Skip to Content

UK Edition. Click here for US version.

MIRTAZAPINE 45MG ORODISPERSIBLE TABLETS

Active substance(s): MIRTAZAPINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Mirtazapine 15 mg Orodispersible Tablets
Mirtazapine 30 mg Orodispersible Tablets
Mirtazapine 45 mg Orodispersible Tablets
Mirtazapine

production in the bone marrow. While
rare, these symptoms most commonly
appear after 4-6 weeks of treatment.
• if you are an elderly person. You could
be more sensitive to the side effects
of antidepressants.

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. This
includes any possible side
effects not listed in this leaflet.
See section 4.

Other medicines and Mirtazapine
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not take Mirtazapine in combination
with:
• 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 Parkinsonʼs disease).

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. Contents of the pack and other
information

Take care when taking Mirtazapine in
combination with:
• antidepressants such as SSRIs,
venlafaxine and L-tryptophan, or
triptans (used to treat migraine),
tramadol (a pain-killer), linezolid (an
antibiotic), lithium (used to treat some
psychiatric conditions), methylene
blue (used to treat high levels of
methemoglobin in the blood) and St.
Johnʼs 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,
overactive reflexes, restlessness, mood
changes, and unconsciousness. If you
get a combination of these symptoms,
talk to your doctor immediately.
• 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.
• 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.
• 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), and drugs
for stomach ulcers (such as
cimetidine). 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.
• 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 needed
to increase the dose of Mirtazapine,
or when these medicines are stopped
to lower the dose of Mirtazapine again.
• 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.
• medicines that may affect the
heartʼs rhythm such as certain
antibiotics and some anti- psychotics.

1. WHAT MIRTAZAPINE IS AND
WHAT IT IS USED FOR
Mirtazapine is one of a group of
medicines called antidepressants.
Mirtazapine is used to treat depressive
illness in adults.
Mirtazapine will take 1 to 2 weeks
before it starts working. After 2 to 4
weeks you may start feeling better. You
must talk to your doctor if you do not
feel better or if you feel worse after 2 to
4 weeks. More information is in section
3 heading "When can you expect to
start feeling better".

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
MIRTAZAPINE

Do not take Mirtazapine
• if you are allergic 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.
• if you are taking or have recently
taken (within the last two weeks)
medicines called monoamine oxidase
inhibitors (MAO-Is).

Warnings and precautions
Talk to your doctor or pharmacist before
taking Mirtazapine.

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 such as suicide attempt,
suicidal thoughts and hostility
(predominantly aggression, oppositional
behaviour and anger) when they take
this class of medicines. Despite this, your
doctor may prescribe Mirtazapine for
patients under 18 because he/she decides
that this is in their best interests. If your
doctor has prescribed Mirtazapine for a
patient under 18 and you want to discuss
this, please go back to your doctor. You
should inform your doctor if any of the
symptoms listed above develop or worsen
when patients under 18 are taking
Mirtazapine. Also, the long-term safety
effects concerning growth, maturation
and cognitive and behavioural
development of Mirtazapine in this age
group have not yet been demonstrated.
In addition, significant weight gain has
been observed in this age category
more often when treated with
Mirtazapine compared with adults.
Thoughts of suicide and worsening
of your depression
If you are depressed you can
sometimes have thoughts of harming or
killing yourself. These may be increased
when first starting antidepressants,
since these medicines all take time to
work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:
• if you have previously had thoughts
about killing or harming yourself.
• if you are a young adult. Information
from clinical trials has shown an
increased risk of suicidal behaviour in
adults aged less than 25 years with
psychiatric conditions who were
treated with an antidepressant.
→ If you have thoughts of harming or
killing yourself at any time, contact your
doctor or go to a hospital straightaway.
You may find it helpful to tell a
relative or close friend that you are
depressed, and ask them to read this
leaflet. You might ask them to tell you if
they think your depression is getting
worse, or if they are worried about
changes in your behaviour.

Mirtazapine with food and alcohol:
You may get drowsy if you drink alcohol
while you are taking Mirtazapine. You
are advised not to drink any alcohol. You
can take Mirtazapine with or without food.

