MIRTAZAPINE 15MG FILM-COATED TABLETS

Active substance: MIRTAZAPINE

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· swelling (typically in ankles or feet) caused by fluid

5 How to store Mirtazapine

retention (oedema)

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 the blister or bottle 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 throw
away medicines you no longer use. These measures
will help protect the environment.

· tiredness
· vivid dreams
· confusion
· feeling anxious
· sleeping problems

In children under 18 years the following side effects
have been commonly observed:
• significant weight gain
• hives
• increased blood triglycerides
Uncommon (affects 1 to 10 users in 1,000):
· 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

Mirtazapine 15mg and 45mg
Film-coated Tablets
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, pharmacist or nurse.
· 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See
section 4.

6 Contents of the pack and other
information
What Mirtazapine contains

· The active substance is mirtazapine.


Mirtazapine 15mg film-coated tablets contain 15mg
mirtazapine per film-coated tablet.

Mirtazapine 45mg film-coated tablets contain 45mg
mirtazapine per film-coated tablet.
· The other ingredients are:

Tablet core: lactose monohydrate, pregelatinised
maize starch, anhydrous colloidal silica,
croscarmellose sodium, magnesium stearate.

Tablet coating: hypromellose, macrogol 8000,
titanium dioxide (E171) talc.
C
 oating of Mirtazapine 15mg film-coated tablets
also contains yellow iron oxide (E172) and red iron
oxide (E172).

Rare (affects 1 to 10 users in 10,000):
· muscle twitching or contractions (myoclonus)
· feeling aggressive
· pancreatitis
Not known (cannot be estimated from the available
data):
· 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 anemia), a shortage
of blood platelets (thrombocytopenia) or an increase
in the number of white blood cells (eosinophilia).
· abnormal sensations in the mouth (oral paraesthesia)
· swelling in the mouth (mouth oedema)
· increased salivation
· hyponatraemia
· inappropriate anti-diuretic hormone secretion
· slurred speech (dysarthria)
· sleepwalking

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

What Mirtazapine looks like and contents of
the pack
15mg tablets: Yellow, scored on both sides, oval,
biconvex, film-coated tablets. Marked with “I” on one
side. The tablet can be divided into equal halves
45mg tablets: White, oval, biconvex, film-coated
tablets. Marked with “I” on one side.
Pack sizes
28 tablets in blister.
Marketing Authorisation Holder
Caduceus Pharma Ltd
6th floor, Wigmore Street,
London, W1U 3RF, UK

1  hat Mirtazapine is and what it is used
W
for

Mirtazapine is one of a group of medicines called
antidepressants. Mirtazapine is used to treat depressive
illness.

Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

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.

This leaflet was last revised in November 2013

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.
· taking or have recently taken (within the last two
weeks) medicines called monoamine oxidase
inhibitors (MAO-Is).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before
taking Mirtazapine.

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
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.

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

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Mirtazapine 15mg & 45mg tablet leaflet - UK

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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 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.

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- iver disease, including jaundice. If jaundice occurs,
l

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 HIVprotease
inhibitors). 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.

stop taking Mirtazapine and contact your doctor
immediately
- idney disease
k
-  eart disease, or low blood pressure
h
- chizophrenia. If psychotic symptoms, such as
s
paranoid thoughts become more frequent or
severe, contact your doctor straight away
-  anic depression (alternating periods of feeling
m
elated/overactivity and depressed mood). If you
start feeling elated or over-excited, stop taking
Mirtazapine and contact your doctor immediately
-  iabetes (you may need to adjust your dose of
d
insulin or other antidiabetic medicines)
-  ye disease, such as increased pressure in the eye
e
(glaucoma)
-  ifficulty in passing water (urinating), which might
d
be caused by an enlarged prostate.
· 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 production in
the bone marrow. While rare, these symptoms most
commonly appear after 4-6 weeks of treatment.
· are an elderly person. You could be more sensitive to
the side-effects of antidepressants.

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 15mg 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 15mg 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
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 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,
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.

Mirtazapine with food, drink and alcohol

Other medicines and Mirtazapine tablets

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.

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 Parkinson’s disease).

Pregnancy and breast-feeding

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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.
Make sure your midwife and/or doctor knows you are
on Mirtazapine tablets. 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.

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)
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,
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
d
 octor 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

If you forget to take Mirtazapine

If you are supposed to take your dose once a day
· If you have forgotten to take your dose of
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
· 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.

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.

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item no: AAAF6920

dimensions:

print proof no: 6

pharmacode:

origination date: 30.07.13

min pt size:

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date sent:

supplier: Actavis UK

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

4  ossible side effects
P

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 and tell your doctor straight
away if you have any of the following:
·  houghts of harming or killing yourself. Contact your
t
doctor or go to a hospital straight away.
· feeling elated or emotionally ‘high’ (mania).
· yellow colouring of eyes or skin; this may suggest
disturbance in liver function (jaundice).
· signs of infection such as sudden unexplainable high
fever, sore throat and mouth ulcers (agranulocytosis).
· 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 and
unconsciousness. In very rare cases these can be
signs of serotonin syndrome.
· a skin reaction known as ‘erythema 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.)
· severe rash, blistering (bullous dermatitis), peeling
or other effects on the skin, eyes, mouth or genitals,
itching or high temperature (symptoms of severe
skin reactions called Stevens-Johnson syndrome or
toxic epidermal necrolysis).
Other possible side effects of Mirtazapine are listed
below and can be divided as:
Very common (affects more than 1 user in 10):
· increase in appetite and weight gain
· drowsiness or sleepiness
· headache
· dry mouth
Common (affects 1 to 10 users in 100):
· lethargy
· dizziness
· shakiness or tremor
· nausea and vomiting
· diarrhoea
· 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)

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Mirtazapine 15mg & 45mg tablet leaflet - UK

originated by: jh

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.

Mirtazapine can affect your concentration or alertness.
Make sure these abilities are not affected before you
drive or operate machinery.

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If you take more Mirtazapine than you
should

Driving and using machines

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If you stop taking Mirtazapine

3  ow to take Mirtazapine
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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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