MANERIX Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Manerix 150mg Film-coated Tablets.
Qualitative and quantitative composition
1 film-coated 150mg tablet contains 150mg moclobemide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablets containing 150mg of moclobemide.
Therapeutic indications
Major depression. Treatment of social phobia.
Posology and method of administration
Manerix tablets are for oral administration. The tablets should be taken at the end of a meal. Adults Major depression The recommended initial dose is 300mg daily, usually administered in 2-3 divided doses. ...
Contraindications
Manerix is contra-indicated in patients with known hypersensitivity to the drug or to any component of the product, in acute confusional states and in patients with phaeochromocytoma. Manerix should not ...
Special warnings and precautions for use
As with other antidepressants, treatment may exacerbate the schizophrenic symptoms of depressive patients with schizophrenic or schizoaffective psychoses. If possible, therapy with long-acting neuroleptics ...
Interaction with other medicinal products and other forms of interaction
Co-administration of Manerix with pethidine or selegiline is contraindicated (see section 4.3 Contraindications). Co-administration of Manerix with triptans is contraindicated, because they are potent ...
Pregnancy and lactation
Pregnancy Reproduction studies in animals have not revealed any risk to the foetus, but the safety of Manerix in human pregnancy has not been established. Therefore the benefits of drug therapy during ...
Effects on ability to drive and use machines
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told: The medicine is likely to affect your ...
Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very Common (≥1/10) ...
Overdose
Signs Overdoses of moclobemide alone induce generally mild and reversible signs of CNS and gastro-intestinal irritation. Management Treatment of overdose should be aimed primarily at maintenance of the ...
Pharmacodynamic properties
Pharmacotherapeutic group: antidepressant ATC Code: N06AG02 Manerix is an antidepressant which affects the monoaminergic cerebral neurotransmitter system by means of a reversible inhibition of monoamine ...
Pharmacokinetic properties
Absorption After oral administration, moclobemide is completely absorbed from the gastrointestinal tract into the portal blood. Peak plasma concentrations of the drug are usually reached within one hour ...
Preclinical safety data
Preclinical data, based on conventional studies of safety pharmacology, single- and repeat-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction did not reveal special hazards ...
List of excipients
Lactose Maize starch Povidone K30 Sodium starch glycollate Magnesium stearate Hydroxypropyl methylcellulose Ethylcellulose Polyethylene glycol 6000 Talc Titanium dioxide (E171) Yellow iron oxide (E172) ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
Blister packing. Pack sizes: 28, 30, 84 and 100 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0130
Date of first authorization / renewal of the authorization
9<sup>th</sup> September 2009
Date of revision of the text
February 2018
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