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ZISPIN SOLTAB 30MG ORODISPERSIBLE TABLETS

Active substance(s): MIRTAZAPINE

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Package leaflet: Information for the patient
®

®

Zispin soltab 30mg
orodispersible tablets
(mirtazapine)
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.
The name of your medicine is Zispin soltab 30mg
orodispersible tablets but will be referred to as Zispin
soltab throughout this leaflet.
What is in this leaflet
1. What Zispin soltab is and what it is used for
2. What you need to know before you take Zispin
soltab
3. How to take Zispin soltab
4. Possible side effects
5. How to store Zispin soltab
6. Contents of the pack and other information
1. What Zispin soltab is and what it is used for
Zispin soltab is one of a group of medicines called
antidepressants.
Zispin soltab is used to treat depressive illness in adults.
Zispin soltab 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 Zispin
soltab
Do not take Zispin soltab:
 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 Zispin soltab.

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 Zispin
soltab.

Children and adolescents
Zispin soltab 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 Zispin soltab for patients
under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Zispin soltab 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 Zispin soltab. Also, the longterm safety effects concerning growth, maturation and
cognitive and behavioural development of Zispin soltab 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 Zispin
soltab 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.
Also take special care with Zispin soltab
 if you have, or have ever had one of the following
conditions.
 Tell your doctor about these conditions before
taking Zispin soltab, if not done previously
 seizures (epilepsy). If you develop seizures or
your seizures become more frequent, stop taking
Zispin soltab and contact your doctor
immediately;
 liver disease, including jaundice. If jaundice
occurs, stop taking Zispin soltab 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
Zispin soltab 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 heart’s rhythm.
if you develop signs of infection such as inexplicable
high fever, sore throat and mouth ulcers.
 Stop taking Zispin soltab 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.
if you are an elderly person. You could be more
sensitive to the side-effects of antidepressants.

Other medicines and Zispin soltab
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Zispin soltab in combination with:
 monoamine oxidase inhibitors (MAO inhibitors).
Also, do not take Zispin soltab during the two weeks
after you have stopped taking MAO inhibitors. If you
stop taking Zispin soltab, 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 Zispin soltab 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. John’s Wort –
Hypericum perforatum preparations (a herbal
remedy for depression). In very rare cases Zispin
soltab alone or the combination of Zispin soltab 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 Zispin soltab in your blood. Inform your
doctor if you are using this medicine. It might be
needed to lower the dose of Zispin soltab, or when
use of nefazodone is stopped, to increase the dose
of Zispin soltab 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 Zispin soltab 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 Zispin soltab these medicines
can increase the amount of Zispin soltab in your
blood. Inform your doctor if you are using these
medicines. It might be needed to lower the dose of
Zispin soltab, or when these medicines are stopped,
to increase the dose of Zispin soltab again.
medicines for epilepsy such as carbamazepine and
phenytoin;
medicines for tuberculosis such as rifampicin.
In combination with Zispin soltab these medicines
can reduce the amount of Zispin soltab in your blood.
Inform your doctor if you are using these medicines.
It might be needed to increase the dose of Zispin
soltab, or when these medicines are stopped to lower
the dose of Zispin soltab again.
medicines to prevent blood clotting such as
warfarin.
Zispin soltab 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 heart’s rhythm such
as certain antibiotics and some anti-psychotics.

Zispin soltab with food and alcohol
You may get drowsy if you drink alcohol while you are
taking Zispin soltab. You are advised not to drink any
alcohol. You can take Zispin soltab 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 Zispin soltab administration to
pregnant women does not indicate an increased risk.
However, caution should be exercised when used during
pregnancy.
If you use Zispin soltab 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.

