ATROLAK Prolonged-release tablet Ref.[7063] Active ingredients: Quetiapine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Atrolak XL 50 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Peach colored, round shaped, biconvex film coated tablets, debossed with ‘Q50’ on one side and plain on the other.

Note: Diameter of the tablet 11.2 ± 0.2 mm.

Qualitative and quantitative composition

Each 50 mg prolonged release tablet contains 50 mg quetiapine (as quetiapine fumarate).

Excipient(s) with known effect: 140.925 mg Lactose monohydrate per tablet

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Quetiapine

Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors.

List of Excipients

Core:

Lactose monohydrate
Hypromellose
Sodium chloride
Povidone K-30
Silicified Microcrystalline Cellulose (Siliciumdioxide & Microcrystalline Cellulose)
Talc
Magnesium stearate

Coating:

Opadry II 85F540003 Pink contains:

Poly (Vinyl alcohol)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc
Iron oxide red (E172)
Iron oxide yellow (E172)

Pack sizes and marketing

PVC/PVDC-Alu blister pack or OPA/Alu/PVC–Alu blister pack. Pack size of 6, 10, 20, 28, 30, 50, 60, 90 and 100 tablets per pack.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0213

19/06/2013

Drugs

Drug Countries
ATROLAK Spain, Poland, United Kingdom

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