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MIRTAZAPINE 15 MG TABLETS

Active substance(s): MIRTAZAPINE

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Reporting of side effects:
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
9OUCANALSOREPORTSIDEEFFECTSVIATHE
9ELLOW#ARD3CHEMEAT
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.

Do not use this medicine after the expiry
date, which is stated on the carton
packaging and blister after EXP. The expiry
date refers to the last day of that month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
you no longer use. These measures will
help to protect the environment.

6 CONTENT OF THE PACK AND
OTHER INFORMATION

What Mirtazapine contains
Film coated tablets
s 4HEACTIVESUBSTANCEISMIRTAZAPINE%ACH
film-coated tablet contains 15 mg/ 30 mg/
45 mg of Mirtazapine.
s /THERINGREDIENTSPRESENTINTHEMG
30 mg and 45 mg of Mirtazapine tablets
are lactose monohydrate, maize starch,
POVIDONE+  ANHYDROUSCOLLOIDALSILICA
magnesium stearate, hypromellose,
titanium dioxide (E171), macrogol 400,
macrogol 6000, 15 mg: yellow iron oxide
(E172) and 45 mg: yellow iron oxide
(E172) and red iron oxide (E172).
What Mirtazapine looks like and contents
of the pack
s 4HEMGTABLETSAREYELLOW 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 “7206”. The
tablet can be divided into equal doses.
s 4HEMGTABLETSAREREDDISHBROWN
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.
s 4HEMGTABLETSAREWHITETOOFF WHITE
round tablets, debossed with the number
“93” on one side of the tablet and
debossed with the number “7208” on the
other side.
s 4HEMGTABLETSAREAVAILABLEINPACK
sizes of 14, 20, 28, 30, 50, 56, 60, 70 and
100 tablets.
s 4HEMGTABLETSAREAVAILABLEINPACK
sizes of 14, 20, 28, 30, 50, 60, 100 and 200
(2 x 100) tablets.
s 4HEMGTABLETSAREAVAILABLEINPACK
sizes of 20, 28, 30, 50, 60, 100 and 200
tablets.
s .OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture is:
4%6!5+,IMITED %ASTBOURNE ".!'
This leaflet was last revised in: June 2013
PL 00289/0438
PL 00289/0439
PL 00289/0440

HOW TO STORE MIRTAZAPINE
Keep this medicine out of the sight and
reach of children.

88365-C
320 x 323

MIRTAZAPINE 15 mg,
30 mg AND 45 mg TABLETS
0!#+!'%,%!&,%4: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
again.
s )FYOUHAVEANYFURTHERQUESTIONS ASK
your doctor or pharmacist.
s 4HISMEDICINEHASBEENPRESCRIBEDFOR
you only. Do not pass it on to others. It
may harm them, even if their symptoms
are the same as yours.
s )FYOUGETANYSIDEEFFECTSTALKTOYOUR
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:

1. What Mirtazapine is and what it is used for
2. What you need to know before you take
Mirtazapine
3. How to take Mirtazapine
4. Possible side effects
5. How to store Mirtazapine
6. Content of the pack and other
information

1 WHAT MIRTAZAPINE IS AND WHAT
IT IS USED FOR

s -IRTAZAPINEISONEOFAGROUPOF
medicines called antidepressants.
s -IRTAZAPINEISUSEDTOTREATDEPRESSIVE
illness.

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE MIRTAZAPINE

Do not take Mirtazapine
s )FYOUAREallergic (hypersensitive) to
mirtazapine or any of the other ingredients
of this medicine (listed in section 6). If so,
you must talk to your doctor as soon as
you can before taking Mirtazapine.
s )FYOUARETAKINGORHAVERECENTLYTAKEN
(within the last two weeks) medicines
called monoamine oxidase inhibitors
(MAO-Is).