Driving and using machines
Zispin soltab can affect your concentration or alertness.
Make sure these abilities are not affected before you
drive or operate machinery. If your doctor has prescribed
Zispin soltab for a patient under 18 years make sure the
concentration and alertness is not affected before
participation in traffic (e.g. on bicycle).
Zispin soltab orodispersible tablets contain sugar
spheres, containing sucrose.
Zispin soltab orodispersible tablets contain sugar
spheres, containing sucrose. If you have been told by
your doctor that you have intolerance for some sugars,
contact your doctor before taking this medicinal product.
Zispin soltab orodispersible tablets contain
aspartame, a source of phenylalanine.
Zispin soltab orodispersible tablets contain aspartame, a
source of phenylalanine. May be harmful for people with
phenylketonuria.
3. How to take Zispin soltab
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. However, if you are an elderly person
or if you have renal or liver disease, your doctor may
adapt the dose.
When to take Zispin soltab
 Take Zispin soltab at the same time each day.
It is best to take Zispin soltab as a single dose before you
go to bed. However your doctor may suggest to split your
dose of Zispin soltab – 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 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).

Fig. A.

2. Tear off one tablet pocket
Each blister contains six tablet pockets, which are
separated by perforations. Tear off one tablet pocket
along the dotted lines (Figure 1).

Fig. 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.

Fig. 3.
4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and
place it on the tongue.
(Figure 4).

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 Zispin
soltab until your symptoms of depression have
disappeared for 4 to 6 months.
If you take more Zispin soltab than you should
 If you or someone else has taken too much Zispin
soltab, call a doctor straightaway.
The most likely signs of an overdose of Zispin soltab
(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.
If you forget to take Zispin soltab
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.
If you stop taking Zispin soltab
 Only stop taking Zispin soltab 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 Zispin soltab, even when
your depression has lifted. If you suddenly stop taking
Zispin soltab 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 or pharmacist.
4. Possible side effects

Fig. 4.
It will rapidly disintegrate and can be swallowed without
water.
When can you expect to start feeling better
Usually Zispin soltab 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
Zispin soltab:
 2 to 4 weeks after you have started taking Zispin
soltab, talk to your doctor about how this medicine
has affected you.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience any of the following serious side
effects, stop taking mirtazapine and tell your doctor
immediately.
Uncommon (may affect up to 1 in 100 people):
 feeling elated or emotionally ‘high’ (mania)
Rare (may affect up to 1 in 1,000 people):
 yellow colouring of eyes or skin; this may suggest
disturbance in liver function (jaundice)

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 anemia), 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,
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)
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
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
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

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)
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 (generalized oedema)
 localized swelling
 hyponatraemia
 inappropriate anti-diuretic hormone secretion
 severe skin reactions (dermatitis bullous, erythema
multiforme)
 sleep walking (somnambulism)
 speech disorder
 increased creatinine kinase blood levels
 difficulty in passing urine (urinary retention)
 muscle pain, stiffness and/or weakness, darkening or
discolouration of the urine (rhabdomyolysis)
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, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. You can also report any side effects
directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Zispin soltab
Keep out of the sight and reach of children.
Store in the original package in order to protect from light
and moisture.
Do not take the tablets after the expiry date which is
stated on the carton and blister label after ‘Exp’. The
expiry date refers to the last day of that month.
If the tablets becomes discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your pharmacist
for safe disposal. Only keep them if your doctor tells you
to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6. Contents of the pack and other information
What Zispin soltab contains
Each tablet contains 30mg mirtazapine, which is an
antidepressant, as the active ingredient.
The other ingredients are sugar spheres, hypromellose,
povidone K30, magnesium stearate, basic butylated
methacrylate copolymer, aspartame (E951), anhydrous
citric acid, crospovidone (type A), mannitol (E421),
microcrystalline cellulose, natural and artificial orange
flavour (No. SN027512) and sodium hydrogen carbonate.
What Zispin soltab looks like and contents of the
pack
Zispin soltab is round, white, standard bevelled-edge
orodispersible tablet imprinted ‘TZ 2’ on one face.
Zispin soltab is packed in child-resistant perforated unit
dose blister strip.
Zispin soltab comes in packs of 30 orodispersible tablets.
Manufactured by: N.V. Organon, Kloosterstraat 6,
5349 AB Oss, The Netherlands.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

®

Zispin soltab 30mg orodispersible tablets;
PL18799/1254
POM
Leaflet date: 22.08.2017
Zispin, soltab are registered trademarks of Merck Sharp
and Dohme.

