MIRTAZAPINE GH mirtazapine 45mg tablets blister pack

Main information

  • Trade name:
  • MIRTAZAPINE GH mirtazapine 45mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MIRTAZAPINE GH mirtazapine 45mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191020
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191020

MIRTAZAPINE GH mirtazapine 45mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

27/04/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MIRTAZAPINE GH mirtazapine 45mg tablets blister pack

Product Type

Single Medicine Product

Effective date

7/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. MIRTAZAPINE GH mirtazapine 45mg tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, film coated tablets, circular, biconvex

Active Ingredients

Mirtazapine

45 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 10:34:28 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

MIRTAZAPINE GH

Mirtazapine GH

®

mirtazapine tablets

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Mirtazapine GH.

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 this medicine

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 the medicine.

You may need to read it again.

WHAT MIRTAZAPINE

GH IS USED FOR

This medicine is used to treat

depression.

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 this medicine

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

This medicine is not addictive.

BEFORE YOU TAKE

MIRTAZAPINE GH

When you must not take it

Do not take this medicine:

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 difficulty breathing.

Do not take this medicine 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.

Examples of MAOIs include

phenelzine, tranylcypromine and

selegiline.

Taking this medicine with a MAOI

may cause a serious reaction with a

sudden increase in body temperature,

extremely high blood pressure and

severe convulsions.

Ask your doctor or pharmacist if

you are not sure if you are or if you

have been taking a MAOI

medicine.

Do not take this medicine if the

packaging is torn or shows signs of

tampering.

Do not take this medicine if the

expiry date printed on the pack has

passed.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Do not give this medicine to a child

or adolescent.

The safety of this medicine is

patients under 18 years has not

been established.

Tell your doctor if:

you are allergic to any other

medicines, foods, dyes, or

preservatives

you are pregnant or plan to

become pregnant. Like most

medicines of this kind, this

medicine is not recommended to

be used during pregnancy. Your

doctor will discuss the risks and

benefits of taking this medicine

when pregnant.

you are breastfeeding or wish to

breastfeed. It is not known

whether this medicine passes into

breast milk

if you have or have had any

medical conditions, especially the

following:

MIRTAZAPINE GH

thoughts of suicide or self

harm

epilepsy (fits or convulsions)

liver disease such as jaundice

kidney disease

heart disease

low blood pressure

(hypotension)

certain kinds of heart

conditions that may change

your heart rhythm, a recent

heart attack, heart failure, or

take certain medicines that

may affect the heart's rhythm

any mental illness (e.g.

schizophrenia, manic

depression)

diabetes

glaucoma (increased pressure

in your eyes)

problems in urinating due to

an enlarged prostate

unexplainable high fever, sore

throat or mouth ulcers

galactose intolerance

glucose-galactose

malabsorption.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

Mirtazapine GH.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines may be affected by

Mirtazapine GH or may affect how

well it works. These include:

other medicines (e.g. SSRIs,

venlafaxine, L-tryptophan,

nefazodone) for depression,

anxiety, obsessive compulsive

disorders or pre-menstrual

dysphoric disorder

monoamine oxidase inhibitors

(MAOIs) such as

tranylcypromine, phenelzine and

selegiline

medicines containing St John's

Wort (Hypericum perforatum)

phenytoin or carbamazepine,

medicines used to treat epilepsy

benzodiazepines, medicines used

to treat anxiety and sleeping

problems

lithium, a medicine used to treat

psychiatric conditions

methylene blue (used to treat high

levels of methemoglobin in the

blood)

tramadol, a pain killer

morphine, a medicine for severe

pain

cetirizine, a medicine for allergies

warfarin, a medicine used to

prevent blood clots

linezolid or erythromycin, both

antibiotics

rifampicin, a medicine used to

treat tuberculosis

medicines used for fungal

infections, such as ketoconazole

medicines used to treat

HIV/AIDS

cimetidine, a medicine used to

treat reflux and stomach ulcers

triptans such as sumatriptan,

naratriptan and zolmitriptan,

medicines used to treat migraines

medicines that may affect the

heart's rhythm such as certain

antibiotics and some

antipsychotics.

Your doctor will tell you what to do

if you are taking any of these

medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

If you are not sure whether you are

taking any of these medicines, check

with your doctor or pharmacist.

HOW TO TAKE

MIRTAZAPINE GH

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

How much to take

Ask your doctor or pharmacist if

you are unsure of the correct dose

for you.

They will tell you exactly how much

to take.

