ZISPIN SOLTAB 15MG ORODISPERSIBLE TABLETS

Active substance: MIRTAZAPINE

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Zispin SolTab 15mg Orodispersible Tablets/
Mirtazapine Soltab 15mg Orodispersible Tablets/
(Mirtazapine)
Your medicine is known by one of the above names, but will be referred to
as Zispin Soltab throughout this:
Patient Information 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 more questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Don’t 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 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 for
Zispin SolTab is one of a group of medicines called anti-depressants.
Zispin SolTab is used to treat depressive illness.

2) Before you take Zispin Soltab
Don’t 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 over-excited, stop taking
Zispin SolTab and contact your doctor immediately;
- diabetes (you may need to adjust your dose of insulin or other antidiabetic
medicines);
- eye disease, such as increased pressure in the eye (glaucoma);
- difficulty in passing water (urinating), which might be caused by an
enlarged prostate.
 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 sideeffects 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 socalled 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 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 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 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

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.

Peel back the foil as shown, to release the tablet.

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

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)

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
→ 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:
Common:
Uncommon:
Rare:
Very rare:
Not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
cannot be estimated from the available data

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





Do not use Zispin SolTab after the ‘Use by’ date on the strip and pack.
Do not store above 30°C. Store in the original package.
Keep all medicines out of the reach and sight of children
If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
 Medicines should not be thrown in your bin or put down the drain. If they
are out of date, or no longer suitable for you, return them to your
pharmacist for safe disposal.

6) Further information
What Zispin SolTab contains:
Each orodispersible tablet contains 15mg of mirtazapine as the active
ingredient.
The tablets also contain the following inactive ingredients sugar spheres,
hypromellose, povidone, magnesium stearate, aminoalkyl methacrylate
copolymer E, aspartame (contains 2.6 mg 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 white and marked with TZ1 on one side.
Zispin SolTab Tablets comes in pack of 30 tablets.
PL 10383/1449

POM

Who makes and repackages your medicine?
Your medicine is manufactured by N.V. Organon, 5340 BH Oss,
Netherland. Procured from within the EU and repackaged by Product
Licence Holder: Primecrown Ltd, 28 Sarum Complex, Uxbridge, Middlesex
UB8 2RZ.
Leaflet date: 25.08.2011

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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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