MIRTAZAPINE 30MG TABLETS

Active substance: MIRTAZAPINE

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•  ot known: severe rash, blistering (bullous
N
dermatitis), peeling or other effects on the skin,
eyes, mouth or genitals, itching or high temperature
(symptoms of severe skin reactions called StevensJohnson syndrome or toxic epidermal necrolysis).
•  ncommon: feeling elated or emotionally ‘high’
U
(mania).

Other side effects

Other possible side effects of Mirtazapine tablets are
listed below and can be divided as:
Very common (affects more than 1 user in 10):
• ncrease in appetite and weight gain
i
•  rowsiness or sleepiness
d
•  eadache
h
•  ry mouth
d
Common (affects 1 to 10 users in 100):
• ethargy, tiredness, vivid dreams, sleeping
l
problems
•  izziness, feeling dizzy or faint when you stand
d
up suddenly (orthostatic hypotension), confusion,
feeling anxious
•  hakiness or tremor
s
•  ausea, diarrhoea, vomiting
n
•  ash or skin eruptions (exanthema)
r
•  ain in your joints (arthralgia) or muscles (myalgia),
p
back pain
•  welling (typically in ankles or feet) caused by fluid
s
retention (oedema)
In children under 18 years the following side effects
have been commonly observed:
•  ignificant weight gain
s
•  ives
h
• ncreased blood triglycerides
i
Uncommon (affects 1 to 10 users in 1,000):
•  bnormal sensation in the skin e.g. burning,
a
stinging, tickling or tingling (paraesthesia)
•  estless legs, urge to move
r
•  ainting (syncope)
f
•  ensations of numbness in the mouth (oral
s
hypoaesthesia)
• ow blood pressure
l
•  ightmares, feeling agitated, hallucinations
n
Rare (affects 1 to 10 users in 10,000):
•  uscle twitching or contractions (myoclonus)
m
• eeling aggressive
f
•  ancreatitis
p
Frequency not known:
• n rare cases Mirtazapine can cause disturbances
i
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 anemia),
a shortage of blood platelets (thrombocytopenia)
or an increase in the number of white blood cells
(eosinophilia).
•  bnormal sensations in the mouth (oral
a
paraesthesia)
•  welling in the mouth (mouth oedema)
s
•  yponatraemia
h
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nappropriate anti-diuretic hormone secretion
i
ncreased salivation
i
 lurred speech (dysarthria)
s
 leepwalking
s

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine..
Keep this medicine out of the sight and reach of
children.
Store in the original package. Keep the blister in the
outer carton.
Do not use this medicine after the expiry date stated
on the carton or foil after EXP. The expiry date refers
to the last day of that month.
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 is in this leaflet:
1 What Mirtazapine tablets are and what
they are 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

What Mirtazapine tablets contain

•  he active substance is mirtazapine. Each tablet
T
contains 30mg of the active ingredient
•  he other ingredients are lactose monohydrate,
T
pregelatinised maize starch, silica colloidal
anhydrous, croscarmellose sodium and
magnesium stearate.
•  he film coating contains hypromellose, macrogol
T
8000, titanium dioxide (E171), red iron oxide
(E172), yellow iron oxide (E 172) and talc.

What Mirtazapine tablets look like and
contents of the pack

Mirtazapine 30mg tablets are film-coated tablets.
Brownish, scored on both sides, oval, biconvex,
film-coated tablets. Marked with “I” on one side. The
tablets can be divided into equal halves.
Pack size is 28 tablets.

1 
What Mirtazapine tablets are and what
they are used for
Mirtazapine is one of a group of medicines called
antidepressants. Mirtazapine tablets are used to treat
depressive illness.

Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

2 What you need to know before you
take Mirtazapine tablets

This leaflet was last revised in September 2013.

Do not take Mirtazapine tablets if you are

•  llergic to mirtazapine or any of the other
a
ingredients of this medicine (listed in section 6). If
so, you must talk to your doctor as soon as you can
before taking Mirtazapine tablets.
•  aking or have recently taken (within the last two
t
weeks) medicines called monoamine oxidase
inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before
taking Mirtazapine tablets
Children and adolescents
Mirtazapine should normally not be used for children
and adolescents under 18 years because efficacy
has not been demonstrated. Also, you should know
that patients under 18 have an increased risk of sideeffects 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:
• f you have previously had thoughts about killing
i
or harming yourself.
• f you are a young adult. Information from clinical
i
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
straight away.
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.

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AAAF7424 50749853

Actavis, Barnstaple, EX32 8NS, UK



page 4

Mirtazapine 30mg tablet leaflet - UK

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dimensions:

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Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your
I
doctor, pharmacist or nurse.
•  his medicine has been prescribed for you
T
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• f you get any side effects, talk to your doctor,
I
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.

5 How to store Mirtazapine tablets

AAAF7424 50749853

approved for print/date

Mirtazapine 30mg tablets

2.
3.
4.
5.

