Quetiapine/VIATRIS 200 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

ATC code:

N05AH04

INN (International Name):

QUETIAPINE FUMARATE 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

QUETIAPINE FUMARATE 200 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-04-27

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Quetiapine/VIATRIS 25 mg film-coated tablets
Quetiapine/VIATRIS 100 mg film-coated tablets
Quetiapine/VIATRIS 200 mg film-coated tablets
Quetiapine/VIATRIS 300 mg film-coated tablets
quetiapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Quetiapine/VIATRIS is and what it is used for
2.
What you need to know before you take Quetiapine/VIATRIS
3.
How to take Quetiapine/VIATRIS
4.
Possible side effects
5.
How to store Quetiapine/VIATRIS
6.
Contents of the pack and other information.
1.
WHAT QUETIAPINE/VIATRIS IS AND WHAT IT IS USED FOR
Quetiapine/VIATRIS contains a substance called quetiapine. This
belongs to a group of medicines
called anti-psychotics. Quetiapine can be used to treat several
illnesses, such as:
•
Bipolar depression: where you feel sad. You may find that you feel
depressed, feel guilty,
lack energy, lose your appetite or can’t sleep.
•
Mania: where you may feel very excited, elated, agitated, enthusiastic
or hyperactive or have
poor judgment including being aggressive or disruptive.
•
Schizophrenia: where you may hear or feel things that are not there,
believe things that are not
true or feel unusually suspicious, anxious, confused, guilty, tense or
depressed.
Your doctor may continue to prescribe Quetiapine/VIATRIS even when you
are feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE/VIATRIS
DO NOT TAKE QUETIAPINE/VIATRIS:
•
if you are allergic to quetiapine or any of the other ingredients of
t

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Quetiapine/VIATRIS 25 mg film-coated tablets
Quetiapine/VIATRIS 100 mg film-coated tablets
Quetiapine/VIATRIS 200 mg film-coated tablets
Quetiapine/VIATRIS 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Quetiapine/VIATRIS 25 mg _
Each tablet contains 25 mg of quetiapine as quetiapine fumarate
_Quetiapine/VIATRIS 100 mg _
Each tablet contains 100 mg of quetiapine as quetiapine fumarate
_Quetiapine/VIATRIS 200 mg _
Each tablet contains 200 mg of quetiapine as quetiapine fumarate
_Quetiapine/VIATRIS 300 mg _
Each tablet contains 300mg of quetiapine as quetiapine fumarate
Excipient with known effect
Quetiapine/VIATRIS 25 mg: Each tablet contains 4.50 mg of lactose (as
lactose monohydrate) and
approximately 0.22 mg of sodium
Quetiapine/VIATRIS 100 mg: Each tablet contains 18.00 mg of lactose
(as lactose monohydrate) and
approximately 0.87 mg of sodium
Quetiapine/VIATRIS 200 mg: Each tablet contains of lactose 36.00 mg
(as lactose monohydrate) and
approximately 1.74 mg of sodium
Quetiapine/VIATRIS 300 mg: Each tablet contains 54.00 mg of lactose
(as lactose monohydrate) and
approximately 2.61 mg of sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Quetiapine/VIATRIS 25 mg film-coated tablets _
Peach coloured, round, biconvex, film-coated tablet engraved ‘Q’
on one side.
_Quetiapine/VIATRIS 100 mg film-coated tablets _
Yellow, round, biconvex, film-coated tablet engraved ‘Q’ over
‘100’ on one side.
_Quetiapine/VIATRIS 200 mg film-coated tablets _
White, round, biconvex, film-coated tablet engraved ‘Q’ over
‘200’ on one side.
_Quetiapine/VIATRIS 300 mg film-coated tablets _
White, capsule shaped, biconvex, film-coated tablet engraved ‘Q’
breakline ‘300’ on one side.
The tablet can be divided into equal doses.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapine/VIATRIS is indicated for:
•
Treatment of