Also take special care with Mirtazapine
s IFYOUHAVE ORHAVEEVERHADONEOFTHE
following conditions.
Tell your doctor about these conditions
before taking Mirtazapine, if not done
previously.
s seizures (epilepsy). If you develop
seizures or your seizures become more
frequent, stop taking Mirtazapine and
contact your doctor immediately
s liver disease, including jaundice. If
jaundice occurs, stop taking Mirtazapine
and contact your doctor immediately
s kidney disease
s heart disease or low blood pressure
s schizophrenia. If psychotic symptoms,
such as paranoid thoughts become
more frequent or severe, contact your
doctor straight away
s manic depression (alternating periods
of feeling elated/over activity and
depressed mood). If you start feeling
elated or over excited, stop taking
Mirtazapine and contact your doctor
immediately
s diabetes (you may need to adjust your
dose of insulin or other antidiabetic
medicines)
s eye disease, such as increased
pressure in the eye (glaucoma)
s difficulty in passing water (urinating),
which might be caused by an enlarged
prostate.
s IFYOUDEVELOPSIGNSOFINFECTIONSUCHAS
inexplicable high fever, sore throat and
mouth ulcers.
Stop taking Mirtazapine and consult your
doctor immediately for a blood test.
In rare cases these symptoms can be
signs of disturbances in blood cell
production in the bone marrow. While
rare, these symptoms most commonly
appear after 4-6 weeks of treatment.
s IFYOUAREANELDERLYPERSON9OUCOULDBE
more sensitive to the side effects of
antidepressants.

Children and adolescents
Mirtazapine should normally not be used
for children and adolescents under 18 years
because efficacy was not demonstrated.
Also, you should know that patients under
18 have an increased risk of side effects
Warnings and precautions
such as suicide thoughts and hostility
Talk to you doctor before taking Mirtazapine (predominantly aggression, oppositional
Thoughts of suicide and worsening of your behaviour and anger) when they take this
depression
class of medicines. Despite this, your
If you are depressed you can sometimes
doctor may prescribe Mirtazapine for
have thoughts of harming or killing
patients under 18 because he/she decides
yourself. These may be increased when
that this is in their best interests. If your
first starting antidepressants, since these
doctor has prescribed Mirtazapine for a
medicines all take time to work, usually
patient under 18 and you want to discuss
about two weeks but sometimes longer.
THIS PLEASEGOBACKTOYOURDOCTOR9OU
should inform your doctor if any of the
9OUMAYBEMORELIKELYTOTHINKLIKETHIS
symptoms listed above develop or worsen
s IFYOUHAVEPREVIOUSLYHADTHOUGHTS
when patients under 18 are taking
about killing or harming yourself
Mirtazapine. Also, the long term safety
s if you are a young adult. Information from effects concerning growth, maturation and
clinical trials has shown an increased risk cognitive and behavioural development of
of suicidal behaviour in adults aged less Mirtazapine in this age group have not yet
than 25 years with psychiatric conditions been demonstrated. In addition, significant
who were treated with an antidepressant. weight gain has been observed in this age
category more often when treated with
If you have thoughts of harming or killing
Mirtazapine compared with adults.
yourself at any time, contact your doctor or
go to a hospital straight away.
Other medicines and Mirtazapine
Tell your doctor or pharmacist if you are
You may find it helpful to tell a relative or
taking (or plan to take) any of the
close friend that you are depressed, and
medicines in the following list.
ASKTHEMTOREADTHISLEAFLET9OUMIGHTASK
them to tell you if they think your
Tell your doctor or pharmacist if you are
depression is getting worse, or if they are
taking or have recently taken any other
worried about changes in your behaviour.
Peel Here To Open

Pharma code 318 (00111111)
First bar is 105mm from top edge.

