Quetiapine Krka 200mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine

Available from:

KRKA, d.d., Novo mesto

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine

Dosage:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Authorization status:

Marketed

Authorization date:

2013-06-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUETIAPINE KRKA 25 MG FILM-COATED TABLETS
QUETIAPINE KRKA 100 MG FILM-COATED TABLETS
QUETIAPINE KRKA 200 MG FILM-COATED TABLETS
QUETIAPINE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Quetiapine Krka
3.
How to take Quetiapine Krka
4.
Possible side effects
5.
How to store Quetiapine Krka
6.
Contents of the pack and other information
1.
WHAT QUETIAPINE KRKA IS AND WHAT IT IS USED FOR
Quetiapine Krka contains a substance called quetiapine. This belongs
to a group of medicines called
antipsychotics. Quetiapine Krka 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 Krka even when you
are feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE KRKA
DO NOT TAKE QUETIAPINE KRKA

if you are allergic to quetiapine or any of the other ingredients of
this medicine (listed in
section 6).

if you are

Summary of Product characteristics

Health Products Regulatory Authority
10 December 2021
CRN00CMDN
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetiapine Krka 200mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg quetiapine (as quetiapine
hemifumarate).
Excipient(s) with known effect
200 mg
Lactose monohydrate
36 mg
​
sodium
​
< 23 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Tablets are round (diameter 11 mm), white film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetiapine Krka is indicated for:
-treatment of schizophrenia.
-treatment of bipolar disorder:
● For the treatment of moderate to severe manic episodes in bipolar
disorder,
● For the treatment of major depressive episodes in bipolar disorder
● For the prevention of recurrence of manic or depressed episodes in
patients with bipolar disorder who previously responded
to quetiapine treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Different dosing schedules exist for each indication. It must
therefore be ensured that patients receive clear information on the
appropriate dosage for their condition.
ADULTS:
FOR THE TREATMENT OF SCHIZOPHRENIA
For the treatment of schizophrenia, Quetiapine Krka should be
administered twice a day. The total daily dose for the first four
days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and
300 mg (Day 4). From Day 4 onwards, the dose should
be titrated to the usual effective dose of 300 to 450 mg/day.
Depending on the clinical response and tolerability of the
individual patient, the dose may be adjusted within the range 150 to
750 mg/day.
FOR THE TREATMENT OF MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR
DISORDER
For the treatment of manic episodes associated with bipolar disorder,
Quetiapine Krka should be administered twice a day. The
total daily dose for the first four days of therapy is 100 mg (Day 1),
200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further
do