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MIRTAZAPINE 15MG ORODISPERSIBLE TABLETS

Active substance: MIRTAZAPINE

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Zispin®

Do not take Zispin in combination with:

monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Zispin 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).

SolTab®

15mg
Mirtazapine 15mg Orodispersible Tablets
(mirtazapine)

Take care when taking Zispin 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 alone or the combination of Zispin 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 in your blood. Inform your
doctor if you are using this medicine. It might be needed to lower the dose of Zispin, or when use
of nefazodone is stopped, to increase the dose of Zispin 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 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 these medicines can increase the amount of Zispin in your blood.
Inform your doctor if you are using these medicines. It might be needed to lower the dose of
Zispin, or when these medicines are stopped, to increase the dose of Zispin again.

medicines for epilepsy such as carbamazepine and phenytoin;
medicines for tuberculosis such as rifampicin.
In combination with Zispin these medicines can reduce the amount of Zispin in your blood. Inform
your doctor if you are using these medicines. It might be needed to increase the dose of Zispin, or
when these medicines are stopped to lower the dose of Zispin again.

medicines to prevent blood clotting such as warfarin.
Zispin 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.

PATIENT INFORMATION LEAFLET
Your tablets are available using the above names, but will be referred to as Zispin 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
1.
2.
3.
4.
5.
6.

this leaflet:
What Zispin is and what it is used for
Before you take Zispin
How to take Zispin
Possible side effects
How to store Zispin
Further information

1.

WHAT ZISPIN IS AND WHAT IT IS USED FOR

2.

BEFORE YOU TAKE ZISPIN

Zispin is one of a group of medicines called antidepressants.
Zispin is used to treat depressive illness.

Do not take Zispin



if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Zispin. If so
you must talk to your doctor as soon as you can before taking Zispin.
if you are taking or have recently taken (within the last two weeks) medicines called monoamine
oxidase inhibitors (MAO-Is).

Taking Zispin with food and drink

Take special care with Zispin

You may get drowsy if you drink alcohol while you are taking Zispin.
You are advised not to drink any alcohol.
You can take Zispin with or without food.

Use in children and adolescents under 18 years of age

Zispin 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 for patients under 18 because he/she decides that this is in their best interests. If your doctor
has prescribed Zispin 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. Also, the long-term safety effects concerning growth, maturation
and cognitive and behavioural development of Zispin 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 compared with adults.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
Limited experience with Zispin administration to pregnant women does not indicate an increased risk.
However, caution should be exercised when used during pregnancy.
If you are taking Zispin and you become pregnant or you plan to get pregnant, make sure your
midwife and/or doctor knows you are on Zispin and ask your doctor whether you may continue taking
Zispin. If you use Zispin 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.

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.

Driving and using machines

Zispin 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

Zispin 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 orodispersible tablets contain aspartame, a source of phenylalanine. May be harmful for people
with phenylketonuria.

Also take special care with Zispin

if you have, or have ever had one of the following conditions.
Tell your doctor about these conditions before taking Zispin, if not done previously

seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop
taking Zispin and contact your doctor immediately;

liver disease, including jaundice. If jaundice occurs, stop taking Zispin 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/over activity and depressed mood). If
you start feeling elated or over-excited, stop taking Zispin 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 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.

3.

HOW TO TAKE ZISPIN

Always take Zispin 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 30mg 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 45mg 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

Take Zispin at the same time each day.
It is best to take Zispin as a single dose before you go to bed.
However your doctor may suggest to split your dose of Zispin – once in the morning and once at nighttime 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.

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.

Page 1 of 2

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).


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:

Fig. 2.

Fig. 3.











feeling elated or emotionally ‘high’ (mania)
Stop taking Zispin 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:
4.
Take out the orodispersible tablet
Take out the orodispersible tablet with dry hands and place it on the tongue. (Figure 4).




yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice)
Stop taking Zispin and tell your doctor straight away.
muscle twitching or contractions (myoclonus)

Not known:
Fig. 4.

It will rapidly disintegrate and can be swallowed without water.

When can you expect to start feeling better

Usually Zispin 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:
2 to 4 weeks after you have started taking Zispin, 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 until your symptoms of
depression have disappeared for 4 to 6 months.

If you take more Zispin than you should

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

If you forget to take Zispin

If you are supposed to take your dose once a day

If you have forgotten to take your dose of Zispin, 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

Only stop taking Zispin 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, even when your depression has lifted. If you suddenly stop taking
Zispin 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 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 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



signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers
(agranulocytosis)
Stop taking Zispin and contact your doctor straight away for a blood test.
In rare cases Zispin can cause disturbances in the production of blood cells (bone marrow depression).
Some people become less resistant to infection because Zispin can cause a temporary shortage of
white blood cells (granulocytopenia). In rare cases Zispin 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 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 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 get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5.







HOW TO STORE ZISPIN

Keep Zispin out of the sight and reach of children.
Do not use Zispin after the expiry date on the strip and pack. The expiry date refers to the last day
of that month.
Do not store above 30°C.
Store in the original package.
If your tablets appear discoloured, or show any other signs of deterioration, take them to your
pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Zispin contains

The active ingredient in Zispin is mirtazapine.
Each orodispersible tablet contains: 15 milligrams (15mg) of mirtazapine.
The tablets also include: sugar spheres, hydroxypropyl methylcellulose, polyvinylpyrrolidone
(povidone), magnesium stearate, aminoalkyl methacrylate copolymer E, aspartame (contains 2.6mg
phenylalanine), citric acid, crospovidone, mannitol, microcrystalline cellulose, natural and artificial
orange flavour and sodium bicarbonate.

What Zispin looks like and contents of the pack

Zispin tablets are white, flat-faced, round, orodispersible tablets, imprinted ‘TZ1’ on one side, with an
orange odour.
The tablets come in packs of 6 and 30 tablets.

Manufacturer

Manufactured by: N.V. Organon, 5340 BH Oss, The Netherlands.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0366

POM

Leaflet revision and issue date (Ref): 03.07.12
Zispin® and SolTab® are registered trademarks of N.V. Organon.

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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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