R.Wrey (BST Technical)
J. Howard (Artwork)

6.
Non Printing Colours

revision date: 12.09.13

Technical Approval

revised by: jh

date sent:

30/07/13

supplier: UK

technically app. date:

30/07/13

1.
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3.

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page 1

Also take special care with Mirtazapine tablets
if you
•  ave, or have ever had one of the following
h
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 straight away
- anic depression (alternating periods of
m
feeling elated/overactivity and depressed
mood). If you start feeling elated or overexcited, stop taking Mirtazapine and contact
your doctor immediately
- 
diabetes (you may need to adjust your dose of
insulin or other antidiabetic medicines)
-  disease, such as increased pressure in the
eye
eye (glaucoma)
- 
difficulty in passing water (urinating), which
might be caused by an enlarged prostate.
•  evelop signs of infection such as inexplicable
d
high fever, sore throat and mouth ulcers.
Stop taking Mirtazapine tablets 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.
•  re an elderly person. You could be more sensitive
a
to the side-effects of antidepressants.

overactive reflexes, restlessness, mood changes and
unconsciousness. If you get a combination of these
symptoms, talk to your doctor immediately.
•  he antidepressant nefazodone. It can increase
t
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.
•  edicines for anxiety or insomnia such as
m
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.
•  edicines for infections; medicines for bacterial
m
infections (such as erythromycin), medicines
for fungal infections (such as ketoconazole),
medicines for HIV/AIDS (such as HIV protease
inhibitors) and cimetidine (used for stomach
ulcers and heartburn). 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.
•  edicines for epilepsy such as carbamazepine
m
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.
•  edicines to prevent blood clotting such as
m
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.

Other medicines and Mirtazapine tablets

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:
•  onoamine oxidase inhibitors (MAO
m
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).

Mirtazapine tablets contain lactose

Mirtazapine tablets contain lactose. If you have been
told by your doctor that you have an intolerance for
some sugars, contact your doctor before taking this
medicinal product.

3 How to take Mirtazapine tablets

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 30mg
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 45mg 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 adapt the dose.

When to take Mirtazapine tablets

Take Mirtazapine at the same time each day. It
is best to take Mirtazapine tablets as a single dose
before you go to bed. However your doctor may
suggest you 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. Take your tablets orally. Swallow your
prescribed dose of Mirtazapine without chewing,
with some 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 tablets, 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.

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 tablets 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

If you take more Mirtazapine tablets than
you should

If you or someone else have taken too many
Mirtazapine tablets, 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.

Continued over page

Mirtazapine 30mg tablet leaflet - UK

colours/plates:
1. Black

296x210 Reel fed

item no: AAAF7424 50749853

dimensions:

print proof no: 4

pharmacode: 3912

origination date: 20.08.13

min pt size:

2.
3.
4.
5.

R.Wrey (BST Technical)
J. Howard (Artwork)

6.
Non Printing Colours

revision date: 12.09.13

Technical Approval

revised by: jh

date sent:

30/07/13

supplier: UK

technically app. date:

30/07/13

1.
2.
3.

If you forget to take Mirtazapine tablets

If you are supposed to take your dose once a day.
• f you have forgotten to take your dose of
I
Mirtazapine, do not take the missed dose. Just skip
it. Take your next dose at the normal time.
If you are supposed to take your dose twice a day.
• f you have forgotten to take your morning dose,
I
simply take it together with your evening dose.
• f you have forgotten to take your evening dose,
I
do not take it with the next morning dose; just skip
it and continue with your normal morning and
evening doses.
• f you have forgotten to take both doses, do not
I
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 tablets

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

4 Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some side effects are more likely to occur than others.

Stop taking Mirtazapine tablets and tell your
doctor immediately if you experience any of
the following side effects:
•  are: yellow colouring of eyes or skin; this may
R
suggest disturbance in liver function (jaundice).
•  ot known: signs of infection such as sudden
N
unexplainable high fever, sore throat and mouth
ulcers (agranulocytosis).
•  ot known: epileptic attack (convulsions).
N
•  ot known: a combination of symptoms such as
N
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.
•  ot known: thoughts of harming or killing yourself
N
– contact your doctor or go to a hospital straight
away.
•  ot known: a skin reaction known as ‘erythema
N
multiforme’(itchy reddish purple patches on the
skin, especially on the palms of the hands or soles of
the feet, ‘hive-like’ raised swollen areas on the skin,
tender areas on the surfaces of the mouth, eyes and
genitals, which may be accompanied by fever and
tiredness.)

Continued top of next column



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originated by:

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 tablets with food, drink and
alcohol

Take care when taking Mirtazapine in combination
with:
•  ntidepressants such as SSRIs, venlafaxine and
a
L-tryptophan or triptans (used to treat migraine),
tramadol (a pain-killer), linezolid (an antibiotic),
lithium (used to treat some psychiatric conditions)
and St. Johns 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,
Continued top of next column

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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.

296x210 reel fed bi-fold leaflet profile UK BST

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(DR/RW/MC 10.02.11)

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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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