epidermal necrolysis - very rare but very
serious side effects. If you experience any
of the following side effects tell your
doctor or nurse straight away:
s SKINPEELING
s SORESONTHEMUCOUSMEMBRANES
s SKINRASH
s ERYTHEMAMULTIFORME ASKINDISEASE
characterised by itchy pink-red blotches
starting on your feet and hands
s BLISTERSFULLOFFLUIDDERMATITISBULLOUS
s SIGNSOFINFECTIONSUCHASSUDDEN
unexplainable high fever, sore throat and
mouth ulcers (agranulocytosis).
Stop taking Mirtazapine and contact your
doctor straight away for a blood test.
In rare cases Mirtazapine can cause
disturbances in the production of blood
cells (bone marrow depression). Some
people become less resistant 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 anaemia), a
shortage of blood platelets
(thrombocytopenia) or an increase in the
number of white blood cells (eosinophilia).
s EPILEPTICATTACKCONVULSIONS 
Stop taking Mirtazapine and tell your
doctor straight away.
s ACOMBINATIONOFSYMPTOMSSUCHAS
inexplicable fever, sweating, increased
heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering,
overactive reflexes, restlessness, mood
changes and unconsciousness. In very
rare cases, these can be signs of
serotonin syndrome.
Stop taking Mirtazapine and tell your
doctor straight away.
s THOUGHTSOFHARMINGORKILLINGYOURSELF
Contact your doctor or go to a hospital
straight away.
s ABNORMALSENSATIONSINTHEMOUTHORAL
paraesthesia)
s SWELLINGINTHEMOUTHMOUTHOEDEMA
s HYPONATRAEMIA
s INAPPROPRIATEANTIDIURETICHORMONE
secretion
s DISTORTEDSPEECHDYSARTHRIA
s INCREASEDSALIVATION
s SLEEPWALKING
Additional side effects in children and
adolescents
In children under 18 years the following
adverse events were observed commonly
in clinical trials: significant weight gain,
hives and increased blood triglycerides.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

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medicines, including medicines obtained
without a prescription.
Do not take Mirtazapine in combination
with:
s monoamine oxidase inhibitors (MAO
inhibitors). Also, do not take Mirtazapine
during the two weeks after you have
stopped taking MAO inhibitors. If you
stop taking Mirtazapine, do not take MAO
inhibitors during the next two weeks
either.
Examples of MAO inhibitors are
moclobemide, tranylcypromine (both are
antidepressants) and selegiline (used for
Parkinson’s disease).
Take care when taking Mirtazapine in
combination with:
s antidepressants such as SSRIs,
venlafaxine and L-tryptophan or triptans
(used to treat migraine), tramadol (a
painkiller), linezolid (an antibiotic),
lithium (used to treat some psychiatric
conditions) and St. John's Wort –
Hypericum perforatum preparations (a
herbal remedy for depression). In very
rare cases Mirtazapine alone or the
combination of Mirtazapine with these
medicines, can lead to a so called
serotonin syndrome. Some of the
symptoms of this syndrome are
inexplicable fever, sweating, increased
heart rate, diarrhoea, (uncontrollable)
muscle contractions, shivering, over
active reflexes, restlessness, mood
changes and unconsciousness. If you get
a combination of these symptoms, talk to
your doctor immediately.
s the antidepressant nefazodone. It can
increase the amount of Mirtazapine in
your blood. Inform your doctor if you are
using this medicine. It might be needed
to lower the dose of Mirtazapine, or when
use of nefazodone is stopped, to increase
the dose of Mirtazapine again.
s medicines for anxiety or insomnia such
as benzodiazepines;
medicines for schizophrenia such as
olanzapine;
medicines for allergies such as cetirizine;
medicines for severe pain such as
morphine.
In combination with these medicines
Mirtazapine can increase the drowsiness
caused by these medicines.
s medicines for infections; medicines for
bacterial infections (such as erythromycin),
medicines for fungal infections (such as
ketoconazole) and medicines for HIV/AIDS
(such as HIV protease inhibitors);
cimetidine (a medicine for certain
digestive disorders).
In combination with Mirtazapine these
medicines can increase the amount of
Mirtazapine in your blood. Inform your
doctor if you are using these medicines.
It might be needed to lower the dose of
Mirtazapine, or when these medicines
are stopped, to increase the dose of
Mirtazapine again.
s medicines for epilepsy such as
carbamazepine and phenytoin;
medicines for tuberculosis such as
rifampicin.
In combination with Mirtazapine these
medicines can reduce the amount of
Mirtazapine in your blood. Inform your
doctor if you are using these medicines.
It might be necessary to increase the
dose of Mirtazapine, or when these
medicines are stopped to lower the dose

