ZISPIN SOLTAB 15MG ORODISPERSIBLE TABLETS

Active substance: MIRTAZAPINE

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ZISPIN® SolTab®
15mg
orodispersible tablets

Mirtazapine
Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Zispin Soltab
15mg orodispersible tablets but will be
referred to as Zispin Soltab in this leaflet.
In this leaflet
1. What Zispin SolTab is and what it is
used for
2. Before you take Zispin SolTab
3. How to take Zispin SolTab
4. Possible side effects
5. How to store Zispin SolTab
6. Further 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.

2. Before you take Zispin SolTab
Do not take Zispin SolTab
• if you are allergic (hypersensitive) to
mirtazapine or any of the other ingredients of
Zispin SolTab. 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).
Take special care with Zispin SolTab
Use in children and adolescents under
18 years of age
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 long-term 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 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 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
straight away;
– manic depression (alternating periods of
feeling elated/overactivity and depressed
mood). If you start feeling elated or overexcited,
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.
• 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking
(or plan to take) any of the medicines in the
following list.
Please also tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
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) 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.
Taking Zispin SolTab with food and drink
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
Ask your doctor or pharmacist for advice before
taking any 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 are taking Zispin SolTab and you become
pregnant or you plan to get pregnant, make sure
your midwife and/or doctor knows you are on
Zispin Soltab and ask your doctor whether you
may continue taking Zispin SolTab. 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.
Ask your doctor whether you can breast-feed,
while taking Zispin SolTab.
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.
Important information about some of the
ingredients of Zispin SolTab
Zispin SolTab orodispersible tablets contain sugar
spheres, containing sucrose. If you have been told
by your doctor that you have an intolerance for
some sugars, contact your doctor before taking
this medicinal product.
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 Zispin SolTab exactly as
your doctor has told you to. Check with
your doctor or pharmacist if you’re not
sure.
How much to take
The usual 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.

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

Take the orodispersible tablet as follows
Take your tablets orally.

Fig. 4.

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.

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.
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 have taken too much
Zispin SolTab, call a doctor straight away.
The most likely signs of an overdose of Zispin
SolTab (without other medicines or alcohol) are
drowsiness, disorientation and increased
heart rate.
If you forget to take Zispin SolTab
If you are supposed to take your dose once
a day
• If you have forgotten to take your dose of
Zispin SolTab, 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.

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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Zispin SolTab can cause side
effects, although not everybody gets these side
effects.
Some side effects are more likely to occur than
others. The possible side effects of Zispin SolTab
are listed below and can be divided as:
• Very common: affects more than 1 user in 10
• Common: affects 1 to 10 users in 100
• Uncommon: affects 1 to 10 users in 1,000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 user in 10,000
• Not known: cannot be estimated from the
available data
Very common:
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common:
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• 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

In children under 18 years the following adverse
events were observed commonly in clinical
trials: significant weight gain, hives and
increased blood triglycerides.
Uncommon:
• feeling elated or emotionally ‘high’ (mania)
➜Stop taking Zispin SolTab and tell your
doctor straight away.
• 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:
• yellow colouring of eyes or skin; this may
suggest disturbance in liver function (jaundice)
➜Stop taking Zispin SolTab and tell your
doctor straight away.
• muscle twitching or contractions (myoclonus)
Not known:
• signs of infection such as sudden
unexplainable high fever, sore throat and
mouth ulcers (agranulocytosis)
➜Stop taking Zispin SolTab and contact your
doctor straight away for a blood test.
In rare cases Zispin SolTab can cause
disturbances in the production of blood cells
(bone marrow depression). Some people
become less resistant to infection because Zispin
SolTab can cause a temporary shortage
of white blood cells (granulocytopenia). In rare
cases Zispin SolTab 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)
➜Stop taking Zispin SolTab and tell your
doctor straight away.
• 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.
➜Stop taking Zispin SolTab and tell your
doctor straight away.

• thoughts of harming or killing yourself
➜Contact your doctor or go to a hospital
straight away.
• abnormal sensations in the mouth (oral
paraesthesia)
• swelling in the mouth (mouth oedema)
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
• severe skin reactions (Stevens-Johnson
Syndrome, dermatitis bullous, erythema
multiforme, toxic epidermal necrolysis).
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5. How to store Zispin SolTab
KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN.
Do not use Zispin Soltab after the “Use by” date on the
push through strip and pack. If your doctor tells you to
stop taking this medicine, take any unused tablets
back to your pharmacist for safe disposal. Only keep
them if your doctor tells you to. Store the tablets in the
original package. Do not store above 30°C. If the
tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.
6. Further information
What Zispin SolTab contains
• Each tablet contains 15mg of mirtazapine, which is
an antidepressant, as the active ingredient.
• Zispin Soltab also contains sugar spheres,
hypromellose, magnesium stearate, aminoalkyl
methacrylate copolymer E, aspartame (contains
2.6mg phenylalanine), citric acid, crospovidone,
mannitol, microcrystalline cellulose, natural and
artificial orange flavour, sodium bicarbonate and
povidone
What Zispin SolTab looks like and contents of the
pack
Zispin Soltab are round, white, bevelled-edge tablets
marked with the code ‘TZ1’ on one side and plain on
the other.
Zispin Soltab come in packs of 30 orodispersible
tablets.
Manufactured by: N.V. Organon, oss, Holland.
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 15mg orodispersible Tablets
- PL No: 18799/1394
POM
Leaflet date: 12.08.2011

