MIRTAZAPINE 15MG ORODISPERSIBLE TABLETS

Active substance: MIRTAZAPINE

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• 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
• 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

5. HOW TO STORE ZISPIN SOLTAB

• Keep out of the sight and reach of children.
• Store in the original package to protect from






light and moisture.
Do not store above 30°C
Do not take this medicine after the expiry date
shown on the carton label.
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become discoloured or show
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
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
protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFROMATION
What Zispin SolTab contains
Each Tablet contains 15mg mirtazapine. Zispin
SolTab also contains the following inactive
ingredients: sugar spheres (sucrose),
hypromellose, povidone K30, magnesium stearate,
basic butylated methacrylate copolymer,
aspartame E951, anhydrous citric acid,
crospovidone (type A), mannitol E421,
microcrystalline cellulose, orange flavour
(SN027512) and sodium hydrogen carbonate.
What Zispin SolTab looks like and contents of
the pack
Zispin SolTab 15mg tablets are round, white,
standard bevelled-edge tablets marked with the
code TZ/1 on one side and plain on the other side.
Zispin SolTab comes in blister packs of 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by N.V. Organon,
Kloosterstraat 6, P.O box 20, 5340 BH Oss, The
Netherlands and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1311

Zispin, Remergon and SolTab are registered
trademarks of N.V. Organon.
Leaflet revision date: 22/07/13

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
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.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET
®

Ref: 1311/220713/1/F

®

ZISPIN SOLTAB 15MG ORODISPERSIBLE TABLETS
(mirtazapine)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important infromation 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.
Your medicine is called Zispin SolTab 15mg
Orodispersible Tablets, but will be referred to as
Zispin SolTab throughout
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.
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.

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) 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.
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 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
an intolerance for some sugars, contact your
doctor before taking this medicinal product.
Zispin Soltab 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 Zispin SolTab exactly as your doctor
or pharmacist tells you to. You should 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).

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
• 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

Fig. A.

• if you have forgotten to take your morning dose,

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 have forgotten to take your evening dose,

simply take it together with your evening dose.

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.

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, this medicine can cause
side effects, although not everybody gets them.

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 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)

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.

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).
Ref: 1311/220713/1/B

• 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
• 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
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
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.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. HOW TO STORE MIRTAZAPINE

• Keep out of the sight and reach of children
• Store in the original package to protect from

PATIENT INFORMATION LEAFLET

Ref: 1311/220713/2/F

MIRTAZAPINE 15MG ORODISPERSIBLE TABLETS

light and moisture.

• Do not store above 30°C.
• Do not take this medicine after the expiry date




shown on the carton label.
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine become discoloured or show
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
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
protect the environment.

6. FURTHER INFORMATION
What Mirtazapine tablets contains
Each tablet contains 15mg mirtazapine.
Mirtazapine also contains the following inactive
ingredients: sugar spheres (sucrose),
hypromellose, povidone K30, magnesium stearate,
basic butylated methacrylate copolymer,
aspartame E951, anhydrous citric acid,
crospovidone (type A), mannitol E421,
microcrystalline cellulose, orange flavour
(SN027512) and sodium hydrogen carbonate.
What Mirtazapine tablets looks like and
contents of the pack
Mirtazapine 15mg tablets are round, white,
standard bevelled-edge tablets marked with the
code TZ/1 on one side and plain on the other.
Mirtazapine comes in blister packs of 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by N.V. Organon,
Kloosterstraat 6, P.O box 20, 5340 BH Oss, The
Netherlands and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1311

Leaflet revision date: 22/07/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important infromation 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.
Your medicine is called Mirtazapine tablets 15mg
Orodispersible Tablets, but will be referred to as
Mirtazapine tablets throughout
What is in this leaflet:
1. What Mirtazapine tablets is and what it is used
for
2. What you need to know before you take
Mirtazapine
3. How to take Mirtazapine tablets
4. Possible side effects
5. How to store Mirtazapine tablets
6. Contents of the pack and other infromation
1. WHAT MIRTAZAPINE TABLETS IS AND
WHAT IT IS USED FOR
Mirtazapine Tablets is one of a group of medicines
called antidepressants.
Mirtazapine Tablets is used to treat depressive
illness in adults.
Mirtazapine Tablets 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. BEFORE YOU TAKE MIRTAZAPINE
TABLETS
Do not take Mirtazapine Tablets
• 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
Mirtazapine Tablets.
Take special care with Mirtazapine tablets
Use in children and adolescents under 18
years of age
Mirtazapine tablets 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 tablets for patients under 18 because
he/she decides that this is in their best interests. If
your doctor has prescribed Mirtazapine tablets 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 tablets.

Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of Mirtazapine tablets 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 tablets 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 tablets
• if you have, or have ever had one of the
following conditions.
➜Tell your doctor about these conditions
before taking Mirtazapine tablets, if not done
previously.
• seizures (epilepsy). If you develop seizures or
your seizures become more frequent, stop
taking Mirtazapine tablets and contact your
doctor immediately;
• liver disease, including jaundice. If jaundice
occurs, stop taking Mirtazapine tablets 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 tablets 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 tablets and consult your
doctor mmediately 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 tablets
Tell your doctor or pharmacist if you are
taking , have recently taken or might take
any other medicines.
Do not take Mirtazapine tablets in combination
with:
• monoamine oxidase inhibitors (MAO
inhibitors). Also, do not take Mirtazapine tablets
during the two weeks after you have stopped
taking MAO inhibitors. If you stop taking Zispin,
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 tablets 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 tablets alone or the
combination of Mirtazapine tablets 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 tablets in
your blood. Inform your doctor if you are using
this medicine. It might be needed to lower the
dose of Mirtazapine tablets, or when use of
nefazodone is stopped, to increase the dose
of Mirtazapine tablets 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 tablets 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 tablets 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 tablets, or when these medicines
are stopped, to increase the dose of Mirtazapine
tablets again.
• medicines for epilepsy such as carbamazepine
and phenytoin;
• medicines for tuberculosis such as rifampicin.
In combination with Mirtazapine tablets these
medicines can reduce the amount of Mirtazapine
tablets in your blood. Inform your doctor if you
are using these medicines. It might be needed
to increase the dose of Mirtazapine tablets, or
when these medicines are stopped to lower the
dose of Mirtazapine tablets again.
• medicines to prevent blood clotting such as
warfarin.Mirtazapine tablets 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.

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 Mirazapine with or without food.

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

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.
Fig. A.
Limited experience with Mirazapine
administration to pregnant women does not
indicate an increased risk. However, caution
should be exercised when used during pregnancy.
If you use Mirazapine 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
Mirazapine can affect your concentration
or alertness. Make sure these abilities are not
affected before you drive or operate machinery.
If your doctor has prescribed Mirazapine
for a patient under 18 years make sure the
concentration and alertness is not affected
before participation in traffic (e.g. on bicycle).
Mirazapine tablets contain sugar spheres
containing sucrose
Mirazapine 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.
Mirazapine tablets contain aspartame, a source
of phenylalanine.
Mirazapine orodispersible tablets contain
aspartame, a source of phenylalanine. May be
harmful for people with phenylketonuria.

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).

When to take Mirtazapine tablets
➜Take Mirtazapine tablets at the same time each
day.
It is best to take Mirtazapine tablets as a single
dose before you go to bed. However your doctor
may suggest to split your dose of Mirtazapine
tablets 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.

If you forget to take Mirtazapine tablets
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.



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.

If you stop taking Mirtazapine tablets
➜Only stop taking Mirtazapine tablets 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 tablets,
even when your depression has lifted. If you
suddenly stop taking Mirtazapine tablets 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.

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

3. HOW TO TAKE MIRTAZAPINE TABLETS
Always take Mirtazapine tablets exactly as your
doctor or pharmacist tells you to. You should
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.

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

4. POSSIBLE SIDE EFFECTS
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)

Fig. 4.
It will rapidly disintegrate and can be swallowed
without water.
When can you expect to start feeling better
Usually Mirtazapine tablets 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 tablets:
➜2 to 4 weeks after you have started taking
Mirtazapine tablets, talk to your doctor about
how this medicine has affected you.
If you still don’t feel better, your doctor may
prescribe a higher dose. In that case, talk to your
doctor again after another 2 to 4 weeks. Usually
you will need to take Mirtazapine tablets until your
symptoms of depression have disappeared for 4
to 6 months.

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)

Ref: 1311/220713/2/B

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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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