Pregnancy and breast-feeding:
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.
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 use Mirtazapine until, or shortly
before birth, your baby should be
supervised for possible adverse effects.
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.

draft: 992032, 992033, 992034
laetus code: 0000
mat.no.: 00000000

Also take special care with Mirtazapine
• if you have, or have ever had one of
the following conditions.
→ Tell your doctor about these
conditions before taking Mirtazapine,
if not done previously.
• 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 straightaway.
• manic depression (alternating
periods of feeling elated/overactivity
and depressed mood). If you start
feeling elated or over-excited, stop
taking Mirtazapine and contact your
doctor immediately.
• diabetes (you may need to adjust
your dose of insulin or other
antidiabetic medicines).
• eye disease, such as increased
pressure in the eye (glaucoma).
• difficulty in passing water
(urinating), which might be caused
by an enlarged prostate.
• 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 heartʼs rhythm.
• if you develop signs of infection such
as 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

Driving and using machines:
Mirtazapine can affect your concentration
or alertness. Make sure these abilities
are not affected before you drive or
operate machinery. If your doctor has
prescribed Mirtazapine for a patient under
18 years make sure the concentration
and alertness is not affected before
participation in traffic (e.g. on bicycle).

Mirtazapine contains aspartame:
Mirtazapine orodispersible tablets contain
aspartame, a source of phenylalanine.
This may be harmful for people with
phenylketonuria.

Mirtazapine contains sulphites:
This medicine contains a very low
amount of sulphites. This may rarely
cause severe allergic (hypersensitivity)
reactions and bronchospasm.

3. HOW TO TAKE
MIRTAZAPINE
Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

How much to take
The recommended starting dose is
15 or 30 mg every day. Your doctor
may advise you to increase your dose
after a few days to the amount that is
best for you (between 15 and 45 mg per
day). The dose is usually the same for
all ages.

Continued on the next page >>

Artwork Proof Box
Ref: V034: SPC+PIL update in line with reference
Proof no.
011.0

Date prepared:
09/10/2014

Colours:
Black
Dimensions: 138 x 745 mm

Font size:
9pt
Fonts:
Helvetica

However, if you are an elderly person or
if you have renal or liver disease, your
doctor may adapt the dose.

unconsciousness and increased
salivation. In very rare cases these
can be signs of serotonin syndrome.
• thoughts of harming or killing yourself
• severe skin reactions
(Stevens-Johnson Syndrome, toxic
epidermal necrolysis)

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 to 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.

Other possible side-effects with
Mirtazapine are:

Very common (may affect more than
1 in 10 people):
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth.

Take the orodispersible tablet as
follows
Take your tablets orally.

1. Do not crush the
orodispersible tablet
In order to prevent crushing
the orodispersible tablet, do
not push against the tablet
pocket (Figure A).

Common (may affect up to 1 in 10
people):
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• constipation
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or
muscles (myalgia)
• back pain
• feeling dizzy or faint when you stand
up suddenly (orthostatic hypotension)
• swelling (typically in ankles or feet)
caused by fluid retention (oedema)
• tiredness
• vivid dreams
• confusion
• feeling anxious
• sleeping problems.

Fig. A.

2. Tear off one
tablet pocket
Each blister
Fig. 1.
contains tablet
pockets, which are separated by
perforations. Tear off one tablet pocket
along the dotted lines (Figure 1).
3. Peel off the lid
Carefully peel off the lidding foil, starting
in the corner indicated by the arrow
(Figures 2 and 3).

Fig. 2.

Uncommon (may affect up to 1 in 100
people):
• abnormal sensation in the skin e.g.
burning, stinging, tickling or tingling
(paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth
(oral hypoaesthesia)
• low blood pressure
• nightmares
• feeling agitated
• hallucinations
• urge to move.

Fig. 3.

4. Take out the
orodispersible tablet
Take out the orodispersible
tablet with dry hands and
place it on the tongue
(Figure 4).

Fig. 4.

