Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Major depression.
Treatment of social phobia.
Manerix tablets are for oral administration.
The tablets should be taken at the end of a meal.
The recommended initial dose is 300mg daily, usually administered in 2-3 divided doses. The dose may be increased up to 600mg/day depending on the severity of the depression.
The individual response may allow a reduction of the daily dose to 150mg.
The dose should not be raised until after the first week, as bioavailability increases during this period.
Treatment should continue for at least 4-6 weeks in order to assess the efficacy of the drug.
The recommended dose of moclobemide is 600mg/day, given in 2 divided doses. The moclobemide dose should be started at 300mg/day and should be increased to 600mg/day on day 4. Continuing the 300mg/day dose for longer than 3 days is not recommended, as the efficacious dose is 600mg/day. Treatment with 600mg/day should continue for 8-12 weeks in order to assess the efficacy of the drug. Social phobia may be a chronic condition and it is reasonable to consider continuation of treatment for a responding patient. Patients should be periodically re-evaluated to determine need for further treatment.
Elderly patients do not require a special dose adjustment of Manerix.
In view of the lack of clinical data available, Manerix is not recommended for use in children.
Patients with reduced renal function do not require a special dose adjustment of Manerix.
When hepatic metabolism is severely impaired by hepatic disease or a drug that inhibits microsomal mono-oxygenase activity (e.g. cimetidine), normal plasma levels are achieved by reducing the daily dose of Manerix to half or one third (see section 4.5 Interaction with other medicinal products and other forms of interaction and see section 5.2 Pharmacological properties).
Overdoses of moclobemide alone induce generally mild and reversible signs of CNS and gastro-intestinal irritation.
Treatment of overdose should be aimed primarily at maintenance of the vital functions.
As with other antidepressants, mixed overdoses of moclobemide with other drugs (e.g. other CNS-acting drugs) could be life-threatening. Therefore, patients should be hospitalised and closely monitored so that appropriate treatment may be given.
5 years.
No special precautions for storage.
Blister packing.
Pack sizes: 28, 30, 84 and 100 tablets.
Not applicable.
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