NALION Tablet Ref.[28285] Active ingredients: Alprazolam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Nalion 0.25mg tablets.

Nalion 0.5mg tablets.

Pharmaceutical Form

Tablet.

Nalion 0.25mg: white, round, flat scored tablets.

Nalion 0.5mg: yellow, round, flat, scored tablets.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each tablet of Nalion 0.25mg contains 0.25mg of alprazolam.

Each tablet of Nalion 0.50mg contains 0.50mg of alprazolam.

Excipient with known effect: lactose.

Each tablet of Nalion 0.25mg includes 65.75mg lactose.

Each tablet of Nalion 0.5mg includes 70mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alprazolam

Alprazolam, like other benzodiazepines, has a high affinity for the benzodiazepine binding site in the brain. It facilitates the inhibitory neurotransmitter action of gamma-aminobutyric acid, which mediates both pre- and post synaptic inhibition in the central nervous system (CNS).

List of Excipients

Nalion 0.25 mg tablets also contain:

Lactose
Microcrystalline cellulose
Sodium lauryl sulphate
Colloidal silicon dioxide
Maize starch
Magnesium stearate

Nalion 0.5 mg tablets also contain:

Lactose
Microcrystalline cellulose
Sodium lauryl sulphate
Colloidal silicon dioxide
Maize starch
Quinoline yellow
Magnesium stearate

Pack sizes and marketing

Tablets are packaged in aluminium foil-polyvinylchloride blisters, with a patient information leaflet in a carton of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Nalion 0.25mg tablets: 19847
Nalion 0.5mg tablets: 19848

Nalion 0.25mg tablets: Date of first authorization: 19/12/2005, Date of renewal: 31/08/2012

Nalion 0.5mg tablets: Date of first authorization: 19/12/2005, Date of renewal: 07/09/2011

Drugs

Drug Countries
NALION Cyprus, Hong Kong

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