Mirtazapine 30mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Mirtazapine

থেকে পাওয়া:

Arrow Generics 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: 5060034832799

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mirtazapine 30mg Tablets
(Mirtazapine)
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Mirtazapine
Tablets is and what it is used for
2. What you need to know before you take Mirtazapine
Tablets
3. How to take Mirtazapine
Tablets
4. Possible side effects
5. How to store Mirtazapine Tablets
6. Contents of the pack and other information
1. WHAT MIRTAZAPINE TABLETS IS AND WHAT IT IS USED FOR
Mirtazapine 30mg Tablets contain the active substance, mirtazapine.
Mirtazapine is one of a group of medicines called antidepressants.
Depression is linked to a shortage of
substances which carry messages in the brain (including serotonin and
noradrenaline). Mirtazapine helps
to relieve the shortage of these ‘brain messages’. Common signs of
depression include feelings of
worthlessness or deep sadness; difficulty with everyday tasks;
sleeping too much or not being able to
sleep; feeling anxious; and changes in appetite.
It may take 2 to 4 weeks before you start to feel better and sleep
better. It is important to take your
medicine every day and not to stop taking it unless your doctor tells
you to. If you do, your symptoms
may come back.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE TABLETS
DO NOT TAKE MIRTAZAPINE 30MG TABLETS
•
if you are allergic to Mirtazapine or any of the other ingredients of
Mirtazapine 30mg Tablets
•
if you are taking or have recently taken (within the last two weeks)
medicines called monoamine
oxidase inhibitors (MAOIs)
W

পণ্য বৈশিষ্ট্য

OBJECT 1
MIRTAZAPINE 30 MG TABLETS (ARROW)
Summary of Product Characteristics Updated 21-Jan-2014 | Accord-UK Ltd
1. Name of the medicinal product
Mirtazapine 30 mg Tablets
2. Qualitative and quantitative composition
30mg: Each tablet contains 30mg mirtazapine.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet.
Mirtazapine 30 mg Tablets are beige, oblong and biconvex tablets with
a score line on one side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of episodes of major depression.
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.
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.
Children and adolescents under the age of 18 years
Mirtazapine Tablets 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 renal impairment
(creatinine clearance <40 ml/min). This should be taken into account
when prescribing Mirtazapine
Tablets to this category of patients (see section 4.4).
Hepatic impairment
The clearance of mirtazapine may be decreased in patients with hepatic
impairment. This should be taken
into account when prescribing Mirtazapine Tablets to this category of
patients, particularly with severe
hepatic impairment, as patients with sever