GALSYA Prolonged-release capsule, hard Ref.[28018] Active ingredients: Galantamine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Galsya SR 8 mg prolonged-release capsules, hard.

Pharmaceutical Form

Prolonged-release capsule, hard.

White capsulessize 2 (capsule length: 17.6-18.4 mm) with G8 imprinted on the capsule’s cap. Content of capsule is one white oval, prolonged-release tablet core.

Qualitative and quantitative composition

Each prolonged-release capsule, hard contains 8 mg galantamine (as hydrobromide).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Galantamine

Galantamine, a tertiary alkaloid is a selective, competitive and reversible inhibitor of acetylcholinesterase. In addition, galantamine enhances the intrinsic action of acetylcholine on nicotinic receptors, probably through binding to an allosteric site of the receptor. As a consequence, an increased activity in the cholinergic system associated with improved cognitive function can be achieved in patients with dementia of the Alzheimer type.
List of Excipients

Prolonged-release tablet core:

Sodium laurilsulfate
Ammonio methacrylate copolymer (type B)
Hypromellose
Carbomers
Hydroxypropylcellulose
Magnesium stearate
Talc

Capsule shell:

Gelatin
Titanium dioxide (E171)

Black ink:

Shellac
Propylene glycol
Ammonia solution, concentrated
Iron oxide, black (E172)
Potassium hydroxide

Pack sizes and marketing

Blister (OPA/Alu/PVC+Alu or PVC/PE/PVDC+Alu): 10, 14, 28, 30, 56, 60, 84, 90 and 100 prolonged-release capsules, hard, in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/015/001

Date of first authorisation: 3 June 2011
Date of last renewal: 28 October 2015

Drugs

Drug Countries
GALSYA Estonia, Ireland, Lithuania, Poland, Romania, United Kingdom
 
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