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Active substance(s): MIRTAZAPINE

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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:

characterised by itchy pink-red blotches
starting on your feet and hands

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.


Additional side effects in children and
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
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
By reporting side effects you can help
provide more information on the safety of
this medicine.

round tablets, debossed with the number
“93” on one side of the tablet and
debossed with the number “7208” on the
other side.
sizes of 14, 20, 28, 30, 50, 56, 60, 70 and
100 tablets.
sizes of 14, 20, 28, 30, 50, 60, 100 and 200
(2 x 100) tablets.
sizes of 20, 28, 30, 50, 60, 100 and 200
Marketing Authorisation Holder and
The Marketing Authorisation holder and
company responsible for manufacture is:
This leaflet was last revised in: June 2013
PL 00289/0438
PL 00289/0439
PL 00289/0440

Keep this medicine out of the sight and
reach of children.

320 x 323

30 mg AND 45 mg TABLETS

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
your doctor or pharmacist.
you only. Do not pass it on to others. It
may harm them, even if their symptoms
are the same as yours.
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

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


medicines called antidepressants.



Also take special care with Mirtazapine
following conditions.
Tell your doctor about these conditions
before taking Mirtazapine, if not done
seizures (epilepsy). If you develop
seizures or your seizures become more
frequent, stop taking Mirtazapine and
contact your doctor immediately
liver disease, including jaundice. If
jaundice occurs, stop taking Mirtazapine
and contact your doctor immediately
kidney disease
heart disease or low blood pressure
schizophrenia. If psychotic symptoms,
such as paranoid thoughts become
more frequent or severe, contact your
doctor straight away
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
diabetes (you may need to adjust your
dose of insulin or other antidiabetic
eye disease, such as increased
pressure in the eye (glaucoma)
difficulty in passing water (urinating),
which might be caused by an enlarged
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.

Do not take Mirtazapine
allergic (hypersensitive) to
mirtazapine or any of the other ingredients
more sensitive to the side effects of
of this medicine (listed in section 6). If so,
you must talk to your doctor as soon as
you can before taking Mirtazapine.
Children and adolescents
Mirtazapine should normally not be used
(within the last two weeks) medicines
for children and adolescents under 18 years
called monoamine oxidase inhibitors
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
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.
should inform your doctor if any of the
symptoms listed above develop or worsen
when patients under 18 are taking
about killing or harming yourself
Mirtazapine. Also, the long term safety
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.
them to tell you if they think your
depression is getting worse, or if they are
worried about changes in your behaviour.

Tell your doctor or pharmacist if you are
taking or have recently taken any other
Peel Here To Open

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

unexplainable high fever, sore throat and
mouth ulcers (agranulocytosis).
Stop taking Mirtazapine and contact your
doctor straight away for a blood test.
What Mirtazapine contains
In rare cases Mirtazapine can cause
Film coated tablets
disturbances in the production of blood
cells (bone marrow depression). Some
film-coated tablet contains 15 mg/ 30 mg/
people become less resistant to infection
45 mg of Mirtazapine.
because Mirtazapine can cause a
temporary shortage of white blood cells
30 mg and 45 mg of Mirtazapine tablets
(granulocytopenia). In rare cases,
are lactose monohydrate, maize starch,
Mirtazapine can also cause a shortage of
red and white blood cells, as well as
magnesium stearate, hypromellose,
blood platelets (aplastic anaemia), a
titanium dioxide (E171), macrogol 400,
shortage of blood platelets
macrogol 6000, 15 mg: yellow iron oxide
(thrombocytopenia) or an increase in the
(E172) and 45 mg: yellow iron oxide
number of white blood cells (eosinophilia).
(E172) and red iron oxide (E172).
Stop taking Mirtazapine and tell your
What Mirtazapine looks like and contents
doctor straight away.
of the pack
inexplicable fever, sweating, increased
tablets. One side of the tablet has a
heart rate, diarrhoea, (uncontrollable)
scoreline with the marking “9” on one
muscle contractions, shivering,
side of the scoreline and the number “3”
overactive reflexes, restlessness, mood
on the other. The other side of the tablet
changes and unconsciousness. In very
is marked with the number “7206” The
rare cases, these can be signs of
tablet can be divided into equal doses.
serotonin syndrome.
Stop taking Mirtazapine and tell your
round tablets. One side of the tablet has
doctor straight away.
a scoreline with the marking ”9” on one
side of the scoreline and the number ”3”
Contact your doctor or go to a hospital
on the other. The other side of the tablet
straight away.
is marked with the number ”7207” The
tablet can be divided into equal doses.


