ZISPIN SOLTAB 15MG ORODISPERSIBE TABLETS

Active substance: MIRTAZAPINE

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Zispin SolTab
15mg
Orodispersible tablets/

Mirtazapine 15mg
Orodispersible Tablets

Mirtazapine
Your medicine is known as either of the above
names but will be referred to as Zispin SolTab
throughout this leaflet.

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.
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.

Take other medicines

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.

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.

Taking Zispin SolTab with food and
drink

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).

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.

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 painkiller), 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;

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

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.

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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.

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

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.

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. 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.
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
Fig. 2.

Fig. 3.

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
affects 1 to 10 users in 100
• Common:
• Uncommon: affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
• Rare:
affects less than 1 user in
• Very rare:
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).

Manufacturer

This product is manufactured by N.V.
Organnon, Oss, The Netherlands and procured
within the EU by the Product Licence Holder
Polyfarma Ltd. and repackaged by Kent
Pharmaceuticals, both at, Wotton Road, Kent,
TN23 6LL.
POM
Zispin 15mg SolTabs

PL No: 17211/1039

Leaflet revision and issue date: 04.04.2011

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
Don't use Zispin SolTab after the 'use by' date
shown on the pack and the strip.
Don't store above 30°C (86°F)
If you have unwanted Zispin SolTab, don't
dispose of it in your waste water or your
household rubbish. Take it back to your
pharmacist, who will dispose of it in a way that
won't harm the environment.

6. Further Information
What Zispin SolTab contains

The active ingredient of Zispin SolTab 15mg is
Mirtazapine. The tablets are white in colour,
and each tablet contains 15mg of Mirtazapine,
which is an antidepressant.
The tablets also contain sugar spheres,
hypromellose, polyvinylpyrrolidone (povidone),
ethanol, methanol, purified water, magnesium
stearate, aminoalkyl metacrylate copolymer E,
aspartame (contains 2.6mg phenylalanine),
citric acid, crospovidone, mannitol,
microcrystalline cellulose, natural and artificial
orange flavour and sodium bicarbonate.

What Zispin SolTab looks like and
contents of the pack

The tablets are round, white, standard
bevelled-edge tablets, marked with TZ1 on one
side and plain on the other.
Zispin SolTab 15mg come in packs of 30
tablets.

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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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