MIRTAZAPINE SolTab
15mg
orodispersible tablets
Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Mirtazapine Soltab
15mg orodispersible tablets but will be referred to as
Mirtazapine Soltab in this leaflet.
In this leaflet
1. What Mirtazapine SolTab is and what it is
used for
2. Before you take Mirtazapine SolTab
3. How to take Mirtazapine SolTab
4. Possible side effects
5. How to store Mirtazapine SolTab
6. Further Information

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

2. Before you Take Mirtazapine SolTab
Do not take Mirtazapine SolTab
• if you are allergic (hypersensitive) to
Mirtazapine or any of the other ingredients of
Mirtazapine SolTab. If so, you must talk to your
doctor as soon as you can before taking
Mirtazapine SolTab.
• if you are taking or have recently taken (within
the last two weeks) medicines called
monoamine oxidase inhibitors (MAO-Is).
Take special care with Mirtazapine SolTab
Use in children and adolescents under
18 years of age
Mirtazapine 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 Mirtazapine SolTab for patients under 18
because he/she decides that this is in their best
interests. If your doctor has prescribed Mirtazapine
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 Mirtazapine SolTab.
Also, the long-term safety effects concerning
growth, maturation and cognitive and
behavioural development of Mirtazapine 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
Mirtazapine 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 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 SolTab
• if you have, or have ever had one of the following
conditions.
➜Tell your doctor about these conditions
before taking Mirtazapine SolTab, if not done
previously.
– seizures (epilepsy). If you develop seizures or
your seizures become more frequent, stop
taking Mirtazapine SolTab and contact your
doctor immediately;
– liver disease, including jaundice. If jaundice
occurs, stop taking Mirtazapine 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
straight away;
– manic depression (alternating periods of
feeling elated/overactivity and depressed
mood). If you start feeling elated or overexcited,
stop taking Mirtazapine 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.
• if you develop signs of infection such as
inexplicable high fever, sore throat and mouth
ulcers.
➜Stop taking Mirtazapine 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking
(or plan to take) any of the medicines in the
following list.
Please also tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Do not take Mirtazapine SolTab in combination with:
• monoamine oxidase inhibitors (MAO
inhibitors). Also, do not take Mirtazapine SolTab
during the two weeks after you have stopped
taking MAO inhibitors. If you stop taking Mirtazapine
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 Mirtazapine 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) and St. John’s Wort –
Hypericum perforatum preparations
(a herbal remedy for depression). In very rare
cases Mirtazapine SolTab alone or the combination
of Mirtazapine 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 Mirtazapine SolTab in your blood.
Inform your doctor if you are using this medicine. It
might be needed to lower the dose of Mirtazapine
SolTab, or when use of
nefazodone is stopped, to increase the dose
of Mirtazapine 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 Mirtazapine
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 Mirtazapine SolTab these
medicines can increase the amount of Mirtazapine
SolTab in your blood. Inform your doctor if you are
using these medicines. It might be needed to lower
the dose of Mirtazapine SolTab, or when these
medicines are stopped, to increase the dose of
Mirtazapine SolTab again.
medicines for epilepsy such as carbamazepine
and phenytoin;
medicines for tuberculosis such as rifampicin.
In combination with Mirtazapine SolTab these
medicines can reduce the amount of Mirtazapine
SolTab in your blood. Inform your doctor if you
are using these medicines. It might be needed
to increase the dose of Mirtazapine SolTab, or when
these medicines are stopped to lower the dose of
Mirtazapine SolTab again.
medicines to prevent blood clotting such as
warfarin. Mirtazapine 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.

Taking Mirtazapine SolTab with food and drink
You may get drowsy if you drink alcohol while you
are taking Mirtazapine SolTab.
You are advised not to drink any alcohol.
You can take Mirtazapine SolTab with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Limited experience with Mirtazapine SolTab
administration to pregnant women does not

indicate an increased risk. However, caution
should be exercised when used during pregnancy.
If you are taking Mirtazapine SolTab and you become
pregnant or you plan to get pregnant, make sure your
midwife and/or doctor knows you are on
Mirtazapine Soltab and ask your doctor whether you
may continue taking Mirtazapine SolTab. If you use
Mirtazapine 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.
Ask your doctor whether you can breast-feed, while
taking Mirtazapine SolTab.
Driving and using machines
Mirtazapine SolTab can affect your concentration or
alertness. Make sure these abilities are not affected
before you drive or operate machinery.
Important information about some of the
ingredients of Mirtazapine SolTab
Mirtazapine SolTab orodispersible tablets contain
sugar spheres, containing sucrose. If you have been
told by your doctor that you have an intolerance for
some sugars, contact your doctor before taking
this medicinal product.
Mirtazapine SolTab orodispersible tablets contain
aspartame, a source of phenylalanine. May be harmful
for people with phenylketonuria.
3. How to take Mirtazapine SolTab
Always take Mirtazapine SolTab exactly as your doctor
has told you to. Check with your doctor or pharmacist
if you’re not sure.
How much to take
The usual 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 SolTab
➜Take Mirtazapine SolTab at the same time each
day. It is best to take Mirtazapine SolTab as a single
dose before you go to bed. However your doctor may
suggest to split your dose of Mirtazapine 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.