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Package leaflet: Information for the patient

Mirtazapine 30mg orodispersible
tablets
(mirtazapine)
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.
The name of your medicine is Mirtazapine 30mg
orodispersible tablets but will be referred to as
Mirtazapine throughout this leaflet.
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
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.
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 heart’s 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 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.







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
Parkinson’s disease).
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. 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, 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 heart’s rhythm such
as certain antibiotics and some anti-psychotics.

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.

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 orodispersible tablets contain sugar
spheres, containing sucrose.
Mirtazapine orodispersible tablets contain sugar spheres,
containing sucrose. If you have been told by your doctor
that you have intolerance for some sugars, contact your
doctor before taking this medicinal product.
Mirtazapine orodispersible tablets contain
aspartame, a source of phenylalanine.
Mirtazapine orodispersible tablets contain aspartame, a
source of phenylalanine. May be harmful for people with
phenylketonuria.
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. 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 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 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).

Fig. A.

2. Tear off one tablet pocket
Each blister contains six tablet pockets, which are
separated by perforations. Tear off one tablet pocket
along the dotted lines (Figure 1).

Fig. 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.

Fig. 3.
4. Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and
place it on the tongue.
(Figure 4).

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 should
 If you or someone else has taken too much
Mirtazapine, call a doctor straightaway.
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.
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.
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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects

Fig. 4.
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.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience any of the following serious side
effects, stop taking mirtazapine and tell your doctor
immediately.
Uncommon (may affect up to 1 in 100 people):
 feeling elated or emotionally ‘high’ (mania)
Rare (may affect up to 1 in 1,000 people):
 yellow colouring of eyes or skin; this may suggest
disturbance in liver function (jaundice)

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 anemia), 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,
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)
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
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
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

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)
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 (generalized oedema)
 localized swelling
 hyponatraemia
 inappropriate anti-diuretic hormone secretion
 severe skin reactions (dermatitis bullous, erythema
multiforme)
 sleep walking (somnambulism)
 speech disorder
 increased creatinine kinase blood levels
 difficulty in passing urine (urinary retention)
 muscle pain, stiffness and/or weakness, darkening or
discolouration of the urine (rhabdomyolysis)
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, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. You can also report any side effects
directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Mirtazapine
Keep out of the sight and reach of children.
Store in the original package in order to protect from light
and moisture.
Do not take the tablets after the expiry date which is
stated on the carton and blister label after ‘Exp’. The
expiry date refers to the last day of that month.
If the tablets becomes discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this
medicine, return any unused medicine to your pharmacist
for safe disposal. Only keep them if your doctor tells you
to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6. Contents of the pack and other information
What Mirtazapine contains
Each tablet contains 30mg mirtazapine, which is an
antidepressant, as the active ingredient.
The other ingredients are sugar spheres, hypromellose,
povidone K30, magnesium stearate, basic butylated
methacrylate copolymer, aspartame (E951), anhydrous
citric acid, crospovidone (type A), mannitol (E421),
microcrystalline cellulose, natural and artificial orange
flavour (No. SN027512) and sodium hydrogen carbonate.
What Mirtazapine looks like and contents of the pack
Mirtazapine is round, white, standard bevelled-edge
orodispersible tablet imprinted ‘TZ 2’ on one face.
Mirtazapine is packed in child-resistant perforated unit
dose blister strip.
Mirtazapine comes in packs of 30 orodispersible tablets.
Manufactured by: N.V. Organon, Kloosterstraat 6,
5349 AB Oss, The Netherlands.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Mirtazapine 30mg orodispersible tablets;
PL18799/1254
POM
Leaflet date: 22.08.2017

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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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