Top of page cut-off to middle of registration mark = 44 mm




of Mirtazapine again.
medicines to prevent blood clotting such
as warfarin.
Mirtazapine can increase the effects of
Do not take Mirtazapine in combination
warfarin on the blood. Inform your
doctor if you are using this medicine. In
monoamine oxidase inhibitors (MAO
case of combination it is advised that a
inhibitors). Also, do not take Mirtazapine
doctor monitors your blood carefully.
during the two weeks after you have
stopped taking MAO inhibitors. If you
stop taking Mirtazapine, do not take MAO Mirtazapine with food, drink and alcohol
inhibitors during the next two weeks
advised not to drink any alcohol.
Examples of MAO inhibitors are
moclobemide, tranylcypromine (both are
antidepressants) and selegiline (used for food.
Parkinson’s disease).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
Take care when taking Mirtazapine in
before taking any medicine.
combination with:
antidepressants such as SSRIs,
venlafaxine and L-tryptophan or triptans Limited experience with Mirtazapine
administration to pregnant women does
(used to treat migraine), tramadol (a
not indicate an increased risk. However,
painkiller), linezolid (an antibiotic),
caution should be exercised when used
lithium (used to treat some psychiatric
during pregnancy. If you are taking
conditions) and St. John's Wort –
Mirtazapine and you become pregnant or
Hypericum perforatum preparations (a
you plan to get pregnant, ask your doctor
herbal remedy for depression). In very
whether you may continue taking
rare cases Mirtazapine alone or the
Mirtazapine. If you use Mirtazapine until, or
combination of Mirtazapine with these
shortly before birth, your baby should be
medicines, can lead to a so called
supervised for possible adverse effects.
serotonin syndrome. Some of the
symptoms of this syndrome are
Make sure your midwife and/or doctor
inexplicable fever, sweating, increased
knows you are on Mirtazapine. When taken
heart rate, diarrhoea, (uncontrollable)
during pregnancy, similar drugs (SSRIs)
muscle contractions, shivering, over
may increase the risk of a serious condition
active reflexes, restlessness, mood
changes and unconsciousness. If you get in babies, called persistent pulmonary
a combination of these symptoms, talk to hypertension of the newborn (PPHN),
making the baby breathe faster and appear
your doctor immediately.
bluish. These symptoms usually begin
the antidepressant nefazodone. It can
during the first 24 hours after the baby is
increase the amount of Mirtazapine in
your blood. Inform your doctor if you are born. If this happens to your baby you
should contact your midwife and/or doctor
using this medicine. It might be needed
to lower the dose of Mirtazapine, or when immediately.
use of nefazodone is stopped, to increase
Ask your doctor whether you can
the dose of Mirtazapine again.
breast-feed while taking Mirtazapine.
medicines for anxiety or insomnia such
If you are pregnant or breast-feeding, think
as benzodiazepines;
you may be pregnant or are planning to
medicines for schizophrenia such as
have a baby, ask your doctor or pharmacist
medicines for allergies such as cetirizine; for advice before taking this medicine.
medicines for severe pain such as
Driving and using machines
Mirtazapine can affect your concentration
In combination with these medicines
Mirtazapine can increase the drowsiness or alertness. Make sure these abilities are
not affected before you drive or operate
caused by these medicines.
medicines for infections; medicines for
bacterial infections (such as erythromycin),
Mirtazapine contains lactose
medicines for fungal infections (such as
ketoconazole) and medicines for HIV/AIDS Mirtazapine contains lactose. If you have
been told by your doctor that you have an
(such as HIV protease inhibitors);
intolerance to some sugars, contact your
cimetidine (a medicine for certain
doctor before taking this medicinal
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
Always take this medicine exactly as your
Mirtazapine, or when these medicines
doctor or pharmacist has told you to.
are stopped, to increase the dose of
Check with your doctor or pharmacist if
Mirtazapine again.
you are not sure.
medicines for epilepsy such as
carbamazepine and phenytoin;
The recommended dose is between 15 mg
medicines for tuberculosis such as
and 45 mg.
The usual starting dose is 15 mg or 30 mg
In combination with Mirtazapine these
every day.
medicines can reduce the amount of
increase your dose after a few days to the
Mirtazapine in your blood. Inform your
amount that is best for you (between
doctor if you are using these medicines. 15 mg and 45 mg per day). The dose is
It might be necessary to increase the
usually the same for all ages. However, if
dose of Mirtazapine, or when these
you are an elderly person or if you have
medicines are stopped to lower the dose renal or liver disease, your doctor may
medicines, including medicines obtained
without a prescription.



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.
Take your tablets orally. Swallow your
prescribed dose of Mirtazapine without
chewing, with some water or juice.
When can you expect to start feeling better
Usually Mirtazapine will start working after
1 to 2 weeks and after 2 to 4 weeks you
may start to feel better.
It is important that, during the first few
weeks of the treatment, you talk with your
doctor about the effects of Mirtazapine:
2 to 4 weeks after you have started taking
Mirtazapine, talk to your doctor about how
this medicine has affected you.
If you still don’t feel better, your doctor
may prescribe a higher dose. In that case,
talk to your doctor again after another 2 to
4 weeks.
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
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.

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

Like all medicines, this medicine can cause
side effects, although not everybody gets
Some side effects are more likely to occur
than others. The possible side effects of
Mirtazapine are listed below and can be
divided as:
10 people.
10,000 people
estimated from the available data.
Very common:


suddenly (orthostatic hypotension)

If you forget to take Mirtazapine
If you are supposed to take your dose once
a day

caused by fluid retention (oedema)

a forgotten dose. Just skip it. Take your
next dose at the normal time.
If you are supposed to take your dose
twice a day
morning dose, simply take it together
with your evening dose
if you have forgotten to take your evening
dose, do not take it with the next morning
dose; just skip it and continue with your
normal morning and evening doses
do not attempt to make up for the missed
doses. Skip both doses and continue the
next day with your normal morning and
evening doses.
If you stop taking Mirtazapine
Only stop taking Mirtazapine in consultation
with your doctor.
If you stop too early, your depression
might come back. Once you are feeling
decide when treatment can be stopped.
Do not suddenly stop taking Mirtazapine,
even when your depression has lifted. If
you suddenly stop taking Mirtazapine you
may feel sick, dizzy, agitated or anxious,
and have headaches. These symptoms can
doctor will tell you how to decrease the
dose gradually.

Stop taking Mirtazapine and tell your
doctor straight away.
burning, stinging, tickling or tingling

(oral hypoaesthesia)

may suggest disturbance in liver function
Stop taking Mirtazapine and tell your
doctor straight away.
Not known:

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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.