The usual starting dose is 15 mg per

day. Your doctor may slowly

increase this dose depending on how

you respond to Mirtazapine GH. The

effective dose for most people is

usually between 30 mg and 45 mg

per day.

Your doctor may have prescribed a

different dose.

Follow the instructions they give

you.

If you take the wrong dose,

Mirtazapine GH may not work as

well and your problem may not

improve.

How to take it

Swallow the tablets whole with a full

glass of water.

If you need to break Mirtazapine GH

30 mg tablets in half, hold the tablet

with both hands and snap along the

break line.

When to take Mirtazapine

GH

Take your medicine at about the

same time each day, preferably as

a single night-time dose before

going to bed.

Taking it at the same time each day

will help you remember when to take

MIRTAZAPINE GH

If recommended by your doctor, this

medicine may be taken in sub-doses

equally divided over the day (for

example, once in the morning and

once at night-time before going to

bed).

How long to take

Mirtazapine GH

Continue taking your medicine for

as long as your doctor tells you.

For depression, the length of

treatment depends on how quickly

your symptoms improve.

Most antidepressants take time to

work, so do not be discouraged if you

don't feel better right away. Some

symptoms may improve in 1 to 2

weeks, but it can take up to 2 to 4

weeks to feel the full benefit of the

medicine.

It is important to keep taking your

medicine even if you feel well,

usually for about 4 to 6 months or

even longer, to make sure the

benefits will last.

If you forget to take it

Once daily dosing:

If you forget to take the tablet before

you go to bed, do not take the missed

dose the next morning.

This medicine may cause drowsiness

or sleepiness during the day.

Continue treatment in the evening

with your usual dose, and continue to

take it as you would normally.

Twice daily dosing:

If you forget your morning

dose:

take your morning dose together

with your evening dose.

If you forget your evening dose:

do not take it with the next

morning dose. Continue treatment

with your usual evening dose, and

continue to take it as you would

normally.

If you forget both doses:

do not try to make up for missed

doses. Continue treatment with

your usual morning and evening

dose the next day.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much Mirtazapine GH.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention. If you take too many

tablets, you may feel drowsy, dizzy,

confused, agitated, have increased

heart rate or lose consciousness.

You may also have changes to your

heart rhythm (fast, irregular heartbeat

and/or fainting which could be

symptoms of a life-threatening

condition known as Torsade de

Pointes.

WHILE YOU ARE

TAKING

MIRTAZAPINE GH

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Mirtazapine GH.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Do not stop taking your tablets

until you have spoken to your

doctor.

If you develop fever, chills, sore

throat or mouth ulcers or other

signs of frequent infections, tell

your doctor immediately.

In rare cases, mirtazapine can cause a

shortage of white blood cells (bone

marrow depression), resulting in

lowering body resistance to infection

because Mirtazapine can cause a

temporary shortage of white blood

cells (granulocytopenia). In rare

cases, Mirtazapine can also cause a

shortage of red and white blood cells,

as well as blood platelets (aplastic

anemia), a shortage of blood platelets

(thombocytopenia) or an increase in

the number of white blood cells

(eosinophilia).These symptoms may

appear after 2-6 weeks of treatment.

If you have any suicidal thoughts

or other mental/mood changes, tell

your doctor immediately or go to

the nearest hospital for treatment.

Occasionally, the symptoms of

depression or other psychiatric

conditions may include thoughts of

harming yourself or committing

suicide. Until the full effects of your

medicine become apparent, these

symptoms may increase in the first

few weeks of treatment.

If you or someone you know is

showing signs of suicide-related

behaviour while taking

Mirtazapine GH, contact your

doctor or a mental health

professional immediately or go to

the nearest hospital for treatment.

These signs include:

thoughts or talk about death or

suicide

thoughts or talk of self-harm or

harm to others

any recent attempts of self-harm

increase in aggressive behaviour,

irritability or agitation.

Any mention of self-harm, violence

or suicide must be taken seriously.

Keep all of your doctor's

appointments so that your progress

can be checked.

MIRTAZAPINE GH

Your doctor may do some blood tests

from time to time. This helps to

prevent unwanted side effects.

Tell your doctor if you feel the

tablets are not helping your

condition.

Tell your doctor if you have not

taken your medicine exactly as

prescribed.

If you use Mirtazapine until, or

shortly before birth, your baby

should be supervised for possible

adverse effects.

Ask your doctor whether you can

breast-feed, while taking

Mirtazapine.