of Mirtazapine again.
s medicines to prevent blood clotting such
as warfarin.
Mirtazapine can increase the effects of
warfarin on the blood. Inform your
doctor if you are using this medicine. In
case of combination it is advised that a
doctor monitors your blood carefully.
Mirtazapine with food, drink and alcohol
9OUMAYGETDROWSYIFYOUDRINKALCOHOL
WHILEYOUARETAKING-IRTAZAPINE9OUARE
advised not to drink any alcohol.
9OUCANTAKE-IRTAZAPINEWITHORWITHOUT
food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
Limited experience with Mirtazapine
administration to pregnant women does
not indicate an increased risk. However,
caution should be exercised when used
during pregnancy. If you are taking
Mirtazapine and you become pregnant or
you plan to get pregnant, ask your doctor
whether you may continue taking
Mirtazapine. If you use Mirtazapine until, or
shortly before birth, your baby should be
supervised for possible adverse effects.
Make sure your midwife and/or doctor
knows you are on Mirtazapine. When taken
during pregnancy, similar drugs (SSRIs)
may increase the risk of a serious condition
in babies, called persistent pulmonary
hypertension of the newborn (PPHN),
making the baby breathe faster and appear
bluish. These symptoms usually begin
during the first 24 hours after the baby is
born. If this happens to your baby you
should contact your midwife and/or doctor
immediately.
Ask your doctor whether you can
breast-feed while taking Mirtazapine.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Driving and using machines
Mirtazapine can affect your concentration
or alertness. Make sure these abilities are
not affected before you drive or operate
machinery.
Mirtazapine contains lactose
Mirtazapine contains lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicinal
product.

3 HOW TO TAKE MIRTAZAPINE
Always take this medicine exactly as your
doctor or pharmacist has told you to.
Check with your doctor or pharmacist if
you are not sure.
The recommended dose is between 15 mg
and 45 mg.
The usual starting dose is 15 mg or 30 mg
every day.9OURDOCTORMAYADVISEYOUTO
increase your dose after a few days to the
amount that is best for you (between
15 mg and 45 mg per day). The dose is
usually the same for all ages. However, if
you are an elderly person or if you have
renal or liver disease, your doctor may

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adapt the dose.
When to take Mirtazapine
Take Mirtazapine at the same time each
day. It is best to take Mirtazapine as a
single dose before you go to bed.
However, your doctor may suggest you
split your dose of Mirtazapine – once in the
morning and once at night time before you
go to bed. The higher dose should be taken
before you go to bed.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

POSSIBLE SIDE EFFECTS
Like
4 all medicines, this medicine can cause
side effects, although not everybody gets
them.

Some side effects are more likely to occur
than others. The possible side effects of
Mirtazapine are listed below and can be
divided as:
s 6ERYCOMMONMAYAFFECTMORETHANIN
10 people.
When can you expect to start feeling better
Usually Mirtazapine will start working after s #OMMONMAYAFFECTUPTOINPEOPLE
s 5NCOMMONMAYAFFECTUPTOIN
1 to 2 weeks and after 2 to 4 weeks you
people
may start to feel better.
s 2AREMAYAFFECTUPTOINPEOPLE
s 6ERYRAREMAYAFFECTUPTOUSERIN
It is important that, during the first few
10,000 people
weeks of the treatment, you talk with your
s .OTKNOWNFREQUENCYCANNOTBE
doctor about the effects of Mirtazapine:
estimated from the available data.
2 to 4 weeks after you have started taking
Mirtazapine, talk to your doctor about how
Very common:
this medicine has affected you.
s INCREASEINAPPETITEANDWEIGHTGAIN
If you still don’t feel better, your doctor
s DROWSINESSORSLEEPINESS
may prescribe a higher dose. In that case,
talk to your doctor again after another 2 to s HEADACHE
s DRYMOUTH
4 weeks.
Take your tablets orally. Swallow your
prescribed dose of Mirtazapine without
chewing, with some water or juice.

