MOVOX fluvoxamine maleate 100mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

fluvoxamine maleate, Quantity: 100 mg

Sẵn có từ:

Viatris Pty Ltd

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: mannitol; maize starch; pregelatinised potato starch; sodium stearylfumarate; colloidal anhydrous silica; hypromellose; macrogol 6000; purified talc; titanium dioxide

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

MOVOX (fluvoxamine maleate) is indicated for the treatment of major depression in adults. MOVOX (fluvoxamine maleate) is also indicated for the treatment of Obsessive Compulsive Disorder (OCD) in both children aged 8 years and older, adolescent, and adults.

Tóm tắt sản phẩm:

Visual Identification: Oval, biconvex, scored, white to off-white film coated tablet inscribed on one face with 313 on either side of the score line and other face plain; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2002-07-29

Tờ rơi thông tin

MOVOX
®
M
O
V
O
X
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MOVOX?
MOVOX contains the active ingredient fluvoxamine. MOVOX is used to
treat depression and Obsessive Compulsive Disorder
(OCD). For more information, see Section 1. Why am I using MOVOX? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MOVOX?
Do not use if you have ever had an allergic reaction to fluvoxamine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use MOVOX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MOVOX and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE MOVOX?
•
Your doctor will decide what dose you should receive.
•
The usual starting dose for adults is 50 mg each day, but your doctor
may adjust the number of tablets or the strength of the
tablets you are taking until the desired response is achieved up to a
maximum of 300 mg per day.
More instructions can be found in Section 4. How do I use MOVOX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MOVOX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MOVOX.
•
Tell your doctor immediately if you become pregnant or are
breast-feeding while taking MOVOX.
•
Tell your doctor immediately if you have any suicidal thoughts or
other mental/mood changes.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly, increase or lower the dose,
without first checking with your
doctor.
•
Do not give this medicine to anyone else, even if their symptoms seem
similar to yours.
•
Do not use MOVOX to treat any other complaints u

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
MOVOX
®
_Fluvoxamine maleate tablets_
_ _
1
NAME OF THE MEDICINE
Fluvoxamine maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of MOVOX contains 50 mg or 100 mg of fluvoxamine maleate.
Fluvoxamine is a member of a class of antidepressant agents known as
selective serotonin reuptake inhibitors
(SSRI). It is chemically unrelated to the tricyclic antidepressants,
and to other serotonin reuptake inhibitors as
it is a monocyclic compound.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MOVOX (fluvoxamine maleate) 50 mg: Round, biconvex, scored, white to
off-white film coated tablet
inscribed on one face with 291 on either side of the score line and
other face plain.
MOVOX (fluvoxamine maleate) 100 mg: Oval, biconvex, scored, white to
off-white film coated tablet
inscribed on one face with 313 on either side of the score line and
other face plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOVOX (fluvoxamine maleate) is indicated for the treatment of major
depression in adults.
MOVOX (fluvoxamine maleate) is also indicated for the treatment of
Obsessive Compulsive Disorder (OCD)
in children aged 8 years and older, adolescents, and adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
DEPRESSION
The recommended starting dose of fluvoxamine is 50 mg per day for one
week, given as a single dose in the
evening. Doses should be gradually increased (by 50 mg per week) until
an effective dose is reached, with a
maximum of 300 mg per day (the usually effective dose is 100 mg/day.)
Doses up to 150 mg can be given as
a single dose. It is recommended that total daily doses of greater
than 150 mg be given in 2 or 3 divided doses.
If no improvement is observed within 6 weeks of initiation of therapy,
treatment with fluvoxamine should be
reconsidered. It is important to ascertain that an adequate
therapeutic dose has been maintained throughout
this period.
In agreement with the consensus statement of the WHO, antidepressant
medication should be c