Otherwise your doctor may think that

it was not effective and change your

treatment unnecessarily.

Things you must not do

Do not drive or operate machinery

until you know how Mirtazapine

GH affects you.

This medicine may cause drowsiness,

dizziness or sleepiness in some

people and affect alertness and

concentration. If you have any of

these symptoms, do not drive,

operate machinery or do anything

else that could be dangerous.

Do not take Mirtazapine GH to

treat any other complaints unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

Do not stop taking this medicine,

even if you feel better, unless

advised by your doctor.

Suddenly stopping this medicine may

cause nausea, headache, dizziness,

anxiety, agitation.

Your doctor may want you to

gradually reduce the amount you are

taking before stopping completely.

This may help reduce the possibility

of withdrawal symptoms such as

nausea, headache, dizziness, anxiety

and agitation.

Things to be careful of

Be careful when drinking alcohol

while you are taking this medicine.

Combining this medicine and

alcohol can make you more sleepy

and less alert. Your doctor may

suggest you avoid alcohol while

being treated with this medicine.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Mirtazapine GH.

Mirtazapine GH helps most people

with depression, but it may have

unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical attention if you get

some of the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Tell your doctor if you notice any

of the following and they bother

you:

lethargy, drowsiness or sleepiness

headache

tiredness

increase in appetite and weight

gain

dry mouth

nausea, vomiting

diarrhoea

constipation

occasional dizziness or faintness,

especially when getting up

quickly from a lying or sitting

position (low blood pressure)

swollen ankles or feet due to fluid

accumulation (oedema)

abnormal sensations in the mouth,

sensations of numbness in the

mouth or swelling in the mouth

aggression

rash or skin eruption

nightmares/vivid dreams

tingling fingers or toes

painful joints

back pain, muscle aches and

pains

abnormal sensation in the skin for

example burning, stinging,

tickling or tingling

urge to move

difficulty in passing urine

(urinary retention)

restless legs

speech disorder

anxiety*

insomnia*

*May be symptoms of depression

Tell your doctor immediately, or

go the the Accident and

Emergency at your nearest

hospital if you notice any of the

following:

suicidal ideation or behaviour

epileptic attack (seizures)

shaking or tremors

sudden muscle contractions

(myoclonus)

attack of excessive excitability

(mania)

agitation

confusion

hallucinations

changes to your heart rhythm

fainting

yellow colouring of eyes or skin;

this may suggest disturbance in

liver function

abdominal pain and nausea; this

may suggest inflammation of the

pancreas

generalised fluid retention with

weight gain

MIRTAZAPINE GH

skin rashes, itching or hives;

swelling of the face, lips, or

tongue which may cause

difficulty breathing

signs of infection such as sudden

unexplainable high fever, sore

throat and mouth ulcers

fever, sore throat, mouth ulcers,

gastrointestinal (stomach, bowels)

disturbances and other signs of

infection

fever, sweating, increased heart

rate, uncontrollable diarrhoea,

muscle contractions, shivering,

overactive reflexes, restlessness,

mood changes and

unconsciousness (serotonin

syndrome)

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

AFTER TAKING

MIRTAZAPINE GH

Storage

Keep your medicine in the original

container.

If you take it out of its original

container it may not keep well.

Keep your medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store Mirtazapine GH or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or the expiry date has

passed, ask your pharmacist what to

do with any medicine that is left

over.

PRODUCT

DESCRIPTION

What it looks like

Mirtazapine GH comes in two types

of tablets:

Mirtazapine GH 30 mg - beige, film-

coated tablets, round, biconvex with

a score notch on one side.

Mirtazapine GH 45 mg - white, film-

coated tablets, circular, biconvex.

Available in blisters of 30 tablets.

Ingredients

Active ingredients:

Mirtazapine GH 30 mg - 30 mg

mirtazapine

Mirtazapine GH 45 mg - 45 mg

mirtazapine.

Inactive ingredients:

Lactose monohydrate

maize starch

hyprolose

colloidal anhydrous silica

magnesium stearate

hypromellose

titanium dioxide

macrogol 8000.

Mirtazapine GH 30 mg tablets also

contain:

iron oxide red

iron oxide yellow

iron oxide black.

This medicine does not contain

sucrose, gluten, tartrazine or any

other azo dyes.

Supplier

Mirtazapine GH is supplied in

Australia by:

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 726 369

This leaflet was revised in January

2019.

Australian Register Numbers

30 mg tablets: AUST R 191019

45 mg tablets: AUST R 191020