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MIRTAZAPINE SOLTAB 15MG ORODISPERSIBLE TABLETS

Active substance(s): MIRTAZAPINE

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PATIENT INFORMATION LEAFLET

1176
03.11.15[17]

Zispin® SolTab® 15 mg Orodispersible
Tablets
Mirtazapine SolTab® 15 mg Orodispersible
Tablets
(mirtazapine)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information 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. See section
4.
This medicine is available using any one of the above names but will be
referred to as Zispin SolTab throughout this leaflet.
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.
Children and adolescents
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 longterm 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 straightaway.

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
straightaway;
 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;
 certain kinds of heart conditions that may change your heart
rhythm, a recent heart attack, heart failure, or take certain
medicines that may affect the heart’s rhythm.
 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.
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),
methylene blue (used to treat high levels of methemoglobin in the
blood) 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 increase 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.
 medicines that may affect the heart’s rhythm such as certain
antibiotics and some anti-psychotics.
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 orodispersible 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 orodispersible 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 this medicine exactly as your doctor or pharmacist has told
you. 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).
Fig A

2. Tear off one tablet pocket
Each blister contains six tablet pockets, which are separated by
perforations. Tear off one tablet pocket along the dotted lines (Figure 1).

Fig 1

3. Peel off the lid
Carefully peel off the lidding foil, starting in the corner indicated by the
arrow (Figures 2 and 3).

Fig. 2

Fig. 3

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

Fig. 4

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)
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)
 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)

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 has 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. The symptoms of a possible overdose may include changes
to your heart rhythm (fast, irregular heartbeat) and/or fainting which could
be symptoms of a life-threatening condition known as Torsade de
Pointes.
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
 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.

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
 constipation
 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
 abdominal pain and nausea; this may suggest inflammation of the
pancreas (pancreatitis)
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Zispin SolTab
Keep out of the sight and reach of children.
Do not use Zispin SolTab after the expiry date which is stated on the
carton and the blister. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package.
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.
If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
6. Contents of the pack and other information
What Zispin SolTab contains
 The active substance is mirtazapine.
Zispin SolTab 15 mg orodispersible tablets contain 15 mg mirtazapine
per orodispersible tablet.
 The other ingredients are sugar spheres, hypromellose, povidone K30,
magnesium stearate, basic butylated methacrylate copolymer,
aspartame (E951), anhydrous citric acid, crospovidone (type-A),
mannitol (E421), microcrystalline cellulose, natural and artificial orange
flavour (No. SN027512) and sodium bicarbonate.
What Zispin SolTab looks like and contents of the pack
Zispin SolTab are white, round tablets marked with ‘TZ 1’ on one side and
plain on the other side. Zispin SolTabs come in packs of 30 tablets.
Product licence holder and Manufacturer
Manufactured by N.V.Organon, PO Box 20, 5340 BH Oss, The
Netherlands and are procured from the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL No: 20636/1176

Leaflet revision and issue date (Ref): 03.11.15[17]
Zispin® and SolTab® are 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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