Quetiapine 25mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Quetiapine fumarate

Boleh didapati daripada:

Kent Pharma (UK) Ltd

Kod ATC:

N05AH04

INN (Nama Antarabangsa):

Quetiapine fumarate

Dos:

25mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04020100

Risalah maklumat

Quetiapine contains the active substance quetiapine.
It belongs to a group of medicines called antipsychotics.
Quetiapine can be used to treat several illnesses, such as:
• 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.
• Mania: where you may feel very excited, elated,
agitated, enthusiastic or hyperactive or have poor
judgment including being aggressive or disruptive.
• Bipolar depression: where you feel sad. You may find
that you feel depressed, feel guilty, lack energy, lose
your appetite or can’t sleep.
Your doctor may continue to prescribe Quetiapine even
when you are feeling better.
DO NOT TAKE QUETIAPINE
• If you are allergic to quetiapine or any of the other
ingredients of this medicine (listed in section 6)
• If you are taking any of the following medicines:
– some medicines used to treat HIV infections
– azole medicines (medicines used to treat fungal
infections)
– erythromycin or clarithromycin (medicines used to
treat bacterial infections)
– nefazodone (medicine used to treat depression).
Do not take Quetiapine if the above applies to you.
If you are not sure, talk to your doctor or pharmacist
before taking Quetiapine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Quetiapine:
• if you, or someone in your family, have or have had
any heart problems, for example heart rhythm
problems, weakening of the heart muscle or
inflammation of the heart or if you are taking any
medicines that may have an impact on the way your
heart beats.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have problems with your liver.
• if you have ever had a fit (seizure).
• if you have diabetes or have a risk of getting diabetes.
If you do, your doctor may check your blood sugar
levels while you are taking Quetiapine.
• if you know that you have had low levels of white
blood cells in the

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Quetiapine 25 mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg quetiapine (as quetiapine
fumarate).
Excipient(s) with known effect
Each film-coated tablet contains 14 mg of lactose and 0.031 mg of
sunset yellow FCF
aluminium lake (E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Light-orange, round, biconvex, film-coated tablet, engraved “25”
on one side and plain on the
other
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapine is indicated for:
•
treatment of schizophrenia.
•
treatment of bipolar disorder:
o
For the treatment of moderate to severe manic episodes in bipolar
disorder
o
For the treatment of major depressive episodes in bipolar disorder
o
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 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 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
dos