
Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT
09 JUNE 1989

Updated on this site: May 2014
Source: Pharmaceutical Industry

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