It will rapidly disintegrate and can be swallowed
without water.

symptoms can be avoided by stopping gradually. Your
doctor will tell you how to decrease the dose gradually.

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

When can you expect to start feeling better
Usually Mirtazapine 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 Mirtazapine SolTab:
➜2 to 4 weeks after you have started taking
Mirtazapine SolTab, 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 SolTab until
yoursymptoms of depression have disappeared for 4

to 6 months.

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

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)

If you take more Mirtazapine SolTab than
you should
➜If you or someone else have taken too much
Mirtazapine SolTab, call a doctor straight away.
The most likely signs of an overdose of Mirtazapine
SolTab (without other medicines or alcohol) are
drowsiness, disorientation and increased heart
rate.
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)

Fig. 4.

If you forget to take Mirtazapine SolTab
If you are supposed to take your dose once
a day
• If you have forgotten to take your dose of
Mirtazapine SolTab, 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.
If you stop taking Mirtazapine SolTab
➜Only stop taking Mirtazapine 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 Mirtazapine SolTab, even
when your depression has lifted. If you suddenly stop
taking Mirtazapine SolTab you may feel sick, dizzy,
agitated or anxious, and have headaches. These

4. Possible side effects
Like all medicines, Mirtazapine SolTab can cause side
effects, although not everybody gets these side
effects. Some side effects are more likely to occur
than others. The possible side effects of Mirtazapine
SolTab are listed below and can be divided as:
• Very common: affects more than 1 user in 10
• Common: affects 1 to 10 users in 100
• Uncommon: affects 1 to 10 users in 1,000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 user in 10,000
Not known: cannot be estimated from the available
data
Very common:
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common:
• lethargy
• dizziness
• shakiness or tremor
• nausea
• diarrhoea
• vomiting
• 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
In children under 18 years the following adverse
events were observed commonly in clinical
trials: significant weight gain, hives and
increased blood triglycerides.
Uncommon:
• feeling elated or emotionally ‘high’ (mania)
➜Stop taking Mirtazapine SolTab and tell your
doctor straight away.
• 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:
• yellow colouring of eyes or skin; this may
suggest disturbance in liver function (jaundice)
➜Stop taking Mirtazapine SolTab and tell your
doctor straight away.
• muscle twitching or contractions (myoclonus)
Not known:
• signs of infection such as sudden
unexplainable high fever, sore throat and
mouth ulcers (agranulocytosis)
➜Stop taking Mirtazapine SolTab and contact
your doctor straight away for a blood test.
In rare cases Mirtazapine SolTab can cause
disturbances in the production of blood cells
(bone marrow depression). Some people
become less resistant to infection because
Mirtazapine SolTab can cause a temporary shortage
of white blood cells (granulocytopenia).
In rare cases Mirtazapine SolTab 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)
➜Stop taking Mirtazapine SolTab and tell your
doctor straight away.
• 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.
➜Stop taking Mirtazapine SolTab and tell your
doctor straight away.
• thoughts of harming or killing yourself
➜Contact your doctor or go to a hospital
straight away.
• abnormal sensations in the mouth (oral
paraesthesia)
• swelling in the mouth (mouth oedema)
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
• severe skin reactions (Stevens-Johnson
Syndrome, dermatitis bullous, erythema
multiforme, toxic epidermal necrolysis).
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Mirtazapine
KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN.
Do not use Mirtazapine after the “Use by” date on the
push through strip and pack. If your doctor tells you to
stop taking this medicine, take any unused tablets
back to your pharmacist for safe disposal. Only keep
them if your doctor tells you to.
Store the tablets in the original package. Do not store
above 30°C.
If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.

6.

Further information

What Mirtazapine contains
• Each tablet contains 15mg of mirtazapine, which is
an antidepressant, as the active ingredient.
• Mirtazapine also contains sugar spheres,
hypromellose, magnesium stearate, aminoalkyl
methacrylate copolymer E, aspartame (contains
2.6mg phenylalanine), citric acid, crospovidone,
mannitol, microcrystalline cellulose, natural and
artificial orange flavour, sodium bicarbonate and
povidone
What Mirtazapine looks like and contents of the
pack
Mirtazapine are round, white, bevelled-edge tablets
marked with the code ‘TZ1’ on one side and plain on
the other.
Mirtazapine come in packs of 30 orodispersible
tablets.
Manufactured by: N.V. Organon, oss, Holland.
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 SolTab 15mg orodispersible Tablets PL No: 18799/1394

POM
Leaflet date: 12.08.2011

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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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