AXIT 15 mirtazapine 15mg tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

mirtazapine, Quantity: 15 mg

থেকে পাওয়া:

Alphapharm Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: hyprolose; magnesium stearate; maize starch; colloidal anhydrous silica; lactose; lactose monohydrate; hypromellose; quinoline yellow; iron oxide yellow; macrogol 4000

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

30 tablets, 90 tablets, 5 tablets, 60 tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Treatment of major depression including relapse prevention.

পণ্য সারাংশ:

Visual Identification: Circular (8mm), scored, yellow film-coated, normal convex, debossed with 'MR / 15' on one side and 'G' on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2003-09-25

তথ্য লিফলেট

AXIT
_mirtazapine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Axit. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Axit against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT AXIT IS USED FOR
Axit is used in the treatment of
depression including relapse
prevention.
Depression is longer lasting or more
severe than "low moods" everyone
has from time to time due to the
stress of everyday life. It is thought
to be caused by a chemical imbalance
in parts of the brain. This affects your
whole body and can cause emotional
and physical symptoms such as
feeling low in spirit, loss of interest
in activities, unable to enjoy life,
poor appetite or overeating, disturbed
sleep, often waking up early, loss of
sex drive, lack of energy and feeling
guilty over nothing.
This medicine corrects this chemical
imbalance and may help relieve the
symptoms of depression.
Your doctor, however, may prescribe
it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
Axit is not addictive.
BEFORE YOU TAKE AXIT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AXIT:
•
IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING MIRTAZAPINE
•
IF YOU ARE ALLERGIC TO ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips, mouth, throat or other parts of
the body, shortness of breath,
wheezing or trouble breathing.
DO NOT TAKE AXIT IF YOU ARE TAKING
ANOTHER MEDICINE FOR DEPRESSION
CALLED A MONOAMINE OXIDASE
INHIBITOR (MAOI) OR HAVE BEEN
TAKING AN MAOI WITHIN THE LAST 14
DAYS

পণ্য বৈশিষ্ট্য

AUSTRALIAN PRODUCT INFORMATION
AXIT
_mirtazapine film coated tablets _
1
NAME OF THE MEDICINE
Mirtazapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AXIT tablet contains either 15 mg, 30 mg or 45 mg of mirtazapine.
Excipients with known effect: lactose, and traces of sulfites and
galactose.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
AXIT 15: circular, normal convex, yellow, film-coated tablets debossed
“MR|15” on one side and “G” on the
other. The tablets have a breakline and can be broken into two halves
if required.
AXIT 30: Circular, normal convex, buff, film-coated tablets debossed
“MR|30” on one side and “G” on the
other. The tablets have a breakline and can be broken into two halves
if required.
AXIT 45: Circular, normal convex, white, film-coated tablets debossed
“MR 45” on one side and “G” on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression including relapse prevention.
4.2
DOSE AND METHOD OF ADMINISTRATION
The tablets should be taken orally with water and swallowed without
chewing.
ADULTS
Treatment should begin with 15 mg daily. The dosage generally needs to
be increased to obtain an optimal
clinical response. The effective daily dose is usually between 30 and
45 mg, but responses have been observed
at 60 mg per day.
ELDERLY
The recommended dose is the same as that for adults. In elderly
patients an increase in dosing should be done
under close supervision to elicit a satisfactory and safe response.
The clearance of mirtazapine may be decreased in patients with renal
or hepatic insufficiency. This should be
taken into account when prescribing AXIT to this category of patients
(see section 4.4 Special Warnings and
Precautions for Use and section 5.2 Pharmacokinetic Properties).
Mirtazapine
has
a
half-life
of
20 to
40
hours
and
therefore
mirtazapine
is
suitable
for
once-a-day
administration. It should be taken preferably as a single night-time
dose before going to bed. Mirtazapine may
als