Common:
s LETHARGY
s DIZZINESS
s SHAKINESSORTREMOR
s NAUSEA
s DIARRHOEA
s VOMITING
s RASHORSKINERUPTIONSEXANTHEMA
s PAININYOURJOINTSARTHRALGIA ORMUSCLES
(myalgia)
s BACKPAIN
s FEELINGDIZZYORFAINTWHENYOUSTANDUP
suddenly (orthostatic hypotension)
s SWELLINGTYPICALLYINANKLESORFEET
If you forget to take Mirtazapine
caused by fluid retention (oedema)
If you are supposed to take your dose once
s TIREDNESS
a day
s $ONOTTAKEADOUBLEDOSETOMAKEUPFOR s VIVIDDREAMS
s CONFUSION
a forgotten dose. Just skip it. Take your
s FEELINGANXIOUS
next dose at the normal time.
s SLEEPINGPROBLEMS
If you are supposed to take your dose
Uncommon:
twice a day
s FEELINGELATEDOREMOTIONALLY@HIGH
s IFYOUHAVEFORGOTTENTOTAKEYOUR
(mania)
morning dose, simply take it together
Stop taking Mirtazapine and tell your
with your evening dose
doctor straight away.
s if you have forgotten to take your evening
dose, do not take it with the next morning s ABNORMALSENSATIONINTHESKINEG
burning, stinging, tickling or tingling
dose; just skip it and continue with your
(paraesthesia)
normal morning and evening doses
s IFYOUHAVEFORGOTTENTOTAKEBOTHDOSES s RESTLESSLEGS
do not attempt to make up for the missed s FAINTINGSYNCOPE
doses. Skip both doses and continue the s SENSATIONSOFNUMBNESSINTHEMOUTH
(oral hypoaesthesia)
next day with your normal morning and
s LOWBLOODPRESSURE
evening doses.
s NIGHTMARES
s FEELINGAGITATED
If you stop taking Mirtazapine
Only stop taking Mirtazapine in consultation s HALLUCINATIONS
s URGETOMOVE
with your doctor.
If you stop too early, your depression
Rare:
might come back. Once you are feeling
BETTER TALKTOYOURDOCTOR9OURDOCTORWILL s YELLOWCOLOURINGOFEYESORSKINTHIS
may suggest disturbance in liver function
decide when treatment can be stopped.
(jaundice).
Stop taking Mirtazapine and tell your
Do not suddenly stop taking Mirtazapine,
doctor straight away.
even when your depression has lifted. If
you suddenly stop taking Mirtazapine you s MUSCLETWITCHINGORCONTRACTIONS
(myoclonus)
may feel sick, dizzy, agitated or anxious,
and have headaches. These symptoms can s AGGRESSION
s INFLAMMATIONOFTHEPANCREAS
BEAVOIDEDBYSTOPPINGGRADUALLY9OUR
Not known:
doctor will tell you how to decrease the
s 3TEVENS*OHNSONSYNDROMEAND4OXIC
dose gradually.
Usually you will need to take Mirtazapine
until your symptoms of depression have
disappeared for 4 to 6 months.

If you take more Mirtazapine than you
should
If you or someone else have taken too
much Mirtazapine, call a doctor straight
away. The most likely signs of an overdose
of Mirtazapine (without other medicines or
alcohol) are drowsiness, disorientation and
increased heart rate.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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