Rare (may affect up to 1 in 1,000
people):
• muscle twitching or contractions
(myoclonus)
• aggression
• abdominal pain and nausea; this may
suggest inflammation of the pancreas
(pancreatitis)

It will rapidly disintegrate and can be
swallowed without water.

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 donʼt 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.

Not known (frequency cannot be
estimated from the available data):
• abnormal sensations in the mouth
(oral paraesthesia)
• swelling in the mouth (mouth oedema)
• swelling throughout the body
(generalised oedema)
• localised swelling
• hyponatraemia
• inappropriate anti-diuretic hormone
secretion
• Severe skin reactions (dermatitis
bullous, erythema multiforme)
• sleep walking (somnambulism)
• speech disorder

If you take more Mirtazapine than you
should
→ If you or someone else has 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. The symptoms of a possible
overdose may include 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.

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.
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. You can also report side effects
directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By
reporting side effects you can help
provide more information on the safety
of this medicine.

If you forget to take Mirtazapine
If you are supposed to take your dose
once a day
• Do not take a double dose to make up
for a forgotten dose.
• Take your next dose at the normal time.

If you are supposed to take your dose
twice a day
• if you have forgotten to take your
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.
• if you have forgotten to take both
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.

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

Do not use this medicine after the expiry
date which is stated on the carton and
blister. The expiry date refers to the last
day of that month.
Do not store above 30°C. Store in the
original package in order to protect from
moisture.

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
better, talk to your doctor. Your doctor will
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 be avoided by
stopping gradually. Your doctor will tell
you how to decrease the dose gradually.

Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6. CONTENTS OF THE PACK
AND OTHER INFORMATION
What Mirtazapine contains
• The active substance is: Mirtazapine.
Each orodispersible tablet contains
15 mg, 30 mg or 45 mg mirtazapine.
• The other ingredients are: mannitol
(E421), povidone K30, crospovidone,
silica colloidal anhydrous, aspartame
(E951), calcium stearate, orange
flavour [maltodextrin, natural and
artificial flavourings,
dl-alpha-tocopherol], peppermint
flavour [maltodextrin, natural
flavourings, dextrin, sulphites].

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

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

What Mirtazapine looks like and
contents of the pack
Orodispersible tablets: White to
off-white, round, flat tablets with
bevelled edges and plain on both sides.

If you experience any of the following
serious side effects, stop taking
Mirtazapine and tell your doctor
immediately.

Aluminium/Aluminium blisters containing
6, 10, 14, 18, 20, 28, 30, 30 (unit dose),
48, 50, 56, 60, 84, 90, 96, 100 or 100
(unit dose) orodispersible tablets. Not all
pack sizes may be marketed.

Uncommon (may affect up to 1 in 100
people):
• feeling elated or emotionally ʻhighʼ
(mania)

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR.

Rare (may affect up to 1 in 1,000
people):
• yellow colouring of eyes or skin; this
may suggest disturbance in liver
function (jaundice)

Manufacturer
LEK d.d. Pharmaceuticals,
Verovškova 57,
1526 Ljubljana,
Slovenia

draft: 992032, 992033, 992034
laetus code: 0000
mat.no.: 00000000

Not known (frequency cannot be
estimated from the available data):
• signs of infection such as sudden
unexplainable high fever, sore throat
and mouth ulcers (agranulocytosis). 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).
• epileptic attack (convulsions)
• a combination of symptoms such as
inexplicable fever, sweating,
increased heart rate, diarrhoea,
(uncontrollable) muscle contractions,
shivering, overactive reflexes,
restlessness, mood changes,

Salutas Pharma,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
Sandoz GmbH,
Biochemiestrasse 10,
6250 Kundl
Austria

Salutas Pharma GmbH,
Dieselstrasse 5,
70839 Gerlinger,
Germany.

This leaflet was last revised in
10/2014.

00000000
SZ00000LT000

Artwork Proof Box
Ref: V034: SPC+PIL update in line with reference
Proof no.
011.0

Date prepared:
09/10/2014

Colours:
Black
Dimensions: 138 x 745 mm

Font size:
9pt
Fonts:
Helvetica

Expand view ⇕

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.

Hide