Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
Treatment of major depressive episodes.
EMERDYNE should be administered as a single oral dose of 10 mg daily in otherwise healthy adults. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2-4 weeks are necessary to obtain antidepressant response.
A longer half-life and a decreased clearance have been demonstrated in the elderly, therefore a lower initial and maximum dose should be considered.
The maximum recommended dose for elderly patients is 10 mg daily.
Dosage adjustment is not necessary in patients with mild to moderate renal impairment. No information is available on the treatment of patients with severely reduced renal function (creatinine clearance <30 ml/min) (see Section 4.4).
Dosages should be halved to the lower end of the dose range in patients with hepatic insufficiency. The maximum recommended dose for adult patients with hepatic impairment is 10 mg daily.
When stopping EMERDYNE therapy, gradual dose reduction should be considered. EMERDYNE is administered as a single daily dose.
EMERDYNE may be taken without regard to food intake.
(See Section 4.8)
There is no specific antidote. Treatment is supportive and symptomatic.
Gastric lavage should be carried out as soon as possible after oral ingestion.
Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures.
24 months from the date of manufacture.
Store at or below 25°C.
Protect from light.
The blisters are to be kept in the carton until required for use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
EMERDYNE 10 mg.
EMERDYNE 20 mg.
Blister pack:
Tablets are packed in cold form laminate, 25 µm OPA/45 µm Aluminum foil/60 µm PVC as the forming material and plain 25 micron, aluminum foil, 6-8 gsm HSL, as the lidding material.
Aluminium blister pack of 3 × 10 (30) tablets. The blisters are placed in an outer carton.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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