Mirtazapine 30mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Mirtazapine

থেকে পাওয়া:

Teva UK Ltd

এটিসি কোড:

N06AX11

INN (আন্তর্জাতিক নাম):

Mirtazapine

ডোজ:

30mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04030400; GTIN: 5017007029007

তথ্য লিফলেট

ZINC Ref:
EAS4539B LEA MIRTAZAPINE 15MG 45MG TAB TUK

সম্পূর্ণ নথি পড়ুন

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of mirtazapine
Excipients with known effect:
30 mg: Each tablet contains 215.3 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
30 mg: Reddish brown, round tablets. One side of the tablet has a
scoreline
with the marking ”9” on one side of the scoreline and the number
”3” on the
other. The other side of the tablet is marked with the number
”7207”. The
tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of episodes of major depression
Mirtazapine is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_ _
The effective daily dose is usually between 15 and 45 mg; the starting
dose is 15 or
30 mg.
Mirtazapine begins to exert its effect in general after 1-2 weeks of
treatment. Treatment
with an adequate dose should result in a positive response within 2-4
weeks. With an
insufficient response, the dose can be increased up to the maximum
dose. If there is no
response within a further 2-4 weeks, then treatment should be stopped.
Patients with depression should be treated for a sufficient period of
at least 6 months to
ensure that they are free from symptoms.
It is recommended to discontinue treatment with mirtazapine gradually
to avoid
withdrawal symptoms (see section 4.4).
Older people
The recommended dose is the same as that for adults. In older people
an increase in
dosing should be done under close supervision to elicit a satisfactory
and safe response.
Paediatric population
Mirtazapine should not be used in children and adolescents under the
age of 18 years as
efficacy was not demonstrated in two short-term clinical trials (see
section 5.1) and
because of safety concerns (see sections 4.4, 4.8 and 5.1).
_ _
Renal impairment
The clearance of mirtazapine may be decreased in patients with
moderate to severe